A Study of DF6002 Alone and in Combination With Nivolumab

April 19, 2023 updated by: Dragonfly Therapeutics

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

The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 alone and in combination with Nivolumab in participants with advanced solid tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

473

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Box Hill, Australia, 3128
        • Withdrawn
        • Local Institution - 0023
      • Heidelberg, Australia, 3084
        • Withdrawn
        • Local Institution - 0022
      • Bordeaux Cedex, France, 33000
        • Recruiting
        • Local Institution - 0026
      • Paris, France, 75010
        • Recruiting
        • Local Institution - 0002
      • Pierre-Benite, France, 69495
        • Recruiting
        • Local Institution - 0027
      • Villejuif, France, 94805
        • Recruiting
        • Local Institution - 0001
    • Ile-de-France
      • Paris, Ile-de-France, France, 75010
        • Recruiting
        • Local Institution
    • Rhone
      • Pierre-Bénite, Rhone, France, 69495
        • Recruiting
        • Local Institution
      • Barcelona, Spain, 08035
        • Recruiting
        • Local Institution - 0029
      • Madrid, Spain, 28034
        • Recruiting
        • Local Institution
      • Madrid, Spain, 08040
        • Recruiting
        • Local Institution
      • Madrid, Spain, 28027
        • Recruiting
        • Local Institution - 0031
      • Madrid, Spain, 28034
        • Recruiting
        • Local Institution - 0030
      • Madrid, Spain, 28040
        • Recruiting
        • Local Institution - 0028
      • Pamplona, Spain, 31008
        • Recruiting
        • Local Institution - 0025
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Local Institution
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine
        • Contact:
          • Jennifer Valerin, MD
      • Orange, California, United States, 92868
        • Recruiting
        • Local Institution
    • Colorado
      • Denver, Colorado, United States, 80218
        • Withdrawn
        • SCRI - HealthOne Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale School of Medicine
        • Contact:
          • Mario Sznol, MD
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Local Institution
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
          • Jose Lutzky, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • Local Institution
    • Georgia
      • Augusta, Georgia, United States, 30912-0003
        • Recruiting
        • Augusta University Georgia Cancer Center
        • Contact:
          • Sharad Ghamande, MD
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Local Institution
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
          • Mohammed Milhem, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • Elizabeth Buchbinder, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Local Institution
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Barbara Ann Karmanos Cancer Institute
        • Contact:
          • Dipesh Uprety, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
          • Raghad Abdul-Karim, MD
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Local Institution
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • HealthPartners Cancer Center at Regions Hospital
        • Contact:
          • Arkadiusz Dudek, MD
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Local Institution
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Atlantic Health System
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
          • Jinyu Lu, MD
      • Bronx, New York, United States, 10461
        • Recruiting
        • Local Institution
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Comprehensive Cancer Center
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Local Institution
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
          • Jorge Garcia, MD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Stephenson Cancer Center
        • Contact:
          • Raid Aljumaily, MD
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Local Institution
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
          • Benedito Carneiro, MD
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Local Institution
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Local Institution
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • SCRI - Tennessee Oncology - Saint Thomas West Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Recruiting
        • Local Institution
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute and Hospital
        • Contact:
          • Siwen Hu-Lieskovan, MD
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Local Institution
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Local Institution
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • USOR - Virginia Cancer Specialists - Fairfax Office
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital
        • Contact:
          • Ariel Nelson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessed by Investigator as being at high risk for venous thromboembolism (VTE) or history of VTE ≥ 6 months from enrollment

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
  • Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy Dose Escalation
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: Monotherapy Dose Expansion (Melanoma)
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: Monotherapy Dose Expansion (NSCLC)
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: Combination Dose Escalation
Specified dose on specified days
Other Names:
  • Opdivo
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: Combination Dose Expansion (Melanoma)
Specified dose on specified days
Other Names:
  • Opdivo
Specified dose on specified days
Other Names:
  • BMS-986415
Experimental: Combination Dose Expansion (NSCLC)
Specified dose on specified days
Other Names:
  • Opdivo
Specified dose on specified days
Other Names:
  • BMS-986415

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: During the first 3 weeks of treatment
Phase 1/1b only
During the first 3 weeks of treatment
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
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment emergent adverse events (TEAEs)
Time Frame: Up to 2 years
Up to 2 years
Severity of TEAEs
Time Frame: Up to 2 years
Up to 2 years
Duration of TEAEs
Time Frame: Up to 2 years
Up to 2 years
Number of participants with changes from baseline in clinical laboratory parameters
Time Frame: Up to 2 years
Up to 2 years
Number of participants with changes from baseline in electrocardiogram (ECG) parameters
Time Frame: Up to 2 years
Up to 2 years
Number of participants with changes from baseline in vital sign parameters
Time Frame: Up to 2 years
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
Up to 2 years
Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment
Time Frame: Up to month 24
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
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
Up to day 28
Maximum serum concentration observed post-dose (Cmax)
Time Frame: Up to day 28
Up to day 28
Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
Time Frame: Approximately one year
Approximately one year
Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
Time Frame: Up to 2 years
Up to 2 years
Confirmed ORR per RECIST 1.1 per Investigator assessment
Time Frame: Up to 2 years
Phase 1/1b only
Up to 2 years
Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
CBR according to RECIST 1.1 per IERC
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
PFS according to RECIST 1.1 per IERC
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
DOR according to RECIST 1.1 per IERC
Time Frame: Up to month 24
Phase 2 only
Up to month 24
Unconfirmed response after 4 cycles according to RECIST 1.1
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
Overall Survival (OS)
Time Frame: Up to 5 years
Phase 2 only
Up to 5 years
Serum titers of anti-DF6002 antibodies
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years
Serum titers of anti-nivolumab antibodies
Time Frame: Up to 2 years
Phase 2 only
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jean-Marie Cuillerot, MD, Chief Medical Officer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Anticipated)

July 19, 2024

Study Completion (Anticipated)

December 16, 2025

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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