New combo therapy shows promise for Tough-to-Treat endometrial cancer

NCT ID NCT05538897

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study tests whether adding the drug ipatasertib to standard hormone therapy (megestrol acetate) works better than hormone therapy alone for people with recurrent or metastatic endometrioid endometrial cancer. About 96 participants with grade 1 or 2 cancer will receive either the combination or megestrol alone. The goal is to see if the combination slows cancer growth and is safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer * Patients must have measurable disease according to RECIST version (v)1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by CT or MRI. Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation * Patients may have received unlimited prior lines of therapy. If patient received prior hormonal therapy (e.g., megestrol acetate, medroxyprogesterone acetate, aromatase inhibitor, tamoxifen, fulvestrant) it must have completed at least 6 months prior to registration * Age \>= 18 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 * Platelets \>= 100,000/mcl within 14 days prior to registration * Absolute neutrophil count (ANC) \>= 1,500/mcl within 14 days prior to registration * Hemoglobin \>= 9 g/dL within 14 days prior to registration * Glomerular filtration rate (GFR) \>= 60 mL/min/1.73m\^2 measured using Cockcroft-Gault equation or the estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study within 14 days prior to registration * Total bilirubin =\< 1.5 x the upper limit of normal (ULN) within 14 days prior to registration * Patients with known Gilbert syndrome who have bilirubin =\< 3 x ULN may be enrolled * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN within 14 days prior to registration * Albumin \>= 3 g/dL within 14 days prior to registration * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * The effects of ipatasertib on the developing human fetus are unknown. For this reason and because AKT inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 28 days following the last dose of study therapy. Should a participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * For patients with known human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infection: * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial * Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * Patients must be able to swallow and retain oral medications and not have gastrointestinal illnesses that would preclude absorption of megestrol acetate or ipatasertib as judged by the treating physician * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information Exclusion Criteria: * Patients who have had prior treatment with an AKT inhibitor (Prior treatment with PI3K or mTOR inhibitors is allowed) * Patients who have received treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to study registration * Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product * Patients with diabetes either requiring insulin therapy or with a baseline fasting glucose \> 160 mg/dL and/or high glycosylated hemoglobin A1c (HbA1c) (\> 8), suggesting poorly controlled diabetes. Fasting is defined as abstaining from food and drink (with the exception of water) for at least 8 hours * Patients who require chronic corticosteroid therapy of \> 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease * Patients with grade 2 or greater uncontrolled or untreated hypercholesterolemia (\> 300 mg/dL) or hypertriglyceridemia (\> 300 mg/dL) * Patients with a history of known or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis) * Patients with a history of or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion (including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction) * Patients with known clinically significant history of liver disease consistent with Child-Pugh class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis * Patients with lung disease: Grade 2 or greater pneumonitis, grade 2 or greater interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia) within the past 6 months * No active infection requiring parenteral antibiotics * Women who are pregnant or unwilling to discontinue nursing

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Conditions

The condition(s) this trial relates to.

endometrial endometrioid adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Figo grade 1 endometrial endometrioid adenocarcinoma Figo grade 2 endometrial endometrioid adenocarcinoma Metastatic endometrial endometrioid adenocarcinoma Recurrent endometrial endometrioid adenocarcinoma

Contacts and locations

Locations

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States
Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025, United States
Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States
Augusta University Medical Center

Augusta, Georgia, 30912, United States
Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States
Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan, 49009, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Billings Clinic Cancer Center

Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Bronson Battle Creek

Battle Creek, Michigan, 49017, United States
Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States
Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States
Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444, United States
Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24033, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Community Hospital of Anaconda

Anaconda, Montana, 59711, United States
Community Medical Center

Missoula, Montana, 59804, United States
Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085, United States
Corewell Health Reed City Hospital

Reed City, Michigan, 49677, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
FPG - Surgical Oncology Clinics Gynecologic Oncology Surgery

Sarasota, Florida, 34239, United States
Fairview Southdale Hospital

Edina, Minnesota, 55435, United States
Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida, 34239, United States
Florida Cancer Specialists - Venice Pinebrook

Venice, Florida, 34275, United States
Forbes Hospital

Monroeville, Pennsylvania, 15146, United States
Geauga Hospital

Chardon, Ohio, 44024, United States
Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220, United States
Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States
Harold Alfond Center for Cancer Care

Augusta, Maine, 04330, United States
Highlands Oncology Group

Springdale, Arkansas, 72762, United States
Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group - Rogers

Rogers, Arkansas, 72758, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
IU Health North Hospital

Carmel, Indiana, 46032, United States
Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Jefferson Hospital

Jefferson Hills, Pennsylvania, 15025, United States
Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States
Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States
Lyndon Baines Johnson General Hospital

Houston, Texas, 77026-1967, United States
MU Health - University Hospital/Ellis Fischel Cancer Center

Columbia, Missouri, 65212, United States
MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States
MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States
Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Mercy Hospital South

St Louis, Missouri, 63128, United States
Mercy Hospital Springfield

Springfield, Missouri, 65804, United States
Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331, United States
Miami Valley Hospital

Dayton, Ohio, 45409, United States
Miami Valley Hospital North

Dayton, Ohio, 45415, United States
Miami Valley Hospital South

Centerville, Ohio, 45459, United States
Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States
Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States
Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States
Munson Medical Center

Traverse City, Michigan, 49684, United States
Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States
Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States
Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States
Northwestern University

Chicago, Illinois, 60611, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, 74146, United States
Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States
Parkland Memorial Hospital

Dallas, Texas, 75235, United States
Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States
Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States
Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914, United States
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States
Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States
Sarasota Memorial Hospital-Venice

N. Venice, Florida, 34275, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
Springfield Clinic

Springfield, Illinois, 62702, United States
Springfield Memorial Hospital

Springfield, Illinois, 62781, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Summa Health System - Akron Campus

Akron, Ohio, 44304, United States
Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026, United States
Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States
Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States
UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States
UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States
UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States
UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, 44145, United States
UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104, United States
United Hospital

Saint Paul, Minnesota, 55102, United States
University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States
University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States
University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States
University of Michigan Health - West

Wyoming, Michigan, 49519, United States
University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States
Upper Valley Medical Center

Troy, Ohio, 45373, United States
VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States
West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States
Wexford Health and Wellness Pavilion

Wexford, Pennsylvania, 15090, United States
Women and Infants Hospital

Providence, Rhode Island, 02905, United States

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