Active — Not RecruitingPhase 3

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

United States805 participantsStarted 2020-05-05

Plain-language summary

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

Who can participate

Age range18 Years – 150 Years

SexFEMALE

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Inclusion criteria

✓. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),
✓. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)
✓. Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.

What they're measuring

Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments

Timeframe: At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months

Trial details

NCT IDNCT04269200

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-08

Results submitted2025-07-02

View on ClinicalTrials.gov More Endometrial Neoplasms trials