A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer

• Sponsor: AbbVie (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03026166
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 42
• Locations: 35
• Arms: 3
• Actual Duration (Months): 27.1
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: Ipilimumab; Drug: Nivolumab; Drug: Rovalpituzumab tesirine	Phase 1/Phase 2

Detailed Description

The study planned to enroll three cohorts with approximately 30 participants in each, including a dose-limiting toxicity (DLT) evaluation phase (the first 12 weeks of any treatment) and an expansion phase. Initially, up to 12 participants were to be enrolled into Cohort 1 in order to obtain 6 evaluable participants through the DLT evaluation period of 12 weeks. Safety data were reviewed by a Safety Monitoring Committee (SMC) for each cohort during the DLT evaluation phase before the next cohort opened. Once a new cohort was opened, the previously opened cohort was permitted to continue enrolling participants for the expansion phase for a total of 30 participants per cohort.

Only two of the planned three cohorts enrolled participants in the study based on the SMC recommendation after DLTs were identified in Cohort 2.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination With Nivolumab or Nivolumab and Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
• Actual Study Start Date: Mar 30, 2017
• Actual Primary Completion Date: Jul 3, 2019
• Actual Study Completion Date: Jul 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rovalpituzumab Tesirine and Nivolumab Participants will receive 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants will then receive maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.	Drug: Nivolumab; Administered by intravenous infusion; Other Names: Opdivo® ; Drug: Rovalpituzumab tesirine; Administered by intravenous infusion; Other Names: SC16LD6.5
Experimental: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg Participants will receive 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants will then receive maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.	Drug: Ipilimumab; Administered by intravenous infusion; Other Names: Yervoy® ; Drug: Nivolumab; Administered by intravenous infusion; Other Names: Opdivo® ; Drug: Rovalpituzumab tesirine; Administered by intravenous infusion; Other Names: SC16LD6.5
Experimental: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg Participants will receive 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 3 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After an 8-week washout, participants will then receive maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.	Drug: Ipilimumab; Administered by intravenous infusion; Other Names: Yervoy® ; Drug: Nivolumab; Administered by intravenous infusion; Other Names: Opdivo® ; Drug: Rovalpituzumab tesirine; Administered by intravenous infusion; Other Names: SC16LD6.5

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Dose-limiting Toxicities (DLT) [Up to 12 weeks]

   Dose-limiting toxicities were defined as any of the following in the 12-week DLT-evaluation period, graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03: Grade 4 thrombocytopenia (or Grade 3 thrombocytopenia with bleeding) lasting more than 7 days and/or requiring platelet transfusion Grade 4 neutropenia lasting more than 7 days, and/or requiring hematopoietic growth factor rescue, or any febrile neutropenia (Grade 3 or 4 neutropenia with concurrent fever ≥ 38.3°C) Grade 4 anemia unrelated to underlying disease Clinically significant Grade 3 or 4 non-hematologic laboratory abnormality that did not resolve to Grade 0/1 or baseline within 7 days Grade 3 or 4 non-laboratory adverse event (AE), except fatigue, asthenia, nausea, or other manageable constitutional symptom

2. Number of Participants With Adverse Events (AEs) [From the first dose of study drug until 100 days after the last dose of study drug; median duration of treatment was 65 days and 53 days in each cohort respectively.]

   The investigator rated the severity of each AE according to the NCI CTCAE Version 4.03 and according to the following: Grade 1: The AE is transient and easily tolerated by the subject (mild). Grade 2: The AE causes the subject discomfort and interrupts the subject's usual activities (moderate). Grade 3/4: The AE causes considerable interference with the subject's usual activities and may be incapacitating or life-threatening (severe). Grade 5: The AE resulted in death of the subject (severe). The maximum severity AE for each participant is reported. A serious adverse event was defined as an AE meeting any of the following: Death Life-threatening Resulted in hospitalization or prolongation of hospitalization Resulted in congenital abnormality Resulted in persistent or significant disability or incapacity Was an important medical event requiring medical intervention to prevent a serious outcome. Relationship to study drug was assessed by the Investigator.

