Clinical Trials /

Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

NCT04349267

Description:

Study of BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors

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

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors
  • Official Title: A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA047-004
  • NCT ID: NCT04349267

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
BMS-986315BMS-986315
nivolumabBMS-986315 + nivolumab
cetuximabBMS-986315 + cetuximab

Purpose

Study of BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumors

Trial Arms

NameTypeDescriptionInterventions
BMS-986315Experimental
  • BMS-986315
BMS-986315 + nivolumabExperimental
  • BMS-986315
  • nivolumab
BMS-986315 + cetuximabExperimental
  • BMS-986315
  • cetuximab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Participants must have histologic confirmation of advanced (metastatic, recurrent,
             and/or unresectable) squamous cell carcinoma of the head and neck (SCCHN), nonsmall
             cell lung cancer (NSCLC), or renal cell cancer (RCC) with measurable disease per
             RECIST 1.1

          -  Participants expected to have received standard of care therapies including an
             available PD-(L)1 inhibitor

          -  Eastern cooperative oncology group performance status of 0 or 1

          -  Men and women must agree to follow methods of contraception

        Exclusion Criteria:

          -  Participants with active, known or suspected autoimmune disease

          -  Participants with a condition requiring systemic treatment with either corticosteroids
             or other immunosuppressive medications

          -  Uncontrolled or significant cardiovascular disease

          -  History of or with active interstitial lung disease or pulmonary fibrosis

          -  Prior participation in anti-NKG2A clinical study

          -  History of allergy or hypersensitivity to study drug components

        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:Up to 119 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Progression-Free Survival Rate (PFSR)
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Maximum observed serum concentration (Cmax) of BMS-986315
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Time of maximum observed serum concentration (Tmax) of BMS-986315
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies to BMS-986315
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies to BMS-986315 with nivolumab
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies to BMS-986315 with cetuximab
Time Frame:Up to 120 weeks
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • NSCLC (Non-small cell lung cancer)
  • RCC (Renal cell carcinoma)
  • SCCHN (Squamous cell carcinoma of the head and neck)

Last Updated

April 15, 2020