ICONIC: JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors

• Sponsor: Jounce Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02904226
• Collaborator: (none)
• Enrollment: 242
• Locations: 16
• Arms: 8
• Actual Duration (Months): 47
• Patients Per Site: 15.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: JTX-2011; Drug: Nivolumab; Drug: Ipilimumab; Drug: Pembrolizumab	Phase 1/Phase 2

Detailed Description

JTX-2011 is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.

Study Design

• Study Type: Interventional
• Actual Enrollment: 242 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1/2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX-2011 Alone and in Combination With Nivolumab, Ipilimumab, or Pembrolizumab in Adult Subjects With Advanced and/or Refractory Solid Tumor Malignancies
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Jul 1, 2020
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A (JTX-2011) Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion	Drug: JTX-2011; Specified dose on specified days; Other Names: ICOS agonist monoclonal antibody
Experimental: Part B (JTX-2011 + nivolumab) Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion	Drug: JTX-2011; Specified dose on specified days; Other Names: ICOS agonist monoclonal antibody ; Drug: Nivolumab; Specified dose on specified days; Other Names: Opdivo
Experimental: Part C (JTX-2011) Phase 2 expansion of JTX-2011 by IV infusion	Drug: JTX-2011; Specified dose on specified days; Other Names: ICOS agonist monoclonal antibody
Experimental: Part D (JTX-2011 + nivolumab) Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion	Drug: JTX-2011; Specified dose on specified days; Other Names: ICOS agonist monoclonal antibody ; Drug: Nivolumab; Specified dose on specified days; Other Names: Opdivo
Experimental: Part E (JTX-2011 + ipilimumab) Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion	Drug: JTX-2011; Specified dose on specified days; Other Names: ICOS agonist monoclonal antibody ; Drug: Ipilimumab; Specified dose on specified days; Other Names: Yervoy
Experimental: Part F (JTX-2011 + ipilimumab) Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion	Drug: JTX-2011; Specified dose on specified days; Other Names: ICOS agonist monoclonal antibody ; Drug: Ipilimumab; Specified dose on specified days; Other Names: Yervoy
Experimental: Part G (JTX-2011 + pembrolizumab) Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion	Drug: JTX-2011; Specified dose on specified days; Other Names: ICOS agonist monoclonal antibody ; Drug: Pembrolizumab; Specified dose on specified days; Other Names: Keytruda
Experimental: Part H (JTX-2011 + pembrolizumab) Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion	Drug: JTX-2011; Specified dose on specified days; Other Names: ICOS agonist monoclonal antibody ; Drug: Pembrolizumab; Specified dose on specified days; Other Names: Keytruda

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events (TEAE) [46.3 months]

   Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated

2. Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE) [46.3 months]

   Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

3. Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE) [46.3 months]

   Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

4. Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE) [46.3 months]

   Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03."

5. Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE) [46.3 months]

   Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

6. Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE) [46.3 months]

   Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

7. Number of Participants With Dose Limiting Toxicities [33 months]

   Number of participants with at least one dose limiting toxicity (DLT)

8. Overall Response Rate [46.5 months]

   Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review

9. Disease Control Rate [46.5 months]

   Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)

10. Progression Free Survival [46.5 months]

    Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

11. 6 Month Landmark Progression Free Survival [46.5 months]

    Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.

12. 12 Month Landmark Progression Free Survival [46.5 months]

    Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.

13. Landmark Overall Survival at 6 Months [46.5 months]

    Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.

14. Landmark Overall Survival at 12 Months [46.5 months]

    Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.

15. Overall Survival [46.5 months]

    The time from first dose date to the date of death for any cause

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures

2. Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, and meet the requirements for the intended study cohort

3. Male or Female ≥ 18 years of age

4. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Subjects with ECOG 2 may be considered for enrollment in Parts C, D, F, and H if approved by Medical Monitor

5. Have a predicted life expectancy of ≥ 3 months

6. Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance with the study protocol

7. If medical history of the following, case should be reviewed by the Medical Monitor: prior biliary tract disorders (as based on Hepatobiliary SOC high level terms of: obstructive bile duct disorders, hepatic vascular disorders, structural and other bile duct disorders) or portal hypertension and/or hepatic vascular disorders

8. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of JTX-2011

9. WOCBP and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment

Exclusion Criteria:

1. Receiving concurrent anti-cancer treatment (excluding radiation therapy), either approved or investigational

2. Have refused standard therapy

3. Have received anti-cancer therapies listed below within the specified timeframe, or who have ongoing toxicity from prior therapy > Grade 1 according to the Common Terminology for Adverse Events (CTCAE). Exceptions to this are: > Grade 1 toxicities which in the opinion of the Investigator should not exclude the subject (e.g. alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism or other endocrinopathies that are well-controlled with hormone replacement) and are approved by the Medical Monitor.

