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.
* Intervention model: Single group for Stage 1 DLT, then Parallel * Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
61
University Of Colorado Hosp
Aurora, Colorado, United States
Indiana University Health
Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
Columbia University Medical Center (Cumc)
New York, New York, United States
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs
The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.
Time frame: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
Objective Response Rate (ORR) Per RECIST 1.1 Criteria
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.
Time frame: From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)
Overall Survival (OS)
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.
Time frame: From date of randomization to date of death (assessed up to study completion, approximately 18 months)
Number of Participants With Laboratory Abnormalities
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.
Time frame: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Local Institution
Helsinki, Finland
Number of Participants With Electrocardiogram Abnormalities
The number of participants experiencing electrocardiogram abnormalities was reported for each arm
Time frame: From first dose to date of last dose plus 30 days
Progression-Free Survival (PFS)
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.
Time frame: From first dose to date of progression (assessed up to January 2017, approximately 18 months)