Secondary Outcome Measures

1. Objective Response Rate (ORR) [Cohort 1: at Week 6, Week 13, and every 8 weeks thereafter; Cohort 2: at Week 6, Week 12, Week 18, and every 8 weeks thereafter, to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively.]

   Treatment response was assessed by radiographic tumor evaluations conducted by a central radiology review. Objective response rate (ORR) is defined as the percentage of participants whose best overall response is either a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial response (PR): A ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR or PR must have been confirmed at least 4 weeks (28 days) from the initial determination per RECIST v 1.1.

2. Duration of Response (DOR) [Cohort 1: at Week 6, Week 13, and every 8 weeks thereafter; Cohort 2: at Week 6, Week 12, Week 18 and every 8 weeks thereafter, to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively.]

   Duration of overall response is defined as the time from the date of first documented CR or PR, assessed by central radiology review and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first. Participants who neither progressed nor died were censored at the last evaluable disease assessment. Duration of response was evaluated using Kaplan-Meier methodology. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 0.5 cm, or the unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

3. Progression-free Survival (PFS) [From first dose of study drug to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively.]

   Progression-free survival is defined as the time from the first dose date to the documented date of PD or death, whichever occurred first, based on central radiology review according to RECIST v 1.1. Progression-free survival was evaluated using Kaplan-Meier methodology. Participants who neither progressed nor died were censored at the last evaluable disease assessment. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 0.5 cm, or the unequivocal progression of non-target lesions, or the appearance of one or more new lesions.

4. Overall Survival (OS) [From first dose of study drug to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively.]

   Overall survival is defined as the time from the first dose date to death for any reason. Participants who were still alive were censored at the last known alive date. Overall survival was evaluated using Kaplan-Meier methodology.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Participants with histologically or cytologically confirmed extensive-stage small cell lung cancer (SCLC) with progressive disease after at least one platinum-based chemotherapeutic regimen and with evaluable or measurable disease

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

• Has active, known, or suspected autoimmune disease

• Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ucsd /Id# 161030	La Jolla	California	United States	92093
2	Florida Hospital /ID# 161017	Orlando	Florida	United States	32803
3	University Cancer & Blood Cent /ID# 161028	Athens	Georgia	United States	30607
4	University of Chicago /ID# 161006	Chicago	Illinois	United States	60637-1443
5	The University of Kansas Clini /ID# 162915	Fairway	Kansas	United States	66205
6	Washington University-School of Medicine /ID# 161011	Saint Louis	Missouri	United States	63110
7	Rutgers Cancer Institute of NJ /ID# 161032	New Brunswick	New Jersey	United States	08903
8	Memorial Sloan Kettering Cancer Center /ID# 161010	New York	New York	United States	10065-6007
9	Duke University Medical Center /ID# 161009	Durham	North Carolina	United States	27710-3000
10	Oregon Health and Science University /ID# 161029	Portland	Oregon	United States	97239
11	Medical University of South Carolina /ID# 161007	Charleston	South Carolina	United States	29425
12	Tennessee Oncology, PLLC /ID# 161012	Nashville	Tennessee	United States	37203
13	Vanderbilt University Med Ctr /ID# 162916	Nashville	Tennessee	United States	37232-6307
14	Virginia Cancer Institute /ID# 161025	Richmond	Virginia	United States	23230
15	University of Wisconsin Clinic /ID# 161013	Madison	Wisconsin	United States	53705
16	CHU de Besancon - Jean Minjoz /ID# 165173	Besancon	Doubs	France	25000
17	Centre Oscar Lambret /ID# 165169	Lille	Hauts-de-France	France	59020
18	Institut Gustave Roussy /ID# 165168	Villejuif	Val-de-Marne	France	94800
19	Institut Sainte Catherine /ID# 165172	Avignon		France	84082
20	CHRU de Brest - Hospital Morva /ID# 165170	Brest Cedex		France	29609
21	Hopital La Timone /ID# 165171	Marseille		France	13005
22	KH Martha-Maria Halle Dolau /ID# 165180	Halle (Saale)	Sachsen-Anhalt	Germany	06120
23	Asklepios Fachkliniken M. Gaut /ID# 165183	Gauting		Germany	82131
24	Lungen Clinic Grosshansdorf /ID# 165182	Grosshansdorf		Germany	22927
25	Lungenfachklinik Immenhausen /ID# 165181	Immenhausen		Germany	34376
26	Istituto Clinico Humanitas /ID# 165176	Rozzano	Milano	Italy	20089
27	Centro di Riferimento Oncologi /ID# 165174	Aviano		Italy	33081
28	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 165178	Catania		Italy	95123
29	Istituto Europeo di Oncologia /ID# 165175	Milan		Italy	20141
30	AO Univ di Modena /ID# 165177	Modena		Italy	41100
31	Clinica Universitar de Navarra - Pamplona /ID# 165165	Pamplona	Navarra, Comunidad	Spain	31008
32	Hosp Univ Quiron Dexues /ID# 165166	Barcelona		Spain	08028
33	Hospital Genl Gregorio Maranon /ID# 165162	Madrid		Spain	28007
34	Hospital Universitario Fundacion Jimenez Diaz /ID# 165164	Madrid		Spain	28040
35	Hospital Universitario Madrid /ID# 165163	Madrid		Spain	28050

