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Monoclonal Antibodies

Avelumab + Berzosertib for Advanced Cancer

Phase 1 & 2
Waitlist Available
Led By Timothy A Yap
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum creatinine =< 2 X ULN or estimated creatinine clearance >= 30 mL/min
Subjects with germline defects in DDR genes are eligible for this trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post treatment
Awards & highlights

Study Summary

This trial is studying avelumab and M6620 to see how well they work in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body and have a deficiency in their ability to repair damaged DNA.

Who is the study for?
This trial is for adults with solid tumors that have spread or can't be surgically removed, and are not responding to standard treatments. Participants must have a certain level of physical fitness (ECOG 0-1), adequate organ function, and no severe allergies to study drugs. They should also agree to use effective contraception if applicable.Check my eligibility
What is being tested?
The trial is testing the combination of Avelumab, an immunotherapy drug, with M6620 in patients whose tumors show DNA repair deficiencies. It aims to find the safest dose and see how well these drugs work together against advanced cancers.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions like inflammation in various organs, infusion-related symptoms, fatigue, changes in blood counts which could affect infection risk or cause bleeding issues, liver or kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the required range.
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I have a genetic defect in DNA repair genes.
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I've tried all treatments for my condition without success or couldn't tolerate them.
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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
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My cancer has spread, cannot be surgically removed, and standard treatments are not effective.
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I have received treatment for cancer that has spread.
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My cancer has specific genetic changes that can be targeted with treatment.
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I am fully active or can carry out light work.
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I am fully active or can carry out light work.
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I have a genetic defect in DNA repair genes.
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I have tried or cannot tolerate all known beneficial treatments and haven't refused any available therapies.
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I am not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Arm A)
Incidence of dose limiting toxicities (DLTs) (Arm A)
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of MM3814 and avelumab in patients with deoxyribonucleic acid (DNA) damage response (DDR) deficient advanced solid tumors
Secondary outcome measures
Clinical benefit rate
Overall survival (OS)
Progression free survival (PFS)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (avelumab, M6620)Experimental Treatment2 Interventions
Patients receive avelumab IV over 60 minutes on days 1 and 15, and M6620 IV over 60 minutes on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Berzosertib
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,191 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
511 Total Patients Enrolled

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04266912 — Phase 1 & 2
Solid Tumors Research Study Groups: Treatment (avelumab, M6620)
Solid Tumors Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT04266912 — Phase 1 & 2
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04266912 — Phase 1 & 2

Frequently Asked Questions

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

What is the maximum allowable enrollment for this research project?

"Correct. Data hosted on clinicaltrials.gov affirms that this medical study, which was initially launched on March 17th 2020, is currently seeking out participants. Approximately 36 patients must be recruited from a single clinical centre."

Answered by AI

Does this trial represent a groundbreaking innovation in clinical research?

"At present, there are 126 studies of the medication Berzosertib occurring across 1048 cities and 52 countries. This is a relatively new drug; it was first tested in 2014 by EMD Serono Research & Development Institute, Inc., involving 204 patients during its Phase 2 clinical trial stage. Since then, 51 trials have been concluded successfully."

Answered by AI

What other experiments have been undertaken with Berzosertib as the focus?

"Currently, research initiatives studying Berzosertib have proliferated to 126 trials with 10 of them in the Phase 3 stage. While a handful are conducted in Houston, Texas, the total number of locations across America hosting clinical trial for this drug exceeds three thousand nine hundred and sixty one (3961)."

Answered by AI

Is enrollment for this trial open to the public?

"Currently, clinicaltrials.gov states that this medical investigation is recruiting patients. An initial posting of March 17th 2020 was recently revised on November 16th 2021."

Answered by AI

What objectives is this trial seeking to accomplish?

"The primary assessment of this clinical trial, which is to be conducted over a 28-day period, will focus on the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dosage (RP2D) when combining MM3814 and Avelumab for patients with DNA Damage Responsive Deficient advanced solid tumors. Secondary outcomes consist of Response Rate, Clinical Benefit Rate and Progression Free Survival respectively; all estimated through 95% Confidence Intervals in addition to Kaplan-Meier methods."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors
2020. "Avelumab and M6620 for the Treatment of DDR Deficient Metastatic or Unresectable Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04266912.
~2 spots leftby Sep 2024
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