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Immunotherapy plus chemo shows promise in advanced uterine cancer trial

NCT ID NCT03981796

Disease control Sponsor: Tesaro, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 study tests whether adding the immunotherapy drug dostarlimab to standard chemotherapy (carboplatin and paclitaxel) helps people with advanced or recurrent endometrial cancer live longer without their cancer growing. About 785 participants receive either dostarlimab plus chemo or a placebo plus chemo, followed by additional treatment with or without niraparib. The study measures progression-free and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dostarlimab (an immunotherapy drug) plus carboplatin and paclitaxel (chemotherapy), followed by dostarlimab with or without niraparib (another drug)
What this could lead to
If successful, this combination could become a new standard treatment to help control advanced endometrial cancer for longer.
What could go wrong
This is a large phase 3 trial, but results are not yet final. The added drugs may cause more side effects, and not all patients may benefit.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

785 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: Part 1 and Part 2: * 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: Part 1 and Part 2: * 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

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Conditions

The condition(s) this trial relates to.

endometrial cancer neoplasm Recurrence

As listed by the trial registrant

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

Neoplasms

Contacts and locations

Locations

  • GSK Investigational Site

    Miami, Florida, 33136, United States

  • GSK Investigational Site

    Miami, Florida, 33176, United States

  • GSK Investigational Site

    Orlando, Florida, 32804, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30342, United States

  • GSK Investigational Site

    Augusta, Georgia, 30912, United States

  • GSK Investigational Site

    Savannah, Georgia, 31405, United States

  • GSK Investigational Site

    Hinsdale, Illinois, 60521, United States

  • GSK Investigational Site

    Zion, Illinois, 60099, United States

  • GSK Investigational Site

    Fort Wayne, Indiana, 46845, United States

  • GSK Investigational Site

    Indianapolis, Indiana, 46202, United States

  • GSK Investigational Site

    Indianapolis, Indiana, 46260, United States

  • GSK Investigational Site

    Iowa City, Iowa, 52242, United States

  • GSK Investigational Site

    Lexington, Kentucky, 40536, United States

  • GSK Investigational Site

    Covington, Louisiana, 70433, United States

  • GSK Investigational Site

    New Orleans, Louisiana, 70121, United States

  • GSK Investigational Site

    Shreveport, Louisiana, 71103, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02114, United States

  • GSK Investigational Site

    Springfield, Massachusetts, 01199, United States

  • GSK Investigational Site

    Detroit, Michigan, 48201, United States

  • GSK Investigational Site

    St Louis, Missouri, 63108, United States

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756, United States

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131, United States

  • GSK Investigational Site

    Rio Rancho, New Mexico, 87124, United States

  • GSK Investigational Site

    Albany, New York, 12208, United States

  • GSK Investigational Site

    Mineola, New York, 10016, United States

  • GSK Investigational Site

    New York, New York, 10016, United States

  • GSK Investigational Site

    The Bronx, New York, 10461, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28204, United States

  • GSK Investigational Site

    Durham, North Carolina, 27710, United States

  • GSK Investigational Site

    Kernersville, North Carolina, 27284, United States

  • GSK Investigational Site

    Mount Airy, North Carolina, 27030, United States

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45219, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45220, United States

  • GSK Investigational Site

    Cleveland, Ohio, 44106, United States

  • GSK Investigational Site

    Columbus, Ohio, 43210, United States

  • GSK Investigational Site

    Hilliard, Ohio, 43026, United States

  • GSK Investigational Site

    Hilliard, Ohio, 43210, United States

  • GSK Investigational Site

    Tulsa, Oklahoma, 74146, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15224, United States

