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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04895709
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 19, 2021
First Posted Date  ICMJE May 20, 2021
Last Update Posted Date June 2, 2023
Actual Study Start Date  ICMJE May 27, 2021
Estimated Primary Completion Date April 10, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2023)
  • Incidence of adverse events (AEs) [ Time Frame: Up to 120 weeks ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 120 weeks ]
  • Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 120 weeks ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 120 weeks ]
  • Incidence of AEs leading to death [ Time Frame: Up to 120 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
  • Incidence of adverse events (AEs) [ Time Frame: Up to 120 weeks ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 120 weeks ]
  • Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 120 weeks ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 120 weeks ]
  • Incidence of AEs leading to death [ Time Frame: Up to 120 weeks ]
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 120 weeks ]
  • Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 120 weeks ]
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 120 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2023)
  • Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
  • PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
  • 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 ]
  • PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 120 weeks ]
  • PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
  • PK parameters of BMS-986340 administered in combination with docetaxel: Cmax [ Time Frame: Up to 120 weeks ]
  • PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
  • PK parameters of BMS-986340 administered in combination with docetaxel: Tmax [ Time Frame: Up to 120 weeks ]
  • 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 ]
  • PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU) [ Time Frame: Up to 120 weeks ]
  • 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 ]
  • PK parameters of BMS-986340 administered in combination with docetaxel: Ctau [ Time Frame: Up to 120 weeks ]
  • Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy [ Time Frame: Up to 120 weeks ]
  • Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab [ Time Frame: Up to 120 weeks ]
  • Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel [ Time Frame: Up to 120 weeks ]
  • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  • Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  • Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  • Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
  • Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
  • PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
  • 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 ]
  • PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 120 weeks ]
  • PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
  • PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
  • 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 ]
  • 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 ]
  • Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy [ Time Frame: Up to 120 weeks ]
  • Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab [ Time Frame: Up to 120 weeks ]
  • Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  • Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  • Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  • Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Official Title  ICMJE A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Brief Summary 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 or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Cancer
  • Gastric/Gastroesophageal Junction Adenocarcinoma
  • Microsatellite Stable Colorectal Cancer
  • Non-Small-Cell Lung Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Carcinoma, Renal Cell
  • Urothelial Carcinoma
  • Pancreatic Adenocarcinoma
  • Melanoma
  • Ovarian Neoplasms
  • Triple Negative Breast Neoplasms
Intervention  ICMJE
  • Drug: BMS-986340
    Specified dose on specified days
  • Drug: BMS-936558-01
    Specified dose on specified days
    Other Name: Nivolumab
  • Drug: Docetaxel
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Part 1A: BMS-986340 Dose Escalation
    Intervention: Drug: BMS-986340
  • Experimental: Part 2A: BMS-986340 Dose Expansion
    Intervention: Drug: BMS-986340
  • Experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation
    Interventions:
    • Drug: BMS-986340
    • Drug: BMS-936558-01
  • Experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion
    Interventions:
    • Drug: BMS-986340
    • Drug: BMS-936558-01
  • Experimental: Part 1C: BMS-986340 + Docetaxel Dose Escalation
    Interventions:
    • Drug: BMS-986340
    • Drug: Docetaxel
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: January 31, 2023)		 665
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2021)		 185
Estimated Study Completion Date  ICMJE September 15, 2026
Estimated Primary Completion Date April 10, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
  • 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, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
  • Advanced or metastatic disease 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
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: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Israel,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04895709
Other Study ID Numbers  ICMJE CA052-002
2021-001188-26 ( EudraCT Number )
U1111-1265-4508 ( Registry Identifier: WHO )
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
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2023

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