Study Comparing Ipilimumab and Nivolumab with Standard Nivolumab for Patients with Stage III Melanoma

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What is this study about?

This clinical trial is focused on studying treatments for Stage III melanoma, a type of skin cancer that has spread to nearby lymph nodes. The study is comparing two different treatment approaches. One group of patients will receive a combination of two medications, Ipilimumab and Nivolumab, before surgery. This is known as neoadjuvant therapy, which means treatment given as a first step to shrink a tumor before the main treatment, usually surgery. After surgery, these patients may continue with Nivolumab or switch to other medications if needed. The other group will receive Nivolumab after surgery, which is called adjuvant therapy, meaning treatment given after the primary treatment to lower the risk of the cancer coming back.

The purpose of the study is to compare how well these treatments work in preventing the cancer from returning or spreading. The trial will involve regular visits to the clinic for treatment, which is given through an intravenous infusion, meaning the medication is delivered directly into a vein. Patients will be monitored over a period of time to see how the cancer responds to the treatment and to check for any side effects. Some patients may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, doctors will assess the health and progress of the participants, looking at factors like the time it takes for the cancer to progress or return, and overall survival rates. The study aims to provide valuable information on the effectiveness of these treatment strategies for Stage III melanoma, potentially leading to improved outcomes for patients with this condition.

1 initial treatment phase

The trial begins with the administration of two medications: ipilimumab and nivolumab. These are given as a solution through an intravenous infusion.

The purpose of this phase is to prepare the body for the main treatment by using these medications to help the immune system recognize and attack cancer cells.

2 neoadjuvant treatment

During this phase, the combination of ipilimumab and nivolumab is administered. This is done to shrink the tumor before surgery.

The treatment is given through an intravenous infusion, which means the medication is delivered directly into the bloodstream.

3 surgery

After the neoadjuvant treatment, surgery is performed to remove the tumor and any affected lymph nodes.

The goal of the surgery is to eliminate as much of the cancer as possible.

4 adjuvant treatment

Following surgery, nivolumab is administered as an adjuvant treatment. This is intended to prevent the cancer from returning.

In some cases, if the initial treatment did not achieve the desired response, a combination of dabrafenib and trametinib may be used instead.

5 follow-up and monitoring

Regular follow-up visits are scheduled to monitor the patient’s health and check for any signs of cancer recurrence.

These visits may include physical exams, imaging tests, and blood tests to ensure the treatment is working effectively.

Who Can Join the Study?

Men and women, at least 16 years of age.
Women who can have children must use a reliable method of birth control to prevent pregnancy during the study and for 23 weeks after the last dose of the study drugs ipilimumab and nivolumab.
Men who are sexually active with women who can have children do not need to use birth control during treatment with nivolumab and/or ipilimumab, but must use a reliable method of birth control to prevent pregnancy during the study and for 17 weeks after the last dose of the study drugs dabrafenib and trametinib.
Patient must be willing and able to understand the study requirements and follow the treatment schedule, attend scheduled visits, report outcomes electronically, undergo tumor biopsies and extra blood tests during screening and if the cancer returns, and meet other study requirements.
Patient must have signed the Informed Consent document, which means they agree to participate in the study after being informed about it.
Patient must have a World Health Organization (WHO) Performance Status of 0 or 1, which means they are fully active or have some symptoms but do not need help with daily activities.
Patient must have a confirmed diagnosis of resectable stage III melanoma, which is a type of skin cancer that can be surgically removed, with one or more large lymph node metastases that can be detected and biopsied. A maximum of 3 additional resectable in-transit metastases is allowed. A concurrent resectable primary melanoma is also allowed.
Patient must not have any other cancers, except those that have been treated and have a life expectancy of more than 5 years related to cancer.
Patient must not have had any previous immunotherapy targeting specific proteins like CTLA-4, PD-1, PD-L1, or LAG-3, which are used to help the immune system fight cancer.
Patient must not have had any previous targeted therapy targeting BRAF and/or MEK, which are specific treatments for certain types of cancer.
Patient must not have taken any immunosuppressive medications within 6 months before joining the study, except for low-dose steroids equivalent to prednisolone 10 mg or less.
Patient’s laboratory test results must meet specific criteria, including certain levels of white blood cells, neutrophils, platelets, hemoglobin, creatinine, AST, ALT, and bilirubin. These tests help ensure the patient is healthy enough to participate in the study.
Patient’s LDH level must be less than 1.5 times the upper limit of normal. LDH is a substance in the blood that can be higher in some medical conditions.

