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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

  • Clinicaltrials.gov identifier

    NCT03956680

  • Recruitment Status

    Recruiting

  • First Posted

    May 21, 2019

  • Last update posted

    October 4, 2021

Study Description

Brief 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.

  • Condition or Disease:Advanced Solid Cancers
  • Intervention/Treatment: Drug: BMS-986301
    Biological: Nivolumab
    Biological: Ipilimumab
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 190 participants
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: November 2022
  • Estimated Study Completion Date: July 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1A Group 1: BMS-986301 Monotherapy Intramuscular (IM)
Drug: BMS-986301
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 1A Group 2: BMS-986301 Monotherapy Intratumoral (I-TUMOR) Sub-study
Drug: BMS-986301
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 1A Group 3: BMS-986301 Monotherapy Intravenous (IV) Sub-study
Drug: BMS-986301
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 1B Group 4: Systemic BMS-986301 + Nivolumab + Ipilimumab
Drug: BMS-986301
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days
Experimental: Part 1B Group 5: I-TUMOR BMS-986301 + Nivolumab + Ipilimumab
Drug: BMS-986301
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days

Biological: Ipilimumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 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) ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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 could apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, Please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Illinois
The University of Chicago Medicine
Chicago

United States, Missouri
Washington University School OF Medicine-Siteman Cancer Center
Saint Louis

United States, Pennsylvania
UPMC Hillman Cancer Center
Pittsburgh

United States, Texas
MD Anderson Cancer Center
Houston

Canada, Ontario
Local Institution
Toronto

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03956680 History of Changes
  • Other Study ID Numbers: CA046-006, 2018-003610-41
  • First Posted: May 21, 2019 Key Record Dates
  • Last Update Posted: October 4, 2021
  • Last Verified: October 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No