An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

NCT03994601 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CA043-0012021-004284-27
• Study Type: interventional
• Target: 219
• Locations: 7 countries
• Sites: 40

Brief Summary

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

• Safety Related Events for Cohorts 1A, 1B and 2B.

  Safety releated events for Cohorts 1A, 1B and 2B.

  approximately 6 months

• Dose Limiting Toxicities Cohorts 1A, 1B and 2B.

  A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.

  approximately 5 weeks

• Objective Response Rate by BICR in Cohort 2C

  The percentage of all treated participants whose BOR is either CR or PR by BICR per RECIST v1.1.

  approximately 2.15 Months

Secondary Outcomes (17)

• Objective Response Rate in Cohorts 1A, 1B and 2B

  approximately 2.15 Months

• Duration of Response in Cohorts 1A, 1B and 2B

  approximately 2.15 Months

• Time to Response in Cohorts 1A, 1B and 2B

  approximately 2.15 Months

• Progression Free Survival in Cohorts 1A, 1B and 2B

  approximately 2.15 Months

• Duration of Response by BICR in Cohort 2C

  approximately 2.5 Months

Study Arms (3)

Arm A: BMS-986288 Monotherapy

EXPERIMENTAL

Drug: BMS-986288

Arm B: BMS-986288 in combination with Nivolumab

EXPERIMENTAL

Drug: BMS-986288; Drug: Nivolumab

Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib

EXPERIMENTAL

Drug: BMS-986288; Drug: Nivolumab; Drug: Regorafenib

Interventions

BMS-986288 DRUG

Specified dose on specified days

Arm A: BMS-986288 Monotherapy; Arm B: BMS-986288 in combination with Nivolumab; Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Arm B: BMS-986288 in combination with Nivolumab; Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib

Regorafenib DRUG

Specified dose on specified days

Part 2C: BMS-986288 in combination with Nivolumab and Regorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies

You may not qualify if:

• Active, known or suspected autoimmune disease
• Active malignancy requiring concurrent intervention
• Primary Central Nervous System (CNS) malignancies or tumors with CNS metastasis as the only site of disease, will be excluded

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (40)

Local Institution - 0075

Costa Mesa, California, 92627, United States

Location

Local Institution - 0050

Orange, California, 92868-3201, United States

Location

Local Institution - 0005

Aurora, Colorado, 80045, United States

Location

Local Institution - 0002

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0004

St Louis, Missouri, 63110, United States

Location

Local Institution - 0001

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0011

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426, Argentina

Location

Local Institution - 0074

Buenos Aires, Buenos Aires F.D., C1096AAS, Argentina

Location

Local Institution - 0014

Córdoba, Córdoba Province, X5000HXL, Argentina

Location

Local Institution - 0013

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Local Institution - 0008

ABB, Distrito Federal, C1199, Argentina

Location

Local Institution - 0012

CABA, Distrito Federal, C1430, Argentina

Location

Local Institution - 0017

Buenos Aires, 1431, Argentina

Location

Local Institution - 0016

Buenos Aires, C1280AEB, Argentina

Location

Local Institution - 0006

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0042

Montreal, Quebec, H2X 0A9, Canada

Location

Local Institution - 0046

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 0010

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0036

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Local Institution - 0019

Santiago, Santiago Metropolitan, 7510032, Chile

Location

Local Institution - 0035

Santiago, Santiago Metropolitan, 7620002, Chile

Location

Local Institution - 0009

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0034

Bordeaux, Gironde, 33075, France

Location

Local Institution - 0022

Saint-Herblain, Loire-Atlantique, 44800, France

Location

Local Institution - 0018

Bron, 69677, France

Location

Local Institution - 0026

Marseille, 13915, France

Location

Local Institution - 0015

Paris, 75248, France

Location

Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

Toulon, 83100, France

Location

Local Institution - 0040

Milan, Lombardy, 20133, Italy

Location

Local Institution - 0038

Padua, Veneto, 35128, Italy

Location

Local Institution - 0028

Ancona, 60126, Italy

Location

Local Institution - 0033

Catanzaro, 88100, Italy

Location

Local Institution - 0031

Milan, 20162, Italy

Location

Local Institution - 0039

Roma, 00168, Italy

Location

Local Institution - 0056

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0054

Barcelona, Catalunya [Cataluña], 08036, Spain

Location

Local Institution - 0023

Madrid, 28041, Spain

Location

Local Institution - 0024

Majadahonda, 28222, Spain

Location

Local Institution - 0055

Seville, 41013, Spain

Location

Local Institution - 0025

Valencia, 46026, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab; regorafenib

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 21, 2019
• Study Start: September 6, 2019
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2025-12

Locations

AR (8); CA (3); CL (5); FR (6); IT (6); US (6); ES (6)