4. Have received biologic therapy, including immunotherapy, < 28 days prior to C1D1;

5. Have received CAR-T therapy;

6. Have received chemotherapy < 21 days prior to C1D1, or < 42 days for mitomycin or nitrosoureas;

7. Have received targeted small molecule therapy < 14 days prior to C1D1;

8. Have undergone organ transplantation including allogeneic or autologous stem-cell transplantation, at any time;

9. Have undergone a major surgery (excluding minor procedures, e.g. placement of vascular access, biopsy, etc.) < 6 months prior to the first day of study treatment, C1D1

10. Have a history of intolerance, hypersensitivity, or treatment discontinuation due to severe immune adverse events on prior immunotherapy, or documented presence of neutralizing anti-drug antibody to nivolumab, ipilimumab, or pembrolizumab. Subjects who discontinued prior immunotherapies for immune-related adverse events that are well-controlled with appropriate treatment may be enrolled if approved by the Medical Monitor.

11. Have a diagnosis of immunodeficiency, either primary or acquired, or treatment with systemic steroids or any other form of immunosuppressive therapy within 7 days prior to C1D1. Exception: inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease as well as a one-time dose of immunosuppressive agents used prophylactically for contrast allergies

12. Have any active disease requiring systemic immunosuppressive treatment

13. Have known severe intolerance to or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous immunoglobulin preparations; any history of anaphylaxis; prior history of human anti-human antibody response; known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent

14. Are symptomatic or have uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation (brain metastases that are stable and asymptomatic, either treated or untreated, will be allowed)

15. Have current second malignancy at other sites, which requires treatment, or in the judgement of the Investigator, may require treatment within the next year. Concurrent malignancies that do not require treatment and are clinically stable are allowed. A past history of other malignancies is allowed as long as the subject is not receiving specific treatment other than hormonal therapy, and, in the judgement of the Investigator, is unlikely to have a recurrence.

16. Have active and clinically relevant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required)

17. Have received live vaccines within past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date prior to first infusion day)

18. Women who are pregnant or breastfeeding

19. Have experienced symptomatic cardiac disease that is unresponsive to surgical or medical management

20. Have any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical trial data interpretation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Palo Alto	California	United States	94304
2	Sarah Cannon Research Institute at HealthONE	Denver	Colorado	United States	80218
3	Yale New Haven Hospital	New Haven	Connecticut	United States	06510
4	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia	United States	20007
5	The University of Chicago Medicine Comprehensive Cancer Center	Chicago	Illinois	United States	60637
6	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
7	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
8	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
9	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
10	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
11	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
12	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
13	Sarah Cannon Research Institute at TriStar Health	Nashville	Tennessee	United States	37203
14	The University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030
15	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas	United States	78229
16	University of Washington	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Jounce Therapeutics, Inc.

Investigators

• Study Director: Elizabeth Trehu, MD, FACP, Jounce Therapeutics, Inc.

Study Documents (Full-Text)

• Study Protocol - May 30, 2019
• Statistical Analysis Plan - Mar 4, 2020

More Information

Publications

None provided.

• Responsible Party: Jounce Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02904226
• Other Study ID Numbers: JTX-2011-101
• First Posted: Sep 16, 2016
• Last Update Posted: Sep 9, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jounce Therapeutics, Inc.: ICOS; ICOS agonist monoclonal antibody; JTX-2011; Anti-PD-1; Nivolumab; ICONIC; Immunotherapy; Immuno-oncology; Cancer; Solid Tumor; Dose Escalation; Dose Expansion; Anti-CTLA-4; Ipilimumab; Pembrolizumab
• Additional relevant MeSH terms: Pembrolizumab; Nivolumab; Ipilimumab

Study Results

Participant Flow

Pre-assignment Detail	The protocol enrollment number of 242 is the number of participants who signed the ICF. The number that Started the Participant flow module (218) are those subjects who received any amount of study drug (JTX-2011 and/or nivolumab and/or ipilimumab and/or pembrolizumab). The difference between these two values (24) are the number of patients who screen failed.

