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COMPLETEDPHASE1

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

A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

NCT03956680•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (5)

Local Institution - 0003

Chicago, Illinois, United States

Local Institution - 0005

St Louis, Missouri, United States

Local Institution - 0006

Pittsburgh, Pennsylvania, United States

Local Institution - 0002

Nashville, Tennessee, United States

Local Institution - 0001

Toronto, Ontario, Canada

Key Dates

Start Date

March 26, 2019

Primary Completion Date

April 17, 2024

Completion Date

April 24, 2024

Last Updated

February 19, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Solid Cancers

Interventions

BMS-986301

DRUG

Nivolumab

BIOLOGICAL

Ipilimumab

BIOLOGICAL

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

NCT07186842

Advanced Solid Cancers

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TERMINATEDPHASE1/PHASE2

A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

NCT00886782

Advanced Solid CancersMetastatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9

A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers