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Monoclonal Antibodies
Arm 2 (tuvusertib, avelumab) for Merkel Cell Carcinoma
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite progression-free survival (PFS)
Secondary outcome measures
Duration of response
Gene expression-based immunologic signatures predictive of response
Overall response rate (ORR)
+1 moreOther outcome measures
Biomarker levels
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/rectal swabs 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/rectal swabs 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
Biospecimen Collection
2004
Completed Phase 2
~1700
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biopsy
2014
Completed Phase 4
~1090
Avelumab
2018
Completed Phase 2
~2450
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,391 Total Patients Enrolled
Paul NghiemPrincipal InvestigatorFred Hutchinson Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently seeking participants for this study?
"Indeed, clinicaltrials.gov indicates that this clinical trial is actively seeking participants. The initial posting of the trial occurred on September 13th, 2024 and it was last updated on January 4th, 2024."
Answered by AI
Has the combination of tuvusertib and avelumab received official approval from the FDA in Arm 2?
"Based on the phase 2 trial design, Arm 2 (consisting of tuvusertib and avelumab) received a safety rating of 2 from our team at Power. While there is data supporting its safety, no efficacy data has been established yet."
Answered by AI
What is the total number of participants being recruited for this clinical investigation?
"Indeed, the details provided on clinicaltrials.gov indicate that this trial is currently seeking eligible candidates. The study was initially listed on September 13, 2024, and underwent its latest update on January 4, 2024. It aims to enroll a total of 50 participants from a single location."
Answered by AI
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