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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03956680
Recruitment Status : Active, not recruiting
First Posted : May 21, 2019
Last Update Posted : April 26, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Intervention/treatment Phase
Advanced Solid Cancers Drug: BMS-986301 Biological: Nivolumab Biological: Ipilimumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: N/A
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 26, 2019
Estimated Primary Completion Date : August 20, 2025
Estimated Study Completion Date : November 28, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Other Name: OPDIVO

Biological: Ipilimumab
Specified dose on specified days
Other Name: YERVOY
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
Other Name: OPDIVO

Biological: Ipilimumab
Specified dose on specified days
Other Name: YERVOY
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
Other Name: OPDIVO

Biological: Ipilimumab
Specified dose on specified days
Other Name: YERVOY
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
Other Name: OPDIVO

Biological: Ipilimumab
Specified dose on specified days
Other Name: YERVOY
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
Other Name: OPDIVO

Biological: Ipilimumab
Specified dose on specified days
Other Name: YERVOY


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

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956680


Locations
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United States, Illinois
Local Institution - 0003
Chicago, Illinois, United States, 60637
United States, Missouri
Local Institution - 0005
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Local Institution - 0006
Pittsburgh, Pennsylvania, United States, 15232-1305
United States, Tennessee
Local Institution - 0002
Nashville, Tennessee, United States, 37232
Canada, Ontario
Local Institution - 0001
Toronto, Ontario, Canada, M5G 1Z5
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03956680    
Other Study ID Numbers: CA046-006
2018-003610-41 ( EudraCT Number )
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: April 26, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action