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

Advanced Cancer Clinical Trial

Official title:

Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03110107
• Other study ID #: CA022-001
• Secondary ID: 2017-000597-11
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 4, 2017
• Est. completion date: April 4, 2024

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 512
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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)

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

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Biological:
• Ipilimumab
Specified dose on specified days
• BMS-986218
Specified dose on specified days
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0053	ABB	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0059	Buenos Aires	Distrito Federal
Argentina	Local Institution - 0057	Caba	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0042	Ciudad Autónoma De Buenos Aires	Buenos Aires
Argentina	Local Institution - 0062	Córdoba	Cordoba
Argentina	Local Institution - 0060	Rio Cuarto	Cordoba
Argentina	Local Institution - 0047	Villa Siburu	Cordoba
Australia	Local Institution - 0049	Murdoch	Western Australia
Australia	Local Institution - 0026	Northmead	New South Wales
Australia	Local Institution - 0006	Wollstonecraft	New South Wales
Belgium	Local Institution - 0039	Gent
Canada	Local Institution - 0037	Edmonton	Alberta
Canada	Local Institution - 0027	Ottawa	Ontario
Canada	Local Institution - 0022	Toronto	Ontario
Canada	Local Institution - 0023	Vancouver	British Columbia
Chile	Local Institution - 0041	Santiago	Metropolitana
Chile	Local Institution - 0048	Santiago	Metropolitana
Chile	Local Institution - 0052	Vina del Mar	Valparaiso
Finland	Local Institution - 0045	Helsinki
France	Local Institution - 0019	Lyon Cedex 08
France	Local Institution - 0020	Toulouse Cedex 9
France	Local Institution - 0018	Villejuif
Germany	Local Institution - 0009	Dresden
Germany	Local Institution - 0030	Essen
Israel	Local Institution - 0029	Haifa
Israel	Local Institution - 0008	Ramat Gan
Italy	Local Institution - 0011	Napoli
Italy	Local Institution - 0061	Rozzano
Italy	Local Institution - 0010	Siena
Netherlands	Local Institution - 0038	Amsterdam
Netherlands	Local Institution - 0043	Nijmegen
Norway	Local Institution - 0040	Oslo
Poland	Local Institution - 0036	Warszawa
Romania	Local Institution - 0034	Cluj Napoca
Romania	Local Institution - 0035	Craiova
Spain	Local Institution - 0014	Barcelona
Spain	Local Institution - 0013	Madrid
Spain	Local Institution - 0055	Madrid
Spain	Local Institution - 0056	Madrid
Spain	Local Institution - 0054	Malaga
Spain	Local Institution - 0012	Pamplona
Switzerland	Local Institution - 0017	Lausanne
Switzerland	Local Institution - 0031	Zuerich
United States	Local Institution - 0058	Atlanta	Georgia
United States	Local Institution - 0025	Boston	Massachusetts
United States	Local Institution - 0002	Hackensack	New Jersey
United States	Local Institution - 0015	Monroeville	Pennsylvania
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 - 0004	Philadelphia	Pennsylvania
United States	Local Institution - 0033	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Chile,  Finland,  France,  Germany,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Romania,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 2 years
Primary	Incidence of Serious Adverse Events (SAEs)		Up to 2 years
Primary	Incidence of AEs meeting protocol- defined dose-limiting toxicity (DLT) criteria		Up to 2 years
Primary	Incidence of AEs leading to discontinuation		Up to 2 years
Primary	Incidence of death		Up to 2 years
Primary	Objective Response Rate (ORR)	Parts 2A, 2B, 2C and 2D	Up to 4 years
Primary	Median Duration of Response (mDOR)	Parts 2A, 2B, 2C and 2D	Up to 4 years
Primary	Progression Free Survival Rate (PFSR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Parts 2A, 2B, 2C and 2D	Up to 4 years
Secondary	ORR	Parts 1A and 1B	Up to 4 years
Secondary	mDOR	Parts 1A and 1B	Up to 4 years
Secondary	PFSR by RECIST v1.1	Parts 1A and 1B	Up to 4 years
Secondary	Incidence of anti-drug antibody (ADA)		Up to 4 years
Secondary	Maximum observed plasma concentration (Cmax)		Up to 4 years
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to 4 years
Secondary	Trough observed serum concentration (Ctrough)		Up to 4 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting