A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer
NCT ID: NCT03981796
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
785 participants
INTERVENTIONAL
2019-07-18
2026-11-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: Participants receiving dostarlimab + Carboplatin-paclitaxel followed by dostarlimab
Dostarlimab
Participants will be administered dostarlimab
Carboplatin
Participants will be administered carboplatin
Paclitaxel
Participants will be administered paclitaxel
Arm 2: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
Placebo matching dostarlimab
Participants will be administered placebo matching dostarlimab
Carboplatin
Participants will be administered carboplatin
Paclitaxel
Participants will be administered paclitaxel
Arm 3: Participants receiving dostarlimab + carboplatin-paclitaxel followed by dostarlimab+niraparib
Dostarlimab
Participants will be administered dostarlimab
Carboplatin
Participants will be administered carboplatin
Paclitaxel
Participants will be administered paclitaxel
Niraparib
Participants will be administered niraparib
Arm 4: Participants receiving placebo + carboplatin-paclitaxel followed by placebo
Placebo matching dostarlimab
Participants will be administered placebo matching dostarlimab
Carboplatin
Participants will be administered carboplatin
Paclitaxel
Participants will be administered paclitaxel
Placebo matching Niraparib
Participants will be administered placebo matching Niraparib
Interventions
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Dostarlimab
Participants will be administered dostarlimab
Placebo matching dostarlimab
Participants will be administered placebo matching dostarlimab
Carboplatin
Participants will be administered carboplatin
Paclitaxel
Participants will be administered paclitaxel
Niraparib
Participants will be administered niraparib
Placebo matching Niraparib
Participants will be administered placebo matching Niraparib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female participant is at least 18 years of age.
* Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
* Participant must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination and meet at least one of the following criteria;
1. Participant has primary Stage IIIA to IIIC1 disease with presence of evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 based on Investigator's assessment. Lesions that are equivocal or can be representative of post-operative change should be biopsied and confirmed for the presence of tumor;
2. Participant has primary Stage IIIC1 disease with carcinosarcoma, clear cell, serous, or mixed histology (containing greater than or equal to \[\>=\] 10 percent carcinosarcoma, clear cell, or serous histology) regardless of presence of evaluable or measurable disease on imaging;
3. Participant has primary Stage IIIC2 or Stage IV disease regardless of the presence of evaluable or measurable disease;
4. Participant has first recurrent disease and is naïve to systemic anticancer therapy;
5. Participant has received prior neo-adjuvant/adjuvant systemic anticancer therapy and had a recurrence or progression of disease (PD) \>=6 months after completing treatment (first recurrence only).
* Participant has an ECOG performance status of 0 or 1.
* Participant has adequate organ function.
Part 2 only:
* Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP lesser than or equal to \[\<=\] 140 millimeter of mercury \[mmHg\] and diastolic BP \<=90 mmHg).
* Participants must be able to take medication orally, by mouth (PO).
Exclusion Criteria
* Participant has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and:
1. has not had a recurrence or PD prior to first dose on the study OR
2. has had a recurrence or PD within 6 months of completing systemic anticancer therapy treatment prior to first dose on the study.
* Participant has had \>1 recurrence of endometrial cancer.
* Participant has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-ligand 1 (anti-PD-L1), or anti-PD-ligand 2 (anti-PD-L2) agent.
* Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or \<5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.
* Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for \<3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
* Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
* Participant has not recovered (that is \[i.e.\], to Grade \<=1 or to Baseline) from cytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\], or recombinant erythropoietin) within 21 days prior to the first dose of study drug.
* Participant has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.
* Participant is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.
* Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy.
* Participant has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study treatment.
Part 2 only:
* Participant has received prior therapy with a poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor.
* Participant has clinically significant cardiovascular disease.
* Participant has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
* Participant is at increased bleeding risk due to concurrent conditions.
* Participant has participated in Part 1 of this study
18 Years
FEMALE
No
Sponsors
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
GOG Foundation
NETWORK
Tesaro, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Newport Beach, California, United States
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Palo Alto, California, United States
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Deerfield Beach, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Savannah, Georgia, United States
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Hinsdale, Illinois, United States
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Zion, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Lexington, Kentucky, United States
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Covington, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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St Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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Albuquerque, New Mexico, United States
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Rio Rancho, New Mexico, United States
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Albany, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Kernersville, North Carolina, United States
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Mount Airy, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Hilliard, Ohio, United States
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Hilliard, Ohio, United States
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Tulsa, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Providence, Rhode Island, United States
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Knoxville, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Charlottesville, Virginia, United States
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Roanoke, Virginia, United States
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Seattle, Washington, United States
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Grodno, , Belarus
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Minsk, , Belarus
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Aalst, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Calgary, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Ottawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Brno, , Czechia
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Prague, , Czechia
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Aalborg, , Denmark
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Copenhagen, , Denmark
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Herlev, , Denmark
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Odense C, , Denmark
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Roskilde, , Denmark
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Kuopio, , Finland
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Tampere, , Finland
