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An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

NCT ID: NCT03956680

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2024-04-24

Brief Summary

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The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, best route of administration, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab in participants with cancers that have failed to respond to T cell checkpoint inhibiting antibodies.

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Detailed Description

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Conditions

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Advanced Solid Cancers

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)

Group Type EXPERIMENTAL

BMS-986301

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 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study

Group Type EXPERIMENTAL

BMS-986301

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 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study

Group Type EXPERIMENTAL

BMS-986301

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 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab

Group Type EXPERIMENTAL

BMS-986301

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 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab

Group Type EXPERIMENTAL

BMS-986301

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-986301

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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OPDIVO YERVOY

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed advanced unresectable/metastatic malignancy of the squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), triple negative breast cancer (TNBC), and urothelial carcinoma (UCC), that are refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
* Must have experienced radiographically documented progressive disease on or after the most recent therapy
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria

* Primary central nervous system (CNS) malignancy
* Other active malignancy requiring concurrent intervention
* Uncontrolled or significant cardiovascular disease
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 - 0003

Chicago, Illinois, United States

Site Status

Local Institution - 0005

St Louis, Missouri, United States

Site Status

Local Institution - 0006

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0002

Nashville, Tennessee, United States

Site Status

Local Institution - 0001

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

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

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2018-003610-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA046-006

Identifier Type: -

Identifier Source: org_study_id

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