Sponsors and Collaborators

• AbbVie
• Bristol-Myers Squibb

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 1, 2017

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03026166
• Other Study ID Numbers: M16-300; 2016-003686-26
• First Posted: Jan 20, 2017
• Last Update Posted: Jul 17, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by AbbVie: Cancer; Extensive-Stage Small Cell Lung Cancer; Nivolumab; Ipilimumab; Rovalpituzumab tesirine
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Nivolumab; Ipilimumab

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at 17 clinical study sites in 4 countries: United States, France, Italy, and Germany.
Pre-assignment Detail	Three study cohorts were planned to enroll approximately 30 participants in each, including a dose-limiting toxicity (DLT) evaluation phase (the first 12 weeks of any treatment for all participants) and an expansion phase. However, Cohort 2 was limited to 12 participants and Cohort 3 was not opened.

Arm/Group Title	Rovalpituzumab Tesirine and Nivolumab	Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
Arm/Group Description	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.
Period Title: Overall Study
STARTED	30	12
COMPLETED	0	0
NOT COMPLETED	30	12

Baseline Characteristics

Arm/Group Title	Rovalpituzumab Tesirine and Nivolumab	Rovalpituzumab Tesirine and Nivolumab + Ipilimumab	Total
Arm/Group Description	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.	Total of all reporting groups
Overall Participants	30	12	42
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.87 (8.195)	57.25 (14.085)	60.55 (10.256)
Age, Customized (Count of Participants)
< 40 years	0 0%	1 8.3%	1 2.4%
≥ 40 to < 60 years	11 36.7%	5 41.7%	16 38.1%
≥ 60 years	19 63.3%	6 50%	25 59.5%
Sex: Female, Male (Count of Participants)
Female	14 46.7%	5 41.7%	19 45.2%
Male	16 53.3%	7 58.3%	23 54.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 6.7%	0 0%	2 4.8%
Not Hispanic or Latino	28 93.3%	11 91.7%	39 92.9%
Unknown or Not Reported	0 0%	1 8.3%	1 2.4%
Race/Ethnicity, Customized (Count of Participants)
White	29 96.7%	10 83.3%	39 92.9%
Black or African American	1 3.3%	1 8.3%	2 4.8%
Not Reported	0 0%	1 8.3%	1 2.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Dose-limiting Toxicities (DLT)
Description	Dose-limiting toxicities were defined as any of the following in the 12-week DLT-evaluation period, graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03: Grade 4 thrombocytopenia (or Grade 3 thrombocytopenia with bleeding) lasting more than 7 days and/or requiring platelet transfusion Grade 4 neutropenia lasting more than 7 days, and/or requiring hematopoietic growth factor rescue, or any febrile neutropenia (Grade 3 or 4 neutropenia with concurrent fever ≥ 38.3°C) Grade 4 anemia unrelated to underlying disease Clinically significant Grade 3 or 4 non-hematologic laboratory abnormality that did not resolve to Grade 0/1 or baseline within 7 days Grade 3 or 4 non-laboratory adverse event (AE), except fatigue, asthenia, nausea, or other manageable constitutional symptom
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

DLT-evaluable participants were those who completed 4 cycles treatment during the DLT period or stopped treatment earlier due to DLT.

