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An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed

  • Clinicaltrials.gov identifier

    NCT03444753

  • Recruitment Status

    Recruiting

  • First Posted

    February 23, 2018

  • Last update posted

    March 24, 2020

Save Trial
Clinical Trial Information for Patients Visit BMS Study Connect

Study Description

Brief summary:

The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Drug: BMS-986299
    Biological: Nivolumab
    Biological: Ipilimumab
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 117 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers
  • Actual Study Start Date: March 2018
  • Estimated Primary Completion Date: November 2021
  • Estimated Study Completion Date: December 2021

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A
BMS-986299		 Drug: BMS-986299
Specified dose on specified day
Experimental: Arm B
BMS-986299 in combination with nivolumab and ipilimumab		 Drug: BMS-986299
Specified dose on specified day

Biological: Nivolumab
Specified dose on specified day

Biological: Ipilimumab
Specified dose on specified day

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • 2. Incidence of adverse events (AEs) [ Time Frame: Approximately 2 years ]
  • 3. Incidence of clinical laboratory abnormalities [ Time Frame: Approximately 2 years ]
  • 4. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 2 years ]
  • 5. Incidence of AEs leading to discontinuation and deaths [ Time Frame: Approximately 2 years ]
  • Secondary Outcome Measures: 1. Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 2 years ]
  • 2. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 2 years ]
  • 3. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 2 years ]
  • 4. Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)] [ 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: - Histologically or cytologically confirmed advanced/metastatic solid tumor and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant - IO therapy resistant or insensitive tumors - Have at least 2 tumor lesions accessible for biopsy - Eastern Cooperative Oncology Group Performance Status of 0 or 1 Exclusion Criteria: - Primary CNS malignancy - Participants with other active malignancy requiring concurrent intervention - Uncontrolled or significant cardiovascular disease Other protocol defined inclusion/exclusion criteria could 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
University Of California San Diego Moores Cancer Center
La Jolla

United States, California
University of California Davis Medical Center
Sacramento

United States, Connecticut
Local Institution
New Haven

United States, Missouri
Washington University
Saint Louis

United States, Pennsylvania
Local Institution
Pittsburgh

United States, Texas
MD Anderson Cancer Center
Houston

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: NCT03444753 History of Changes
  • Other Study ID Numbers: CA039-001
  • First Posted: February 23, 2018 Key Record Dates
  • Last Update Posted: March 24, 2020
  • Last Verified: March 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No