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NCT02431559 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT02431559 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 53 participants.
The verdict
NCT02431559, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
This is an ongoing Phase 1/2, open-label, multicenter, non-randomized study of MEDI4736 (durvalumab) in subjects with recurrent, platinum-resistant ovarian cancer who are scheduled to receive pegylated liposomal doxorubicin (PLD).The primary objective of Phase 1 is to determine the maximum tolerated dose (MTD) and safety profile, with a secondary objective to evaluate the clinical efficacy as measured by progression-free survival (PFS) rate at 6 months (PFS-6). The primary objective of Phase 2 is the evaluation of clinical efficacy as measured by PFS-6. For both phases, secondary objectives include evaluation of clinical efficacy as measured by overall response rate, PFS, and overall survival (OS), safety and tolerability, and immunological responses.
Interventions
- DRUG Durvalumab
- DRUG Pegylated Liposomal Doxorubicin
- DRUG Motolimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2015-12-02 |
| Est. Completion | 2021-06-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02431559
The ClinicalTrials.gov registry entry for NCT02431559 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ludwig Institute for Cancer Research, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Durvalumab is the first listed.
NCT02431559 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02431559 about?
NCT02431559 is a clinical study titled "Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer". This is an ongoing Phase 1/2, open-label, multicenter, non-randomized study of MEDI4736 (durvalumab) in subjects with recurrent, platinum-resistant ovarian cancer who are scheduled to receive pegylated liposomal doxorubicin (PLD).The primary objective of Phase 1 is to determine the maximum tolerated...
What is the current status of trial NCT02431559?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2015-12-02. Estimated completion is 2021-06-10.
What interventions are being tested in trial NCT02431559?
The interventions under investigation include: Durvalumab (DRUG), Pegylated Liposomal Doxorubicin (DRUG), Motolimod (DRUG).
Who is sponsoring clinical trial NCT02431559?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
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