close-icon

Log In to Bolder Science

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number

By completing and submitting this form, you agree to allow Bolder Science to collect the information provided and to receive communications from Bolder Science in the future regarding disease education and research updates.

close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

  • Clinicaltrials.gov identifier

    NCT04423029

  • Recruitment Status

    Recruiting

  • First Posted

    June 9, 2020

  • Last update posted

    April 15, 2022

Study Description

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.

  • Condition or Disease:Solid Tumors
  • Intervention/Treatment: Drug: DF6002
    Drug: Nivolumab
  • Phase: Phase 1/Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 473 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study to Assess DF6002 (BMS-986415) Alone and in Combination With Nivolumab in Participants With Locally Advanced or Metastatic Solid Tumors
  • Actual Study Start Date: July 2020
  • Estimated Primary Completion Date: August 2024
  • Estimated Study Completion Date: May 2027

Arms and interventions

Arm Intervention/treatment
Experimental: Combination Dose Escalation
Drug: DF6002
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
Experimental: Combination Dose Expansion (Melanoma)
Drug: DF6002
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
Experimental: Combination Dose Expansion (NSCLC)
Drug: DF6002
Specified dose on specified days

Drug: Nivolumab
Specified dose on specified days
Experimental: Monotherapy Dose Escalation
Drug: DF6002
Specified dose on specified days
Experimental: Monotherapy Dose Expansion (Melanoma)
Drug: DF6002
Specified dose on specified days
Experimental: Monotherapy Dose Expansion (NSCLC)
Drug: DF6002
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: During the first 3 weeks of treatment ]
    Phase 1/1b only
  • 2. 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
  • Secondary Outcome Measures: 1. Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]
  • 2. Severity of TEAEs [ Time Frame: Up to 2 years ]
  • 3. Duration of TEAEs [ Time Frame: Up to 2 years ]
  • 4. Number of participants with changes from baseline in clinical laboratory parameters [ Time Frame: Up to 2 years ]
  • 5. Number of participants with changes from baseline in electrocardiogram (ECG) parameters [ Time Frame: Up to 2 years ]
  • 6. Number of participants with changes from baseline in vital sign parameters [ Time Frame: Up to 2 years ]
  • 7. Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Up to 2 years ]
  • 8. Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment [ Time Frame: Up to month 24 ]
  • 9. 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 ]
  • 10. Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF) [ Time Frame: Up to day 28 ]
  • 11. Maximum serum concentration observed post-dose (Cmax) [ Time Frame: Up to day 28 ]
  • 12. Best overall response (BOR) according to RECIST 1.1 per Investigator assessment [ Time Frame: Approximately one year ]
  • 13. Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
  • 14. Confirmed ORR per RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
    Phase 1/1b only
  • 15. Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment [ Time Frame: Up to 2 years ]
    Phase 2 only
  • 16. CBR according to RECIST 1.1 per IERC [ Time Frame: Up to 2 years ]
    Phase 2 only
  • 17. PFS according to RECIST 1.1 per IERC [ Time Frame: Up to 2 years ]
    Phase 2 only
  • 18. DOR according to RECIST 1.1 per IERC [ Time Frame: Up to month 24 ]
    Phase 2 only
  • 19. Unconfirmed response after 4 cycles according to RECIST 1.1 [ Time Frame: Up to 2 years ]
    Phase 2 only
  • 20. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Phase 2 only
  • 21. Serum titers of anti-DF6002 antibodies [ Time Frame: Up to 2 years ]
    Phase 2 only
  • 22. Serum titers of anti-nivolumab antibodies [ Time Frame: Up to 2 years ]
    Phase 2 only

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

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 #.

Locations

United States, California
Local Institution
Orange

United States, Connecticut
Local Institution
New Haven

United States, Florida
Local Institution
Miami

United States, Georgia
Local Institution
Augusta

United States, Massachusetts
Local Institution
Boston

United States, Michigan
Local Institution
Detroit

United States, Minnesota
Local Institution
Saint Paul

United States, New York
Local Institution
Bronx

United States, New York
Local Institution
Buffalo

United States, Ohio
Local Institution
Cleveland

United States, Oklahoma
Local Institution
Oklahoma City

United States, Rhode Island
Local Institution
Providence

United States, Tennessee
Local Institution
Nashville

United States, Texas
Local Institution
Houston

United States, Utah
Local Institution
Salt Lake City

United States, Virginia
Local Institution
Fairfax

France, Ile-de-France
Local Institution
Paris

France, Rhone
Local Institution
Pierre-Bénite

Spain, Navarre
Local Institution
Pamplona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04423029 History of Changes
  • Other Study ID Numbers: CA101-001, 2021-000038-33
  • First Posted: June 9, 2020 Key Record Dates
  • Last Update Posted: April 15, 2022
  • Last Verified: March 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Advanced or Metastatic Solid Tumors
    Melanoma
    Non-small Cell Lung Cancer
    Nivolumab
    DF6002 (BMS-986415)
  • Additional relevant MeSH terms: Neoplasms