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Study of DF6002 alone and combined with nivolumab in patients with advanced solid tumors: A safety and effectiveness trial

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates a treatment for patients with advanced solid tumors, which are cancers that have spread or cannot be surgically removed. The study tests two medications: a new drug called DF6002 and an existing medication called nivolumab. The treatment will be given either as an injection under the skin (DF6002) or through an intravenous infusion into a vein (nivolumab).

The research aims to determine the safety and effectiveness of DF6002 when used alone and when combined with nivolumab. The study includes several types of cancers, such as melanoma, non-small cell lung cancer, head and neck cancer, urothelial cancer, gastric cancer, and others. The study is divided into different phases to test different aspects of the treatment.

During the study, patients will receive either DF6002 by itself or DF6002 together with nivolumab. The doctors will monitor patients' responses to the treatment and check for any side effects. They will also measure how the medications work in the body and track whether the tumors respond to the treatment. Some patients may need to provide tissue samples (biopsies) during the study to help researchers better understand how the treatment works.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Your participation begins with receiving either DF6002 alone or in combination with nivolumab, depending on your assigned study group.
If you are in the combination group, you will receive nivolumab through an intravenous infusion (into a vein) and DF6002 as a subcutaneous injection (under the skin).
The first 3 weeks of treatment are crucial for monitoring how your body responds to the medication.
Step 2
Ongoing treatment and monitoring
Regular medical check-ups will track your health status throughout the treatment period.
Your doctor will perform physical examinations and assess your overall condition using a scale called ECOG performance status.
Blood tests, heart monitoring (ECG), and vital signs will be checked regularly.
Imaging scans will be performed to measure how your tumor responds to treatment according to standardized criteria (RECIST 1.1).
Step 3
Tumor assessment
Your tumor response will be evaluated regularly through imaging scans.
An independent group of experts will review your scans to determine if the treatment is working.
The assessment will look for changes in tumor size and any new tumor growth.
Step 4
Safety monitoring
Any side effects will be monitored and recorded throughout the study.
Side effects will be rated according to standardized criteria to determine their severity.
Laboratory tests will be performed regularly to monitor your body's response to treatment.
Step 5
Study completion
The study is expected to continue until August 2025.
Your participation duration will depend on how your body responds to the treatment and any side effects you may experience.
Final assessments will be conducted to evaluate the overall effectiveness of the treatment.

Who can join the trial?

11 criteria

Must be at least 18 years old
Must provide written informed consent (formal agreement to participate in the study)
Must have one of these confirmed advanced cancers: melanoma (skin cancer), lung cancer, head and neck cancer, bladder cancer, stomach cancer, esophageal cancer, cervical cancer, liver cancer, Merkel cell cancer, skin squamous cell cancer, kidney cancer, endometrial cancer, triple-negative breast cancer, ovarian cancer, or prostate cancer
Must have a good physical condition, measured as ECOG score of 0 or 1 (able to perform daily activities with minimal assistance)
Must have a life expectancy of at least 3 months
Must have evidence of cancer that can be measured by scans or clinical examination
Must agree to undergo tumor tissue sampling (biopsy) before and during treatment
For melanoma patients: Must have Stage III or IV melanoma that cannot be surgically removed
For lung cancer patients: Must have Stage IIIB, Stage IV, or recurring lung cancer
For lung cancer patients: Must have had previous treatment with platinum-based chemotherapy that didn't work or stopped working
Must have received previous treatments appropriate for their type of cancer with documented disease progression

Who cannot join the trial?

15 criteria

Age under 18 years
Active or untreated brain metastases (cancer that has spread to the brain)
History of severe allergic reactions to biological treatments
Current treatment with other immunotherapy medications
Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
Uncontrolled or significant heart disease
Active infection requiring treatment, including HIV, Hepatitis B, or Hepatitis C
Pregnant or breastfeeding women
Major surgery within 4 weeks before starting the study treatment
Participation in another clinical trial within 4 weeks before starting this study
Life expectancy less than 3 months
Severe organ dysfunction
Previous treatment with similar study medications (DF6002 or Nivolumab)
Psychiatric conditions that could interfere with study participation
Use of systemic steroids (except for specific medical conditions approved by study doctor)

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France
Verified
Hospital Universitario De Navarra
Pamplona, Spain

Trial locations

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Investigated drugs

DF6002
is an investigational medication being studied for the first time in humans. It is given as an injection under the skin (subcutaneously) to treat patients with advanced solid tumors that have spread or cannot be removed by surgery. This medication is being tested both alone and in combination with another drug.
Nivolumab
is a cancer immunotherapy medication that helps the immune system fight cancer cells. It is given through an intravenous (IV) infusion directly into the bloodstream. In this trial, it is being tested in combination with DF6002 to see if the two medications together can better help patients with advanced solid tumors.

What is already known about the treatment

DF6002
An investigational therapeutic agent administered subcutaneously that is currently being studied in Phase 1/2 clinical trials for patients with advanced solid tumors. The medication is being evaluated both as a monotherapy and in combination with nivolumab to determine its safety, tolerability, and clinical effectiveness. While its specific molecular mechanism of action is not disclosed in the source data, it is being investigated for use in patients with unresectable, recurrent, or metastatic solid tumors.
Nivolumab
An established immunotherapy medication administered intravenously that belongs to the class of PD-1 inhibitors. It works by blocking the PD-1 protein on T cells, helping the immune system recognize and attack cancer cells more effectively. In this clinical trial, nivolumab is being studied in combination with DF6002 for the treatment of advanced solid tumors to evaluate their combined therapeutic potential and safety profile.

Investigated diseases

Advanced Solid Tumors - A condition where abnormal cells form solid masses or tumors that have spread beyond their original location to other parts of the body. These tumors can develop in various organs and tissues, such as the lungs, liver, bones, or lymph nodes. The tumors are characterized by uncontrolled cell growth and the ability to invade nearby tissues. Advanced solid tumors are typically described as unresectable (cannot be completely removed by surgery), recurrent (have returned after previous treatment), or metastatic (have spread to other parts of the body). The disease process involves the continuous growth and spread of cancer cells through the bloodstream or lymphatic system.