Arm/Group Title	Rovalpituzumab Tesirine and Nivolumab	Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
Arm/Group Description	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.
Measure Participants	6	6
Count of Participants [Participants]	1 3.3%	3 25%

2. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	The investigator rated the severity of each AE according to the NCI CTCAE Version 4.03 and according to the following: Grade 1: The AE is transient and easily tolerated by the subject (mild). Grade 2: The AE causes the subject discomfort and interrupts the subject's usual activities (moderate). Grade 3/4: The AE causes considerable interference with the subject's usual activities and may be incapacitating or life-threatening (severe). Grade 5: The AE resulted in death of the subject (severe). The maximum severity AE for each participant is reported. A serious adverse event was defined as an AE meeting any of the following: Death Life-threatening Resulted in hospitalization or prolongation of hospitalization Resulted in congenital abnormality Resulted in persistent or significant disability or incapacity Was an important medical event requiring medical intervention to prevent a serious outcome. Relationship to study drug was assessed by the Investigator.
Time Frame	From the first dose of study drug until 100 days after the last dose of study drug; median duration of treatment was 65 days and 53 days in each cohort respectively.

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Rovalpituzumab Tesirine and Nivolumab	Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
Arm/Group Description	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.
Measure Participants	30	12
Any adverse event	30 100%	12 100%
Drug-related adverse event	29 96.7%	12 100%
Serious adverse event	23 76.7%	9 75%
Drug-related serious adverse event	13 43.3%	6 50%
Grade 3 adverse event	11 36.7%	7 58.3%
Grade 4 adverse event	1 3.3%	1 8.3%
Grade 5 adverse event	14 46.7%	4 33.3%
Drug-related Grade 3 adverse event	9 30%	10 83.3%
Drug-related Grade 4 adverse event	3 10%	1 8.3%
Drug-related Grade 5 adverse event	4 13.3%	0 0%
AE leading to study drug withdrawal	12 40%	6 50%
AE leading to treatment interruption	18 60%	8 66.7%
AE leading to dose reduction	0 0%	1 8.3%
Drug-related AE leading to study drug withdrawal	9 30%	4 33.3%
Drug-related AE leading to treatment interruption	17 56.7%	8 66.7%
Drug-related AE leading to dose reduction	0 0%	0 0%

3. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	Treatment response was assessed by radiographic tumor evaluations conducted by a central radiology review. Objective response rate (ORR) is defined as the percentage of participants whose best overall response is either a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1. Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial response (PR): A ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR or PR must have been confirmed at least 4 weeks (28 days) from the initial determination per RECIST v 1.1.
Time Frame	Cohort 1: at Week 6, Week 13, and every 8 weeks thereafter; Cohort 2: at Week 6, Week 12, Week 18, and every 8 weeks thereafter, to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively.

Outcome Measure Data

Analysis Population Description

The Efficacy Analysis Set includes participants who received at least one dose of study drug, had a target lesion identified at Baseline, and either had at least 1 post-dose tumor assessment or discontinued treatment due to AE, progressive disease (PD) or death.

Arm/Group Title	Rovalpituzumab Tesirine and Nivolumab	Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
Arm/Group Description	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.
Measure Participants	29	11
Number (95% Confidence Interval) [percentage of participants]	27.6 92%	36.4 303.3%

4. Secondary Outcome

Title	Duration of Response (DOR)
Description	Duration of overall response is defined as the time from the date of first documented CR or PR, assessed by central radiology review and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first. Participants who neither progressed nor died were censored at the last evaluable disease assessment. Duration of response was evaluated using Kaplan-Meier methodology. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 0.5 cm, or the unequivocal progression of non-target lesions, or the appearance of one or more new lesions.
Time Frame	Cohort 1: at Week 6, Week 13, and every 8 weeks thereafter; Cohort 2: at Week 6, Week 12, Week 18 and every 8 weeks thereafter, to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively.

Outcome Measure Data

Analysis Population Description

The analysis includes participants in the Efficacy Analysis Set with a best overall response of unconfirmed CR or PR.

