NRG GY012

Official Title

Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combinations of Cediranib/Olaparib, Olaparib/Durvalumab (MEDI4736), Cediranib/Durvalumab (MEDI4736), Olaparib/AZD5363 (Capivasertib) in Women with Recurrent, Persistent or Metastatic Endometrial Cancer.

Study Purpose

To compare the safety and effects of cediranib alone, combinations of olaparib with AZD5363 (capivasertib), or durvalumab (MEDI4736) or the combination of cediranib and durvalumab (MEDI4736).

Diagnosis

Eligibility

Patients must have recurrent or persistent endometrial carcinoma.

Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

There are four study groups that patients will be placed in at random:

• Group 1: Cediranib alone
• Group 4: Olaparib and AZD5363 (capivasertib)
• Group 5: Olaparib and Durvalumab (MEDI4736)
• Group 6: Cediranib and Durvalumab (MEDI4736)

First radiological assessment of response will be at 8 weeks, then every 8 weeks thereafter for the first year; then every 12 weeks thereafter until disease progression is confirmed.

Radiological assessment will also be repeated at any other time if clinically indicated based on symptoms or physical signs suggestive of new or progressive disease.