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part F (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)	Part H (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Period Title: Overall Study
STARTED	40	31	30	100	11	0	6	0
COMPLETED	0	2	0	4	0	0	0	0
NOT COMPLETED	40	29	30	96	11	0	6	0

Baseline Characteristics

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part F (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)	Part H (JTX-2011 + Pembrolizumab)	Total
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days	Total of all reporting groups
Overall Participants	40	31	30	100	11	0	6	0	218
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 0%
Between 18 and 65 years	28 70%	27 87.1%	13 43.3%	64 64%	7 63.6%	2 Infinity	141 2350%
>=65 years	12 30%	4 12.9%	17 56.7%	36 36%	4 36.4%	4 Infinity	77 1283.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.6 (10.94)	56.2 (9.87)	64.4 (10.57)	61.1 (9.65)	58.8 (9.95)	65.7 (8.77)	60.8 (10.22)
Sex: Female, Male (Count of Participants)
Female	22 55%	19 61.3%	13 43.3%	39 39%	3 27.3%	3 Infinity	99 1650%
Male	18 45%	12 38.7%	17 56.7%	61 61%	8 72.7%	3 Infinity	119 1983.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 10%	4 12.9%	2 6.7%	4 4%	0 0%	0 NaN	14 233.3%
Not Hispanic or Latino	35 87.5%	27 87.1%	26 86.7%	91 91%	11 100%	6 Infinity	196 3266.7%
Unknown or Not Reported	1 2.5%	0 0%	2 6.7%	5 5%	0 0%	0 NaN	8 133.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 0%
Asian	0 0%	2 6.5%	2 6.7%	4 4%	0 0%	0 NaN	8 133.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	1 1%	1 9.1%	0 NaN	2 33.3%
Black or African American	6 15%	3 9.7%	1 3.3%	5 5%	2 18.2%	0 NaN	17 283.3%
White	29 72.5%	22 71%	22 73.3%	77 77%	7 63.6%	6 Infinity	163 2716.7%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 0%
Unknown or Not Reported	5 12.5%	4 12.9%	5 16.7%	13 13%	1 9.1%	0 NaN	28 466.7%
Region of Enrollment (participants) [Number]
United States	40 100%	31 100%	30 100%	100 100%	11 100%	6 Infinity	218 3633.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAE)
Description	Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated
Time Frame	46.3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	40	31	30	100	11	6
Count of Participants [Participants]	38 95%	31 100%	30 100%	98 98%	11 100%	6 Infinity

2. Primary Outcome

Title	Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE)
Description	Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time Frame	46.3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	40	31	30	100	11	6
Count of Participants [Participants]	2 5%	2 6.5%	3 10%	5 5%	0 0%	1 Infinity

3. Primary Outcome

Title	Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE)
Description	Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time Frame	46.3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	40	31	30	100	11	6
Count of Participants [Participants]	1 2.5%	1 3.2%	2 6.7%	4 4%	2 18.2%	0 NaN

4. Primary Outcome

Title	Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE)
Description	Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03."
Time Frame	46.3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	40	31	30	100	11	6
Count of Participants [Participants]	17 42.5%	8 25.8%	14 46.7%	43 43%	4 36.4%	2 Infinity

5. Primary Outcome

Title	Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE)
Description	Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time Frame	46.3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	40	31	30	100	11	6
Count of Participants [Participants]	10 25%	16 51.6%	8 26.7%	32 32%	5 45.5%	3 Infinity

6. Primary Outcome

Title	Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE)
Description	Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time Frame	46.3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	40	31	30	100	11	6
Count of Participants [Participants]	8 20%	4 12.9%	3 10%	14 14%	0 0%	0 NaN

7. Primary Outcome

Title	Number of Participants With Dose Limiting Toxicities
Description	Number of participants with at least one dose limiting toxicity (DLT)
Time Frame	33 months

Outcome Measure Data

Analysis Population Description

Part C and D did not have any participants analyzed for this outcome measure because DLT is only relevant to the Phase 1 parts of study (Part A, Part B, Part E and Part G).

