V940 + Pembrolizumab for Kidney Cancer
(INTerpath-004 Trial)
Trial Summary
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.
What data supports the effectiveness of the drug Pembrolizumab for kidney cancer?
Research shows that pembrolizumab, when used as an adjuvant therapy (additional treatment given after the primary treatment), significantly improves disease-free survival in patients with renal cell carcinoma after surgery. Additionally, a combination of axitinib and pembrolizumab has shown a 73% response rate in advanced renal cell carcinoma.12345
Is the combination of V940 and Pembrolizumab safe for humans?
Pembrolizumab, also known as Keytruda, has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, cough, and nausea. Some serious side effects include pneumonitis (lung inflammation), colitis (colon inflammation), and thyroid disorders. There have also been rare cases of kidney issues, so it's important to discuss potential risks with your doctor.14678
How does the drug V940 + Pembrolizumab differ from other kidney cancer treatments?
Pembrolizumab is a unique drug because it is an immune checkpoint inhibitor that helps the body's immune system attack cancer cells by blocking the PD-1 pathway, which is different from traditional chemotherapy that directly kills cancer cells. This combination with V940 may offer a novel approach for kidney cancer by potentially enhancing the immune response against the tumor.13489
What is the purpose of this trial?
The primary objective of the study is to compare intismeran autogene plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinoma (RCC) with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
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
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
Treatment Details
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