Arm/Group Title	Rovalpituzumab Tesirine and Nivolumab	Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
Arm/Group Description	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.
Measure Participants	10	6
Median (95% Confidence Interval) [months]	3.8	3.3

5. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	Progression-free survival is defined as the time from the first dose date to the documented date of PD or death, whichever occurred first, based on central radiology review according to RECIST v 1.1. Progression-free survival was evaluated using Kaplan-Meier methodology. Participants who neither progressed nor died were censored at the last evaluable disease assessment. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 0.5 cm, or the unequivocal progression of non-target lesions, or the appearance of one or more new lesions.
Time Frame	From first dose of study drug to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively.

Outcome Measure Data

Analysis Population Description

Efficacy Analysis Set

Arm/Group Title	Rovalpituzumab Tesirine and Nivolumab	Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
Arm/Group Description	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.
Measure Participants	29	11
Median (95% Confidence Interval) [months]	4.8	4.1

6. Secondary Outcome

Title	Overall Survival (OS)
Description	Overall survival is defined as the time from the first dose date to death for any reason. Participants who were still alive were censored at the last known alive date. Overall survival was evaluated using Kaplan-Meier methodology.
Time Frame	From first dose of study drug to the end of follow-up; median duration on follow-up was 31.7 and 48.0 weeks in each cohort respectively.

Outcome Measure Data

Analysis Population Description

The Full Analysis Set includes participants who received at least one dose of study drug.

Arm/Group Title	Rovalpituzumab Tesirine and Nivolumab	Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
Arm/Group Description	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.
Measure Participants	30	12
Median (95% Confidence Interval) [months]	7.4	11.0

