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Clinical Trial 20529

Cancer Type: Gynecological Tumor
Study Type: Treatment
NCT#: NCT04269200

Phase: Phase III
Prinicipal Investigator: Hye Sook Chon

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or 1-800-679-0775 Learn More
Overview

Study Title

A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)

Summary

This Phase III study will 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.

Objective

Primary Objective: To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy(paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) compared to platinum-based chemotherapy (Arm A) by assessment of progression-free survival (PFS), in patients with newly diagnosed advanced or recurrent endometrial cancer Secondary Objectives: To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab in combination with olaparib (Arm C) when compared to platinum-based chemotherapy (Arm A) by assessment of PFS in patients with newly diagnosed advanced or recurrent endometrial cancer To determine the efficacy of durvalumab in combination with platinum-based chemotherapy(paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy (Arm A) in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of: PFS2, OS, ORR, DoR, TFST, TSST, and TDT To characterise the PK and immunogenicity of durvalumab and durvalumab in combination with olaparib To determine effects on symptoms, functioning and overall health-related quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy alone (Arm A) in newly diagnosed advanced or recurrent endometrial cancer patients Safety Objective: To evaluate the safety and tolerability of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin)followed by maintenance durvalumab (Arm B)or durvalumab with olaparib (Arm C) compared to platinum-based chemotherapy (Arm A) in newly diagnosed advanced or recurrent endometrial cancer patients

Treatments

Therapies

Medications

AMP-514 (Durvalumab); Durvalumab (); MEDI4736 (Durvalumab); Olaparib (Lynparza); Paraplatin (carboplatin); Placebo (); Taxol (paclitaxel); carboplatin (); paclitaxel ()

Inclusion Criteria

  • Age >18 years at the time of screening and female.
  • Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.
  • Patient must have endometrial cancer in one of the following categories:
  • 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 where the potential for cure by surgery alone or in combination is poor.
  • Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior chemotherapy is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of chemotherapy administered to date of subsequent relapse
  • FPPE tumor sample must be available for MMR evaluation.
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.

  • Exclusion Criteria

  • History of leptomeningeal carcinomatosis.
  • Brain metastases or spinal cord compression.
  • Prior treatment with PARP inhibitors.
  • Prior immune checkpoint inhibitors or prior treatment with an agent directed to a stimulatory or co-inhibitor T-cell receptor other than anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

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