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	40	31	0	0	11	6
Count of Participants [Participants]	2 5%	0 0%	0 0%	0 0%	0 0%	0 NaN

8. Primary Outcome

Title	Overall Response Rate
Description	Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review
Time Frame	46.5 months

Outcome Measure Data

Analysis Population Description

Response Evaluable Set: subjects who received any study drug and have a baseline tumor assessment, and either has at least one post-baseline tumor assessment scan and/or discontinued treatment due to death or disease progression The number of participants analyzed is zero for Part F and Part H because there were no participants enrolled in those two groups of the study

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	38	29	30	90	9	6
Count of Participants [Participants]	0 0%	1 3.2%	1 3.3%	2 2%	0 0%	0 NaN

9. Primary Outcome

Title	Disease Control Rate
Description	Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)
Time Frame	46.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	38	29	30	90	9	6
Count of Participants [Participants]	7 17.5%	7 22.6%	3 10%	23 23%	2 18.2%	4 Infinity

10. Primary Outcome

Title	Progression Free Survival
Description	Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time Frame	46.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	38	29	30	90	9	6
Median (95% Confidence Interval) [months]	2.1	2.0	1.9	2.0	2.5	4.0

11. Primary Outcome

Title	6 Month Landmark Progression Free Survival
Description	Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time Frame	46.5 months

Outcome Measure Data

Analysis Population Description

The 95% CI is not estimable by Kaplan-Meier method for Part E since the probability of event was 0.

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	38	29	30	90	9	6
Mean (95% Confidence Interval) [Probability of event free at month 6 (%)]	10.0	10.2	4.1	9.1	0	33.3

12. Primary Outcome

Title	12 Month Landmark Progression Free Survival
Description	Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time Frame	46.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	38	29	30	90	9	6
Mean (95% Confidence Interval) [Probability of event free at month 12(%)]	NA	10.2	4.1	4.6	0	0

13. Primary Outcome

Title	Landmark Overall Survival at 6 Months
Description	Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time Frame	46.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	38	29	30	90	9	6
Mean (95% Confidence Interval) [Probability of event free at month 6 (%)]	69.4	61.8	47.9	70.2	77.8	66.7

14. Primary Outcome

Title	Landmark Overall Survival at 12 Months
Description	Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time Frame	46.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	38	29	30	90	9	6
Mean (95% Confidence Interval) [Probability of event free at month 12(%)]	12.2	41.2	16.0	40.5	31.1	16.7

15. Primary Outcome

Title	Overall Survival
Description	The time from first dose date to the date of death for any cause
Time Frame	46.5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Part A (JTX-2011)	Part B (JTX-2011 + Nivolumab)	Part C (JTX-2011)	Part D (JTX-2011 + Nivolumab)	Part E (JTX-2011 + Ipilimumab)	Part G (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days	Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days	Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days	Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
Measure Participants	38	29	30	90	9	6
Median (95% Confidence Interval) [months]	7.6	8.9	4.9	9.5	9.3	8.2

