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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: Clinical Trial Phase 1 study, sponsored by ModernaTX.
NCT03323398 is a Phase 1 study that was terminated before completion, run by ModernaTX. The registered enrollment target is 79 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLTs: assessed by Investigator as unrelated to disease, disease progression, intercurrent illness, or concomitant medications; at least possibly related to study drug; and occurred within first 28 days of the study. DLTs in Arm A participants: Grade (Gr)3 adverse events (AEs) (except Gr3 thrombocytopenia lasting \<7 days/Gr3 neutropenia without fever or lasting \<7 days) and any Gr4/5 toxicity. DLTs (criteria assessed by Investigator) participants in Arm B: diarrhea/colitis; pneumonitis; hepatit
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 |
Why NCT03323398 stopped before completion
NCT03323398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT03323398 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03323398's enrollment target sits among peer trials
79 696th of 2000 higher than 1,304 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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