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| Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors |
| Clinicaltrials.gov identifier | recruitment status | First Posted | Last update posted |
| NCT04349267 | Recruiting | April 16, 2020 | June 24, 2022 |
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| study description |
| Brief Summary |
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The purpose of this study is to evaluate BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors. |
| Condition or Disease: | Advanced Solid Tumor |
| Intervention/treatment: |
Biological: BMS-986315 Biological: nivolumab Biological: cetuximab |
| Phase: | Phase 1/Phase 2 |
| Detailed Description |
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N/A |
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| study design | ||||||||||||||||||||
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| Arms and interventions |
| Arm | Intervention/treatment |
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Experimental: BMS-986315 |
Biological: BMS-986315 Specified dose on specified days |
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Experimental: BMS-986315 + cetuximab |
Biological: BMS-986315 Specified dose on specified days Biological: cetuximab Specified dose on specified days |
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Experimental: BMS-986315 + nivolumab |
Biological: BMS-986315 Specified dose on specified days Biological: nivolumab Specified dose on specified days |
| outcome measures |
| Primary Outcome Measures: |
1. Incidence of adverse events (AEs) [ Time Frame: Up to 119 weeks ] |
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2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 119 weeks ] |
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3. Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria [ Time Frame: Up to 119 weeks ] |
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4. Incidence of adverse events (AEs) leading to discontinuation [ Time Frame: Up to 119 weeks ] |
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5. Number of deaths [ Time Frame: Up to 119 weeks ] |
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| Secondary Outcome Measures: |
1. Objective Response Rate (ORR) [ Time Frame: Up to 12 months ] |
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2. Duration of Response (DOR) [ Time Frame: Up to 12 months ] |
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3. Progression-Free Survival Rate (PFSR) [ Time Frame: Up to 12 months ] |
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4. Maximum observed serum concentration (Cmax) of BMS-986315 [ Time Frame: Up to 16 weeks ] |
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5. Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ] |
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6. Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ] |
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7. Time of maximum observed serum concentration (Tmax) of BMS-986315 [ Time Frame: Up to 16 weeks ] |
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8. Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ] |
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9. Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ] |
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10. 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 16 weeks ] |
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11. 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 16 weeks ] |
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12. 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 16 weeks ] |
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13. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 [ Time Frame: Up to 16 weeks ] |
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14. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ] |
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15. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ] |
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16. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 [ Time Frame: Up to 16 weeks ] |
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17. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with nivolumab [ Time Frame: Up to 16 weeks ] |
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18. Observed serum concentration at the end of a dosing interval (Ctau) of BMS-986315 with cetuximab [ Time Frame: Up to 16 weeks ] |
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19. Trough observed serum concentrations (Ctrough) of BMS-986315 [ Time Frame: Up to 119 weeks ] |
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20. Incidence of anti-drug antibodies to BMS-986315 [ Time Frame: Up to 119 weeks ] |
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21. Incidence of anti-drug antibodies to BMS-986315 with nivolumab [ Time Frame: Up to 119 weeks ] |
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22. Incidence of anti-drug antibodies to BMS-986315 with cetuximab [ Time Frame: Up to 119 weeks ] |
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| Eligibility Criteria |
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Criteria |
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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 Women of childbearing potential 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-natural killer cell receptor (anti-NKG2A) clinical study History of allergy or hypersensitivity to study drug components Other protocol-defined inclusion/exclusion criteria apply |
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| Contacts and Locations |
| Contacts |
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com Contact: First line of the email MUST contain NCT # and Site #. |
| Locations |
| United States, Maryland | Local Institution | Baltimore |
| United States, South Dakota | Sanford Clinic Clinical Research | Sioux Falls |
| United States, Tennessee | The West Clinic, P.C. | Germantown |
| Argentina, Distrito Federal | Local Institution | Capital Federal |
| Canada, British Columbia | Local Institution - 0011 | Vancouver |
| Canada, British Columbia | Local Institution | Vancouver |
| Canada, Ontario | Local Institution | Ottawa |
| Canada, Ontario | Local Institution | Toronto |
| Canada, Quebec | Local Institution | Montreal |
| Canada | Local Institution - 0014 | Edmonton |
| Canada | Local Institution - 0013 | Ottawa |
| Chile, Metropolitana | Local Institution | Recoleta |
| Mexico, Distrito Federal | Local Institution | Mexico city |
| Mexico, Nuevo LEON | Local Institution | Monterrey |
| Mexico | Local Institution | San Luis Potosi |
| Sponsors and Collaborators |
| Bristol-Myers Squibb |
| Investigator | ||
| Study Director : | Bristol-Myers Squibb | Bristol-Myers Squibb |
| More Information | |||
| Responsible Party : | Bristol-Myers Squibb | ||
| ClinicalTrials.gov Identifier : | NCT04349267 | ||
| Other Study ID Numbers : | CA047-004 | ||
| First Posted : | April 16, 2020 | ||
| Last Update Posted : | June 24, 2022 | ||
| Last Verified : | June 2022 | ||
| Studies a U.S. FDA-regulated Drug Product: | Yes | ||
| Studies a U.S. FDA-regulated Device Product: | No | ||
| Keywords provided by Bristol-Myers Squibb: |
NSCLC (Non-small cell lung cancer) RCC (Renal cell carcinoma) SCCHN (Squamous cell carcinoma of the head and neck) |
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| Additional relevant MeSH terms : |
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