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NCT03323398 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Efficacy Study of mRNA-2416 for Intratumoral Injection Alone and in Combination With Durvalumab for Participants With Advanced Malignancies
A Phase 1 study, sponsored by ModernaTX.
- Terminated
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
NCT03323398 is a Phase 1 study that was terminated before completion, run by ModernaTX. The registered enrollment target is 79 participants.
The verdict
NCT03323398, a Phase 1 study, was terminated before completion, sponsored by ModernaTX.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
Study Summary
This clinical study will assess the safety and tolerability of escalating doses of mRNA-2416 alone and in combination with administered fixed doses of durvalumab in participants with relapsed/refractory solid tumor malignancies or lymphoma, as well as the objective response rate (ORR) of mRNA-2416 alone or in combination with durvalumab in ovarian cancer based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The applicable dose of mRNA-2416 will be injected directly into the participant's tumor (intratumoral) and the applicable dose of durvalumab will be administered intravenously.
Interventions
- BIOLOGICAL Durvalumab
- BIOLOGICAL mRNA-2416
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2017-08-15 |
| Est. Completion | 2021-08-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03323398
The ClinicalTrials.gov registry entry for NCT03323398 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT03323398 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03323398 about?
NCT03323398 is a clinical study titled "Dose Escalation and Efficacy Study of mRNA-2416 for Intratumoral Injection Alone and in Combination With Durvalumab for Participants With Advanced Malignancies". This clinical study will assess the safety and tolerability of escalating doses of mRNA-2416 alone and in combination with administered fixed doses of durvalumab in participants with relapsed/refractory solid tumor malignancies or lymphoma, as well as the objective response rate (ORR) of mRNA-2416 a...
What is the current status of trial NCT03323398?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2017-08-15. Estimated completion is 2021-08-18.
What interventions are being tested in trial NCT03323398?
The interventions under investigation include: Durvalumab (BIOLOGICAL), mRNA-2416 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03323398?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
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