Who Cannot Join the Study?

Patients with any other type of cancer besides Stage III melanoma cannot participate. Melanoma is a type of skin cancer, and Stage III means it has spread to nearby lymph nodes.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and may include specific age groups.
Patients who are part of a vulnerable population, such as those who cannot give consent or have certain health conditions, are not eligible.
Patients who are not able to follow the study procedures or attend required visits may be excluded.
Patients who have received certain treatments or medications that could interfere with the study may not be eligible.
Patients with certain medical conditions that could affect the study results or their safety may be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Frisius	Heerenveen	The Netherlands
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Isala Klinieken Stichting	Zwolle	The Netherlands
Amphia Hospital	Breda	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Hopital Beaujon	Clichy	France
Cvkowi Lcby Bsfyzo	Lyon	France
Livub Ubxlmczuujjj Mrqwecx Cpbthsz (lqpqz	Leiden	The Netherlands
Uczqiczuvtkp Mkrgrom Cbxuojb Gihplomwc	Groningen	The Netherlands
Acldxlpcz Ugv	Amsterdam	The Netherlands
Eehvyyb Uxeberwuyglc Mdtuzgz Cebgtot Rvoeijgdn (wbrxxcr Mqh	Rotterdam	The Netherlands
Neziifmg Incjmkla Orqibieou Igz Mzkxl Sedghtogeujjgkwqjjmgkgdzjvio Iijwadyz Bdbvhtee	Cracow	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.07.2021
Italy	Not recruiting	08.07.2021
Poland	Not recruiting	08.07.2021
The Netherlands	Not recruiting	08.07.2021

Trial locations

Investigated drugs:

Ipilimumab is a medication used to help the immune system attack cancer cells. It works by blocking a specific protein that usually stops the immune system from working strongly. In this trial, it is used before surgery to try to shrink the melanoma tumors.

Nivolumab is another medication that helps the immune system fight cancer. It also blocks a protein that can slow down the immune system, allowing it to attack cancer cells more effectively. In this trial, it is used both before and after surgery to treat melanoma.

Dabrafenib is a medication that targets specific proteins in cancer cells, which helps to stop the cancer from growing. It is used in this trial for patients who do not respond to the initial treatment, to help control the melanoma.

Trametinib is a medication that works by blocking certain proteins that are involved in the growth and spread of cancer cells. It is used in combination with dabrafenib in this trial for patients who need additional treatment after the initial therapy.

Investigated diseases:

Stage III Melanoma – This is a type of skin cancer that has spread to nearby lymph nodes but not to distant parts of the body. It often begins as a mole or pigmented area on the skin that changes in size, shape, or color. As it progresses, the cancer cells invade deeper layers of the skin and nearby tissues. The disease can cause symptoms such as swelling of lymph nodes, changes in skin appearance, and sometimes ulceration. Stage III melanoma is categorized based on the extent of lymph node involvement and the presence of microscopic or macroscopic metastases. The progression of the disease can vary, with some cases remaining stable for a period while others may advance more rapidly.

Trial ID:

2024-513519-28-00

Protocol code:

M23MAR

NCT ID:

NCT04949113

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Ipilimumab and Nivolumab with Standard Nivolumab for Patients with Stage III Melanoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?