Adverse Events

Time Frame	From the first dose of study drug until 100 days after the last dose of study drug; median duration of treatment was 65 days and 53 days in each cohort respectively. All-cause mortality is reported through the end of follow-up; maximum time on study was 115 weeks.
Arm/Group Title	Cohort 1: Rovalpituzumab Tesirine and Nivolumab		Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
Arm/Group Description	Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3). Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression.		Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5). After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression.
All Cause Mortality
	Cohort 1: Rovalpituzumab Tesirine and Nivolumab		Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/30 (86.7%)		8/12 (66.7%)
Serious Adverse Events
	Cohort 1: Rovalpituzumab Tesirine and Nivolumab		Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/30 (76.7%)		9/12 (75%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation	1/30 (3.3%)	1	0/12 (0%)	0
Cardiac disorders
Acute myocardial infarction	0/30 (0%)	0	1/12 (8.3%)	1
Atrial fibrillation	2/30 (6.7%)	2	0/12 (0%)	0
Cardiac arrest	1/30 (3.3%)	1	0/12 (0%)	0
Cardiac tamponade	1/30 (3.3%)	1	0/12 (0%)	0
Myocardial infarction	0/30 (0%)	0	1/12 (8.3%)	1
Pericardial effusion	2/30 (6.7%)	3	1/12 (8.3%)	1
Tachycardia	0/30 (0%)	0	1/12 (8.3%)	1
Gastrointestinal disorders
Ascites	1/30 (3.3%)	1	0/12 (0%)	0
Colitis	0/30 (0%)	0	1/12 (8.3%)	1
General disorders
Condition aggravated	1/30 (3.3%)	1	0/12 (0%)	0
Face oedema	1/30 (3.3%)	1	0/12 (0%)	0
Fatigue	0/30 (0%)	0	2/12 (16.7%)	2
Generalised oedema	1/30 (3.3%)	2	0/12 (0%)	0
Hepatobiliary disorders
Autoimmune hepatitis	1/30 (3.3%)	1	0/12 (0%)	0
Drug-induced liver injury	0/30 (0%)	0	1/12 (8.3%)	1
Hepatocellular injury	1/30 (3.3%)	1	0/12 (0%)	0
Infections and infestations
Empyema	1/30 (3.3%)	1	0/12 (0%)	0
Influenza	0/30 (0%)	0	1/12 (8.3%)	1
Pneumonia	2/30 (6.7%)	2	0/12 (0%)	0
Pneumonia fungal	1/30 (3.3%)	1	0/12 (0%)	0
Respiratory tract infection bacterial	0/30 (0%)	0	1/12 (8.3%)	1
Sepsis	1/30 (3.3%)	1	1/12 (8.3%)	1
Septic shock	1/30 (3.3%)	1	0/12 (0%)	0
Injury, poisoning and procedural complications
Femoral neck fracture	1/30 (3.3%)	1	0/12 (0%)	0
Investigations
Blood creatinine increased	1/30 (3.3%)	1	0/12 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/30 (3.3%)	1	2/12 (16.7%)	2
Hyponatraemia	2/30 (6.7%)	2	0/12 (0%)	0
Musculoskeletal and connective tissue disorders
Muscular weakness	1/30 (3.3%)	1	0/12 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression	8/30 (26.7%)	8	2/12 (16.7%)	2
Nervous system disorders
Ischaemic stroke	0/30 (0%)	0	1/12 (8.3%)	1
Peroneal nerve palsy	0/30 (0%)	0	1/12 (8.3%)	1
Renal and urinary disorders
Acute kidney injury	1/30 (3.3%)	1	0/12 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/30 (3.3%)	1	0/12 (0%)	0
Acute respiratory failure	2/30 (6.7%)	2	0/12 (0%)	0
Dyspnoea	3/30 (10%)	3	0/12 (0%)	0
Hypoxia	1/30 (3.3%)	1	0/12 (0%)	0
Pleural effusion	8/30 (26.7%)	12	0/12 (0%)	0
Pneumonitis	3/30 (10%)	6	1/12 (8.3%)	1
Pneumothorax	1/30 (3.3%)	1	0/12 (0%)	0