Adverse Events

Time Frame	Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
Adverse Event Reporting Description	The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
Arm/Group Title	Part A (JTX-2011)		Part B (JTX-2011 + Nivolumab)		Part C (JTX-2011)		Part D (JTX-2011 + Nivolumab)		Part E (JTX-2011 + Ipilimumab)		Part F (JTX-2011 + Ipilimumab)		Part G (JTX-2011 + Pembrolizumab)		Part H (JTX-2011 + Pembrolizumab)
Arm/Group Description	Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion JTX-2011: Specified dose on specified days		Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days		Phase 2 expansion of JTX-2011 by IV infusion JTX-2011: Specified dose on specified days		Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion JTX-2011: Specified dose on specified days Nivolumab: Specified dose on specified days		Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days		Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days		Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days		Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
All Cause Mortality
	Part A (JTX-2011)		Part B (JTX-2011 + Nivolumab)		Part C (JTX-2011)		Part D (JTX-2011 + Nivolumab)		Part E (JTX-2011 + Ipilimumab)		Part F (JTX-2011 + Ipilimumab)		Part G (JTX-2011 + Pembrolizumab)		Part H (JTX-2011 + Pembrolizumab)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/40 (47.5%)		19/31 (61.3%)		22/30 (73.3%)		68/100 (68%)		6/11 (54.5%)		0/0 (NaN)		5/6 (83.3%)		0/0 (NaN)
Serious Adverse Events
	Part A (JTX-2011)		Part B (JTX-2011 + Nivolumab)		Part C (JTX-2011)		Part D (JTX-2011 + Nivolumab)		Part E (JTX-2011 + Ipilimumab)		Part F (JTX-2011 + Ipilimumab)		Part G (JTX-2011 + Pembrolizumab)		Part H (JTX-2011 + Pembrolizumab)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/40 (35%)		9/31 (29%)		16/30 (53.3%)		38/100 (38%)		6/11 (54.5%)		0/0 (NaN)		2/6 (33.3%)		0/0 (NaN)
Blood and lymphatic system disorders
Anaemia	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Coagulopathy	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Thrombocytopenia	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Thrombotic microangiopathy	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Cardiac disorders
Pericarditis	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Cardio-respiratory arrest	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Pericardial effusion	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Endocrine disorders
Inappropriate antidiuretic hormone secretion	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Gastrointestinal disorders
Abdominal pain	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		2/100 (2%)		2/11 (18.2%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Nausea	0/40 (0%)		0/31 (0%)		2/30 (6.7%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Small intestinal obstruction	1/40 (2.5%)		0/31 (0%)		1/30 (3.3%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Constipation	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Diarrhea	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Upper gastrointestinal hemorrhage	0/40 (0%)		0/31 (0%)		0/30 (0%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Vomiting	0/40 (0%)		0/31 (0%)		2/30 (6.7%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Ascites	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Colitis	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Duodenal stenosis	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Dysphagia	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Gastric ulcer	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Haematemesis	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Ileus	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Intestinal Obstruction	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Obstruction gastric	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Pancreatitis	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
General disorders
Fatigue	0/40 (0%)		1/31 (3.2%)		1/30 (3.3%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Asthenia	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Chest discomfort	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Non-cardiac chest pain	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Pain	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Pyrexia	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Sudden death	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Hypercalcaemia	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Hepatobiliary disorders
Bile duct obstruction	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Jaundice	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Infections and infestations
Pneumonia	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		5/100 (5%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Urinary tract infection	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Cellulitis	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Peritonitis	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Abdominal infection	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Bacteraemia	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Klebsiella bacteraemia	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Pelvic abscess	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Peritonitis bacterial	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Sepsis	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Sialoadenitis	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Upper respiratory tract infection	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Injury, poisoning and procedural complications
