Study on Dacarbazine, Pembrolizumab, Nivolumab, and Ipilimumab for Patients with Unresectable or Metastatic Melanoma Resistant to Immunotherapy

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What is this study about?

This clinical trial is focused on studying Melanoma, a type of skin cancer that can spread to other parts of the body. The study involves a treatment plan that starts with a medication called Dacarbazine, followed by a re-challenge with immunotherapy. Immunotherapy is a type of treatment that helps the body’s immune system fight cancer. The immunotherapy drugs used in this study include Pembrolizumab, Nivolumab, and Ipilimumab. These medications are known as monoclonal antibodies, which are proteins designed to target and block specific pathways that cancer cells use to grow.

The purpose of the study is to see if using Dacarbazine first can make the cancer more responsive to the immunotherapy drugs. Participants will receive Dacarbazine initially, and then, after a certain period, they will be given the immunotherapy drugs. The study aims to improve the overall response rate, which means seeing how well the cancer responds to the treatment, and to increase the overall survival of the participants. The study will also collect biological samples like tissue, blood, and stool to understand the changes in the immune system during the treatment.

Participants will be monitored throughout the study to assess their quality of life and any changes in their condition. The study is designed to last for a specific period, and the results will help determine if this treatment approach is effective for people with Melanoma that has not responded to previous treatments. The study does not involve explaining the meaning of a placebo, as it is not part of this trial.

1 Initial Treatment with Dacarbazine

The first phase involves the administration of dacarbazine, a chemotherapy drug. This is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of this phase is to prepare the body for the next stage of treatment by potentially making the melanoma more responsive to subsequent immunotherapy.

2 Immunotherapy Re-challenge

Following the initial treatment with dacarbazine, the next phase involves an immunotherapy re-challenge. This includes the administration of pembrolizumab, nivolumab, and ipilimumab, which are drugs designed to help the immune system recognize and attack cancer cells.

These medications are also given intravenously. The specific schedule and dosage will be determined by the healthcare team based on individual patient needs and responses.

3 Monitoring and Assessment

Throughout the trial, regular monitoring will occur to assess the response to treatment. This includes imaging tests such as CT or MRI scans to measure the size of the tumors and determine if they are responding to the treatment.

Blood tests and other assessments will be conducted to monitor overall health and detect any side effects from the medications.

4 Evaluation of Response

At week 14, an evaluation will be conducted to determine the overall response rate. This involves assessing whether there has been a complete or partial response to the treatment, or if the disease has remained stable or progressed.

The primary goal is to improve the overall response rate and increase overall survival.

5 Collection of Biological Samples

During the trial, biological samples such as tissue, blood, and stool may be collected. These samples are used to assess immunological changes and help understand how the treatment is affecting the body.

This information is crucial for evaluating the effectiveness of the treatment and for future research.

6 Quality of Life Assessment

The impact of the treatment on quality of life will be assessed using a standardized questionnaire. This helps to understand how the treatment affects daily living and overall well-being.

The results of this assessment are important for evaluating the benefits and potential drawbacks of the treatment from the patient’s perspective.

Who Can Join the Study?

Must have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can still do light work.
Must be a man or woman aged 18 years or older.
Women who can have children must use a highly effective method of contraception (birth control) during the study and for 6 months after the last dose of the study drug.
Women who can have children must have a negative pregnancy test within 72 hours before starting the study treatment.
Women must not be breastfeeding.
Men who are sexually active with women who can have children must use a highly effective method of contraception during the study and for 8 months after the last dose of the study drug.
Women who cannot have children (due to menopause or surgery) and men who cannot father children do not need to use contraception.
Must have a confirmed diagnosis of unresectable Stage III or Stage IV melanoma, which means the melanoma cannot be removed by surgery and is in an advanced stage.
Must have received certain previous treatments for melanoma and shown resistance, meaning the disease continued to progress without improvement.
Must have measurable disease, which means the cancer can be measured using a CT or MRI scan.
Tumor tissue must be available for testing during the screening and treatment phases.
Must have a BRAF wildtype status, meaning the BRAF gene does not have certain mutations.
If received prior palliative radiotherapy (radiation treatment to relieve symptoms), it must have been completed at least 2 weeks before starting the study drug.
Must meet specific laboratory test values, such as certain levels of white blood cells, platelets, hemoglobin, and liver and kidney function tests, within 14 days before starting the study.
Re-enrollment is allowed if a participant had to leave the study before starting treatment. They must agree to join the study again.

Who Cannot Join the Study?

Patients who have a different type of cancer other than melanoma cannot participate. Melanoma is a type of skin cancer.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not able to give informed consent or understand the study requirements cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received certain treatments or medications that might interfere with the study cannot participate.
Patients who have allergies or reactions to the study medication cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Kwdioske dna Unsaqbgmhily Mpkfehcl Atv	Munich	Germany
Umfonvqnvbicaxgnghlmo Wrfbjzhwq Ayh	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	13.01.2020

Trial locations

Investigated drugs:

Dacarbazine (DTIC) is a type of chemotherapy used in this trial to treat patients with unresectable or metastatic melanoma. It works by slowing or stopping the growth of cancer cells. In this study, dacarbazine is used to prepare the tumor and the immune system for a subsequent round of immunotherapy, aiming to make the cancer more responsive to the treatment.

Immunotherapy Re-challenge involves using treatments that help the immune system recognize and attack cancer cells. In this trial, after the initial treatment with dacarbazine, patients receive another round of immunotherapy. This approach is used for patients whose melanoma did not respond to previous immunotherapy treatments targeting PD-1/PD-L1 or PD-1 combined with CTLA-4. The goal is to improve the effectiveness of the immune system in fighting the cancer.

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing the pigment melanin. It often appears as a new mole or a change in an existing mole, and it can be identified by its irregular shape, multiple colors, and larger size. As melanoma progresses, it can spread to other parts of the body, including the lymph nodes, lungs, liver, brain, and bones. The disease is more likely to spread if it is not detected and treated early. Melanoma is less common than other types of skin cancer but is more dangerous due to its ability to spread rapidly. Early detection and monitoring of skin changes are crucial in managing the progression of melanoma.

Trial ID:

2024-517065-16-00

Protocol code:

PROMIT

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Dacarbazine, Pembrolizumab, Nivolumab, and Ipilimumab for Patients with Unresectable or Metastatic Melanoma Resistant to Immunotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?