Back to resultsA Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Nivolumab
Rovalpituzumab tesirine
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Cancer, Extensive-Stage Small Cell Lung Cancer, Nivolumab, Ipilimumab, Rovalpituzumab tesirine
Eligibility Criteria
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
Sites / Locations
- Ucsd /Id# 161030
- Florida Hospital /ID# 161017
- University Cancer & Blood Cent /ID# 161028
- University of Chicago /ID# 161006
- The University of Kansas Clini /ID# 162915
- Washington University-School of Medicine /ID# 161011
- Rutgers Cancer Institute of NJ /ID# 161032
- Memorial Sloan Kettering Cancer Center /ID# 161010
- Duke University Medical Center /ID# 161009
- Oregon Health and Science University /ID# 161029
- Medical University of South Carolina /ID# 161007
- Tennessee Oncology, PLLC /ID# 161012
- Vanderbilt University Med Ctr /ID# 162916
- Virginia Cancer Institute /ID# 161025
- University of Wisconsin Clinic /ID# 161013
- CHU de Besancon - Jean Minjoz /ID# 165173
- Centre Oscar Lambret /ID# 165169
- Institut Gustave Roussy /ID# 165168
- Institut Sainte Catherine /ID# 165172
- CHRU de Brest - Hospital Morva /ID# 165170
- Hopital La Timone /ID# 165171
- KH Martha-Maria Halle Dolau /ID# 165180
- Asklepios Fachkliniken M. Gaut /ID# 165183
- Lungen Clinic Grosshansdorf /ID# 165182
- Lungenfachklinik Immenhausen /ID# 165181
- Istituto Clinico Humanitas /ID# 165176
- Centro di Riferimento Oncologi /ID# 165174
- Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 165178
- Istituto Europeo di Oncologia /ID# 165175
- AO Univ di Modena /ID# 165177
- Clinica Universitar de Navarra - Pamplona /ID# 165165
- Hosp Univ Quiron Dexues /ID# 165166
- Hospital Genl Gregorio Maranon /ID# 165162
- Hospital Universitario Fundacion Jimenez Diaz /ID# 165164
- Hospital Universitario Madrid /ID# 165163
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Rovalpituzumab Tesirine and Nivolumab
Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg
Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Objective Response Rate (ORR)
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.
Duration of Response (DOR)
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.
Progression-free Survival (PFS)
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.
Overall Survival (OS)
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.
Full Information
NCT ID
NCT03026166
First Posted
January 18, 2017
Last Updated
July 1, 2020
Sponsor
AbbVie
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT03026166
Brief Title
A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was stopped after the dose-limiting toxicity (DLT) evaluation phase of Cohort 2.
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
July 3, 2019 (Actual)
Study Completion Date
July 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Bristol-Myers Squibb
4. Oversight
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
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Cancer, Extensive-Stage Small Cell Lung Cancer, Nivolumab, Ipilimumab, Rovalpituzumab tesirine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rovalpituzumab Tesirine and Nivolumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 1 mg/kg
Arm Type
Experimental
Arm Description
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.
Arm Title
Rovalpituzumab Tesirine and Nivolumab + Ipilimumab 3 mg/kg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy®
Intervention Description
Administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo®
Intervention Description
Administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Rovalpituzumab tesirine
Other Intervention Name(s)
SC16LD6.5
Intervention Description
Administered by intravenous infusion
Primary Outcome Measure Information:
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
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.
Secondary Outcome Measure Information:
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.
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.
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Ucsd /Id# 161030
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Florida Hospital /ID# 161017
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University Cancer & Blood Cent /ID# 161028
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
University of Chicago /ID# 161006
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
The University of Kansas Clini /ID# 162915
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Washington University-School of Medicine /ID# 161011
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers Cancer Institute of NJ /ID# 161032
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center /ID# 161010
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Facility Name
Duke University Medical Center /ID# 161009
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
Facility Name
Oregon Health and Science University /ID# 161029
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Medical University of South Carolina /ID# 161007
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Tennessee Oncology, PLLC /ID# 161012
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Med Ctr /ID# 162916
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Virginia Cancer Institute /ID# 161025
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
University of Wisconsin Clinic /ID# 161013
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
CHU de Besancon - Jean Minjoz /ID# 165173
City
Besancon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Facility Name
Centre Oscar Lambret /ID# 165169
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59020
Country
France
Facility Name
Institut Gustave Roussy /ID# 165168
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Institut Sainte Catherine /ID# 165172
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
CHRU de Brest - Hospital Morva /ID# 165170
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Facility Name
Hopital La Timone /ID# 165171
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
KH Martha-Maria Halle Dolau /ID# 165180
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
Asklepios Fachkliniken M. Gaut /ID# 165183
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Lungen Clinic Grosshansdorf /ID# 165182
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Lungenfachklinik Immenhausen /ID# 165181
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Istituto Clinico Humanitas /ID# 165176
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Centro di Riferimento Oncologi /ID# 165174
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 165178
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Istituto Europeo di Oncologia /ID# 165175
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
AO Univ di Modena /ID# 165177
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Clinica Universitar de Navarra - Pamplona /ID# 165165
City
Pamplona
State/Province
Navarra, Comunidad
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hosp Univ Quiron Dexues /ID# 165166
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Genl Gregorio Maranon /ID# 165162
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 165164
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Madrid /ID# 165163
City
Madrid
ZIP/Postal Code
28050
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Learn more about this trial
A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
We'll reach out to this number within 24 hrs