First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Cancer

In brief

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

Key facts

Study ID

NCT03110107

Run by

Bristol-Myers Squibb

People needed

376

Starts

2017-05-04

Expected to finish

2024-04-04

Last updated by the study team

2025-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
• Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
• Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B \& 2C)
• Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)

You may not qualify if…

• Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
• Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
• Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0025 — Boston, Massachusetts, United States
• Local Institution - 0002 — Hackensack, New Jersey, United States
• Local Institution - 0028 — New Brunswick, New Jersey, United States
• Local Institution - 0001 — New York, New York, United States
• Local Institution - 0007 — New York, New York, United States
• Local Institution - 0015 — Monroeville, Pennsylvania, United States
• Local Institution - 0004 — Philadelphia, Pennsylvania, United States
• Local Institution - 0033 — Sioux Falls, South Dakota, United States
• Local Institution - 0042 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0053 — ABB, Buenos Aires F.D., Argentina
• Local Institution - 0057 — CABA, Buenos Aires F.D., Argentina
• Local Institution - 0062 — Córdoba, Córdoba Province, Argentina
• Local Institution - 0060 — Río Cuarto, Córdoba Province, Argentina
• Local Institution - 0047 — Villa Siburu, Córdoba Province, Argentina
• Local Institution - 0059 — Buenos Aires, Distrito Federal, Argentina
• Local Institution - 0026 — Northmead, New South Wales, Australia
• Local Institution - 0006 — Wollstonecraft, New South Wales, Australia
• Local Institution - 0049 — Murdoch, Western Australia, Australia
• Local Institution - 0039 — Ghent, Belgium
• Local Institution - 0037 — Edmonton, Alberta, Canada
• Local Institution - 0023 — Vancouver, British Columbia, Canada
• Local Institution - 0027 — Ottawa, Ontario, Canada
• Local Institution - 0022 — Toronto, Ontario, Canada
• Local Institution - 0048 — Santiago, Santiago Metropolitan, Chile
• Local Institution - 0058 — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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