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A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT04423029
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE June 5, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date April 15, 2022
Actual Study Start Date  ICMJE July 10, 2020
Estimated Primary Completion Date August 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2022)
  • Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: During the first 3 weeks of treatment ]
    Phase 1/1b only
  • Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC) [ Time Frame: Up to 2 years ]
    Phase 2 only
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • Assessment of the number of dose limiting toxicities experienced on study with monotherapy DF6002 as defined per criteria in the study protocol [ Time Frame: First 3 weeks on treatment for each subject. ]
    To assess the number of adverse events experienced during treatment with monotherapy DF6002 that meet dose limiting toxicity criteria per the study protocol.
  • Assessment of the number of dose limiting toxicities experienced on study with combination therapy of DF6002 and pembrolizumab as defined per criteria in the study protocol [ Time Frame: First 3 weeks on treatment for each subject in the combination therapy cohort. ]
    To assess the number of adverse events experienced during treatment with combination therapy of DF6002 and pembrolizumab that meet dose limiting toxicity criteria per the study protocol.
  • Assess overall response rate [ Time Frame: Through 90 days after completion of the study, an average of 1 year. ]
    To assess the Overall Response Rate (ORR) per RECIST version 1.1 criteria of patients in the Phase 2 expansion cohorts.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2022)
  • Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]
  • Severity of TEAEs [ Time Frame: Up to 2 years ]
  • Duration of TEAEs [ Time Frame: Up to 2 years ]
  • Number of participants with changes from baseline in clinical laboratory parameters [ Time Frame: Up to 2 years ]
  • Number of participants with changes from baseline in electrocardiogram (ECG) parameters [ Time Frame: Up to 2 years ]
  • Number of participants with changes from baseline in vital sign parameters [ Time Frame: Up to 2 years ]
  • Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Up to 2 years ]
  • Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment [ Time Frame: Up to month 24 ]
  • Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T) [ Time Frame: Up to day 28 ]
  • Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF) [ Time Frame: Up to day 28 ]
  • Maximum serum concentration observed post-dose (Cmax) [ Time Frame: Up to day 28 ]
  • Best overall response (BOR) according to RECIST 1.1 per Investigator assessment [ Time Frame: Approximately one year ]
  • Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
  • Confirmed ORR per RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
    Phase 1/1b only
  • Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
    Phase 2 only
  • CBR according to RECIST 1.1 per IERC [ Time Frame: Up to 2 years ]
    Phase 2 only
  • PFS according to RECIST 1.1 per IERC [ Time Frame: Up to 2 years ]
    Phase 2 only
  • DOR according to RECIST 1.1 per IERC [ Time Frame: Up to month 24 ]
    Phase 2 only
  • Unconfirmed response after 4 cycles according to RECIST 1.1 [ Time Frame: Up to 2 years ]
    Phase 2 only
  • Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Phase 2 only
  • Serum titers of anti-DF6002 antibodies [ Time Frame: Up to 2 years ]
    Phase 2 only
  • Serum titers of anti-nivolumab antibodies [ Time Frame: Up to 2 years ]
    Phase 2 only
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • Assess number of treatment emergent adverse events throughout study [ Time Frame: Until 30 days after the last treatment of the last subject enrolled in the Phase 2 portion of the study. ]
    Characterize the safety profile of DF6002 by assessing the number of adverse events occurring while on treatment with DF6002.
  • Determine serum concentrations of DF6002 at various timepoints [ Time Frame: From start of treatment up through 28 days after last treatment ]
    Concentration vs time of DF6002 will be measured using blood samples taken a various time points on study
  • Assess Duration of Response [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    To assess duration of response using RECIST 1.1 criteria
  • Assess Best Overall Response [ Time Frame: Through 90 days after completion of the study, an average of 1 year ]
    To assess best overall response using RECIST 1.1 criteria
  • Assess Overall Survival [ Time Frame: Time from enrollment in the study until death, measured up to 2 years after last treatment on study ]
    To assess overall survival following treatment
  • Assess Overall Response Rate [ Time Frame: Time from enrollment in the study until up to 2 years after last treatment on study ]
    To assess overall response rate according to Investigator judgment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Brief Summary The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 (BMS-986415) alone and in combination with Nivolumab 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: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • Drug: DF6002
    Specified dose on specified days
    Other Name: BMS-986415
  • Drug: Nivolumab
    Specified dose on specified days
    Other Name: Opdivo
Study Arms  ICMJE
  • Experimental: Monotherapy Dose Escalation
    Intervention: Drug: DF6002
  • Experimental: Monotherapy Dose Expansion (Melanoma)
    Intervention: Drug: DF6002
  • Experimental: Monotherapy Dose Expansion (NSCLC)
    Intervention: Drug: DF6002
  • Experimental: Combination Dose Escalation
    Interventions:
    • Drug: DF6002
    • Drug: Nivolumab
  • Experimental: Combination Dose Expansion (Melanoma)
    Interventions:
    • Drug: DF6002
    • Drug: Nivolumab
  • Experimental: Combination Dose Expansion (NSCLC)
    Interventions:
    • Drug: DF6002
    • Drug: 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: April 8, 2022)
473
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2020)
260
Estimated Study Completion Date  ICMJE May 30, 2027
Estimated Primary Completion Date August 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate
  • ECOG performance status of 0 or 1
  • Clinical or radiological evidence of disease
  • Adequate hematological, hepatic and renal function

Exclusion Criteria:

  • Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment
  • Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ
  • Rapidly progressive disease
  • Serious cardiac illness or medical conditions

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 France,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04423029
Other Study ID Numbers  ICMJE CA101-001
2021-000038-33 ( EudraCT Number )
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 March 2022

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