Durvalumab + Olaparib for Endometrial Cancer (DUO-E Trial)

Recruiting in Palo Alto (17 mi)

+171 other locations

Overseen ByShannon Westin, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for women over 18 with advanced or recurrent endometrial cancer, including carcinosarcomas but not sarcomas. Participants can be newly diagnosed or have a recurrence after at least 12 months since last treatment if previously treated in the adjuvant setting. They must have an ECOG performance status of 0 or 1 and cannot have brain metastases, spinal cord compression, history of leptomeningeal carcinomatosis, prior PARP inhibitors use, or previous immune-mediated therapy.

Inclusion Criteria

I have a tumor sample available for a specific genetic test.

I am a woman aged 18 or older.

I have been recently diagnosed with Stage IV cancer.

My cancer is at Stage III and was measured after surgery or biopsy.

My cancer has come back and cannot be cured by surgery alone.

My cancer is a type of endometrial carcinoma, not sarcoma.

Exclusion Criteria

I have cancer that has spread to my brain or spinal cord.

I have previously received immunotherapy, excluding cancer vaccines.

I have been treated with PARP inhibitors before.

I have had cancer spread to the lining of my brain and spinal cord.

Participant Groups

The study tests durvalumab combined with chemotherapy (paclitaxel + carboplatin), followed by maintenance durvalumab alone or with olaparib versus placebo in patients with new or recurring endometrial cancer. The goal is to assess how well these treatments work and their safety as maintenance therapy.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C (durvalumab+olaparib)Experimental Treatment4 Interventions

Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.

Group II: Arm B (durvalumab+placebo)Experimental Treatment4 Interventions

Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo

Group III: Arm A (control)Active Control4 Interventions

Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: