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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

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ClinicalTrials.gov Identifier: NCT03446040
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE February 21, 2018
First Posted Date  ICMJE February 26, 2018
Last Update Posted Date December 23, 2020
Actual Study Start Date  ICMJE March 8, 2018
Estimated Primary Completion Date March 13, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Incidence of adverse events (AEs) [ Time Frame: Approximately 2 years ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 2 years ]
  • Incidence of AEs leading to discontinuation and deaths [ Time Frame: Approximately 2 years ]
  • Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria [ Time Frame: Approximately 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • Objective response rate (ORR) [ Time Frame: up to 12 months ]
  • Median duration of response (mDOR) [ Time Frame: up to 12 months ]
  • Progression free survival (PFS) rate [ Time Frame: up to 12 months ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 2 years ]
  • Time of maximum observed concentration (Tmax) [ Time Frame: Approximately 2 years ]
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 2 years ]
  • Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Approximately 2 years ]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 2 years ]
  • Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Approximately 2 years ]
  • Concentration at the end of infusion (Ceoi) [ Time Frame: Approximately 2 years ]
  • Incidence of anti-drug antibody (ADA) to BMS-986258 [ Time Frame: Approximately 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • Objective response rate (ORR) [ Time Frame: up to 12 months ]
  • Median duration of response (mDOR) [ Time Frame: up to 12 months ]
  • Progression free survival rate (PFSR) [ Time Frame: up to 12 months ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 2 years ]
  • Time of maximum observed concentration (Tmax) [ Time Frame: Approximately 2 years ]
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 2 years ]
  • Observed concentration at the end of a dosing interval (Ctau) [ Time Frame: Approximately 2 years ]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 2 years ]
  • Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Approximately 2 years ]
  • Concentration at the end of infusion (Ceoi) [ Time Frame: Approximately 2 years ]
  • Incidence of anti-drug antibody (ADA) to BMS-986258 [ Time Frame: Approximately 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
Official Title  ICMJE A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Biological: BMS-986258
    Specified dose on specified day
  • Biological: Nivolumab
    Specified dose on specified day
    Other Names:
    • Opdivo
    • BMS-936558
  • Drug: rHuPH20
    Specified dose on specified days
    Other Name: Enhanze
Study Arms  ICMJE
  • Experimental: Part A Dose Escalation: BMS-986258
    Intervention: Biological: BMS-986258
  • Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
    Interventions:
    • Biological: BMS-986258
    • Drug: rHuPH20
  • Experimental: Part B Dose Escalation: BMS-986258 + nivolumab
    Interventions:
    • Biological: BMS-986258
    • Biological: Nivolumab
  • Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab
    Interventions:
    • Biological: BMS-986258
    • Biological: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)		 368
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2018)		 260
Estimated Study Completion Date  ICMJE March 14, 2025
Estimated Primary Completion Date March 13, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) and have at least one lesion accessible for biopsy
  • 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 and men 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Australia,   Canada,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03446040
Other Study ID Numbers  ICMJE CA031-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP