PT2385 for Kidney Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on warfarin or have certain medical conditions. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug PT2385/MK-3795 for kidney cancer?
The combination of cabozantinib (Cabometyx) and nivolumab (Opdivo) has been shown to be effective for advanced kidney cancer, with studies indicating longer survival and better quality of life compared to other treatments. This combination is recommended as a first-line treatment for advanced renal cell carcinoma.12345
What safety information is available for PT2385/MK-3795 (Cabozantinib and Nivolumab) in kidney cancer treatment?
The combination of cabozantinib and nivolumab has been studied for safety in treating advanced kidney cancer. While the safety profile is generally manageable, some side effects like diarrhea, liver issues, skin reactions, fatigue, and kidney problems can occur. These side effects can often be managed with supportive care and dose adjustments.12678
How is the drug PT2385/MK-3795 for kidney cancer different from other treatments?
The drug PT2385/MK-3795 is unique because it combines cabozantinib, which targets multiple pathways involved in kidney cancer growth, with nivolumab, an immune checkpoint inhibitor that helps the immune system attack cancer cells. This combination aims to enhance treatment effectiveness by targeting cancer from different angles, which is different from using a single type of drug.1291011
What is the purpose of this trial?
PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD) of MK-3795, formerly called PT2385 and/or the recommended Phase 2 dose (RP2D) of MK-3795 in patients with advanced clear cell renal cell carcinoma (ccRCC).PART 2: The primary objective of this study is to identify the MTD of MK-3795 up to the RP2D, in combination with nivolumab, in patients with advanced ccRCC.As of Amendment 09 (29 Mar 2024), participants with advanced ccRCC will transition from MK-3795 to belzutifan (MK-6482) in combination with nivolumab or belzutifan alone.PART 3: The primary objective of this study is to identify the MTD of MK-3795 up to the RP2D, in combination with cabozantinib tablets, in patients with advanced ccRCC.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
This trial is for adults over 18 with advanced clear cell renal cell carcinoma who've had at least one prior treatment but no more than three, including a specific type of drug targeting blood vessel growth. They must expect to live at least 3 months, be able to take pills, and use approved birth control if necessary. Exclusions include recent major surgery, other clinical trials participation, untreated brain metastases, uncontrolled hypertension, certain heart conditions within the past 6 months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive MK-3795 at escalating doses to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).
Treatment Part 2
Participants receive MK-3795 in combination with nivolumab, transitioning to belzutifan with or without nivolumab as per protocol amendment.
Treatment Part 3
Participants receive MK-3795 in combination with cabozantinib to determine the MTD and RP2D.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
Treatment Details
Interventions
- Cabozantinib
- Nivolumab
- PT2385/MK-3795
Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
- Hepatocellular carcinoma
- Renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Lead Sponsor
Peloton Therapeutics, Inc.
Lead Sponsor