← Back to Search

Monoclonal Antibodies

Tuvusertib + Avelumab for Merkel Cell Skin Cancer

Phase 2

Recruiting

Led By Paul Nghiem

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must have a history of pathologically confirmed locally advanced/unresectable Merkel cell carcinoma or metastatic Merkel cell carcinoma

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called tuvusertib in combination with avelumab to see if it can control Merkel cell cancer that has not responded to previous treatment. Tuvusert

Who is the study for?

This trial is for adults with advanced or metastatic Merkel cell carcinoma who have previously been treated with anti-PD-1 or anti-PD-L1 therapy without success. Participants must be over 18, have a certain level of physical fitness (ECOG <=2), and meet specific blood count and organ function criteria.

What is being tested?

The MATRiX trial is testing the combination of Tuvusertib, which blocks an enzyme involved in DNA repair and tumor survival, with Avelumab, an immunotherapy drug that may help the immune system fight cancer. The goal is to see if this combo works better than just Avelumab alone for controlling disease progression.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from receiving drugs through a vein, fatigue, possible changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with advanced or metastatic Merkel cell carcinoma.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite progression-free survival (PFS)

Secondary study objectives

Duration of response

Gene expression-based immunologic signatures predictive of response

Overall response rate (ORR)

+1 more

Other study objectives

Biomarker levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 (tuvusertib, avelumab)Experimental Treatment7 Interventions

Patients receive tuvusertib PO QD on days 1-14 of each cycle and avelumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI, biopsy, and collection of blood and stool at screening and on study.

Group II: Arm 1 (tuvusertib)Active Control6 Interventions

Patients receive tuvusertib PO QD on days 1-14 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI, biopsy, and collection of blood and stool at screening and on study. Patients with documented progression may cross over to Arm 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2017

Completed Phase 2

~2440

Biopsy

2014

Completed Phase 4

~1090