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NCT03724890 · ClinicalTrials.gov registry record · Phase 1
Study of Avelumab-M3814 Combinations
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT03724890: Completed Phase 1 study, sponsored by EMD Serono Research & Development Institute.
NCT03724890 is a Phase 1 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03724890, a Phase 1 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
The main purpose of the study was to evaluate a safe, tolerable recommended Phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in participants with selected advanced solid tumors.
Primary Outcome
A DLT was defined as any Grade more than or equal to \>= 3 nonhematologic Adverse Event(AE) or any Grade\>= 4 hematologic,, occurring during the DLT period that is related to any of the study interventions. In addition, a DLT is considered: Grade 3 thrombocytopenia with medically concerning bleeding, Any febrile neutropenia. A study intervention-related Treatment emergent Adverse Event(TEAE) is of potential clinical significance such that further dose escalation would expose participants to unac
Interventions
- RADIATION Radiotherapy
- DRUG Avelumab
- DRUG M3814
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2018-11-27 |
| Est. Completion | 2022-08-17 |
| Phase | Phase 1 |
What the finished NCT03724890 record still lists
NCT03724890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Radiotherapy is the first listed.
NCT03724890 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03724890 about?
NCT03724890 is a clinical study titled "Study of Avelumab-M3814 Combinations". The main purpose of the study was to evaluate a safe, tolerable recommended Phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in participants with selected advanced solid tumors.
What is the current status of trial NCT03724890?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2018-11-27. Estimated completion is 2022-08-17.
What interventions are being tested in trial NCT03724890?
The interventions under investigation include: Radiotherapy (RADIATION), Avelumab (DRUG), M3814 (DRUG).
Who is sponsoring clinical trial NCT03724890?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03724890's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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