Clinical trial NCT02598960: 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.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-11-06
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
timeFrame: From first treatment to 100 days post last dose. Approximately 29 months
measure: Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first treatment to 100 days post last dose. Approximately 29 months
measure: Number of Participants With Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first treatment to 100 days post last dose. Approximately 29 months
Secondary outcomes:
measure: Best Overall Response
timeFrame: From first dose to a response or progressive disease (Approximately 50 Months)
measure: Overall Response Rate
timeFrame: From first dose to CR and PR (Approximately 50 Months)
measure: Progression Free Survival (PFS)
timeFrame: From first dose to disease progression (Approximately 50 Months)
measure: Duration of Response
timeFrame: From first dose to disease progression after a response (Approximately 50 Months)
measure: Number of Participants With Anti-Drug Antibody Response
timeFrame: At Cycle 3 Day 1; where each treatment cycle was 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic, P.C.
state: Tennessee
city: Liverpool
country: Australia
facility: Liverpool Cancer Therapy Center
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Nedlands
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
city: Gent
country: Belgium
facility: Local Institution - 0012
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Paris Cedex 5
country: France
facility: Local Institution
city: Toulouse Cedex 9
country: France
facility: Institut Claudius Regaud
city: Vlllejuif
country: France
facility: Institut Gustave Roussy
city: Bonn
country: Germany
facility: Local Institution
city: Freiburg
country: Germany
facility: Local Institution
city: Wuerzburg
country: Germany
facility: Local Institution
city: Milan
country: Italy
facility: Local Institution - 0015
state: Lombardia
city: Milano
country: Italy
facility: Local Institution - 0014
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
city: Zurich
country: Switzerland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Heinhuis 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.