V940 + Pembrolizumab for Kidney Cancer
(INTerpath-004 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for kidney cancer, specifically targeting patients with renal cell carcinoma (RCC). The researchers aim to determine if adding intismeran autogene (also known as V940, an experimental treatment) to pembrolizumab, an existing cancer treatment, can extend the time patients live without cancer recurrence compared to pembrolizumab with a placebo. Candidates for this study include individuals who have had kidney cancer surgically removed and show no signs of metastasis. The trial compares the effects of the experimental treatment against the placebo to assess which is more effective in preventing cancer recurrence. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic anticancer therapy, steroids, or have received a live vaccine recently, you may need to stop those before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of intismeran autogene (also known as V940) and pembrolizumab is generally safe. A study on this combination found that side effects were usually mild and manageable for patients. No unexpected serious side effects occurred, indicating that the treatment is relatively safe for participants.
Pembrolizumab is already approved for treating several types of cancer, and its safety profile is well-known. It has been widely used and is considered safe for most patients, although, like all treatments, it can have side effects.
Overall, early results for intismeran autogene combined with pembrolizumab are positive regarding safety. While side effects can occur, they have usually been mild and not severe in the studies conducted so far.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of V940 (intismeran autogene) and Pembrolizumab for kidney cancer because it introduces a novel approach to treatment. Unlike traditional therapies that primarily use surgery, radiation, or chemotherapy, this treatment harnesses the power of immunotherapy. Pembrolizumab is a well-known immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. The exciting part is the addition of V940, an investigational therapeutic that may enhance the immune response even further. This combination aims to offer a more targeted approach to treating kidney cancer, potentially resulting in better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for kidney cancer?
In this trial, participants will receive either a combination of intismeran autogene with pembrolizumab or a placebo with pembrolizumab. Research has shown that combining intismeran autogene with pembrolizumab may help treat renal cell carcinoma, a type of kidney cancer. One study found that this combination reduced the risk of the cancer returning or causing death by 49%. It also decreased the chance of the cancer spreading to other parts of the body or leading to death by 62% compared to using pembrolizumab alone. These findings suggest that this treatment could improve outcomes for people with this type of cancer.12467
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with a specific kidney cancer (clear cell or papillary renal cell carcinoma). They should be at intermediate-high risk, have had surgery to remove the tumor and any isolated metastases within the last 12 weeks, and be in good physical condition (ECOG status of 0 or 1).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive V940 or placebo plus Pembrolizumab for up to 54 weeks
Follow-up
Participants are monitored for disease-free survival and overall survival
Long-term follow-up
Participants are monitored for overall survival and distant metastasis-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- V940
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
ModernaTX, Inc.
Industry Sponsor
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris