Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors
- Registration Number
- NCT02472977
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.
- Detailed Description
* Intervention model: Single group for Stage 1 DLT, then Parallel
* Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 61
- SCLC or PAC that is advanced or has spread to other parts of the body
- Treated with at least one other chemotherapy that did not work or where cancer relapsed
- Minimal limitations on activities of daily living as measured by Eastern Cooperative Oncology Group (ECOG) score of 0-1
- Patients with cancer that spread to the brain
- Active, known or suspected autoimmune disease
- Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC) Nivolumab Small cell lung cancer (SCLC) BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC) Nivolumab Pancreatic cancer (PAC) BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC) Ulocuplumab Small cell lung cancer (SCLC) BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC) Ulocuplumab Pancreatic cancer (PAC)
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months) The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.
Objective Response Rate (ORR) Per RECIST 1.1 Criteria From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months) ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.
Overall Survival (OS) From date of randomization to date of death (assessed up to study completion, approximately 18 months) If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.
Number of Participants With Laboratory Abnormalities From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months) The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.
Number of Participants With Electrocardiogram Abnormalities From first dose to date of last dose plus 30 days The number of participants experiencing electrocardiogram abnormalities was reported for each arm
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) From first dose to date of progression (assessed up to January 2017, approximately 18 months) Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.
Trial Locations
- Locations (7)
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University Of Colorado Hosp
🇺🇸Aurora, Colorado, United States
Columbia University Medical Center (Cumc)
🇺🇸New York, New York, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Local Institution
🇫🇮Helsinki, Finland
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States