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Study on Adding Diclofenac to PD-1 Inhibitor Therapy for Patients with Metastatic Melanoma

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What is this study about?

This clinical trial is focused on studying the effects of adding the medication diclofenac to ongoing treatment with a type of cancer therapy known as a PD-1 inhibitor in patients with metastatic melanoma. Metastatic melanoma is a form of skin cancer that has spread to other parts of the body. The PD-1 inhibitors being used in this study include medications like nivolumab and pembrolizumab, which are designed to help the immune system fight cancer cells more effectively.

The purpose of the study is to evaluate how well diclofenac works when added to the existing PD-1 inhibitor therapy in patients whose cancer has not progressed beyond a stable state. Diclofenac is a medication commonly used to reduce inflammation and pain. In this study, it is being tested to see if it can enhance the effects of the PD-1 inhibitors. The study will involve regular monitoring of the patients’ health and response to the treatment over a period of time.

Participants in the study will receive diclofenac in addition to their ongoing PD-1 inhibitor therapy. The treatment will be administered according to a set schedule, and patients will be closely observed to assess any changes in their condition. The study aims to determine if the combination of these treatments can lead to better outcomes for patients with metastatic melanoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of metastatic melanoma and ongoing treatment with an approved anti-PD-1 therapy, which has resulted in stable disease.

Additional criteria include having a BRAF-V600 mutation, if applicable, and having received targeted therapy. Adequate tumor tissue must be available for biopsy, and organ function must be sufficient.

2 treatment initiation

The treatment phase begins with the administration of diclofenac sodium in the form of gastro-resistant tablets. The dosage is 25 mg per tablet, taken orally.

This is added to the ongoing PD-1 inhibitor therapy, which may include medications such as nivolumab or pembrolizumab, administered via intravenous infusion.

3 ongoing treatment and monitoring

Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes imaging studies such as positron emission tomography combined with computed tomography (PET-CT) to evaluate tumor response.

The primary goal is to achieve an objective response, defined as either a complete or partial response, by week 9 of the trial.

4 evaluation at week 9

At week 9, a comprehensive evaluation is performed to determine the best response to the treatment. This involves a detailed assessment using PET-CT imaging.

The response is classified according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

5 continuation or conclusion

Based on the evaluation results, the treatment may continue or conclude. The decision is made according to the response observed and the overall health status of the patient.

The trial is expected to continue until December 31, 2029, with ongoing assessments and adjustments as necessary.

Who Can Join the Study?

  • You must have a type of skin cancer called metastatic melanoma, which means the cancer has spread to other parts of the body and cannot be removed by surgery.
  • You should already be receiving a treatment known as an anti-PD-1 therapy, which is a type of medicine that helps your immune system fight cancer. Your best response to this treatment should be SD, which stands for stable disease, meaning the cancer has not grown or shrunk significantly.
  • If you have a specific genetic change in your cancer called BRAF-V600 mutation, you must have already received a treatment that targets this mutation.
  • There must be enough cancer tissue available for a procedure called a biopsy, where a small sample of the tumor is taken for study.
  • Your overall health should be good, as measured by a scale called ECOG, where you should score 0 or 1. This means you are fully active or have some symptoms but can still do light work.
  • Your organs, like your liver and kidneys, should be working well enough to handle the treatment.
  • Both men and women can participate in the study.
  • You should be within the age range of 18 to 64 years old.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than metastatic melanoma. Metastatic melanoma is a type of skin cancer that has spread to other parts of the body.
  • Patients who are not currently receiving a PD-1 inhibitor therapy. PD-1 inhibitor therapy is a treatment that helps the immune system fight cancer.
  • Patients who have not achieved SD as the best response to their current treatment. SD stands for stable disease, which means the cancer has not grown or shrunk significantly.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Regensburg AöR Regensburg Germany
Mgjnttiyuozpjjchugkberjplz Hvidgqpecqwyoncl Halle (Saale) Germany
Uoyhyuddzvtdrngfwmtjq Eejzl Amq Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.01.2024

Trial locations

Investigated drugs:

Diclofenac is a medication that is being tested in this trial to see if it can help improve the treatment of metastatic melanoma. It is being added to an existing therapy to see if it can make the treatment more effective for patients who have not seen significant improvement with their current treatment.

PD-1 Inhibitor Therapy is a type of cancer treatment that helps the immune system attack cancer cells. In this trial, patients are already receiving this therapy, and the study is looking at whether adding diclofenac can help patients who have only achieved stable disease, meaning their cancer has not grown but also has not shrunk significantly.

Investigated diseases:

Metastatic Melanoma – Metastatic melanoma is a type of skin cancer that has spread from its original site to other parts of the body. It often begins as a mole or pigmented area on the skin and can progress to affect organs such as the lungs, liver, brain, and bones. The disease is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for producing skin pigment. As it advances, metastatic melanoma can cause symptoms like lumps under the skin, swollen lymph nodes, and unexplained weight loss. The progression of the disease can vary, with some individuals experiencing rapid spread while others may have a slower progression. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:
2023-504191-26-00
Protocol code:
DICIT
Trial Phase:
Therapeutic use (Phase IV)

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