AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized phase 2 trial of neoadjuvant pembrolizumab plus belzutifan with or without lenvatinib in patients with localized renal cell carcinoma. The moonlanding trial

This study, called 'The Moonlanding Trial,' is for people with kidney cancer that hasn't spread. It's testing if a combination of medicines can shrink the tumour before surgery. Researchers are using pembrolizumab (Keytruda), belzutifan, and sometimes lenvatinib, to see which combinations work best. They will measure how much the tumours shrink and check for any side effects. The study also looks at how these treatments affect patients' quality of life and general well-being. The goal is to find better ways to treat kidney cancer, potentially making surgery easier and improving outcomes for patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Vall D Hebron Institute Of Oncology

Enrolment target

Start

24 Apr 2026

Patients with localized renal cell carcinoma

What is this study about?

This research study, called 'The Moonlanding Trial,' is for people who have kidney cancer that is still contained in the kidney and hasn't spread to other parts of the body. The main idea behind this study is to see if giving certain medications before surgery can help shrink the cancer. This might make the surgery easier and more effective. We're interested in finding new and better ways to treat kidney cancer, and studies like this help medical professionals understand which treatments work best for patients.

The study is testing a combination of new drugs. One is called pembrolizumab, which helps your body's own immune system fight cancer. Another is belzutifan, which works by targeting specific pathways that help cancer grow. Some patients in the study might also receive lenvatinib, which is another treatment that can help stop cancer cells from growing. By combining these treatments, researchers hope to see a greater effect on the tumour.

Throughout the study, doctors will closely monitor how your body responds to the treatment. They will use scans, like CT scans, to measure if the tumour is getting smaller. They will also pay close attention to any side effects you might experience and how you are feeling generally. Gathering this information is really important for understanding if these new treatments are not only effective but also safe and tolerable for people with kidney cancer.

Key takeaways

This study is testing new drug combinations for kidney cancer before surgery.
It aims to shrink tumours and improve surgery outcomes.
Medicines include pembrolizumab (Keytruda), belzutifan, and sometimes lenvatinib.
Doctors will monitor tumour size and side effects closely.
The study also looks at how treatments affect patients' quality of life.
Participation is for adults aged 18 and over with localized kidney cancer.

Who may be eligible?

To be part of this study, you would generally need to be an adult, aged 18 or older. Both men and women can join.

The study is specifically looking for people who have kidney cancer that is still localized, meaning it hasn't spread to other parts of your body. Doctors will perform tests to confirm this and ensure your kidney cancer fits the specific type they are investigating.

There might be other health requirements or conditions that would determine if this study is right for you, or if it might not be a good fit. These details are usually discussed with your care team.

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.

Are you 18 years old or older?
Do you have kidney cancer that has not spread to other parts of your body?
Are you able to attend regular hospital appointments?
Are you planning to have surgery for your kidney cancer?
Are you open to trying new combinations of medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a series of check-ups to make sure the study is right for you. If you qualify, you'd receive the study medication before your surgery. This would involve regular visits to the hospital for infusions (where medicine goes into your vein) or to take tablets, and to have various tests done, such as blood tests and CT scans, to see how the treatment is working and to check for any side effects.

After your surgery, you would continue to have follow-up appointments to ensure your recovery is going well and to monitor your health over time. The exact number of visits, tests, and the total duration in the study would be explained in detail by the study team, as it can vary depending on individual response and the study's design.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving new treatments that aren't yet widely available, which could potentially shrink your tumour before surgery. However, there are also potential risks, as these medications can have side effects, and some might be serious. The study team will closely monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What kind of kidney cancer is this study for?

This study is for people who have kidney cancer that is still located in the kidney and hasn't spread to other parts of their body.

What are the main medicines being tested?

The main medicines being tested are pembrolizumab (Keytruda), belzutifan, and sometimes lenvatinib.

What does 'neoadjuvant' mean?

'Neoadjuvant' means the treatment is given before the main treatment, which in this case is surgery, to try and shrink the tumour first.

How will doctors know if the treatment is working?

Doctors will use scans, like CT scans, to measure the size of your tumour and see if it has shrunk after the treatment.

Will I have surgery if I join this study?

Yes, this study is designed for patients who are planning to have surgery for their kidney cancer. The study medicines are given before the surgery.