Clinical trial NCT02472977: Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors
Official title: A Phase 1/2 Study of the Safety and Efficacy of Ulocuplumab Combined With Nivolumab in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-06-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs
timeFrame: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
measure: Objective Response Rate (ORR) Per RECIST 1.1 Criteria
timeFrame: From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)
measure: Overall Survival (OS)
timeFrame: From date of randomization to date of death (assessed up to study completion, approximately 18 months)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)
measure: Number of Participants With Electrocardiogram Abnormalities
timeFrame: From first dose to date of last dose plus 30 days
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From first dose to date of progression (assessed up to January 2017, approximately 18 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University Of Colorado Hosp
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
state: Maryland
city: New York
country: United States
facility: Columbia University Medical Center (Cumc)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Helsinki
country: Finland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: