A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03029832
• Collaborator: (none)
• Enrollment: 5
• Locations: 22
• Arms: 2
• Actual Duration (Months): 11.9
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a Phase II, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting and who are ineligible to receive cisplatin-based therapy.

Condition or Disease	Intervention/Treatment	Phase
Urothelial Carcinoma	Drug: MOXR0916; Drug: Atezolizumab	Phase 2

Detailed Description

The study design has been amended after the decision to prematurely stop patient accrual due to enrollment challenges. As only 5 participants were enrolled, the study blinding will not be maintained, and placebo infusions will not be administered. Patients assigned to the MOXR0916 arm may continue study treatment with the combination of atezolizumab and MOXR0916 or with atezolizumab alone based on a discussion of benefit and risk with the treating investigator.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: The study design has been amended in that the study blinding will not be maintained.
• Primary Purpose: Treatment
• Official Title: A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy
• Actual Study Start Date: Apr 27, 2017
• Actual Primary Completion Date: Apr 25, 2018
• Actual Study Completion Date: Apr 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MOXR0916 plus Atezolizumab	Drug: MOXR0916; MOXR0916, 300 milligram (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.; Drug: Atezolizumab; Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Active Comparator: Atezolizumab	Drug: Atezolizumab; Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) [Up to approximately 45 months]

   PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of >= 5 millimeter (mm) in the sum of diameters.

2. Overall Survival (OS) [Up to approximately 45 months]

   Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.

Secondary Outcome Measures

1. Objective Response (OR) According to RECIST v1.1 [Up to approximately 45 months]

   OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.

2. Duration of Objective Response (DOR) According to RECIST v1.1 [Up to approximately 45 months]

   DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.

3. Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI) [Up to approximately 45 months]

   The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life.

4. Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI [Up to approximately 45 months]

   The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life.

5. Percentage of Participants With Adverse Event (AEs) [Up to approximately 45 months]

   An adverse event is any untoward medical occurrence, regardless of causal attribution.

6. Area Under the Plasma Drug Concentration-time Curve (AUC) of MOXR0916 and Atezolizumab [Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose]

   AUC represents the body's exposure to an administered drug.

7. Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab [Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose]

   Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose.

8. Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab [Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose]

   Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body.

9. Clearance of MOXR0916 and Atezolizumab [Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose]

   Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

10. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to MOXR0916 and Atezolizumab [Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predose]

    ATAs may be produced by the body in response to an administered drug.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Age >= 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status of <= 2

• Life expectancy >= 12 weeks

• Histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (UC)

• Availability of a representative formalin-fixed paraffin-embedded tumor specimen

• No prior systemic therapy for inoperable locally advanced or metastatic UC

• Ineligible for cisplatin-based chemotherapy as defined by any one of the following criteria: Impaired renal function (glomerular filtration rate [GFR] > 30 but < 60 milliliter/minute [mL/min]); National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0 Grade >= 2 audiometric hearing loss (of 25 Decibel at two contiguous frequencies or more severe); NCI CTCAE v 4.0 Grade >= 2 peripheral neuropathy; ECOG Performance Status of 2

• Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1

• Adequate hematologic and end-organ function

Exclusion Criteria:

• Significant cardiovascular disease

• Known clinically significant liver disease

• Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment

• Prior treatment with CD137 or OX40 agonists, anti-cytotoxic T-lymphocyte-associated protein (CTLA4), anti-programmed death-1 (PD-1), anti- programmed death-ligand 1 (PD-L1), anti-CD-27, anti- glucocorticoid-induced tumor necrosis factor receptor (GITR) therapeutic antibody or pathway-targeting agents

• Untreated central nervous system (CNS) metastases or active (progressing or requiring corticosteroids for symptomatic control) CNS metastases

