Study Stopped
Enrollment was stopped after the dose-limiting toxicity (DLT) evaluation phase of Cohort 2.
A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
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
2 other identifiers
interventional
42
5 countries
35
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2017
Typical duration for phase_1
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2017
CompletedFirst Posted
Study publicly available on registry
January 20, 2017
CompletedStudy Start
First participant enrolled
March 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2019
CompletedResults Posted
Study results publicly available
July 1, 2020
CompletedJuly 17, 2020
July 1, 2020
2.3 years
January 18, 2017
June 12, 2020
July 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Dose-limiting Toxicities (DLT)
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
Up to 12 weeks
Number of Participants With Adverse Events (AEs)
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.
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.
Secondary Outcomes (4)
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.
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.
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.
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.
Study Arms (3)
Rovalpituzumab Tesirine and Nivolumab
EXPERIMENTALParticipants 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.
Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg
EXPERIMENTALParticipants 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.
Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg
EXPERIMENTALParticipants 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.
Interventions
Administered by intravenous infusion
Administered by intravenous infusion
Administered by intravenous infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Has active, known, or suspected autoimmune disease
- Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- Bristol-Myers Squibbcollaborator
Study Sites (35)
Ucsd /Id# 161030
La Jolla, California, 92093, United States
Florida Hospital /ID# 161017
Orlando, Florida, 32803, United States
University Cancer & Blood Cent /ID# 161028
Athens, Georgia, 30607, United States
University of Chicago /ID# 161006
Chicago, Illinois, 60637-1443, United States
The University of Kansas Clini /ID# 162915
Fairway, Kansas, 66205, United States
Washington University-School of Medicine /ID# 161011
St Louis, Missouri, 63110, United States
Rutgers Cancer Institute of NJ /ID# 161032
New Brunswick, New Jersey, 08903, United States
Memorial Sloan Kettering Cancer Center /ID# 161010
New York, New York, 10065-6007, United States
Duke University Medical Center /ID# 161009
Durham, North Carolina, 27710-3000, United States
Oregon Health and Science University /ID# 161029
Portland, Oregon, 97239, United States
Medical University of South Carolina /ID# 161007
Charleston, South Carolina, 29425, United States
Tennessee Oncology, PLLC /ID# 161012
Nashville, Tennessee, 37203, United States
Vanderbilt University Med Ctr /ID# 162916
Nashville, Tennessee, 37232-6307, United States
Virginia Cancer Institute /ID# 161025
Richmond, Virginia, 23230, United States
University of Wisconsin Clinic /ID# 161013
Madison, Wisconsin, 53705, United States
CHU de Besancon - Jean Minjoz /ID# 165173
Besançon, Doubs, 25000, France
Centre Oscar Lambret /ID# 165169
Lille, Hauts-de-France, 59020, France
Institut Gustave Roussy /ID# 165168
Villejuif, Val-de-Marne, 94800, France
Institut Sainte Catherine /ID# 165172
Avignon, 84082, France
CHRU de Brest - Hospital Morva /ID# 165170
Brest, 29609, France
Hopital La Timone /ID# 165171
Marseille, 13005, France
KH Martha-Maria Halle Dolau /ID# 165180
Halle, Saxony-Anhalt, 06120, Germany
Asklepios Fachkliniken M. Gaut /ID# 165183
Gauting, 82131, Germany
Lungen Clinic Grosshansdorf /ID# 165182
Großhansdorf, 22927, Germany
Lungenfachklinik Immenhausen /ID# 165181
Immenhausen, 34376, Germany
Istituto Clinico Humanitas /ID# 165176
Rozzano, Milano, 20089, Italy
Centro di Riferimento Oncologi /ID# 165174
Aviano, 33081, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 165178
Catania, 95123, Italy
Istituto Europeo di Oncologia /ID# 165175
Milan, 20141, Italy
AO Univ di Modena /ID# 165177
Modena, 41100, Italy
Clinica Universitar de Navarra - Pamplona /ID# 165165
Pamplona, Navarra, Comunidad, 31008, Spain
Hosp Univ Quiron Dexues /ID# 165166
Barcelona, 08028, Spain
Hospital Genl Gregorio Maranon /ID# 165162
Madrid, 28007, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 165164
Madrid, 28040, Spain
Hospital Universitario Madrid /ID# 165163
Madrid, 28050, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2017
First Posted
January 20, 2017
Study Start
March 30, 2017
Primary Completion
July 3, 2019
Study Completion
July 3, 2019
Last Updated
July 17, 2020
Results First Posted
July 1, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.