A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

Advanced Cancer Clinical Trial

Official title:

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03369223
• Other study ID #: CA030-001
• Secondary ID: 2018-000416-21
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: December 6, 2017
• Est. completion date: September 19, 2024

Study information

• Verified date: October 2023
• 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-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 425
• Est. completion date: September 19, 2024
• Est. primary completion date: September 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.

• Eastern Cooperative Oncology Group Performance Status of 0 or 1

• Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists

• Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants

• Willing and able to comply with all study procedures

Exclusion Criteria:

• Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded

• Other active malignancy requiring concurrent intervention

• Prior organ allograft

• Active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Biological:
• BMS-986249
Specified dose on specified days
• Nivolumab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0037	Buenos Aires
Argentina	Local Institution - 0038	Buenos Aires	Distrito Federal
Argentina	Local Institution - 0052	Caba	Distrito Federal
Australia	Local Institution - 0014	Adelaide	South Australia
Australia	Local Institution	Frankston	Victoria
Australia	Local Institution - 0047	Heidelberg	Victoria
Australia	Local Institution - 0015	North Sydney	New South Wales
Canada	Local Institution - 0026	Edmonton	Alberta
Chile	Local Institution - 0036	Santiago	Metropolitana
Finland	Local Institution - 0039	Helsinki
Germany	Local Institution - 0030	Essen
Germany	Local Institution - 0035	Hamburg
Germany	Local Institution - 0031	Heidelberg
Italy	Local Institution - 0048	Milan
Italy	Istituto Nazionale Tumori Fondazione Pascale	Napoli
Italy	A.O.U.Senese - Policl.S.Maria alle Scotte	Siena
Poland	Local Institution - 0040	Warszawa
Romania	Local Institution - 0045	Bucharest
Romania	Local Institution - 0041	Craiova
Spain	Local Institution - 0042	Badalona	Barcelona [Barcelona]
Spain	Local Institution - 0044	Barcelona
Spain	Local Institution - 0022	Madrid	Madrid, Comunidad De
Spain	Local Institution - 0023	Madrid
Spain	Local Institution - 0050	Madrid
Spain	Local Institution - 0043	Malaga
United States	Local Institution - 0005	Aurora	Colorado
United States	Local Institution - 0010	Austin	Texas
United States	Local Institution - 0024	Baltimore	Maryland
United States	Local Institution - 0029	Cincinnati	Ohio
United States	Local Institution - 0009	Dallas	Texas
United States	Local Institution - 0006	Denver	Colorado
United States	Local Institution - 0013	Eugene	Oregon
United States	Local Institution - 0008	Greenville	South Carolina
United States	Local Institution - 0001	Hackensack	New Jersey
United States	Local Institution - 0021	Houston	Texas
United States	Local Institution - 0012	Leesburg	Virginia
United States	Local Institution - 0017	Miami	Florida
United States	Local Institution - 0002	New York	New York
United States	Local Institution - 0003	New York	New York
United States	Local Institution - 0007	Norfolk	Virginia
United States	Local Institution - 0004	Philadelphia	Pennsylvania
United States	Local Institution - 0016	San Antonio	Texas
United States	Local Institution - 0011	Tyler	Texas
United States	Local Institution - 0018	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  Finland,  Germany,  Italy,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 2.5 years
Primary	Incidence of Serious Adverse Events (SAEs)		Up to 2.5 years
Primary	Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria		Up to 2.5 years
Primary	Incidence of AEs leading to discontinuation		Up to 2.5 years
Primary	Incidence of death		Up to 4 years
Primary	Number of participants with laboratory abnormalities		Up to 2.5 years
Primary	Incidence of treatment-related Grade 3-5 AEs		Within 24 weeks
Primary	Objective Response Rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1		Up to 2.5 years
Secondary	Cmax (Maximum observed serum concentration)		Up to 2 years
Secondary	Tmax (Time of maximum observed concentration)		Up to 2 years
Secondary	AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration)		Up to 2 years
Secondary	ORR as assessed by investigator using RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer)		Up to 4 years
Secondary	Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)		Up to 4 years
Secondary	Progression-Free survival (PFS) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)		Up to 4 years
Secondary	Time to response (TTR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)		Up to 4 years
Secondary	Incidence of AEs in Part 2 of Study		Up to 2.5 years
Secondary	Incidence of SAEs in Part 2 of Study		Up to 2.5 years
Secondary	Incidence of AEs leading to discontinuation in Part 2 of study		Up to 2.5 years
Secondary	Incidence of death in Part 2 of study		Up to 4 years
Secondary	Number of participants with clinical laboratory abnormalities Part 2 of study		Up to 2.5 years
Secondary	Time to Deterioration (TTD) in Part 2 of study		Up to 4 Years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting