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

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What is this study about?

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.

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.

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).

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.

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.

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 Study?

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 Study?

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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Ayhlmomhgl Psqhobzb Hidhavjl Dc Pgbua	Paris	France
Hiofvwtk Veql dygliofh	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.07.2021
Spain	Not recruiting	01.07.2021

Trial locations

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.

Investigated diseases:

Neoplasm

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.

Trial ID:

2023-510511-19-00

Protocol code:

DF6002-001

NCT ID:

NCT04423029

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?