Respiratory failure	2/30 (6.7%)	2	0/12 (0%)	0
Skin and subcutaneous tissue disorders
Rash maculo-papular	0/30 (0%)	0	1/12 (8.3%)	1
Vascular disorders
Hypotension	0/30 (0%)	0	1/12 (8.3%)	1
Other (Not Including Serious) Adverse Events
	Cohort 1: Rovalpituzumab Tesirine and Nivolumab		Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/30 (100%)		12/12 (100%)
Blood and lymphatic system disorders
Anaemia	10/30 (33.3%)	17	6/12 (50%)	6
Leukocytosis	1/30 (3.3%)	1	1/12 (8.3%)	1
Lymphopenia	2/30 (6.7%)	2	0/12 (0%)	0
Neutropenia	1/30 (3.3%)	1	2/12 (16.7%)	2
Thrombocytopenia	9/30 (30%)	14	5/12 (41.7%)	7
Cardiac disorders
Atrial fibrillation	3/30 (10%)	3	0/12 (0%)	0
Palpitations	0/30 (0%)	0	1/12 (8.3%)	1
Pericardial effusion	7/30 (23.3%)	8	1/12 (8.3%)	2
Sinus tachycardia	3/30 (10%)	3	0/12 (0%)	0
Tachycardia	2/30 (6.7%)	2	1/12 (8.3%)	2
Endocrine disorders
Hyperthyroidism	1/30 (3.3%)	2	1/12 (8.3%)	1
Hypothyroidism	3/30 (10%)	3	2/12 (16.7%)	2
Eye disorders
Cataract	0/30 (0%)	0	1/12 (8.3%)	1
Dry eye	0/30 (0%)	0	1/12 (8.3%)	1
Eye pruritus	0/30 (0%)	0	1/12 (8.3%)	1
Eyelid oedema	0/30 (0%)	0	1/12 (8.3%)	1
Ocular hyperaemia	0/30 (0%)	0	1/12 (8.3%)	1
Periorbital oedema	2/30 (6.7%)	2	1/12 (8.3%)	1
Retinopathy	0/30 (0%)	0	1/12 (8.3%)	1
Vision blurred	1/30 (3.3%)	1	1/12 (8.3%)	1
Visual impairment	0/30 (0%)	0	1/12 (8.3%)	1
Xerophthalmia	0/30 (0%)	0	1/12 (8.3%)	1
Gastrointestinal disorders
Abdominal distension	2/30 (6.7%)	2	0/12 (0%)	0
Abdominal pain	7/30 (23.3%)	7	2/12 (16.7%)	2
Abdominal pain upper	2/30 (6.7%)	2	0/12 (0%)	0
Ascites	1/30 (3.3%)	1	2/12 (16.7%)	4
Colitis	0/30 (0%)	0	1/12 (8.3%)	1
Constipation	8/30 (26.7%)	9	3/12 (25%)	3
Diarrhoea	4/30 (13.3%)	4	4/12 (33.3%)	4
Dry mouth	0/30 (0%)	0	2/12 (16.7%)	2
Eructation	0/30 (0%)	0	1/12 (8.3%)	1
Gastrooesophageal reflux disease	2/30 (6.7%)	2	1/12 (8.3%)	1
Lip dry	0/30 (0%)	0	1/12 (8.3%)	1
Nausea	5/30 (16.7%)	6	1/12 (8.3%)	1
Retching	0/30 (0%)	0	1/12 (8.3%)	1
Vomiting	7/30 (23.3%)	10	3/12 (25%)	3
General disorders
Asthenia	5/30 (16.7%)	14	3/12 (25%)	5
Chest pain	1/30 (3.3%)	1	2/12 (16.7%)	2
Face oedema	6/30 (20%)	8	2/12 (16.7%)	2
Fatigue	11/30 (36.7%)	14	4/12 (33.3%)	5
Localised oedema	0/30 (0%)	0	1/12 (8.3%)	1
Mucosal inflammation	0/30 (0%)	0	1/12 (8.3%)	1
Non-cardiac chest pain	2/30 (6.7%)	2	0/12 (0%)	0
Oedema peripheral	12/30 (40%)	18	3/12 (25%)	4
Pain	3/30 (10%)	4	0/12 (0%)	0
Pyrexia	5/30 (16.7%)	7	3/12 (25%)	3
Hepatobiliary disorders
Hepatic function abnormal	0/30 (0%)	0	1/12 (8.3%)	1
Hepatocellular injury	0/30 (0%)	0	1/12 (8.3%)	1
Liver injury	2/30 (6.7%)	2	0/12 (0%)	0
Infections and infestations
Bronchitis	3/30 (10%)	3	0/12 (0%)	0
Conjunctivitis	1/30 (3.3%)	1	2/12 (16.7%)	2
Hordeolum	0/30 (0%)	0	1/12 (8.3%)	1
Oral candidiasis	3/30 (10%)	3	1/12 (8.3%)	1
Pneumonia bacterial	1/30 (3.3%)	1	1/12 (8.3%)	2
Sinusitis	0/30 (0%)	0	1/12 (8.3%)	1
Skin bacterial infection	0/30 (0%)	0	1/12 (8.3%)	1
Urinary tract infection	4/30 (13.3%)	5	2/12 (16.7%)	2
Viral infection	0/30 (0%)	0	1/12 (8.3%)	1
Injury, poisoning and procedural complications
Contusion	0/30 (0%)	0	1/12 (8.3%)	1
Fall	1/30 (3.3%)	1	1/12 (8.3%)	1
Investigations
Alanine aminotransferase increased	3/30 (10%)	6	0/12 (0%)	0
