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

Conditions

• Ovarian Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Chemotherapy + avelumab followed by avelumab + talazoparib — DRUG
  Chemotherapy Period Paclitaxel Carboplatin Avelumab Maintenance Period Avelumab Talazoparib
• Chemotherapy followed by talazoparib maintenance — DRUG
  Chemotherapy Period Paclitaxel Carboplatin Maintenance Period Talazoparib
• Chemotherapy + bevacizumab followed by bevacizumab — DRUG
  Chemotherapy Period Paclitaxel Carboplatin Bevacizumab Maintenance Period Bevacizumab

Study Details

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.

Key Dates

First listed

Aug 22, 2018

Start date

Jul 19, 2018

Status verified

Mar 2023

Primary completion

Dec 22, 2021

Completion

Dec 22, 2021

Study Design

Enrollment

79 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: chemotherapy, avelumab and talazoparib
  Platinum-based chemotherapy + avelumab followed by avelumab + talazoparib maintenance
• Experimental: chemotherapy, and talazoparib
  Platinum-based chemotherapy followed by talazoparib maintenance
• Active Comparator: chemotherapy and bevacizumab
  Platinum-based chemotherapy + bevacizumab followed by bevacizumab maintenance

Primary Outcome Measure

Progression-free Survival (Participants With Newly Diagnosed Advanced Ovarian Cancer With Defects in DDR+） [ Time Frame: At screening, 9 and 18 weeks after date of randomization, then every 12 weeks thereafter until PD by Blinded Independent Central Review (BICR) regardless of initiation of new anti-cancer therapy ]

Locations (46)

Find similar trials in Phoenix, AZ

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