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NCT02994953 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)
A Phase 1 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT02994953 is a Phase 1 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 52 participants.
The verdict
NCT02994953, a Phase 1 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
The study consisted of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase evaluated the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase assessed the safety and clinical activity of the combination regimen in selected tumor types. In Expansion phase subjects who had completed the combination treatment of avelumab at a given dose level of M9241, a safety review was performed by the Safety monitoring committee in order to make a decision on the next dose level. Successive cohorts of 3 to 6 subjects were treated with escalating doses of M9241 with avelumab intravenous (IV).
Interventions
- DRUG Avelumab
- DRUG M9241
- DRUG Avelumab (Once weekly)
- DRUG M9241 (MTD)
- DRUG Avelumab (Expansion cohort)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2020-10-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02994953
The ClinicalTrials.gov registry entry for NCT02994953 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Avelumab is the first listed.
NCT02994953 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02994953 about?
NCT02994953 is a clinical study titled "A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12)". The study consisted of 2 parts: Dose Escalation phase (Part A) and Expansion phase (Part B). The dose escalation phase evaluated the safety, tolerability, and PK of avelumab in combination with M9241 in subjects with locally advanced, unresectable, or metastatic solid tumors. Expansion phase assesse...
What is the current status of trial NCT02994953?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2017-01-31. Estimated completion is 2020-10-08.
What interventions are being tested in trial NCT02994953?
The interventions under investigation include: Avelumab (DRUG), M9241 (DRUG), Avelumab (Once weekly) (DRUG), M9241 (MTD) (DRUG), Avelumab (Expansion cohort) (DRUG).
Who is sponsoring clinical trial NCT02994953?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
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