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Checkpoint Inhibitor
M3814 for Cancer
Phase 1
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Part A and Part FE (M3814 + avelumab): Participants must have histologically or cytologically proven advanced or metastatic solid tumors for which no standard therapy exists, standard therapy has failed, or participants are intolerant to or have rejected established therapy known to provide clinical benefit for their condition
Part A, B and FE: Female participants of childbearing potential should be willing to use a highly effective contraceptive method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a and fe: from baseline to planned final assessment at 305 days; part b: from baseline to planned final assessment at 473 days
Awards & highlights
Study Summary
This study is evaluating whether a combination of a drug and radiation therapy may help treat solid tumors.
Eligible Conditions
- Cancer
- Solid Tumors
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part a and fe: from baseline to planned final assessment at 305 days; part b: from baseline to planned final assessment at 473 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a and fe: from baseline to planned final assessment at 305 days; part b: from baseline to planned final assessment at 473 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Occurrence of Dose-limiting Toxicities (DLTs)
Part B: Occurrence of Dose-limiting Toxicities (DLTs)
Part FE: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of M3814
+1 moreSecondary outcome measures
Part A and B: Accumulation Ratio for AUC [Racc (AUC)] of Avelumab
Part A and B: Accumulation Ratio for Cmax [Racc(Cmax)] of Avelumab
Part A and B: Accumulation ratio for Cmax [Racc(Cmax)] of M3814
+25 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part FE: M3814 + Avelumab (fasted/fed state)Experimental Treatment2 Interventions
Group II: Part B: M3814 + Avelumab + Radiotherapy (RT)Experimental Treatment3 Interventions
Group III: Part A: M3814 + AvelumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610
M3814
2018
Completed Phase 1
~60
Avelumab
2018
Completed Phase 2
~2450
Find a Location
Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,803 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
435 Previous Clinical Trials
114,542 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,918 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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