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New immunotherapy combo tackles Hard-to-Treat cancers

NCT ID NCT04423029

Disease control Sponsor: Dragonfly Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested an experimental drug called DF6002, either alone or combined with the approved immunotherapy nivolumab (Opdivo), in 170 people with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety, find the right dose, and get an early look at whether the drugs shrink tumors. Because it is a Phase 1 study, the focus is on safety and dosing, not on proving the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DF6002 (an experimental immunotherapy) and nivolumab (Opdivo, an approved immunotherapy)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 170 participants, so the main goals are safety and dosing—not proof of effectiveness. Many early-stage cancer drugs fail to show benefit in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

170 people

The number who actually took part.

Started

Jul 2020

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * Prior treatment with DF6002, recombinant human interleukin-12 (rhIL-12)-directed therapy, or any drug containing an interleukin-12 (IL-12) moiety * 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

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Conditions

The condition(s) this trial relates to.

melanoma neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors

Contacts and locations

Locations

  • Atlantic Health System

    Morristown, New Jersey, 07960, United States

  • Augusta University Georgia Cancer Center

    Augusta, Georgia, 30912-0003, United States

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495, France

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008, Spain

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Gustave Roussy

    Villejuif, 94805, France

  • HealthPartners Cancer Center at Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Huntsman Cancer Institute and Hospital

    Salt Lake City, Utah, 84112, United States

  • Hôpital Saint-Louis

    Paris, 75010, France

  • Institut Bergonié

    Bordeaux, 33000, France

  • Local Institution

    Boston, Massachusetts, 02215, United States

  • Local Institution - 0022

    Heidelberg, 3084, Australia

  • Local Institution - 0023

    Box Hill, 3128, Australia

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • SCRI - HealthOne Denver

    Denver, Colorado, 80218, United States

  • SCRI - Tennessee Oncology - Saint Thomas West Clinic

    Nashville, Tennessee, 37205, United States

  • START Madrid - Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • USOR - Virginia Cancer Specialists - Fairfax Office

    Fairfax, Virginia, 22031, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.