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

NCT ID: NCT02913313

Last Updated: 2025-04-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2024-01-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Broad Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A: Dose Escalation Monotherapy

Group Type EXPERIMENTAL

BMS-986207

Intervention Type DRUG

Specified dose on specified days

Part 1B: Dose Escalation Combination Therapy

Group Type EXPERIMENTAL

BMS-986207

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2A: Expansion Monotherapy

Group Type EXPERIMENTAL

BMS-986207

Intervention Type DRUG

Specified dose on specified days

Part 2B: Expansion Combination Therapy

Group Type EXPERIMENTAL

BMS-986207

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 1C: Triplet Cohort

Group Type EXPERIMENTAL

BMS-986207

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Part 2C: Triplet Expansion

Group Type EXPERIMENTAL

BMS-986207

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Ipilimumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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BMS-986207

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Ipilimumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Other Intervention Names

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BMS-936558 Opdivo BMS-734016 Yervoy

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Hackensack, New Jersey, United States

Site Status

Local Institution - 0003

New York, New York, United States

Site Status

Local Institution - 0012

Philadelphia, Pennsylvania, United States

Site Status

Local Institution - 0002

Philadelphia, Pennsylvania, United States

Site Status

Local Institution - 0009

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0010

Salt Lake City, Utah, United States

Site Status

Local Institution - 0023

CABA, Buenos Aires F.D., Argentina

Site Status

Local Institution - 0019

Córdoba, Córdoba Province, Argentina

Site Status

Local Institution - 0022

Buenos Aires, Distrito Federal, Argentina

Site Status

Local Institution - 0006

Nedlands, Western Australia, Australia

Site Status

Local Institution - 0008

Ottawa, Ontario, Canada

Site Status

Local Institution - 0007

Toronto, Ontario, Canada

Site Status

Local Institution - 0021

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0004

Kashiwa-shi, Chiba, Japan

Site Status

Local Institution - 0005

Chuo-ku, Tokyo, Japan

Site Status

Local Institution - 0017

Bucharest, , Romania

Site Status

Local Institution - 0016

Cluj-Napoca, , Romania

Site Status

Local Institution - 0018

Craiova, , Romania

Site Status

Local Institution - 0015

Florești, , Romania

Site Status

Local Institution - 0020

Singapore, , Singapore

Site Status

Countries

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United States Argentina Australia Canada Chile Japan Romania Singapore

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2016-002263-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA020-002

Identifier Type: -

Identifier Source: org_study_id

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