A Study of BMS-986207 Given Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors

NCT02913313 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CA020-0022016-002263-34
• Study Type: interventional
• Target: 101
• Locations: 8 countries
• Sites: 20

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.

Conditions

Broad Solid Tumor

Keywords

First line NSCLC

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Adverse Events

  An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.

  From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)

• Number of Participants Who Died

  Participants who died with any cause are considered in the analysis.

  From first dose (Day 1) untill 100 days after last dose (Up to approximately 27 months)

• Part 1A, 1B and 1C and 2A: Number of Participants With Dose Limiting Toxicities

  Criteria for Dose-Limiting Toxicities (DLTs): Hepatic DLTs (excluding HCC): Grade (Gr) 4 elevations in AST, ALT, ALP, or total bilirubin. Gr 3 elevations in AST, ALT, or ALP \>5 days, with symptoms, or bilirubin \>2xULN without cholestasis. Gr 2 AST or ALT with symptomatic liver inflammation. AST or ALT \>3xULN and bilirubin \>2xULN without cholestasis. Hepatic DLTs for HCC: AST or ALT \>10xULN for \>2 weeks. AST or ALT \>15xULN. Total bilirubin \>8xULN (elevated at entry) or \>5xULN (normal at entry). ALT ≥10xULN and bilirubin ≥2xULN or baseline, without other causes. Hematologic DLTs: Gr 4 neutropenia ≥7 days. Gr 4 thrombocytopenia. Gr 3 thrombocytopenia with bleeding or platelet transfusion. Febrile neutropenia. Gr 3 hemolysis requiring intervention. Gr 4 anemia not due to underlying disease. Dermatologic DLTs: Gr 4 rash. Gr 3 rash not improving to ≤Gr 1 after 1-2 week delay. Other DLTs: Gr 2-4 eye issues, Gr 3-4 toxicities, excluding specific Gr 3 events like nausea, fever.

  From first dose (Day 1) and up to 6 weeks

• Part 1A, 1B and 1C and 2A: Number of Participants With Grade 3/Grade 4 Laboratory Abnormalities

  Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.

  From first dose (Day 1) till 100 days after last dose (Up to approximately 27 months)

• Part 2C: Objective Response Rate (ORR)

  ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  From first dose (Day 1) and up to 24 weeks

• Part 2C: Duration of Response (DOR)

  DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  From first dose (Day 1) and up to 24 weeks

• Part 2C: Progression Free Survival Rate at Week 24

  Progression Free Survival Rates at 24 weeks is defined as the percentage of participants who achieve PFS at 24 weeks. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

  Week 24

Secondary Outcomes (13)

• Objective Response Rate (ORR)

  From first dose (Day 1) and up to 24 weeks

• Duration of Response

  From first dose (Day 1) and up to 24 weeks

• Progression Free Survival Rate at Week 24

  Week 24

• Maximum Observed Concentration (Cmax) of BMS-986207

  Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

• BMS-986207 Time to Maximum Concentration (Tmax)

  Day 1 of Cycle 1, Cycle 2 and Cycle 3 (Each cycle is of 8 weeks)

Study Arms (6)

Part 1A: Dose Escalation Monotherapy

EXPERIMENTAL

Drug: BMS-986207

Part 1B: Dose Escalation Combination Therapy

EXPERIMENTAL

Drug: BMS-986207; Biological: Nivolumab

Part 2A: Expansion Monotherapy

EXPERIMENTAL

Drug: BMS-986207

Part 2B: Expansion Combination Therapy

EXPERIMENTAL

Drug: BMS-986207; Biological: Nivolumab

Part 1C: Triplet Cohort

EXPERIMENTAL

Drug: BMS-986207; Biological: Nivolumab; Biological: Ipilimumab

Part 2C: Triplet Expansion

EXPERIMENTAL

Drug: BMS-986207; Biological: Nivolumab; Biological: Ipilimumab

Interventions

BMS-986207 DRUG

Specified dose on specified days

Part 1A: Dose Escalation Monotherapy; Part 1B: Dose Escalation Combination Therapy; Part 1C: Triplet Cohort; Part 2A: Expansion Monotherapy; Part 2B: Expansion Combination Therapy; Part 2C: Triplet Expansion

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Part 1B: Dose Escalation Combination Therapy; Part 1C: Triplet Cohort; Part 2B: Expansion Combination Therapy; Part 2C: Triplet Expansion

Ipilimumab BIOLOGICAL

Specified dose on specified days

Also known as: BMS-734016, Yervoy

Part 1C: Triplet Cohort; Part 2C: Triplet Expansion

Eligibility Criteria

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

You may qualify if:

• Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive ≥ 1% for a participant to be eligible for enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization

You may not qualify if:

• Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll
• Other active malignancy requiring concurrent intervention
• Uncontrolled or significant cardiovascular disease
• Active, known, or suspected autoimmune disease
• NSCLC without prior treatment in the advanced or metastatic setting (Part 2C)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (20)

Local Institution - 0001

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0003

New York, New York, 10032, United States

Location

Local Institution - 0012

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 0002

Philadelphia, Pennsylvania, 19111, United States

Location

Local Institution - 0009

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0010

Salt Lake City, Utah, 84112, United States

Location

Local Institution - 0023

CABA, Buenos Aires F.D., C1430EGF, Argentina

Location

Local Institution - 0019

Córdoba, Córdoba Province, X5002HWE, Argentina

Location

Local Institution - 0022

Buenos Aires, Distrito Federal, C1093AAS, Argentina

Location

Local Institution - 0006

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0008

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0007

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0021

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0004

Kashiwa-shi, Chiba, 2778577, Japan

Location

Local Institution - 0005

Chuo-ku, Tokyo, 1040045, Japan

Location

Local Institution - 0017

Bucharest, 022328, Romania

Location

Local Institution - 0016

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0018

Craiova, 200542, Romania

Location

Local Institution - 0015

Florești, 407280, Romania

Location

Local Institution - 0020

Singapore, 119074, Singapore

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab; Ipilimumab

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

Please email

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: November 30, 2016
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Locations

US (6); AR (3); SG (1); CA (2); CL (1); JP (2); AU (1); RO (4)