Clinical Trials /

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

NCT03446040

Description:

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.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CA031-002
  • NCT ID: NCT03446040

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
BMS-986258Part A Dose Escalation: BMS-986258
NivolumabOpdivo, BMS-936558Part B Dose Escalation: BMS-986258 + nivolumab
rHuPH20EnhanzePart A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Part A Dose Escalation: BMS-986258Experimental
  • BMS-986258
Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)Experimental
  • BMS-986258
  • rHuPH20
Part B Dose Escalation: BMS-986258 + nivolumabExperimental
  • BMS-986258
  • Nivolumab
Part C Cohort Expansion: BMS-986258 + nivolumabExperimental
  • BMS-986258
  • Nivolumab

Eligibility 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) 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events (AEs)
Time Frame:Approximately 2 years
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

December 23, 2020