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

Phase 1

Terminated

• Conditions: Advanced Cancer
• Interventions: Biological: BMS-986218; Biological: Ipilimumab; Biological: Nivolumab

• Registration Number: NCT03110107
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-12
• Study Start: 2017-05-04
• Status Verified: 2024-04
• Primary Completion: 2024-04-04
• Study Completion: 2024-04-04
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 512

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1B: Combination Therapy (BMS-986218 + Nivolumab)	Nivolumab	-
Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab)	BMS-986218	-
Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab)	Nivolumab	-
Part 1A: Monotherapy (BMS-986218)	BMS-986218	-
Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)	BMS-986218	-
Part 1B: Combination Therapy (BMS-986218 + Nivolumab)	BMS-986218	-
Part 2A: Monotherapy (BMS-986218 OR Ipilimumab)	Ipilimumab	-
Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab)	BMS-986218	-
Part 2B: Monotherapy (BMS-986218)	BMS-986218	-
Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab)	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Up to 2 years
Incidence of AEs meeting protocol- defined dose-limiting toxicity (DLT) criteria	Up to 2 years
Incidence of AEs leading to discontinuation	Up to 2 years
Objective Response Rate (ORR)	Up to 4 years	Parts 2A, 2B, 2C and 2D
Incidence of death	Up to 2 years
Progression Free Survival Rate (PFSR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Up to 4 years	Parts 2A, 2B, 2C and 2D
Incidence of Serious Adverse Events (SAEs)	Up to 2 years
Median Duration of Response (mDOR)	Up to 4 years	Parts 2A, 2B, 2C and 2D

Secondary Outcome Measures

Name	Time	Method
mDOR	Up to 4 years	Parts 1A and 1B
PFSR by RECIST v1.1	Up to 4 years	Parts 1A and 1B
Incidence of anti-drug antibody (ADA)	Up to 4 years
Maximum observed plasma concentration (Cmax)	Up to 4 years
Trough observed serum concentration (Ctrough)	Up to 4 years
ORR	Up to 4 years	Parts 1A and 1B
Time of maximum observed plasma concentration (Tmax)	Up to 4 years

Trial Locations

Locations (52)

Local Institution - 0028; 🇺🇸 New Brunswick, New Jersey, United States

Local Institution - 0010; 🇮🇹 Siena, Italy

Local Institution - 0004; 🇺🇸 Philadelphia, Pennsylvania, United States

Local Institution - 0026; 🇦🇺 Northmead, New South Wales, Australia

Local Institution - 0022; 🇨🇦 Toronto, Ontario, Canada

Local Institution - 0056; 🇪🇸 Madrid, Spain

Local Institution - 0062; 🇦🇷 Córdoba, Cordoba, Argentina

Local Institution - 0034; 🇷🇴 Cluj Napoca, Romania

Local Institution - 0058; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0025; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0002; 🇺🇸 Hackensack, 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 - 0033; 🇺🇸 Sioux Falls, South Dakota, United States

Local Institution - 0042; 🇦🇷 Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina

Local Institution - 0053; 🇦🇷 ABB, Ciudad Autónoma De Buenos Aires, Argentina

Local Institution - 0057; 🇦🇷 Caba, Ciudad Autónoma De Buenos Aires, Argentina

Local Institution - 0060; 🇦🇷 Rio Cuarto, Cordoba, Argentina

Local Institution - 0059; 🇦🇷 Buenos Aires, Distrito Federal, Argentina

Local Institution - 0047; 🇦🇷 Villa Siburu, Cordoba, Argentina

Local Institution - 0037; 🇨🇦 Edmonton, Alberta, Canada

Local Institution - 0006; 🇦🇺 Wollstonecraft, New South Wales, Australia

Local Institution - 0049; 🇦🇺 Murdoch, Western Australia, Australia

Local Institution - 0039; 🇧🇪 Gent, Belgium

Local Institution - 0023; 🇨🇦 Vancouver, British Columbia, Canada

Local Institution - 0027; 🇨🇦 Ottawa, Ontario, Canada

Local Institution - 0048; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0041; 🇨🇱 Santiago, Metropolitana, Chile

Local Institution - 0052; 🇨🇱 Vina del Mar, Valparaiso, Chile

Local Institution - 0045; 🇫🇮 Helsinki, Finland

Local Institution - 0020; 🇫🇷 Toulouse Cedex 9, France

Local Institution - 0019; 🇫🇷 Lyon Cedex 08, France

Local Institution - 0009; 🇩🇪 Dresden, Germany

Local Institution - 0018; 🇫🇷 Villejuif, France

Local Institution - 0030; 🇩🇪 Essen, Germany

Local Institution - 0029; 🇮🇱 Haifa, Israel

Local Institution - 0011; 🇮🇹 Napoli, Italy

Local Institution - 0008; 🇮🇱 Ramat Gan, Israel

Local Institution - 0061; 🇮🇹 Rozzano, Italy

Local Institution - 0038; 🇳🇱 Amsterdam, Netherlands

Local Institution - 0043; 🇳🇱 Nijmegen, Netherlands

Local Institution - 0040; 🇳🇴 Oslo, Norway

Local Institution - 0035; 🇷🇴 Craiova, Romania

Local Institution - 0036; 🇵🇱 Warszawa, Poland

Local Institution - 0014; 🇪🇸 Barcelona, Spain

Local Institution - 0055; 🇪🇸 Madrid, Spain

Local Institution - 0013; 🇪🇸 Madrid, Spain

Local Institution - 0012; 🇪🇸 Pamplona, Spain

Local Institution - 0054; 🇪🇸 Malaga, Spain

Local Institution - 0017; 🇨🇭 Lausanne, Switzerland

Local Institution - 0031; 🇨🇭 Zuerich, Switzerland