Clinical Trials /

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors

NCT04895709

Description:

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Cervical Carcinoma
  • Colorectal Carcinoma
  • Gastric Adenocarcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors
  • Official Title: A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA052-002
  • SECONDARY ID: 2021-001188-26
  • SECONDARY ID: U1111-1265-4508
  • NCT ID: NCT04895709

Conditions

  • Cervical Cancer
  • Gastric/Gastroesophageal Junction Adenocarcinoma
  • Microsatellite Stable Colorectal Cancer
  • Non-Small-Cell Lung Cancer
  • Squamous Cell Carcinoma of Head and Neck

Interventions

DrugSynonymsArms
BMS-986340Part 1A: BMS-986340 Dose Escalation
BMS-936558-01NivolumabPart 1B: BMS-986340 + Nivolumab Dose Escalation

Purpose

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
Part 1A: BMS-986340 Dose EscalationExperimental
  • BMS-986340
Part 2A: BMS-986340 Dose ExpansionExperimental
  • BMS-986340
Part 1B: BMS-986340 + Nivolumab Dose EscalationExperimental
  • BMS-986340
  • BMS-936558-01
Part 2B: BMS-986340 + Nivolumab Dose ExpansionExperimental
  • BMS-986340
  • BMS-936558-01

Eligibility Criteria

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

        Inclusion Criteria:

          -  Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker
             analysis

          -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and
             at least 1 lesion accessible for biopsy

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

          -  Radiographically documented progressive disease on or after the most recent therapy

          -  Received standard-of-care therapies, including an available programmed death
             (ligand)-1 inhibitor known to be effective in the tumor type for which they are being
             evaluated

          -  Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell
             carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/
             gastroesophageal junction adenocarcinoma, or cervical cancer, and have received, be
             refractory to, not be a candidate for, or be intolerant of existing therapies known to
             provide clinical benefit for the condition of the participant

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Primary central nervous system (CNS) malignancy

          -  Untreated CNS metastases

          -  Leptomeningeal metastases

          -  Concurrent malignancy requiring treatment or history of prior malignancy active within
             2 years prior to the first dose of study treatment

          -  Active, known, or suspected autoimmune disease

          -  Condition requiring systemic treatment with either corticosteroids within 14 days or
             other immunosuppressive medications within 30 days of the first dose of study
             treatment

          -  Prior organ or tissue allograft

          -  Uncontrolled or significant cardiovascular disease

          -  Major surgery within 4 weeks of study drug administration

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

        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 120 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab
Time Frame:Up to 120 weeks
Safety Issue:
Description:
Measure:Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame:At 6 months, 12 months
Safety Issue:
Description:
Measure:Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame:At 6 months, 12 months
Safety Issue:
Description:
Measure:Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame:At 6 months, 12 months
Safety Issue:
Description:
Measure:Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame:At 6 months, 12 months
Safety Issue:
Description:

Details

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

Trial Keywords

  • BMS-986340
  • Cervical Cancer
  • CRC
  • First-in-human
  • GEJ
  • Gastric/Gastroesophageal Junction Adenocarcinoma
  • HNSCC
  • Microsatellite Stable Colorectal Cancer
  • MSS CRC
  • Nivolumab
  • Non-Small-Cell Lung Cancer
  • NSCLC
  • SCCHN
  • Squamous Cell Carcinoma of Head and Neck

Last Updated

June 14, 2021