Drug Combinations for Endometrial Cancer

Recruiting at823 trial locations

Overseen by Helen J Mackay

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests different drug combinations to treat endometrial cancer that has come back or doesn't respond to usual treatments. The drugs work by either blocking enzymes needed for cancer growth or helping the immune system attack the cancer. The goal is to find the most effective treatment combination.

Research Team

Helen J Mackay

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for women with certain types of recurrent or refractory endometrial cancer. Participants must have adequate organ function, controlled blood pressure, and no severe allergies to the drugs being tested. They should not be pregnant, must agree to use contraception, and cannot have had certain prior treatments or serious health conditions like bowel obstruction or heart issues.

Inclusion Criteria

Your white blood cell count is higher than 1.5 x 10^9/L within the last 28 days.

I have had Bevacizumab or one immune-checkpoint therapy, but not durvalumab, before joining this trial.

My thyroid function is normal, with no symptoms of issues.

Exclusion Criteria

I have not been in trials for specific cancer drugs before, except for bevacizumab or single-agent immune therapy.

You have had certain types of cancer within the last 5 years, ongoing severe side effects from previous cancer treatments, or a history of serious allergic reactions to specific medications.

I haven't had cancer treatment or been in a trial in the last 4 weeks.

Treatment Details

Interventions

• Capivasertib (AKT Inhibitor)
• Cediranib Maleate (VEGFR Inhibitor)
• Durvalumab (PD-L1 Inhibitor)
• Olaparib (PARP Inhibitor)

Trial Overview The study tests combinations of olaparib with durvalumab, cediranib with durvalumab, olaparib with capivasertib, and cediranib alone in patients whose endometrial cancer has returned or resisted treatment. These drugs aim to block tumor growth by targeting enzymes needed for cell growth or interfering with tumor cells' ability to spread.

Participant Groups

Group I: Arm VI (cediranib maleate, durvalumab) Experimental Treatment 8 Interventions

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.

Group II: Arm V (olaparib, durvalumab) Experimental Treatment 8 Interventions

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.

Group III: Arm IV (olaparib, capivasertib) Experimental Treatment 8 Interventions

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.

Group IV: Arm III (cediranib maleate, olaparib) Experimental Treatment 9 Interventions

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.

Group V: Arm II (olaparib) Experimental Treatment 7 Interventions

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.

Group VI: Arm I (cediranib maleate) Experimental Treatment 8 Interventions

Patients 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School