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Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

NCT ID: NCT04349267

Last Updated: 2025-12-17

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-14

Study Completion Date

2024-08-22

Brief Summary

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The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.

Detailed Description

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Conditions

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Advanced 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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BMS-986315

Group Type EXPERIMENTAL

BMS-986315

Intervention Type BIOLOGICAL

Specified dose on specified days

BMS-986315 + nivolumab

Group Type EXPERIMENTAL

BMS-986315

Intervention Type BIOLOGICAL

Specified dose on specified days

nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

BMS-986315 + cetuximab

Group Type EXPERIMENTAL

BMS-986315

Intervention Type BIOLOGICAL

Specified dose on specified days

cetuximab

Intervention Type BIOLOGICAL

Specified dose on specified days

Interventions

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BMS-986315

Specified dose on specified days

Intervention Type BIOLOGICAL

nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

cetuximab

Specified dose on specified days

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
* Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor
* Eastern cooperative oncology group performance status of 0 or 1
* Women of childbearing potential must agree to follow methods of contraception

Exclusion Criteria

* Participants with active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
* Uncontrolled or significant cardiovascular disease
* History of or with active interstitial lung disease or pulmonary fibrosis
* Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study
* History of allergy or hypersensitivity to study drug components
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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 - 0028

Sioux Falls, South Dakota, United States

Site Status

Local Institution - 0001

Germantown, Tennessee, United States

Site Status

Local Institution - 0014

Edmonton, Alberta, Canada

Site Status

Local Institution - 0011

Vancouver, British Columbia, Canada

Site Status

Local Institution - 0004

Toronto, Ontario, Canada

Site Status

Local Institution - 0005

Montreal, Quebec, Canada

Site Status

Local Institution - 0013

Ottawa, , Canada

Site Status

Local Institution

Mexico City, Mexico City, Mexico

Site Status

Countries

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United States Canada Mexico

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

https://www.bmsclinicaltrials.com/us/en/home

BMS Clinical Trial Patient Recruiting

Other Identifiers

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CA047-004

Identifier Type: -

Identifier Source: org_study_id