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NCT03446040 Clinical Trial

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

Advanced Cancer Clinical Trial

Official title:
A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03446040
Other study ID # CA031-002
Secondary ID 2019-000442-35
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 8, 2018
Est. completion date April 15, 2025

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

Clinical Trial Summary

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 92
Est. completion date April 15, 2025
Est. primary completion date December 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1) - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Participants 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 solid tumor histologies - Women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Active, known or suspected autoimmune disease - Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy - Other active malignancy requiring concurrent intervention Other protocol-defined inclusion/exclusion criteria apply

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• BMS-986258
Specified dose on specified days
• Nivolumab
Specified dose on specified days
Drug:
• rHuPH20
Specified dose on specified days

Locations
Country Name City State
Australia Local Institution - 0015 Melbourne Victoria
Australia Local Institution - 0013 Westmead New South Wales
Canada Local Institution - 0014 Edmonton Alberta
Canada Local Institution - 0019 Vancouver British Columbia
Japan Local Institution - 0008 Chuo-ku Tokyo
Japan Local Institution - 0009 Kobe-shi Hyogo
United States Local Institution - 0018 Ann Arbor Michigan
United States Local Institution - 0007 Aurora Colorado
United States Local Institution - 0016 Cincinnati Ohio
United States Local Institution - 0002 Germantown Tennessee
United States Local Institution - 0010 Grand Rapids Michigan
United States University Of Iowa Hospitals And Clinics Iowa City Iowa
United States Local Institution - 0012 Lebanon New Hampshire
United States Local Institution - 0004 Los Angeles California
United States Local Institution - 0006 Los Angeles California
United States Local Institution - 0005 Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) Approximately 2 years
Primary Incidence of serious adverse events (SAEs) Approximately 2 years
Primary Incidence of AEs leading to discontinuation Approximately 2 years
Primary Incidence of AEs leading to death Approximately 2 years
Primary Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria Approximately 2 years
Secondary Objective response rate (ORR) Up to 12 months
Secondary Median duration of response (mDOR) Up to 12 months
Secondary Progression free survival (PFS) rate Up to 12 months
Secondary Maximum observed serum concentration (Cmax) Approximately 2 years
Secondary Time of maximum observed concentration (Tmax) Approximately 2 years
Secondary Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] Approximately 2 years
Secondary Observed concentration at the end of a dosing interval (Ctau) Approximately 2 years
Secondary Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] Approximately 2 years
Secondary Trough observed serum concentration at the end of the dosing interval (Ctrough) Approximately 2 years
Secondary Concentration at the end of infusion (Ceoi) Approximately 2 years
Secondary Incidence of anti-drug antibody (ADA) to BMS-986258 Approximately 2 years
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