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Turku, , Finland
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Amberg, , Germany
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Bad Homburg, , Germany
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Cologne, , Germany
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Dessau, , Germany
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Dresden, , Germany
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Essen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Giessen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Jena, , Germany
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Karlsruhe, , Germany
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Kiel, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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München, , Germany
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Offenbach, , Germany
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Ravensburg, , Germany
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Rosenheim, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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Wiesbaden, , Germany
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Marousi, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Debrecen, , Hungary
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Ashkelon, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Candiolo, , Italy
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Carpi MO, , Italy
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Lecce, , Italy
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Milan, , Italy
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Naples, , Italy
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Ponderano BI, , Italy
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Rome, , Italy
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Sassuolo, , Italy
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Trento, , Italy
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Udine, , Italy
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Amsterdam, , Netherlands
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Eindhoven, , Netherlands
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Enschede, , Netherlands
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Bergen, , Norway
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Oslo, , Norway
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Stavanger, , Norway
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Troms, , Norway
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Trondheim, , Norway
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Bialystok, , Poland
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Gdynia, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Barcelona, , Spain
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Barcelona, , Spain
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Donostia / San Sebastian, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Málaga, , Spain
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Murcia, , Spain
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Valencia, , Spain
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Linköping, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Adapazarı, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Chernihiv, , Ukraine
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Kharkiv, , Ukraine
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Brighton, , United Kingdom
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Cambridge, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
GSK Investigational Site
Truro, , United Kingdom
Countries
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References
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Mansoor R Mirza, Dana M Chase, Brian M Slomovitz, René dePont Christensen, Zoltán Novák, Destin Black, Lucy Gilbert, Sudarshan Sharma, Giorgio Valabrega, Lisa M Landrum, Lars C Hanker, Ashley Stuckey, Ingrid Boere, Michael A Gold, Annika Auranen, Bhavana Pothuri, David Cibula, Carolyn McCourt, Francesco Raspagliesi, Mark S Shahin, Sarah E Gill, Bradley J Monk, Joseph Buscema, Thomas J Herzog, Larry J Copeland, Min Tian, Zangdong He, Shadi Stevens, Eleftherios Zografos, Robert L Coleman, Matthew A Powell, . Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. The New England journal of medicine. 2023-Jun-08;388(23): 2145-2158. DOI : 10.1056/NEJMoa2216334 PMID: 36972026
Banerjee S, Ingles Russo Garces A, Garside J, Rahman T, Pearson C, Heffernan K. Real-world patient characteristics and survival outcomes in patients with advanced or recurrent endometrial cancer in England: a retrospective, population-based study. BMJ Open. 2024 Nov 24;14(11):e083540. doi: 10.1136/bmjopen-2023-083540.
Auranen A, Powell MA, Sukhin V, Landrum LM, Ronzino G, Buscema J, Bauerschlag D, Lalisang R, Bender D, Gilbert L, Armstrong A, Safra T, Nevadunsky N, Sebastianelli A, Slomovitz B, Ring K, Coleman R, Podzielinski I, Stuckey A, Teneriello M, Gill S, Pothuri B, Willmott L, Sharma S, Dabrowski C, Antony G, Stevens S, Mirza MR, Fleming E. Safety of dostarlimab in combination with chemotherapy in patients with primary advanced or recurrent endometrial cancer in a phase III, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY). Ther Adv Med Oncol. 2024 Sep 28;16:17588359241277656. doi: 10.1177/17588359241277656. eCollection 2024.
Valabrega G, Powell MA, Hietanen S, Miller EM, Novak Z, Holloway R, Denschlag D, Myers T, Thijs AM, Pennington KP, Gilbert L, Fleming E, Zub O, Landrum LM, Ataseven B, Gogoi R, Podzielinski I, Cloven N, Monk BJ, Sharma S, Herzog TJ, Stuckey A, Pothuri B, Secord AA, Chase D, Vincent V, Meyers O, Garside J, Mirza MR, Black D. Patient-reported outcomes in the subpopulation of patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG3031/RUBY trial. Int J Gynecol Cancer. 2025 Jun;35(6):101852. doi: 10.1136/ijgc-2024-005484. Epub 2025 Apr 19.
Mirza MR, Chase DM, Slomovitz BM, Christensen RD, Novak Z, Black D, Gilbert L, Sharma S, Valabrega G, Landrum LM, Hanker LC, Stuckey A, Boere I, Gold MA, Auranen A, Pothuri B, Cibula D, McCourt C, Raspagliesi F, Shahin MS, Gill SE, Monk BJ, Buscema J, Herzog TJ, Copeland LJ, Tian M, He Z, Stevens S, Zografos E, Coleman RL, Powell MA. A Plain Language Summary of "Dostarlimab for primary advanced or recurrent endometrial cancer". Future Oncol. 2025 Jan;21(2):151-168. doi: 10.2217/fon-2023-0940. Epub 2024 Jul 11.
You M, Zeng X, Zhang J, Huang Y, Zhang Y, Cai Z, Hu Y. Cost-effectiveness analysis of dostarlimab plus carboplatin-paclitaxel as first-line treatment for advanced endometrial cancer. Front Immunol. 2023 Sep 4;14:1267322. doi: 10.3389/fimmu.2023.1267322. eCollection 2023.
Morton M, Marcu I, Levine M, Cosgrove C, Backes F, O'Malley D, Chambers L. Evaluation of Efficacy and Adverse Events After Second Immunotherapy Exposure in Endometrial and Cervical Carcinoma. Obstet Gynecol. 2023 Aug 1;142(2):360-363. doi: 10.1097/AOG.0000000000005243. Epub 2023 Jul 5.
Mirza MR, Chase DM, Slomovitz BM, dePont Christensen R, Novak Z, Black D, Gilbert L, Sharma S, Valabrega G, Landrum LM, Hanker LC, Stuckey A, Boere I, Gold MA, Auranen A, Pothuri B, Cibula D, McCourt C, Raspagliesi F, Shahin MS, Gill SE, Monk BJ, Buscema J, Herzog TJ, Copeland LJ, Tian M, He Z, Stevens S, Zografos E, Coleman RL, Powell MA; RUBY Investigators. Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer. N Engl J Med. 2023 Jun 8;388(23):2145-2158. doi: 10.1056/NEJMoa2216334. Epub 2023 Mar 27.
Other Identifiers
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ENGOT-EN6
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-3031
Identifier Type: OTHER
Identifier Source: secondary_id
4010-03-001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506551-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
213361
Identifier Type: -
Identifier Source: org_study_id
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