Infusion related reaction	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Hip fracture	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Humerus fracture	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Subdural haematoma	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Investigations
Blood bilirubin increased	0/40 (0%)		0/31 (0%)		0/30 (0%)		3/100 (3%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Aspartate aminotransferase increased	0/40 (0%)		0/31 (0%)		0/30 (0%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Alanine aminotransferase increased	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Weight decreased	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Metabolism and nutrition disorders
Hyponatraemia	1/40 (2.5%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Dehydration	0/40 (0%)		0/31 (0%)		0/30 (0%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Decreased appetite	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Hypercalcaemia	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Musculoskeletal and connective tissue disorders
Back pain	0/40 (0%)		0/31 (0%)		0/30 (0%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Arthralgia	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Cervical spinal stenosis	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Pain in extremity	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	0/40 (0%)		0/31 (0%)		2/30 (6.7%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Metastases to central nervous system	0/40 (0%)		0/31 (0%)		0/30 (0%)		3/100 (3%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Chondrosarcoma	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Malignant neoplasm progression	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Malignant pleural effusion	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Tumor associated fever	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Tumor hemorrhage	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Tumor pain	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Nervous system disorders
Encephalopathy	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Headache	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Psychiatric disorders
Mental status changes	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Renal and urinary disorders
Acute kidney injury	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	2/40 (5%)		1/31 (3.2%)		0/30 (0%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Dyspnoea	1/40 (2.5%)		1/31 (3.2%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Respiratory failure	1/40 (2.5%)		1/31 (3.2%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Bronchial obstruction	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Haemoptysis	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Hypoxia	1/40 (2.5%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Pulmonary embolism	1/40 (2.5%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Acute respiratory failure	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Dyspnoea exertional	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Paraneoplastic pleural effusion	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Pharyngeal inflammation	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Pneumonitis	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Surgical and medical procedures
Spinal fusion surgery	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Part A (JTX-2011)		Part B (JTX-2011 + Nivolumab)		Part C (JTX-2011)		Part D (JTX-2011 + Nivolumab)		Part E (JTX-2011 + Ipilimumab)		Part F (JTX-2011 + Ipilimumab)		Part G (JTX-2011 + Pembrolizumab)		Part H (JTX-2011 + Pembrolizumab)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/40 (95%)		31/31 (100%)		30/30 (100%)		98/100 (98%)		11/11 (100%)		0/0 (NaN)		6/6 (100%)		0/0 (NaN)
Blood and lymphatic system disorders
Anaemia	9/40 (22.5%)		4/31 (12.9%)		7/30 (23.3%)		11/100 (11%)		3/11 (27.3%)		3/0 (Infinity)		4/6 (66.7%)		4/0 (Infinity)
Thrombocytopenia	0/40 (0%)		0/31 (0%)		0/30 (0%)		2/100 (2%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Lymphopenia	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Cardiac disorders
Tachycardia	3/40 (7.5%)		2/31 (6.5%)		2/30 (6.7%)		5/100 (5%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Endocrine disorders
Hyerthyroidism	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Gastrointestinal disorders
Nausea	10/40 (25%)		14/31 (45.2%)		8/30 (26.7%)		32/100 (32%)		2/11 (18.2%)		0/0 (NaN)		2/6 (33.3%)		0/0 (NaN)
Vomiting	4/40 (10%)		8/31 (25.8%)		7/30 (23.3%)		16/100 (16%)		2/11 (18.2%)		2/0 (Infinity)		2/6 (33.3%)		2/0 (Infinity)
Diarrhea	7/40 (17.5%)		4/31 (12.9%)		5/30 (16.7%)		18/100 (18%)		3/11 (27.3%)		3/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Constipation	3/40 (7.5%)		8/31 (25.8%)		6/30 (20%)		14/100 (14%)		4/11 (36.4%)		4/0 (Infinity)		2/6 (33.3%)		2/0 (Infinity)
Abdominal pain	8/40 (20%)		2/31 (6.5%)		8/30 (26.7%)		8/100 (8%)		2/11 (18.2%)		2/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Dysphagia	1/40 (2.5%)		1/31 (3.2%)		2/30 (6.7%)		12/100 (12%)		1/11 (9.1%)		1/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Abdominal distension	2/40 (5%)		2/31 (6.5%)		3/30 (10%)		4/100 (4%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Ascites	1/40 (2.5%)		1/31 (3.2%)		2/30 (6.7%)		4/100 (4%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Abdominal pain upper	1/40 (2.5%)		0/31 (0%)		1/30 (3.3%)		5/100 (5%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Dry mouth	0/40 (0%)		0/31 (0%)		2/30 (6.7%)		4/100 (4%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Dyspepsia	0/40 (0%)		2/31 (6.5%)		1/30 (3.3%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Proctalgia	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		2/6 (33.3%)		2/0 (Infinity)