• Any history of leptomeningeal disease

• Malignancies other than UC within 5 years prior to Cycle 1, Day 1

• History of autoimmune disease

• History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography scan

• Active hepatitis B and C virus infection

• Positive HIV test at screening

• Active tuberculosis

• Prior allogeneic stem cell or solid organ transplantation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Oncology - HOPE Wilmot	Tucson	Arizona	United States	85710
2	University of Colorado	Denver	Colorado	United States	80045
3	Yale University	New Haven	Connecticut	United States	06510
4	Miami Cancer Institute of Baptist Health, Inc.	Miami	Florida	United States	33176
5	University of Chicago; Hematology/Oncology	Chicago	Illinois	United States	60637
6	Kansas City - Menorah Medical Center	Kansas City	Kansas	United States	66209
7	Maryland Oncology Hematology, P.A.	Columbia	Maryland	United States	21044
8	Nebraska Methodist Hospital; Cancer Center	Omaha	Nebraska	United States	68114
9	New York Oncology Hematology, P.C.	Albany	New York	United States	12208
10	Columbia University Medical Center; Clinical Research Management Office	New York	New York	United States	10032
11	Onc/Hem Care Clin Trials LLC	Cincinnati	Ohio	United States	45242
12	SCRI Tennessee Oncology Chattanooga	Chattanooga	Tennessee	United States	37404
13	Sarah Cannon Research Inst.	Nashville	Tennessee	United States	37203
14	Texas Oncology-Baylor Sammons Cancer Center	Dallas	Texas	United States	75246
15	Virginia Oncology Associates - Lake Wright Cancer Center	Norfolk	Virginia	United States	23502
16	GasthuisZusters Antwerpen	Wilrijk		Belgium	2610
17	Princess Margaret Cancer Center	Toronto	Ontario	Canada	M5G 1Z5
18	Seoul National University Hospital	Seoul		Korea, Republic of	03080
19	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
20	Asan Medical Center - Oncology	Seoul		Korea, Republic of	05505
21	Leicester Royal Infirmary NHS Trust	Leicester		United Kingdom	LE1 5WW
22	Barts and the London NHS Trust.	London		United Kingdom	EC1A 7BE

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 29, 2017

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT03029832
• Other Study ID Numbers: GO39590; 2016-004165-58
• First Posted: Jan 24, 2017
• Last Update Posted: May 31, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Atezolizumab

Study Results

Participant Flow

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Period Title: Overall Study
STARTED	4	1
COMPLETED	0	0
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab	Total
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Total of all reporting groups
Overall Participants	4	1	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 25%	0 0%	1 20%
>=65 years	3 75%	1 100%	4 80%
Sex: Female, Male (Count of Participants)
Female	2 50%	0 0%	2 40%
Male	2 50%	1 100%	3 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	4 100%	1 100%	5 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Progression-Free Survival (PFS)
Description	PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of >= 5 millimeter (mm) in the sum of diameters.
Time Frame	Up to approximately 45 months

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for PFS.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

2. Primary Outcome

Title	Overall Survival (OS)
Description	Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.
Time Frame	Up to approximately 45 months

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for OS.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

3. Secondary Outcome

Title	Objective Response (OR) According to RECIST v1.1
Description	OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time Frame	Up to approximately 45 months

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for OR.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

4. Secondary Outcome

Title	Duration of Objective Response (DOR) According to RECIST v1.1
Description	DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time Frame	Up to approximately 45 months

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for DOR.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

5. Secondary Outcome

Title	Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)
Description	The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life.
Time Frame	Up to approximately 45 months

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for time to pain progression, pain palliation and fatigue progression.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

6. Secondary Outcome

Title	Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI
Description	The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is "as bad as you can imagine" or "interfered completely" with the participant's life.
Time Frame	Up to approximately 45 months

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for percentage of participants reporting symptom interference with daily living at the time of progression according to the MDASI

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

7. Secondary Outcome

Title	Percentage of Participants With Adverse Event (AEs)
Description	An adverse event is any untoward medical occurrence, regardless of causal attribution.
Time Frame	Up to approximately 45 months

Outcome Measure Data

Analysis Population Description

The safety population was defined as all participants who have received at least one dose of study medication. Data were collected but are not being summarized due to privacy concerns with the low number of patients analyzed.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

8. Secondary Outcome

Title	Area Under the Plasma Drug Concentration-time Curve (AUC) of MOXR0916 and Atezolizumab
Description	AUC represents the body's exposure to an administered drug.
Time Frame	Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

9. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab
Description	Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose.
Time Frame	Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

10. Secondary Outcome

Title	Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab
Description	Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body.
Time Frame	Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

11. Secondary Outcome

Title	Clearance of MOXR0916 and Atezolizumab
Description	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time Frame	Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

12. Secondary Outcome

Title	Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to MOXR0916 and Atezolizumab
Description	ATAs may be produced by the body in response to an administered drug.
Time Frame	Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predose

Outcome Measure Data

Analysis Population Description

Due to early termination, no formal analyses were performed for percentage of participants with ATAs to MOXR0916 and Atezolizumab.

Arm/Group Title	MOXR0916 Plus Atezolizumab	Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.	Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Measure Participants	0	0

Adverse Events

Time Frame	Up to approximately 45 months
Adverse Event Reporting Description	The safety population is defined as all patients who received at least one dose of the study medication. Data were collected for the adverse events but are not being summarized due to privacy concerns with low number of patients analyzed.
Arm/Group Title	MOXR0916 Plus Atezolizumab		Atezolizumab
Arm/Group Description	Participants were administered MOXR0916, 300 milligram (mg) and atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.		Participants were administered atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
All Cause Mortality
	MOXR0916 Plus Atezolizumab		Atezolizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/4 (25%)		0/1 (0%)
Serious Adverse Events
	MOXR0916 Plus Atezolizumab		Atezolizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	MOXR0916 Plus Atezolizumab		Atezolizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.