Skip to main content
OpenTrials
Completed

NCT Number: NCT03956680

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Other protocol defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986301

Drug

Specified dose on specified days

Nivolumab

Biological

Specified dose on specified days

Other names: OPDIVO

Ipilimumab

Biological

Specified dose on specified days

Other names: YERVOY

Primary outcomes

  1. Incidence of dose-limiting toxicity (DLTs)

    Time frame: Cycle 1 (28 days)

  2. Incidence of adverse events (AEs)

    Time frame: From Baseline until study exit (up to approximately 2 years)

  3. Incidence of serious adverse events (SAEs)

    Time frame: From Baseline until study exit (up to approximately 2 years)

  4. Incidence of AEs leading to discontinuation

    Time frame: From Baseline until study exit (up to approximately 2 years)

  5. Incidence of deaths

    Time frame: From Baseline until study exit (up to approximately 2 years)

  6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Time frame: From Baseline until disease progression (approximately 2 years)

  7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Time frame: From Baseline until disease progression (approximately 2 years)

  8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Time frame: From Baseline until disease progression (approximately 2 years)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 21, 2019
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.