Active not recruitingPHASE2INTERVENTIONAL

A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).

This study is looking at a new treatment approach for kidney cancer (renal cell carcinoma). After surgery to remove the cancer, some people are still at risk of it returning. This trial is comparing two treatment plans: a new drug called Intismeran autogene given together with an existing medication, Pembrolizumab, versus Pembrolizumab given with a placebo (a dummy treatment). The main goal is to find out if the Intismeran autogene and Pembrolizumab combination can help patients stay cancer-free for a longer time after their operation. This is a Phase 2 study, which means it's still in the earlier stages of testing, building on previous safety information.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

272

Start

10 Apr 2024

Estimated completion

08 Jun 2032

Renal Cell Carcinoma

What is this study about?

When you have kidney cancer and have surgery to remove it, doctors sometimes recommend additional treatment to try and stop the cancer from returning. This study is exploring a new combination of medicines that might help with this. The treatments being tested are Intismeran autogene and Pembrolizumab.

Pembrolizumab is a type of immunotherapy. Immunotherapy works by boosting your body's own immune system to fight cancer cells. Intismeran autogene is a newer investigational drug that may also help the immune system target cancer. By combining these two treatments, researchers hope to give your body a stronger ability to prevent the cancer from coming back.

The main question this study wants to answer is whether giving Intismeran autogene alongside Pembrolizumab will keep people who have had kidney cancer surgery free from the disease for a longer period, compared to just giving Pembrolizumab (which is already an approved treatment in some situations) with a dummy drug (placebo). This is an important step in finding better ways to treat kidney cancer and improve patient outcomes.

Key takeaways

This study evaluates a new combination treatment for specific types of kidney cancer.
It aims to see if combining Intismeran autogene with Pembrolizumab helps prevent cancer recurrence after surgery.
Participation involves receiving assigned treatment (active drug combo or Pembrolizumab + placebo) and regular monitoring.
It's a Phase 2 study, so the treatments are still being tested for effectiveness and safety.
You have the right to withdraw from the study at any time.
Discuss all potential risks and benefits with your doctor before deciding.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older and have been diagnosed with a specific type of kidney cancer (renal cell carcinoma, either clear cell or papillary type). You should also have had surgery to remove your kidney cancer, and if the cancer had spread to a single, isolated spot that could also be completely removed, you might still be eligible.

Your surgery must have been completed within the last 12 weeks, and you need to have recovered well from it. Your general health and ability to carry out everyday activities will also be checked. There are certain things that would mean you can't join, such as having had certain major surgeries recently, remaining blood clots in your main kidney vein, or having received other cancer treatments or certain vaccines shortly before the study starts. You also can't have other serious medical conditions that might make participating unsafe.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with clear cell or papillary renal cell carcinoma?
Have you had surgery to completely remove your kidney cancer recently (within the last 12 weeks)?
Are you generally well and able to carry out daily activities?
Have you avoided other cancer treatments or certain vaccines in the past few weeks?
Do you have no remaining blood clots in your kidney veins after surgery?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups: either receiving Intismeran autogene plus Pembrolizumab, or Pembrolizumab plus a placebo. You wouldn't know which group you're in, and neither would your study doctor. The treatment will involve regular visits to the clinic for your medications and check-ups. You'd have various tests, including blood tests and scans, to monitor your health and how you're responding to treatment. The study team will explain the specific schedule of visits and tests. You would be followed for a period after your main treatment concludes to see how you are doing long-term. The total duration of your participation in the study, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. While there's a chance the new treatment combination could lead to a longer period without your cancer returning, there's no guarantee, and it might not help everyone. You might also experience side effects from the study medications. These could range from mild to more serious, and the study team will discuss all known side effects with you in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (63)

City of Hope Comprehensive Cancer Center-Medical Oncology ( Site 0104)
Duarte, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
Los Angeles, United States
UCSF Medical Center at Mission Bay ( Site 0108)
San Francisco, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 0102)
New Haven, United States
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 0109)
Boston, United States
Dana-Farber Cancer Institute-GU ( Site 0101)
Boston, United States
Memorial Sloan Kettering Cancer Center ( Site 0100)
New York, United States
Duke Cancer Institute ( Site 0106)
Durham, United States
Abramson Cancer Center ( Site 0107)
Philadelphia, United States
Fox Chase Cancer Center ( Site 0111)
Philadelphia, United States
UT Southwestern Medical Center ( Site 0110)
Dallas, United States
Hospital Británico de Buenos Aires-Oncology ( Site 1106)
Ciudad Autónoma de Buenos Aires, Argentina

+51 more sites — see the official record for the full list.

Common questions

What is 'Renal Cell Carcinoma'?

Renal Cell Carcinoma is the most common type of kidney cancer.

What does a 'placebo' mean in this study?

A placebo is an inactive substance that looks like the real study drug. It helps researchers compare the effects of the active medicine more accurately.

What is 'immunotherapy'?

Immunotherapy is a type of cancer treatment that helps your body's immune system fight the cancer.

Why is this study only for people who have had surgery?

This study is testing if these treatments can help prevent the cancer from coming back after it's already been removed by surgery.

What does 'Phase 2' mean for a medical study?

Phase 2 means the study is still in an earlier stage, where researchers are looking at how well the treatment works and further checking its safety. It's not yet widely available.