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

NCT02472977 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: CA212-1152015-000136-15
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 7

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Progression-Free Survival (PFS)

  From first dose to date of progression (assessed up to January 2017, approximately 18 months)

Study Arms (2)

BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)

ACTIVE COMPARATOR

Small cell lung cancer (SCLC)

Drug: Ulocuplumab; Drug: Nivolumab

BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC)

ACTIVE COMPARATOR

Pancreatic cancer (PAC)

Drug: Ulocuplumab; Drug: Nivolumab

Interventions

Ulocuplumab DRUG

Also known as: BMS-936564

BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC); BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)

Nivolumab DRUG

BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC); BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

University Of Colorado Hosp

Aurora, Colorado, 80045, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Columbia University Medical Center (Cumc)

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Local Institution

Helsinki, 00029, Finland

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Interventions

ulocuplumab; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: July 13, 2015
• Primary Completion: January 27, 2017
• Study Completion: January 27, 2017
• Last Updated: November 1, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-10

Locations

US (6); FI (1)