Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors

Study Overview
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Brief Summary
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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
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Intervention model: Single group for Stage 1 DLT, then Parallel Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)

Official Title
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A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: Ulocuplumab
* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)<br>Small cell lung cancer (SCLC) | Drug: Ulocuplumab<br> <br> * Other names: BMS-936564;Drug: Nivolumab<br> <br> |
| Active Comparator: BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC)<br>Pancreatic cancer (PAC) | Drug: Ulocuplumab<br> <br> * Other names: BMS-936564;Drug: Nivolumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months) | 
| Number of Participants With Electrocardiogram Abnormalities | The number of participants experiencing electrocardiogram abnormalities was reported for each arm | From first dose to date of last dose plus 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From first dose to date of progression (assessed up to January 2017, approximately 18 months) |