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Study on Short vs. Long Immunotherapy with Pembrolizumab and Nivolumab for Patients with High-Risk Skin Melanoma After Surgery

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What is this study about?

This clinical trial is focused on studying the treatment of cutaneous malignant melanoma, a type of skin cancer. The study will use two medications: KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab). Both medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to determine if a shorter duration of treatment with these medications is as effective as a longer one. Specifically, it will compare the effects of 6 months of treatment to 12 months of treatment in patients who have undergone radical surgery for high-risk melanoma. The study aims to see if the shorter treatment duration can provide the same benefits in preventing the cancer from returning or spreading.

Participants in the study will receive either KEYTRUDA or OPDIVO after their surgery. The study will monitor the patients over time to assess their health and the effectiveness of the treatment. The main focus will be on how long patients remain free from distant metastases, which are cancer cells that have spread to other parts of the body, and how long they remain free from any signs of cancer returning. Additionally, the study will look at the overall survival of the patients, which refers to the length of time they live after starting the treatment.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to compare the effectiveness of short-term versus long-term immunotherapy after surgery for high-risk skin cancer known as cutaneous malignant melanoma.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes ensuring you have undergone radical surgery for stage IIb-c, III, or IV melanoma and have a performance status of WHO 0-1, which indicates your ability to carry out daily activities.

3 randomization

You will be randomly assigned to one of two groups. One group will receive immunotherapy for 6 months, and the other for 12 months. This process is random to ensure unbiased results.

4 treatment administration

You will receive either pembrolizumab or nivolumab as a solution for infusion. Pembrolizumab is administered as a 25 mg/mL concentrate, and nivolumab as a 10 mg/mL concentrate. The infusion will be given at regular intervals as determined by the study protocol.

5 monitoring and follow-up

Throughout the treatment period, regular monitoring will be conducted to assess your health and the effectiveness of the treatment. This includes checking for any side effects and measuring outcomes like distant metastatic free survival and relapse free survival.

6 completion of treatment

After completing the assigned treatment duration, a final assessment will be conducted. This will help determine the overall survival and effectiveness of the treatment in preventing cancer recurrence.

Who Can Join the Study?

  • Must have a performance status of WHO 0-1, which means you are fully active or have some symptoms but can still carry out light work.
  • Must have had radical surgery for cutaneous malignant melanoma, which is a type of skin cancer, at stage IIb-c, III, or IV.
  • Must be within the age range of 18 to 64 years old.
  • Both males and females can participate.

Who Cannot Join the Study?

  • Patients who do not have cutaneous malignant melanoma cannot participate. This is a type of skin cancer.
  • Patients who are not in stages IIb-c, III, or IV of cutaneous malignant melanoma cannot participate. These stages describe how advanced the cancer is.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. This means people who 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
Oslo Universitetssykehus HF Oslo Norway
Kuopio University Hospital Kuopio Finland
Region Vaestmanland Vasteras Sweden

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
Region Oestergoetland Linkoping Sweden
Region Oerebro Laen Orebro Sweden
Region Vaesterbotten Umea Sweden
St. Olavs Hospital HF Trondheim Norway
Helse Stavanger HF Stavanger Norway
Region Dalarna Falun Sweden
Region Vaesternorrland Sundsvall Sweden
Laenssjukhuset I Kalmar Region Kalmar Laen Kalmar Sweden
Karolinska University Hospital Solna Sweden
Sørlandet sykehus Kristiansand Kristiansand Norway
Region Skane Skanes Universitetssjukhus Lund Sweden
Turku University Hospital Turku Finland
Malarsjukhuset Eskilstuna Eskilstuna Sweden
Region Joenkoepings Laen Jönköping Sweden
Region Kronoberg Vaxjo Sweden
Pirkanmaan hyvinvointialue Tampere Finland
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Vestre Viken HF Drammen Norway
Sykehuset I Vestfold HF Tonsberg Norway
Region Gaevleborg Gavle Sweden
Aeoffyyz Upnffnvryx Hcaymfuy Lorenskog Norway
Uawjyuo Uarhhjvfpx Hvvhxxdh Uppsala Sweden
Hvszq Bapwwq Hp Bergen Norway
Hzckpkxr Uzbctltkdu Cpmgjlj Hgmvtswg Helsinki Finland
Heihr Mfokb Og Rexsxvr Hg Aalesund Norway
Rulrns Vwcnairfw Karlstad Sweden

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

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
19.12.2024
Norway Norway
Recruiting
19.12.2024
Sweden Sweden
Recruiting
19.12.2024

Trial locations

Investigated drugs:

Immunotherapy is a type of treatment that helps your immune system fight cancer. In this trial, it is used after surgery to help prevent the melanoma from coming back. The study is looking at whether taking immunotherapy for 6 months is as effective as taking it for 12 months. This treatment works by boosting your body’s natural defenses to recognize and attack cancer cells.

Investigated diseases:

Cutaneous Malignant Melanoma – This is a type of skin cancer that originates in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It typically begins as a mole or a dark spot on the skin that changes in size, shape, or color over time. As the disease progresses, it can invade deeper layers of the skin and spread to other parts of the body, including lymph nodes and distant organs. The progression is often marked by the tumor’s ability to grow vertically into the skin, increasing the risk of metastasis. Early stages may be confined to the epidermis, but advanced stages involve deeper tissue invasion and potential spread beyond the skin. Monitoring changes in skin lesions is crucial for early detection and management.

Trial ID:
2023-509994-22-00
NCT ID:
NCT06488482
Trial Phase:
Therapeutic confirmatory (Phase III)

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