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NCT03642132 · ClinicalTrials.gov registry record · Phase 3
Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 79
- Enrollment target
NCT03642132: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT03642132 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 79 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03642132, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 79 participants
- Enrollment target
Study Summary
JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III study, and the decision was based on several factors, including previous announced interim results from JAVELIN Ovarian 100 study (B9991010). Patients who remain in B9991030 study will continue receiving their randomized treatment assigned and will be monitored for appropriate safety assessments until treatment discontinuation.
Primary Outcome
Progression-free survival (PFS) was defined as the time from randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurred first. PD: \>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD.
Interventions
- DRUG Chemotherapy + avelumab followed by avelumab + talazoparib
- DRUG Chemotherapy followed by talazoparib maintenance
- DRUG Chemotherapy + bevacizumab followed by bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2018-07-19 |
| Est. Completion | 2021-12-22 |
| Phase | Phase 3 |
Why NCT03642132 stopped before completion
NCT03642132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Chemotherapy + avelumab followed by avelumab + talazoparib is the first listed.
NCT03642132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03642132 about?
NCT03642132 is a clinical study titled "Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)". JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with lo...
What is the current status of trial NCT03642132?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 79 participants. The study started on 2018-07-19. Estimated completion is 2021-12-22.
What interventions are being tested in trial NCT03642132?
The interventions under investigation include: Chemotherapy + avelumab followed by avelumab + talazoparib (DRUG), Chemotherapy followed by talazoparib maintenance (DRUG), Chemotherapy + bevacizumab followed by bevacizumab (DRUG).
Who is sponsoring clinical trial NCT03642132?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03642132's enrollment target sits among peer trials
79 1768th of 2000 higher than 232 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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