Amylase increased	2/30 (6.7%)	3	0/12 (0%)	0
Aspartate aminotransferase increased	4/30 (13.3%)	5	0/12 (0%)	0
Blood alkaline phosphatase increased	2/30 (6.7%)	5	0/12 (0%)	0
Blood bilirubin increased	2/30 (6.7%)	4	0/12 (0%)	0
Blood creatine phosphokinase increased	0/30 (0%)	0	1/12 (8.3%)	1
Blood creatinine increased	2/30 (6.7%)	2	1/12 (8.3%)	1
Blood lactate dehydrogenase increased	2/30 (6.7%)	2	0/12 (0%)	0
Blood thyroid stimulating hormone decreased	2/30 (6.7%)	2	0/12 (0%)	0
Metabolism and nutrition disorders
Decreased appetite	9/30 (30%)	11	5/12 (41.7%)	6
Dehydration	0/30 (0%)	0	2/12 (16.7%)	2
Hypercalcaemia	0/30 (0%)	0	1/12 (8.3%)	1
Hyperglycaemia	4/30 (13.3%)	4	1/12 (8.3%)	1
Hyperkalaemia	0/30 (0%)	0	1/12 (8.3%)	1
Hyperlipasaemia	2/30 (6.7%)	3	0/12 (0%)	0
Hyperphosphataemia	0/30 (0%)	0	1/12 (8.3%)	1
Hypoalbuminaemia	6/30 (20%)	10	2/12 (16.7%)	2
Hypocalcaemia	1/30 (3.3%)	1	1/12 (8.3%)	1
Hypokalaemia	5/30 (16.7%)	5	0/12 (0%)	0
Hypomagnesaemia	4/30 (13.3%)	4	1/12 (8.3%)	1
Hyponatraemia	3/30 (10%)	3	2/12 (16.7%)	6
Hypophosphataemia	3/30 (10%)	3	0/12 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	5/30 (16.7%)	7	1/12 (8.3%)	2
Back pain	2/30 (6.7%)	2	0/12 (0%)	0
Flank pain	2/30 (6.7%)	3	0/12 (0%)	0
Musculoskeletal pain	4/30 (13.3%)	4	0/12 (0%)	0
Myalgia	1/30 (3.3%)	1	2/12 (16.7%)	2
Neck pain	2/30 (6.7%)	2	0/12 (0%)	0
Pain in extremity	2/30 (6.7%)	2	1/12 (8.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain	0/30 (0%)	0	2/12 (16.7%)	2
Nervous system disorders
Dizziness	2/30 (6.7%)	2	1/12 (8.3%)	1
Dysgeusia	2/30 (6.7%)	3	0/12 (0%)	0
Headache	6/30 (20%)	6	0/12 (0%)	0
Hemiparesis	0/30 (0%)	0	1/12 (8.3%)	1
Hyperaesthesia	0/30 (0%)	0	1/12 (8.3%)	1
Neuralgia	0/30 (0%)	0	1/12 (8.3%)	1
Psychiatric disorders
Anxiety	3/30 (10%)	3	0/12 (0%)	0
Confusional state	2/30 (6.7%)	2	1/12 (8.3%)	1
Depression	0/30 (0%)	0	1/12 (8.3%)	2
Insomnia	4/30 (13.3%)	6	0/12 (0%)	0
Renal and urinary disorders
Proteinuria	2/30 (6.7%)	2	0/12 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	3/30 (10%)	4	0/12 (0%)	0
Dyspnoea	11/30 (36.7%)	17	5/12 (41.7%)	5
Dyspnoea exertional	0/30 (0%)	0	1/12 (8.3%)	1
Hiccups	1/30 (3.3%)	2	1/12 (8.3%)	1
Hypoxia	0/30 (0%)	0	1/12 (8.3%)	2
Oropharyngeal pain	0/30 (0%)	0	1/12 (8.3%)	1
Pleural effusion	7/30 (23.3%)	13	5/12 (41.7%)	7
Productive cough	2/30 (6.7%)	2	2/12 (16.7%)	2
Pulmonary hypertension	0/30 (0%)	0	1/12 (8.3%)	1
Rhinorrhoea	1/30 (3.3%)	1	1/12 (8.3%)	2
Wheezing	2/30 (6.7%)	2	0/12 (0%)	0
Skin and subcutaneous tissue disorders
Blister	1/30 (3.3%)	1	2/12 (16.7%)	2
Dry skin	3/30 (10%)	3	0/12 (0%)	0
Erythema	6/30 (20%)	8	2/12 (16.7%)	2
Photosensitivity reaction	7/30 (23.3%)	10	2/12 (16.7%)	4
Pruritus	1/30 (3.3%)	1	3/12 (25%)	4
Pruritus generalised	0/30 (0%)	0	1/12 (8.3%)	1
Rash	1/30 (3.3%)	1	1/12 (8.3%)	2
Rash macular	0/30 (0%)	0	1/12 (8.3%)	1
Rash maculo-papular	5/30 (16.7%)	5	4/12 (33.3%)	6
Subacute cutaneous lupus erythematosus	0/30 (0%)	0	1/12 (8.3%)	1
Vascular disorders
Flushing	1/30 (3.3%)	1	1/12 (8.3%)	1
Hypertension	4/30 (13.3%)	5	0/12 (0%)	0
Hypotension	4/30 (13.3%)	5	1/12 (8.3%)	2

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.