Flatulence	0/40 (0%)		1/31 (3.2%)		2/30 (6.7%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Retching	2/40 (5%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Small intestinal obstruction	0/40 (0%)		0/31 (0%)		2/30 (6.7%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Rectal hemorrhage	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
General disorders
Fatigue	9/40 (22.5%)		10/31 (32.3%)		15/30 (50%)		37/100 (37%)		7/11 (63.6%)		7/0 (Infinity)		2/6 (33.3%)		2/0 (Infinity)
Pyrexia	6/40 (15%)		5/31 (16.1%)		4/30 (13.3%)		24/100 (24%)		0/11 (0%)		0/0 (NaN)		2/6 (33.3%)		2/0 (Infinity)
Chills	6/40 (15%)		3/31 (9.7%)		1/30 (3.3%)		13/100 (13%)		2/11 (18.2%)		2/0 (Infinity)		2/6 (33.3%)		2/0 (Infinity)
Oedema peripheral	2/40 (5%)		3/31 (9.7%)		6/30 (20%)		5/100 (5%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Non-cardiac chest pain	2/40 (5%)		0/31 (0%)		1/30 (3.3%)		5/100 (5%)		1/11 (9.1%)		1/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Chest discomfort	0/40 (0%)		2/31 (6.5%)		0/30 (0%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Chest pain	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Peripheral swelling	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Hepatobiliary disorders
Portal vein thrombosis	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Infections and infestations
Urinary tract infection	1/40 (2.5%)		3/31 (9.7%)		2/30 (6.7%)		9/100 (9%)		1/11 (9.1%)		1/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Upper respiratory tract infection	5/40 (12.5%)		2/31 (6.5%)		2/30 (6.7%)		3/100 (3%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Oral candidiasis	2/40 (5%)		0/31 (0%)		1/30 (3.3%)		3/100 (3%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Sinusitis	1/40 (2.5%)		1/31 (3.2%)		1/30 (3.3%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Herpes zoster	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Pharyngitis	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Skin infection	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Furuncle	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Injury, poisoning and procedural complications
Infusion related reaction	3/40 (7.5%)		9/31 (29%)		3/30 (10%)		16/100 (16%)		2/11 (18.2%)		2/0 (Infinity)		2/6 (33.3%)		2/0 (Infinity)
Contusion	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Fall	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Rib fracture	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Transfusion reaction	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Investigations
Aspartate aminotransferase increased	5/40 (12.5%)		3/31 (9.7%)		4/30 (13.3%)		12/100 (12%)		2/11 (18.2%)		2/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Weight decreased	1/40 (2.5%)		0/31 (0%)		5/30 (16.7%)		14/100 (14%)		2/11 (18.2%)		2/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Alanine aminotransferase increased	5/40 (12.5%)		2/31 (6.5%)		4/30 (13.3%)		4/100 (4%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Blood alkaline phosphatase increased	3/40 (7.5%)		1/31 (3.2%)		3/30 (10%)		6/100 (6%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Blood bilirubin increased	2/40 (5%)		1/31 (3.2%)		2/30 (6.7%)		5/100 (5%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Blood creatinine increased	1/40 (2.5%)		3/31 (9.7%)		1/30 (3.3%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Lymphocyte count decreased	1/40 (2.5%)		0/31 (0%)		1/30 (3.3%)		2/100 (2%)		2/11 (18.2%)		2/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Blood thyroid stimulating hormone increased	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		3/100 (3%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Activated partial thromboplastin time prolonged	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Electrocardiogram QT prolonged	3/40 (7.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
White blood cell count decreased	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Blood phosphorus decreased	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
International normalised ratio increased	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Metabolism and nutrition disorders
Decreased appetite	8/40 (20%)		5/31 (16.1%)		10/30 (33.3%)		29/100 (29%)		6/11 (54.5%)		6/0 (Infinity)		3/6 (50%)		3/0 (Infinity)
Hyponatraemia	2/40 (5%)		3/31 (9.7%)		5/30 (16.7%)		17/100 (17%)		2/11 (18.2%)		2/0 (Infinity)		3/6 (50%)		3/0 (Infinity)
Hypomagnesaemia	4/40 (10%)		4/31 (12.9%)		2/30 (6.7%)		8/100 (8%)		2/11 (18.2%)		2/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Hypoalbuminaemia	3/40 (7.5%)		1/31 (3.2%)		3/30 (10%)		8/100 (8%)		3/11 (27.3%)		3/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Dehydration	2/40 (5%)		1/31 (3.2%)		6/30 (20%)		6/100 (6%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Hypokalaemia	3/40 (7.5%)		1/31 (3.2%)		3/30 (10%)		7/100 (7%)		1/11 (9.1%)		1/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Hypercalcaemia	1/40 (2.5%)		2/31 (6.5%)		1/30 (3.3%)		5/100 (5%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Hypophosphataemia	0/40 (0%)		0/31 (0%)		0/30 (0%)		9/100 (9%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Hyperkalaemia	0/40 (0%)		1/31 (3.2%)		1/30 (3.3%)		2/100 (2%)		2/11 (18.2%)		2/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Hyperglycaemia	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		3/100 (3%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Hypocalcaemia	1/40 (2.5%)		1/31 (3.2%)		1/30 (3.3%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Hyperuricaemia	0/40 (0%)		1/31 (3.2%)		1/30 (3.3%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Musculoskeletal and connective tissue disorders
