Status:
COMPLETED
Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors.
Eligibility Criteria
Inclusion
- Participants must have histologic confirmation of advanced (metastatic, recurrent, and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per RECIST 1.1
- Participants expected to have received standard of care therapies including an available PD-(L)1 inhibitor
- Eastern cooperative oncology group performance status of 0 or 1
- Women of childbearing potential must agree to follow methods of contraception
Exclusion
- Participants with active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
- Uncontrolled or significant cardiovascular disease
- History of or with active interstitial lung disease or pulmonary fibrosis
- Prior participation in anti-natural killer cell receptor (anti-NKG2A) clinical study
- History of allergy or hypersensitivity to study drug components
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04349267
Start Date
July 14 2020
End Date
August 22 2024
Last Update
December 17 2025
Active Locations (8)
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1
Local Institution - 0028
Sioux Falls, South Dakota, United States, 57104
2
Local Institution - 0001
Germantown, Tennessee, United States, 38138
3
Local Institution - 0014
Edmonton, Alberta, Canada, T6X 1E8
4
Local Institution - 0011
Vancouver, British Columbia, Canada, V5Z 4E6