Study on Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma

Sponsor: Yousef Zakharia

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03957551

Provider View

This clinical trial is testing a combination of two drugs, cabozantinib and pembrolizumab, to see if they are safe and effective in treating advanced melanoma that cannot be surgically removed.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of combining cabozantinib and pembrolizumab in treating advanced melanoma. The study is divided into two phases: Phase 1b aims to find the best dose of cabozantinib when used with pembrolizumab and to assess the safety of this combination. Phase 2 will evaluate how well this combination works in shrinking tumors in patients with advanced melanoma that cannot be removed by surgery.

Description

This study is open to adults with advanced melanoma that cannot be surgically removed. In the first part of the study (Phase 1b), researchers will determine the safest and most effective dose of cabozantinib to use with pembrolizumab. They will also monitor the safety and side effects of this combination. In the second part (Phase 2), the study will focus on how well the treatment works in reducing the size of tumors.

Participants must have a confirmed diagnosis of advanced melanoma and meet specific health criteria to join the study. They will need to provide blood samples for future testing and must be able to swallow pills. Women of childbearing potential must use effective birth control during the study and for a period after the last dose. Men must also agree to use contraception during and after the study.

The study excludes individuals who have previously received certain treatments for advanced melanoma, have other types of melanoma, or have certain health conditions that could interfere with the study. Participants must not have active infections, certain viral infections, or be pregnant or breastfeeding. They should not have received a live vaccine recently or require certain medications that could affect the study results.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced melanoma that cannot be surgically removed.
  • Have at least one measurable tumor.
  • Be willing to provide blood samples for future testing.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Be 18 years or older.
  • Not have received prior treatment for advanced melanoma, except for BRAF and/or MEK inhibitors.
  • Have completed any adjuvant therapy at least 6 months before the study.
  • Be able to understand and agree to the study requirements.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception.
  • Men must agree to use contraception during and after the study.
  • Be able to swallow pills.
  • Have recovered from any previous treatment side effects to a certain level.

Exclusion Criteria

  • Have received prior treatment with certain immune therapies for advanced melanoma.
  • Have ocular or mucosal melanoma.
  • Have previously taken cabozantinib.
  • Have taken certain cancer treatments recently.
  • Have active or untreated brain metastases.
  • Have a history of severe allergic reactions to similar treatments.
  • Have an active autoimmune disease requiring treatment.
  • Have an active infection or certain viral infections.
  • Have a history of other cancers within the past 2 years, with some exceptions.
  • Be pregnant or breastfeeding.
  • Have received a live vaccine recently.
  • Require certain medications that could interfere with the study.
  • Have certain heart, liver, or kidney conditions that could affect participation.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.