← Back to Search

Tyrosine Kinase Inhibitor

PT2385 for Kidney Cancer

Phase 1

Waitlist Available

Research Sponsored by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen

Received no more than three prior systemic treatment regimens in the advanced or metastatic setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year

Awards & highlights

Study Summary

This trial is testing a new drug, MK-3795, for patients with advanced kidney cancer. The goal is to find the maximum tolerated dose (MTD) of the drug for future trials.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests different doses of MK-3795 alone and in combination with Nivolumab or Cabozantinib to find the highest dose patients can tolerate without severe side effects (MTD) and recommend for future studies (RP2D). It's divided into three parts: testing MK-3795 alone; then with Nivolumab; and finally with Cabozantinib.See study design

What are the potential side effects?

Possible side effects may include typical reactions from cancer treatments such as fatigue, nausea, liver function changes. Since it involves immune therapy drugs like Nivolumab and targeted therapies like Cabozantinib there could also be risks of immune-related inflammation or high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney cancer has spread and worsened despite treatment.

Select...

I've had 3 or fewer treatments for my advanced cancer.

Select...

I have had 1 or 2 treatments targeting blood vessel growth in my cancer.

Select...

I have been treated with a medication targeting blood vessel growth in cancer.

Select...

I can take pills by mouth.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at week 6 and every 9 weeks thereafter up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD)

Recommended Phase 2 Dose (RP2D)

Secondary outcome measures

Accumulation Ratio (RAC)

Antitumor Activity

Apparent Clearance (CL/F) of Study Treatment

+22 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 3: MK-3795 + CabozantinibExperimental Treatment2 Interventions

Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 in combination with cabozantinib 20mg up to 60mg orally QD for up to approximately 1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later.

Group II: Part 2: MK-3795 + NivolumabExperimental Treatment2 Interventions

Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 orally in combination with nivolumab 240mg by IV infusion over ~60 minutes every 2 weeks for up to approximately 1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later.

Group III: Part 1: MK-3475Experimental Treatment1 Intervention

Participants with advanced ccRCC receive MK-3475 at an initial dose level of 100mg orally, twice daily (BID) up to approximately 3 weeks. Dose levels will be escalated to identify the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) for MK-3475. Each escalated dose will be continued for up to approximately 3 weeks before escalating a dose again until a dose limiting toxicity (DLT) is experienced. Thereafter, participants receive RP2D dose of MK-3795 for up to 2 cycles (each cycle length = 28 days) for up to approximately 1 year. Participants may continue to receive MK-3795 beyond 1 year at the discretion of the Sponsor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Cabozantinib

FDA approved

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor

7 Previous Clinical Trials

348 Total Patients Enrolled

Peloton Therapeutics, Inc.Lead Sponsor

7 Previous Clinical Trials

348 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,370 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02293980 — Phase 1

Renal Cell Carcinoma Research Study Groups: Part 1: MK-3475, Part 2: MK-3795 + Nivolumab, Part 3: MK-3795 + Cabozantinib

Renal Cell Carcinoma Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT02293980 — Phase 1

Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02293980 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the objective of this experiment?

"The primary metric of success, to be measured over a three-week Part 1 and four-week Parts 2 & 3 period, as determined by Peloton Therapeutics is the Recommended Phase 2 Dose (RP2D). Additionally, this trial will evaluate secondary outcomes such as Time to Maximum Concentration (Tmax) of study treatment in blood samples drawn at designated points; Mean Plasma Concentration of Vascular Endothelial Growth Factor A (VEGFa) Level from said samples; and Progression-Free Survival (PFS) per RECIST 1.1 guidelines."

Answered by AI

Are there numerous facilities offering this clinical trial in North America?

"This clinical trial is currently enrolling patients at 25 sites, including Boston, Miami and Indianapolis. To help limit travel costs associated with this study it may be helpful to join the closest clinic you can find."

Answered by AI

Is this a pioneering research endeavor?

"PART 1: PT2385 Tablets was first trialled back in 2012, backed by Exelixis. The success of the initial 86 patients saw it receive Phase 2 drug approval and since then there have been 795 clinical studies located across 53 countries spanning 2553 cities."

Answered by AI

Are there any vacancies in this medical trial that could be filled by participants?

"This trial is not presently seeking participants. Initially posted on November 25th 2014, the most recent modification was made on July 18th 2022. If you are looking for further studies, there are currently 2,643 trials enrolling patients with renal cell carcinoma and 795 in PART 1: PT2385 Tablets that require volunteers."

Answered by AI

What other tests have been conducted concerning the efficacy of PART 1: PT2385 Tablets?

"In 2012, the initial examination of PT2385 Tablets took place at Memorial Sloan Kettering Commack. As of this time, 795 studies are actively recruiting and 307 trials have been completed overall; many of these taking part in Boston, Massachusetts."

Answered by AI

What indications are typically treated with PART 1: PT2385 Tablets?

"When treating malignant neoplasms, PART 1: PT2385 Tablets is the preferred choice of medication. This pharmaceutical compound can also be utilized to treat conditions like unresectable melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma with varying levels of success."

Answered by AI

How have consumers responded to the therapeutic effects of PT2385 Tablets in PART 1?

"Our team at Power gave PART 1: PT2385 Tablets a score of 1 as it is currently in the first phase of clinical trials and there is limited data available to assess its safety or efficacy."

Answered by AI

How many participants are being recruited for this clinical trial?

"This study is no longer accepting patients, having initially been posted on November 25th 2014 and last amended July 18th 2022. However, there are currently 2,643 clinical trials for renal cell carcinoma and 795 PART 1: PT2385 Tablet studies actively recruiting participants."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase I Dose-escalation Trial of PT2385, a First-in-class Hypoxia-inducible Factor-2α Antagonist in Patients with Previously Treated Advanced Clear Cell Renal Cell Carcinoma

Courtney, Kevin D., Jeffrey R. Infante, Elaine T. Lam, Robert A. Figlin, Brian I. Rini, James Brugarolas, Naseem J. Zojwalla, et al.. 2018. “Phase I Dose-escalation Trial of PT2385, a First-in-class Hypoxia-inducible Factor-2α Antagonist in Patients with Previously Treated Advanced Clear Cell Renal Cell Carcinoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.74.2627.

clinicaltrials.govStudy

A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)

2014. "A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02293980.

All > Kidney Cancer > Renal Cell Carcinoma