An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors
2 other identifiers
interventional
295
10 countries
27
Brief Summary
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that have spread.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2015
Longer than P75 for phase_1
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2019
CompletedResults Posted
Study results publicly available
March 6, 2023
CompletedMarch 6, 2023
February 1, 2023
4.2 years
October 21, 2015
December 15, 2022
February 3, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.
From first treatment to 100 days post last dose. Approximately 29 months
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Number of Participants with laboratory abnormalities in specific thyroid tests. TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number
From first treatment to 100 days post last dose. Approximately 29 months
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Number of Participants with laboratory abnormalities in specific liver tests. ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase
From first treatment to 100 days post last dose. Approximately 29 months
Secondary Outcomes (5)
Best Overall Response
From first dose to a response or progressive disease (Approximately 50 Months)
Overall Response Rate
From first dose to CR and PR (Approximately 50 Months)
Progression Free Survival (PFS)
From first dose to disease progression (Approximately 50 Months)
Duration of Response
From first dose to disease progression after a response (Approximately 50 Months)
Number of Participants With Anti-Drug Antibody Response
At Cycle 3 Day 1; where each treatment cycle was 8 weeks
Study Arms (5)
BMS-986156: Dose Escalation
EXPERIMENTALBMS-986156 + nivolumab (nivo): Dose Escalation
EXPERIMENTALBMS-986156: Dose Expansion
EXPERIMENTALBMS-986156 + nivolumab (nivo): Dose Expansion
EXPERIMENTALBMS986156 + Nivo: Cohort Expansion
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- For Dose Escalation:
- Subjects with any previously treated advanced (metastatic or refractory) solid tumor
- For Cohort Expansion:
- Subjects must have a previously treated advanced solid tumor to be eligible
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
- Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
You may not qualify if:
- Known central nervous system metastases or central nervous system as the only source of disease
- Other concomitant malignancies (with some exceptions per protocol)
- Active, known or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- History of active or chronic hepatitis (e.g. Hep B or C)
- Impaired liver or bone marrow function
- Major surgery less than 1 month before start of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294-3300, United States
UCSD Moores Cancer Center
La Jolla, California, 92093-0698, United States
Emory University
Atlanta, Georgia, 30322, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
The West Clinic, P.C.
Germantown, Tennessee, 38138, United States
Liverpool Cancer Therapy Center
Liverpool, New South Wales, 2170, Australia
Local Institution
Westmead, New South Wales, 2145, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009, Australia
Local Institution - 0012
Ghent, 9000, Belgium
Local Institution
Edmonton, Alberta, T6G 1Z2, Canada
Local Institution
Toronto, Ontario, M5G 1Z5, Canada
Local Institution
Paris, 75248, France
Institut Claudius Regaud
Toulouse, 31059, France
Institut Gustave Roussy
Vlllejuif, 94800, France
Local Institution
Bonn, 53127, Germany
Local Institution
Freiburg im Breisgau, 79106, Germany
Local Institution
Würzburg, 97080, Germany
Local Institution - 0015
Milan, Lombardy, 20141, Italy
Local Institution - 0014
Milan, 20133, Italy
Local Institution
Amsterdam, 1066CX, Netherlands
Local Institution
Madrid, 28040, Spain
Local Institution
Madrid, 28041, Spain
Cantonal Hospital St. Gallen
Sankt Gallen, 9007, Switzerland
Local Institution
Zurich, 8091, Switzerland
Related Publications (2)
Wang R, Baxi V, Li Z, Locke D, Hedvat C, Sun Y, Walsh AM, Shao X, Basavanhally T, Greenawalt DM, Patah P, Novosiadly R. Pharmacodynamic activity of BMS-986156, a glucocorticoid-induced TNF receptor-related protein agonist, alone or in combination with nivolumab in patients with advanced solid tumors. ESMO Open. 2023 Apr;8(2):100784. doi: 10.1016/j.esmoop.2023.100784. Epub 2023 Feb 28.
PMID: 36863094DERIVEDHeinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):100-107. doi: 10.1001/jamaoncol.2019.3848.
PMID: 31697308DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2015
First Posted
November 6, 2015
Study Start
October 14, 2015
Primary Completion
December 16, 2019
Study Completion
December 16, 2019
Last Updated
March 6, 2023
Results First Posted
March 6, 2023
Record last verified: 2023-02