Active not recruitingPHASE3INTERVENTIONAL

Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)

This UK-based study is looking at whether a new medicine, pembrolizumab, can help prevent melanoma skin cancer from returning after surgery. It's for people with a high-risk type of melanoma, meaning there's a greater chance the cancer might come back. Half of the participants will receive pembrolizumab, and the other half a dummy medicine (placebo), so doctors can compare how well the new medicine works and if it's safe. The treatment lasts about one year. If the cancer does return, there might be an option to receive pembrolizumab again. The main goal is to see if pembrolizumab can keep people cancer-free for longer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

976

Start

12 Sep 2018

Estimated completion

12 Oct 2033

Melanoma

Results

Results from this study

Posted June 2022

Results have been published for this study.

Primary outcome

Recurrence-free Survival (RFS)

RFS was defined as the time from randomization to any of the following events: recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per protocol, final analysis for this primary outcome measure was performed using the initial pembrolizumab or placebo treatment with a protocol-specified analysis data cut-off date of June-21-2021.

Full results on the registry

What is this study about?

This study is designed for individuals in the UK who have had melanoma, a serious type of skin cancer, removed by surgery. Even after surgery, some melanomas are considered 'high-risk,' meaning there's a concern the cancer might return in the future. The purpose of this study is to investigate whether a medicine called pembrolizumab can help reduce this risk and keep the cancer from coming back.

You might be wondering how the study works. It's set up in two main parts. In the first part, participants will either receive pembrolizumab or a 'placebo,' which looks like the medicine but contains no active drug. This is done to fairly compare the effects of the medicine. Neither you nor your doctor will know which treatment you are receiving at this stage, which is called 'double-blind.' This treatment is given every three weeks for about a year. Doctors will be carefully monitoring your health and whether the cancer returns.

The second part of the study offers an option for those whose cancer does return after the first part. If you were on pembrolizumab and the cancer came back, you might be able to receive pembrolizumab again. If you were on the placebo and the cancer returned, you might then be offered pembrolizumab. This second part helps researchers learn more about how the medicine works over a longer period and in different situations. The main question the study hopes to answer is whether pembrolizumab helps people stay free of melanoma recurrence for a longer time.

Key takeaways

Tests a new medicine, pembrolizumab, for high-risk melanoma after surgery.
Aims to prevent melanoma from returning.
Compares pembrolizumab to a dummy medicine (placebo) for about one year.
Potential re-treatment option if cancer returns.
Rigorous monitoring for safety and effectiveness.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, people need to meet certain conditions. Firstly, you must have been diagnosed with a specific type of melanoma (Stage IIB or IIC) that has been removed by surgery. This must be a new diagnosis, and you can't have received any other treatment for melanoma besides the initial surgery. The surgery should have happened within 12 weeks before joining the study, and scans should show that the cancer hasn't spread to other parts of your body. Participants must also be generally well enough to take part, as assessed by standard health checks.

There are also some reasons why someone might not be able to join. For example, if you have another type of cancer that is currently active and requires treatment (apart from some common and easily treated skin cancers or very early-stage cancers like certain breast or cervical cancers). You also cannot be on medicines that weaken your immune system. Importantly, if you've previously received certain similar types of cancer treatments, you wouldn't be able to join this particular study. Women who are pregnant or breastfeeding, or who could become pregnant and are not using effective birth control, also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you had melanoma (Stage IIB or IIC) removed by surgery?
Was your melanoma a new diagnosis, and have you only had surgery for it?
Were you diagnosed and had surgery within the last 12 weeks?
Scans show your cancer hasn't spread?
Are you generally well and fit enough for the study?
Are you not pregnant, breastfeeding, or using effective contraception if you could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to either receive pembrolizumab or a dummy medicine called a placebo. This will be given through a drip (intravenously) every three weeks for about one year (17 cycles). During this initial year, neither you nor your doctors will know which treatment you are receiving to ensure fair results. You'll have regular hospital visits for these treatments and check-ups. These visits will include physical examinations, blood tests, and scans to monitor your health and see how your body is responding to the treatment.

After the first year, if your cancer thankfully hasn't returned, your participation in this part of the study will end. If, however, your cancer does return during or after the first year, you might have the option to enter the second part of the study. In this second part, everyone who joins will receive pembrolizumab through a drip every three weeks for up to two years. Again, you'd have regular hospital visits for treatment and monitoring. The study team will explain all the visits, tests, and procedures in detail, making sure you fully understand what's involved throughout the total duration of your participation.

Potential risks and benefits

Participating in a clinical trial like this comes with potential benefits and risks. A potential benefit is that you could be among the first to receive pembrolizumab, which might help prevent your melanoma from returning compared to the placebo. However, there's no guarantee it will work for everyone, and it might not offer any personal benefit. Like all medicines, pembrolizumab can have side effects, which could range from mild to serious, and these will be carefully explained to you by the study team. You'll be closely monitored for any reactions. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (159)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Arizona Cancer Center ( Site 0121)
Verified postcode
Tucson, United States
UCSD Moores Cancer Center ( Site 0133)
Verified postcode
La Jolla, United States
The Angeles Clinic and Research Institute ( Site 0029)
Verified postcode
Los Angeles, United States
UCLA Hematology & Oncology ( Site 0130)
Verified postcode
Los Angeles, United States
John Wayne Cancer Institute ( Site 0026)
Verified postcode
Santa Monica, United States
University of Colorado Cancer Center ( Site 0027)
Verified postcode
Aurora, United States
Yale University ( Site 0035)
Verified postcode
New Haven, United States
Mayo Clinic Florida ( Site 0024)
Verified postcode
Jacksonville, United States
Moffitt McKinley Outpatient Center ( Site 0131)
Verified postcode
Tampa, United States
Winship Cancer Institute of Emory University ( Site 0046)
Verified postcode
Atlanta, United States
Northside Hospital ( Site 0115)
Verified postcode
Atlanta, United States
Northwestern Medical Group ( Site 0135)
Verified postcode
Chicago, United States

Common questions

What is melanoma and why is it 'high-risk'?

Melanoma is a type of skin cancer. 'High-risk' means that even after surgery, there's a greater chance the cancer might come back.

What is pembrolizumab?

Pembrolizumab is a medicine that helps your body's immune system fight cancer cells. It's being tested to see if it can stop melanoma from returning.

What is a 'placebo'?

A placebo is a dummy medicine that looks like the real thing but contains no active drug. It's used to compare the effects of the new medicine fairly.

How long will I be involved in the study?

The initial treatment part is for about one year. If your cancer returns, there might be an option to continue in a second part for up to two more years.

Will I know if I'm getting the real medicine or the placebo?

For the first part of the study (about one year), neither you nor your doctor will know if you're receiving pembrolizumab or the placebo. This is called 'double-blind'.