Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

Conditions

• Endometrial Adenocarcinoma
• Endometrial Mixed Cell Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Endometrial Undifferentiated Carcinoma
• Endometrioid Adenocarcinoma
• Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspirate — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Capivasertib — DRUG
  Given PO
• Cediranib Maleate — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Durvalumab — BIOLOGICAL
  Given IV
• Echocardiography Test — PROCEDURE
  Undergo Echo
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Olaparib — DRUG
  Given PO

Study Details

This phase II trial studies the effects of the combination of olaparib and durvalumab, cediranib and durvalumab, olaparib and capivasertib, and cediranib alone in treating patients with endometrial cancer that has come back (recurrent) or does not respond to treatment (refractory). Olaparib, cediranib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Testing the combinations may lower the chance of endometrial cancer growing or spreading compared to usual care.

Key Dates

Start date

Sep 27, 2018

Status verified

Mar 2026

Primary completion

Dec 6, 2024

Completion

Mar 4, 2027

Study Design

Enrollment

288 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (cediranib maleate_reference group 1)
  Patients in reference group 1 receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
• Experimental: Arm II (olaparib)
  Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
• Experimental: Arm III (cediranib maleate, olaparib)
  Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
• Experimental: Arm IV (olaparib, capivasertib)
  Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
• Experimental: Arm V (olaparib, durvalumab)
  Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
• Experimental: Arm VI (cediranib maleate, durvalumab)
  Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.
• Experimental: Arm VII (cediranib maleate_reference group 2)
  Patients in reference group 1 receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Scans were done every 8 weeks for the first year and then every 12 weeks thereafter until disease progression. Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total). ]

Locations (762)

Find similar trials in Birmingham, AL

Related Studies

• Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
  PHASE3 · Recruiting · University of Utah · Palo Alto, California
• Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease
  Recruiting · Memorial Sloan Kettering Cancer Center · Hartford, Connecticut
• Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancers
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama