Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT04349267 |
Recruitment Status :
Recruiting
First Posted : April 16, 2020
Last Update Posted : October 22, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumor | Biological: BMS-986315 Biological: nivolumab Biological: cetuximab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 308 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors |
Actual Study Start Date : | July 14, 2020 |
Estimated Primary Completion Date : | April 14, 2024 |
Estimated Study Completion Date : | April 15, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: BMS-986315 |
Biological: BMS-986315
Specified dose on specified days |
Experimental: BMS-986315 + nivolumab |
Biological: BMS-986315
Specified dose on specified days Biological: nivolumab Specified dose on specified days |
Experimental: BMS-986315 + cetuximab |
Biological: BMS-986315
Specified dose on specified days Biological: cetuximab Specified dose on specified days |
- Incidence of adverse events (AEs) [ Time Frame: Up to 119 weeks ]
- Incidence of serious adverse events (SAEs) [ Time Frame: Up to 119 weeks ]
- Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria [ Time Frame: Up to 119 weeks ]
- Incidence of adverse events (AEs) leading to discontinuation [ Time Frame: Up to 119 weeks ]
- Number of deaths [ Time Frame: Up to 119 weeks ]
- Objective Response Rate (ORR) [ Time Frame: Up to 12 months ]
- Duration of Response (DOR) [ Time Frame: Up to 12 months ]
- Progression-Free Survival Rate (PFSR) [ Time Frame: Up to 12 months ]
- Maximum observed serum concentration (Cmax) of BMS-986315 [ Time Frame: Up to 120 weeks ]
- Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab [ Time Frame: Up to 120 weeks ]
- Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab [ Time Frame: Up to 120 weeks ]
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 [ Time Frame: Up to 120 weeks ]
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab [ Time Frame: Up to 120 weeks ]
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab [ Time Frame: Up to 120 weeks ]
- Time of maximum observed serum concentration (Tmax) of BMS-986315 [ Time Frame: Up to 120 weeks ]
- Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab [ Time Frame: Up to 120 weeks ]
- Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab [ Time Frame: Up to 120 weeks ]
- Incidence of anti-drug antibodies to BMS-986315 [ Time Frame: Up to 120 weeks ]
- Incidence of anti-drug antibodies to BMS-986315 with nivolumab [ Time Frame: Up to 120 weeks ]
- Incidence of anti-drug antibodies to BMS-986315 with cetuximab [ Time Frame: Up to 120 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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
- Men and women must agree to follow methods of contraception
Exclusion Criteria:
- 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-NKG2A clinical study
- History of allergy or hypersensitivity to study drug components
Other protocol-defined inclusion/exclusion criteria apply

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): NCT04349267
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 #. |
United States, Maryland | |
Local Institution | Withdrawn |
Baltimore, Maryland, United States, 21287 | |
United States, Tennessee | |
The West Clinic, P.C. | Recruiting |
Germantown, Tennessee, United States, 38138 | |
Contact: Daniel Vaena, Site 0001 901-683-0055 | |
Canada, British Columbia | |
Local Institution | Not yet recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Site 0009 | |
Canada, Ontario | |
Local Institution | Not yet recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Site 0010 | |
Local Institution | Not yet recruiting |
Toronto, Ontario, Canada, M5G 1Z5 | |
Contact: Site 0004 | |
Canada, Quebec | |
Local Institution | Recruiting |
Montreal, Quebec, Canada, H2X 3E4 | |
Contact: Site 0005 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT04349267 |
Other Study ID Numbers: |
CA047-004 |
First Posted: | April 16, 2020 Key Record Dates |
Last Update Posted: | October 22, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
NSCLC (Non-small cell lung cancer) RCC (Renal cell carcinoma) SCCHN (Squamous cell carcinoma of the head and neck) |
Neoplasms Nivolumab Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |