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Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)

NCT03642132 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-04-06

Study results available
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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.

Conditions

Interventions

DRUG

Chemotherapy + avelumab followed by avelumab + talazoparib

Chemotherapy Period Paclitaxel Carboplatin Avelumab Maintenance Period Avelumab Talazoparib

DRUG

Chemotherapy followed by talazoparib maintenance

Chemotherapy Period Paclitaxel Carboplatin Maintenance Period Talazoparib

DRUG

Chemotherapy + bevacizumab followed by bevacizumab

Chemotherapy Period Paclitaxel Carboplatin Bevacizumab Maintenance Period Bevacizumab

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-19
Primary Completion
2021-12-22
Completion
2021-12-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Ireland
  • Italy
  • Japan
  • Russia
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642132 on ClinicalTrials.gov