Back pain	3/40 (7.5%)		1/31 (3.2%)		3/30 (10%)		18/100 (18%)		2/11 (18.2%)		2/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Arthralgia	2/40 (5%)		5/31 (16.1%)		2/30 (6.7%)		13/100 (13%)		2/11 (18.2%)		2/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Myalgia	2/40 (5%)		3/31 (9.7%)		1/30 (3.3%)		10/100 (10%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Pain in extremity	0/40 (0%)		2/31 (6.5%)		0/30 (0%)		8/100 (8%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Muscular weakness	1/40 (2.5%)		2/31 (6.5%)		2/30 (6.7%)		4/100 (4%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Musculoskeletal pain	1/40 (2.5%)		2/31 (6.5%)		0/30 (0%)		6/100 (6%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Musculoskeletal chest pain	0/40 (0%)		0/31 (0%)		0/30 (0%)		6/100 (6%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Muscle spasms	2/40 (5%)		0/31 (0%)		1/30 (3.3%)		3/100 (3%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Bone pain	0/40 (0%)		0/31 (0%)		0/30 (0%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Joint stiffness	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	0/40 (0%)		2/31 (6.5%)		0/30 (0%)		4/100 (4%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Nervous system disorders
Dizziness	4/40 (10%)		0/31 (0%)		8/30 (26.7%)		13/100 (13%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Headache	4/40 (10%)		2/31 (6.5%)		1/30 (3.3%)		13/100 (13%)		2/11 (18.2%)		2/0 (Infinity)		2/6 (33.3%)		2/0 (Infinity)
Neuropathy peripheral	2/40 (5%)		2/31 (6.5%)		0/30 (0%)		3/100 (3%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Hypoaesthesia	1/40 (2.5%)		2/31 (6.5%)		1/30 (3.3%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Balance disorder	2/40 (5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Peripheral sensory neuropathy	0/40 (0%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Psychiatric disorders
Insomnia	3/40 (7.5%)		1/31 (3.2%)		1/30 (3.3%)		11/100 (11%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Anxiety	2/40 (5%)		2/31 (6.5%)		1/30 (3.3%)		5/100 (5%)		0/11 (0%)		0/0 (NaN)		2/6 (33.3%)		2/0 (Infinity)
Confusional state	2/40 (5%)		0/31 (0%)		1/30 (3.3%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Sleep disorder	0/40 (0%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Renal and urinary disorders
Acute kidney injury	0/40 (0%)		0/31 (0%)		2/30 (6.7%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Haematuria	0/40 (0%)		0/31 (0%)		0/30 (0%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Urinary tract obstruction	0/40 (0%)		2/31 (6.5%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Renal failure	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	5/40 (12.5%)		3/31 (9.7%)		6/30 (20%)		23/100 (23%)		2/11 (18.2%)		2/0 (Infinity)		2/6 (33.3%)		2/0 (Infinity)
Cough	4/40 (10%)		6/31 (19.4%)		3/30 (10%)		22/100 (22%)		2/11 (18.2%)		2/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Pleural effusion	3/40 (7.5%)		3/31 (9.7%)		2/30 (6.7%)		5/100 (5%)		1/11 (9.1%)		1/0 (Infinity)		1/6 (16.7%)		1/0 (Infinity)
Nasal congestion	2/40 (5%)		1/31 (3.2%)		0/30 (0%)		4/100 (4%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Wheezing	4/40 (10%)		1/31 (3.2%)		1/30 (3.3%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Dysphonia	2/40 (5%)		0/31 (0%)		0/30 (0%)		3/100 (3%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Hypoxia	1/40 (2.5%)		0/31 (0%)		2/30 (6.7%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Oropharyngeal pain	0/40 (0%)		0/31 (0%)		2/30 (6.7%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Productive cough	0/40 (0%)		0/31 (0%)		2/30 (6.7%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Sinus congestion	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Rhinitis allergic	0/40 (0%)		0/31 (0%)		0/30 (0%)		1/100 (1%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Atelectasis	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Throat irritation	0/40 (0%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Skin and subcutaneous tissue disorders
Rash	2/40 (5%)		4/31 (12.9%)		3/30 (10%)		9/100 (9%)		0/11 (0%)		0/0 (NaN)		2/6 (33.3%)		2/0 (Infinity)
Pruritus	5/40 (12.5%)		1/31 (3.2%)		2/30 (6.7%)		6/100 (6%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Rash maculo-papular	0/40 (0%)		3/31 (9.7%)		0/30 (0%)		6/100 (6%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Hyperhidrosis	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		2/100 (2%)		0/11 (0%)		0/0 (NaN)		1/6 (16.7%)		1/0 (Infinity)
Night sweats	2/40 (5%)		1/31 (3.2%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Dermatitis	2/40 (5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Dermatitis acneiform	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		0/100 (0%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)
Vascular disorders
Hypertension	3/40 (7.5%)		1/31 (3.2%)		2/30 (6.7%)		7/100 (7%)		0/11 (0%)		0/0 (NaN)		0/6 (0%)		0/0 (NaN)
Hypotension	2/40 (5%)		1/31 (3.2%)		1/30 (3.3%)		5/100 (5%)		0/11 (0%)		0/0 (NaN)		2/6 (33.3%)		2/0 (Infinity)
Hot flush	1/40 (2.5%)		0/31 (0%)		0/30 (0%)		4/100 (4%)		1/11 (9.1%)		1/0 (Infinity)		0/6 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Any publication ("pub.") can be restricted until the 1st to occur of (a) pub. of the clinical trial results, or (b) 18 mo's after the Primary Completion Date. Pub. rights depend on PI conducting the study in compliance with the Protocol, that the pub. is made in a recognized journal or conference, and makes use of all study data. The Sponsor can require removal of Sponsor's confidential information from any pub. and can defer pub. for up to an add'l 60 days to file a related patent application.