Study on Stopping Nivolumab or Pembrolizumab in Advanced Melanoma Patients After Achieving a Response

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What is this study about?

This clinical trial is focused on studying the effects of stopping treatment in patients with advanced or metastatic melanoma, a type of skin cancer. The study involves two medications: nivolumab (also known as OPDIVO) and pembrolizumab (also known as KEYTRUDA). These medications are given as a solution through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to observe what happens when patients who have shown a complete or partial response to these treatments stop taking them. The study will monitor the ongoing response of the cancer after stopping the medication. Patients will be observed over a period to see if the cancer remains under control without the continued use of the medication.

Participants in the study will have regular check-ups and imaging tests, such as MRI or CT scans, to monitor their condition. The study aims to understand the long-term effects of stopping treatment and whether the cancer remains stable or progresses. This information could help in making future treatment decisions for patients with advanced melanoma.

1 initial treatment

Receive treatment with either nivolumab or pembrolizumab. These are medications given through an intravenous infusion, which means they are administered directly into a vein.

The treatment is part of a first-line therapy for advanced or metastatic melanoma, a type of skin cancer that has spread to other parts of the body.

2 response evaluation

Undergo regular evaluations to assess the response of the tumor to the treatment. This involves imaging tests such as a CT scan every 12 weeks, with a margin of one week, to monitor changes in the tumor size.

The evaluations follow a standard set of criteria known as RECIST v1.1, which helps in determining whether the tumor is shrinking, stable, or growing.

3 discontinuation of treatment

If a complete response (CR) or partial response (PR) is achieved, the treatment with nivolumab or pembrolizumab may be discontinued within six weeks, with a margin of one week, after confirmation of the response.

A complete response means no detectable cancer remains, while a partial response indicates a significant reduction in the size of the tumor.

4 monitoring after discontinuation

Continue to be monitored for ongoing response to the treatment after discontinuation. This includes regular follow-up visits and imaging tests to ensure the cancer remains under control.

The primary goal is to observe the rate of ongoing responses at 24 months after the initial start of treatment.

5 potential reintroduction of treatment

If the cancer progresses after discontinuation, there may be a reintroduction of the same treatment with nivolumab or pembrolizumab, or the introduction of other systemic therapies.

The decision to restart treatment will depend on the specific circumstances and the response of the cancer to previous treatments.

6 assessment of quality of life

Throughout the trial, assessments will be made regarding changes in quality of life, including any changes in daily activities, work productivity, and emotional well-being.

These assessments help in understanding the broader impact of the treatment and its discontinuation on overall health and lifestyle.

Who Can Join the Study?

Must be 18 years or older.
Must have advanced or metastatic melanoma. This means the melanoma has spread to other parts of the body.
Currently receiving first-line treatment with either nivolumab or pembrolizumab for advanced or metastatic melanoma. Previous treatments, including immunotherapy (a type of treatment that helps your immune system fight cancer) for melanoma that could be surgically removed, are allowed.
Must have a documented target lesion. This means there is a specific area of cancer that can be measured on a CT scan (a type of detailed imaging test) when starting treatment with nivolumab or pembrolizumab.
Must have a tumor response evaluation every 12 weeks, give or take a week, using a CT scan. This is to check how the cancer is responding to treatment.
Must have an MRI of the brain to check for any cancer spread to the brain before stopping treatment with nivolumab or pembrolizumab.
Must be willing to stop taking nivolumab or pembrolizumab within 6 weeks, give or take a week, after confirming a complete response (CR) or partial response (PR). This means the cancer has either disappeared or shrunk significantly.

Who Cannot Join the Study?

Patients who have not been diagnosed with advanced or metastatic melanoma. This means the melanoma has spread to other parts of the body.
Patients who have not achieved a CR (Complete Response) or PR (Partial Response) with first-line monotherapy using nivolumab or pembrolizumab. A Complete Response means the cancer is no longer detectable, and a Partial Response means the cancer has shrunk but is still present.
Patients who are not within the specified age range for the study. The study includes certain age groups, and patients must fall within these groups to participate.
Patients who belong to a vulnerable population. This means groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Frisius	Heerenveen	The Netherlands
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
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
Lmxni Uiwjxlalundp Muukgzi Cfnstpj (accph	Leiden	The Netherlands
Umqatfmjoimd Mdfdqnk Cgrgofu Gtlsdfdfa	Groningen	The Netherlands
Anxxhjslz Uar	Amsterdam	The Netherlands
Ezvfbwp Upjlwtpzqexl Mookbao Cghstrj Rkrgxmvvm (tbkvcst Mhd	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.01.2019

Trial locations

Investigated drugs:

Nivolumab is a medication used in this trial to treat advanced melanoma. It works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system attack cancer cells more effectively. Patients in the trial receive this medication as a first-line treatment until they achieve a complete or partial response.

Pembrolizumab is another medication used in the trial for treating advanced melanoma. Similar to nivolumab, it targets the PD-1 protein on immune cells, enhancing the body’s immune response against cancer cells. This medication is also given as a first-line treatment, and patients may stop using it once they achieve a complete or partial response.

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, typically with irregular borders and multiple colors. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease is more common in areas of the skin that have been exposed to the sun, but it can also occur in areas not typically exposed. Early stages may be limited to the skin, but advanced stages involve metastasis, where cancer cells travel through the bloodstream or lymphatic system. Regular skin checks and awareness of changes in moles are important for early detection.

Trial ID:

2024-516937-10-01

Protocol code:

Safe Stop

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Stopping Nivolumab or Pembrolizumab in Advanced Melanoma Patients After Achieving a Response

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?