Testing the Combination of Two Cancer Drugs, Tuvusertib and Avelumab, for Treating Merkel Cell Skin Cancer (MATRiX Trial)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05947500

Provider View

This study is testing whether combining two drugs, tuvusertib and avelumab, can delay the worsening of Merkel cell skin cancer compared to using tuvusertib alone. The trial focuses on patients whose cancer has not responded to previous treatments.

Patient Parameters

Program Overview

This phase II trial is exploring if a combination of two drugs, tuvusertib and avelumab, can delay the progression of Merkel cell cancer more effectively than tuvusertib alone. Tuvusertib works by blocking an enzyme that helps cancer cells repair and grow, potentially leading to their death. Avelumab is an immunotherapy drug that helps the immune system attack cancer cells. The study aims to see if using both drugs together can better control the cancer compared to using tuvusertib by itself.

Description

The main goal of this study is to see if combining tuvusertib with avelumab can help patients with advanced Merkel cell carcinoma (MCC) live longer without their cancer getting worse. This is compared to using tuvusertib alone. The study is for patients whose cancer has progressed after previous treatments.

Secondary goals include comparing how well the combination works against the cancer and identifying specific genetic markers that might predict a good response to the treatment.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will take tuvusertib by mouth daily for 14 days in each 21-day cycle. They will also have scans and tests to monitor their cancer.
  • Group 2: Will take tuvusertib by mouth and receive avelumab through an IV on the first day of each 21-day cycle. They will also have scans and tests.

After finishing the treatment, participants will have follow-up visits at 30 days and then every 6 months for 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced or metastatic Merkel cell carcinoma that cannot be surgically removed.
  • Must have measurable cancer according to specific medical criteria.
  • Must have previously been treated with anti-PD-1 or anti-PD-L-1 therapy and experienced cancer progression during or shortly after treatment.
  • Must be 18 years or older.
  • Must have a good performance status, meaning they can carry out daily activities with some limitations.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • HIV-positive patients must have an undetectable viral load.
  • Patients with hepatitis B or C must have controlled or cured infections.
  • Patients with treated brain metastases are eligible if stable.
  • Must not have other health conditions that interfere with the study.
  • Women of childbearing potential must use effective contraception during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • History of severe immune-related side effects from previous treatments.
  • History of a specific genetic disorder called ataxia telangiectasia.
  • Currently taking other experimental drugs.
  • Allergic reactions to similar drugs.
  • Uncontrolled health conditions that make participation unsafe.
  • Pregnant or breastfeeding women.
  • Unable to swallow pills or have digestive issues affecting drug absorption.
  • Taking certain medications that interact with the study drugs and cannot be stopped.
  • On high doses of steroids.
  • Have a specific heart condition affecting the heart's electrical activity.

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