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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT03446040

  • Recruitment Status

    Recruiting

  • First Posted

    February 26, 2018

  • Last update posted

    May 12, 2021

Study Description

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.

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Biological: BMS-986258
    Biological: Nivolumab
    Drug: rHuPH20
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 248 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
  • Actual Study Start Date: March 2018
  • Estimated Primary Completion Date: July 2024
  • Estimated Study Completion Date: July 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Part A Dose Escalation: BMS-986258
Biological: BMS-986258
Specified dose on specified day
Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
Biological: BMS-986258
Specified dose on specified day

Drug: rHuPH20
Specified dose on specified days
Experimental: Part B Dose Escalation: BMS-986258 + nivolumab
Biological: BMS-986258
Specified dose on specified day

Biological: Nivolumab
Specified dose on specified day
Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab
Biological: BMS-986258
Specified dose on specified day

Biological: Nivolumab
Specified dose on specified day

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of adverse events (AEs) [ Time Frame: Approximately 2 years ]
  • 2. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 2 years ]
  • 3. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 2 years ]
  • 4. Incidence of AEs leading to death [ Time Frame: Approximately 2 years ]
  • 5. Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria [ Time Frame: Approximately 2 years ]
  • Secondary Outcome Measures: 1. Median duration of response (mDOR) [ Time Frame: up to 12 months ]
  • 2. Progression free survival (PFS) rate [ Time Frame: up to 12 months ]
  • 3. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 2 years ]
  • 4. Time of maximum observed concentration (Tmax) [ Time Frame: Approximately 2 years ]
  • 5. Objective response rate (ORR) [ Time Frame: up to 12 months ]
  • 6. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 2 years ]
  • 7. Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Approximately 2 years ]
  • 8. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 2 years ]
  • 9. Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Approximately 2 years ]
  • 10. Concentration at the end of infusion (Ceoi) [ Time Frame: Approximately 2 years ]
  • 11. Incidence of anti-drug antibody (ADA) to BMS-986258 [ Time Frame: Approximately 2 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
Hoag Memorial Hospital Presbyterian
Los Angeles

United States, California
Usc/Norris Comprehensive Cancer Center
Los Angeles

United States, Colorado
University Of Colorado
Aurora

United States, Connecticut
Local Institution
New Haven

United States, Iowa
Local Institution
Iowa City

United States, Michigan
Local Institution
Ann Arbor

United States, Michigan
START Midwest
Grand Rapids

United States, New Hampshire
Local Institution
Lebanon

United States, New York
Local Institution
Buffalo

United States, Ohio
University of Cincinnati Medical Center
Cincinnati

United States, Pennsylvania
University Of Pittsburgh Medical Center
Pittsburgh

United States, Tennessee
The West Clinic, P.C.
Germantown

Australia, New South Wales
Local Institution
Westmead

Australia, Victoria
Local Institution
Heidelberg

Canada, Alberta
Local Institution
Edmonton

Canada, British Columbia
Local Institution
Vancouver

Japan, Hyogo
Local Institution
Kobe-shi

Japan, Tokyo
Local Institution
Chuo-ku

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03446040 History of Changes
  • Other Study ID Numbers: CA031-002, 2019-000442-35
  • First Posted: February 26, 2018 Key Record Dates
  • Last Update Posted: May 12, 2021
  • Last Verified: May 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No