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

Phase 1

Active, not recruiting

• Conditions: Advanced Cancer
• Interventions: Biological: BMS-986258; Biological: Nivolumab; Drug: rHuPH20

• Registration Number: NCT03446040
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-26
• Study Start: 2018-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-12-28
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 92

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part B Dose Escalation: BMS-986258 + nivolumab	BMS-986258	-
Part B Dose Escalation: BMS-986258 + nivolumab	Nivolumab	-
Part C Cohort Expansion: BMS-986258 + nivolumab	BMS-986258	-
Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)	BMS-986258	-
Part A Dose Escalation: BMS-986258	BMS-986258	-
Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)	rHuPH20	-
Part C Cohort Expansion: BMS-986258 + nivolumab	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Incidence of AEs leading to discontinuation	Approximately 2 years
Incidence of AEs leading to death	Approximately 2 years
Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria	Approximately 2 years
Incidence of serious adverse events (SAEs)	Approximately 2 years
Incidence of adverse events (AEs)	Approximately 2 years

Secondary Outcome Measures

Name	Time	Method
Incidence of anti-drug antibody (ADA) to BMS-986258	Approximately 2 years
Objective response rate (ORR)	Up to 12 months
Maximum observed serum concentration (Cmax)	Approximately 2 years
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]	Approximately 2 years
Trough observed serum concentration at the end of the dosing interval (Ctrough)	Approximately 2 years
Median duration of response (mDOR)	Up to 12 months
Observed concentration at the end of a dosing interval (Ctau)	Approximately 2 years
Progression free survival (PFS) rate	Up to 12 months
Concentration at the end of infusion (Ceoi)	Approximately 2 years
Time of maximum observed concentration (Tmax)	Approximately 2 years
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]	Approximately 2 years

Trial Locations

Locations (16)

Local Institution - 0012; 🇺🇸 Lebanon, New Hampshire, United States

Local Institution - 0007; 🇺🇸 Aurora, Colorado, United States

Local Institution - 0016; 🇺🇸 Cincinnati, Ohio, United States

Local Institution - 0005; 🇺🇸 Pittsburgh, Pennsylvania, United States

Local Institution - 0006; 🇺🇸 Los Angeles, California, United States

Local Institution - 0004; 🇺🇸 Los Angeles, California, United States

University Of Iowa Hospitals And Clinics; 🇺🇸 Iowa City, Iowa, United States

Local Institution - 0018; 🇺🇸 Ann Arbor, Michigan, United States

Local Institution - 0010; 🇺🇸 Grand Rapids, Michigan, United States

Local Institution - 0014; 🇨🇦 Edmonton, Alberta, Canada

Local Institution - 0002; 🇺🇸 Germantown, Tennessee, United States

Local Institution - 0015; 🇦🇺 Melbourne, Victoria, Australia

Local Institution - 0013; 🇦🇺 Westmead, New South Wales, Australia

Local Institution - 0019; 🇨🇦 Vancouver, British Columbia, Canada

Local Institution - 0008; 🇯🇵 Chuo-ku, Tokyo, Japan

Local Institution - 0009; 🇯🇵 Kobe-shi, Hyogo, Japan