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Study of Nivolumab for Patients with High-Risk Stage II Melanoma After Surgery

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What is this study about?

This clinical trial is focused on studying stage II high-risk melanoma, a type of skin cancer that has been surgically removed but still poses a risk of returning. The treatment being tested is called nivolumab, also known by its code names BMS936558 and ABP 206. Nivolumab is given as a solution through an infusion into the vein. The purpose of the study is to see how effective nivolumab is in preventing the return of melanoma in patients who are at high risk, as determined by a special test called the MelaGenix assay.

Participants in the study will be randomly assigned to one of two groups. One group will receive nivolumab, while the other group will be observed without receiving the medication. The study will follow participants over time to see if the melanoma returns or if there are any other health changes. The main focus is on how long participants remain free from melanoma returning, which is referred to as Relapse-Free Survival (RFS). The study will also look at other outcomes, such as how long participants live without the cancer spreading to other parts of the body, known as distant metastasis-free survival, and overall survival rates.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the status of their melanoma. The study aims to provide valuable information on whether nivolumab can help prevent the return of melanoma in patients who are at high risk, potentially offering a new treatment option for this group. The study is expected to continue until 2027.

1 Joining the study

Upon joining the study, a diagnosis of stage II melanoma from a primary skin site after surgery is confirmed.

Eligibility is determined through laboratory tests and a risk analysis using the MelaGenix assay.

2 Randomization

Participants are randomly assigned to one of three groups: Arm A, Arm B, or Arm C.

Arm A receives the medication nivolumab, while Arm B and Arm C are observed without medication.

3 Treatment with nivolumab

Participants in Arm A receive nivolumab as a solution for infusion.

The medication is administered intravenously, which means it is given through a vein.

4 Observation period

Participants in Arm B and Arm C are monitored without receiving the medication.

The focus is on tracking the time until any tumor recurrence or other significant events.

5 Follow-up and monitoring

All participants are regularly monitored for relapse-free survival, which is the time from joining the study until any tumor recurrence or death.

Additional outcomes such as distant metastasis-free survival and overall survival are also evaluated.

Who Can Join the Study?

  • Must have a confirmed diagnosis of stage II melanoma that started on the skin and has been treated with surgery.
  • Blood tests must show certain levels:
    • White blood cells: At least 2000 per microliter.
    • Neutrophils: At least 1500 per microliter.
    • Platelets: At least 100,000 per microliter.
    • Hemoglobin: At least 9.0 grams per deciliter.
    • Serum creatinine: No more than 1.5 times the normal limit.
    • Creatinine clearance: At least 40 milliliters per minute.
    • AST/ALT: No more than 3 times the normal limit.
    • Total Bilirubin: No more than 1.5 times the normal limit, except for those with Gilbert Syndrome, who can have up to 3.0 mg/dL.
  • Women who can have children must have a negative pregnancy test within 72 hours before joining the study.
  • Women who can have children and men with partners who can have children must agree to use a highly effective form of birth control during the study and for at least 5 months after the last dose of the study medication (only for those in Arm A).
  • Must have had a sentinel node biopsy that did not find melanoma deposits. A sentinel node biopsy is a procedure to check if cancer has spread to the lymph nodes.
  • Must register for the study no later than 12 weeks after the sentinel node biopsy.
  • Must provide tumor tissue from the primary tumor for special tests called biomarker analyses.
  • Must be classified by a test called MelaGenix risk analysis.
  • Must be between 18 and 80 years old.
  • Must sign a written consent form agreeing to participate in the study.
  • Must be willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and other study requirements.
  • Must have a life expectancy of at least five years, not counting the melanoma diagnosis.
  • Must have an ECOG performance status of 0-1, which means being fully active or having some symptoms but being able to carry out light work.

Who Cannot Join the Study?

  • Patients who have not had surgery for their Stage II melanoma. Melanoma is a type of skin cancer, and Stage II means it is in an early stage but has grown deeper into the skin.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of other cancers, unless they have been cancer-free for a certain period.
  • Patients who have an active infection that requires treatment.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have received certain treatments for melanoma in the past that might affect the study results.
  • Patients who have a condition that affects their immune system, which is the body’s defense against illness.
  • Patients who have a mental health condition that might make it difficult to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Rostock University Medical Center Rostock Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Klinikum Dortmund gGmbH Dortmund Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
HELIOS Klinikum Erfurt GmbH Erfurt Germany
St. Josef-Hospital Bochum Germany
Harzklinikum Dorothea Christiane Erxleben GmbH Quedlinburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Fachklinik Hornheide e.V. Munster Germany
Ugtexhukoy Msonzvj Ckcajn Hkatftyxutsabouga Hamburg Germany
Uslydjnwqfgjbxqtqkukg Esjkq Aau Essen Germany
Umflzvioyfgwygopuderg Aqowredm Augsburg Germany
Uotevqzyjswqvcqwihggx Mwopuats Agw Munster Germany
Kzcdmgbz drz Udvllsomxeya Mgqilsth Axl Munich Germany
Ujvcrmxniawoepsqnieda Wxfmwgxko Azc Wuerzburg Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.04.2020

Trial locations

Investigated drugs:

Nivolumab is a medication used in this clinical trial to treat patients with stage II high-risk melanoma. It is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this trial, nivolumab is being tested to see if it can improve the time patients remain free from cancer recurrence compared to those who are only observed without receiving the medication.

Stage II Melanoma – This is a type of skin cancer that originates from melanocytes, the cells responsible for producing pigment in the skin. In Stage II, the melanoma is more advanced than Stage I but has not yet spread to lymph nodes or distant sites. It is characterized by a thicker tumor that may have ulceration, which is a breakdown of the skin over the tumor. The progression involves the potential for the tumor to grow deeper into the skin and possibly spread to nearby tissues. After surgical removal, there is a risk of recurrence, which means the cancer can return at the original site or elsewhere in the body. Monitoring for signs of recurrence is crucial in managing the disease.

Trial ID:
2023-509394-23-00
Protocol code:
CA209-7DL
NCT ID:
NCT04309409
Trial Phase:
Therapeutic confirmatory (Phase III)

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