  • GSK Investigational Site

    Willow Grove, Pennsylvania, 19090, United States

  • GSK Investigational Site

    Providence, Rhode Island, 02905, United States

  • GSK Investigational Site

    Knoxville, Tennessee, 37920, United States

  • GSK Investigational Site

    Austin, Texas, 78731, United States

  • GSK Investigational Site

    Austin, Texas, 78758, United States

  • GSK Investigational Site

    Dallas, Texas, 75246, United States

  • GSK Investigational Site

    Dallas, Texas, 76104, United States

  • GSK Investigational Site

    Charlottesville, Virginia, 22903, United States

  • GSK Investigational Site

    Roanoke, Virginia, 24016, United States

  • GSK Investigational Site

    Seattle, Washington, 98109, United States

  • GSK Investigational Site

    Grodno, 230030, Belarus

  • GSK Investigational Site

    Minsk, 223040, Belarus

  • GSK Investigational Site

    Aalst, 9300, Belgium

  • GSK Investigational Site

    Leuven, 3000, Belgium

  • GSK Investigational Site

    Liège, 4000, Belgium

  • GSK Investigational Site

    Calgary, Alberta, T2N 5G2, Canada

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 0V9, Canada

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    Sault Ste. Marie, Ontario, P6B 0A8, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2X 3E4, Canada

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    Québec, Quebec, G1J 1Z4, Canada

  • GSK Investigational Site

    Brno, 625 00, Czechia

  • GSK Investigational Site

    Prague, 128 51, Czechia

  • GSK Investigational Site

    Aalborg, 9000, Denmark

  • GSK Investigational Site

    Copenhagen, DK-2100, Denmark

  • GSK Investigational Site

    Herlev, 2730, Denmark

  • GSK Investigational Site

    Odense C, 5000, Denmark

  • GSK Investigational Site

    Roskilde, 4000, Denmark

  • GSK Investigational Site

    Kuopio, 70210, Finland

  • GSK Investigational Site

    Tampere, 33520, Finland

  • GSK Investigational Site

    Turku, 20520, Finland

  • GSK Investigational Site

    Amberg, 92224, Germany

  • GSK Investigational Site

    Bad Homburg, 61352, Germany

  • GSK Investigational Site

    Cologne, 50935, Germany

  • GSK Investigational Site

    Dessau, 06847, Germany

  • GSK Investigational Site

    Dresden, 01307, Germany

  • GSK Investigational Site

    Essen, 45136, Germany

  • GSK Investigational Site

    Essen, 45147, Germany

  • GSK Investigational Site

    Frankfurt, 20259, Germany

  • GSK Investigational Site

    Giessen, 35392, Germany

  • GSK Investigational Site

    Hamburg, 20246, Germany

  • GSK Investigational Site

    Hanover, 30177, Germany

  • GSK Investigational Site

    Jena, 07747, Germany

  • GSK Investigational Site

    Karlsruhe, 76135, Germany

  • GSK Investigational Site

    Kiel, 24105, Germany

  • GSK Investigational Site

    Lübeck, 23538, Germany

  • GSK Investigational Site

    Mainz, 55131, Germany

  • GSK Investigational Site

    München, 81675, Germany

  • GSK Investigational Site

    Offenbach, 63069, Germany

  • GSK Investigational Site

    Ravensburg, 88212, Germany

  • GSK Investigational Site

    Rosenheim, 83022, Germany

  • GSK Investigational Site

    Tübingen, 72076, Germany

  • GSK Investigational Site

    Ulm, 89075, Germany

  • GSK Investigational Site

    Wiesbaden, 65189, Germany

  • GSK Investigational Site

    Marousi, 151 23, Greece

  • GSK Investigational Site

    Thessaloniki, 54645, Greece

  • GSK Investigational Site

    Budapest, 1122, Hungary

  • GSK Investigational Site

    Debrecen, 4032, Hungary

  • GSK Investigational Site

    Ashkelon, 78278, Israel

  • GSK Investigational Site

    Beersheba, 8410101, Israel

  • GSK Investigational Site

    Haifa, 3436212, Israel

  • GSK Investigational Site

    Jerusalem, 9112001, Israel

  • GSK Investigational Site

    Petah Tikva, 4941492, Israel

  • GSK Investigational Site

    Rehovot, 7661041, Israel

  • GSK Investigational Site

    Tel Aviv, 6423906, Israel

  • GSK Investigational Site

    Candiolo, 10060, Italy

  • GSK Investigational Site

    Carpi MO, 41012, Italy

  • GSK Investigational Site

    Lecce, 73100, Italy

  • GSK Investigational Site

    Milan, 20133, Italy

  • GSK Investigational Site

    Naples, 00144, Italy

  • GSK Investigational Site

    Ponderano BI, 13875, Italy

  • GSK Investigational Site

    Rome, 00128, Italy

  • GSK Investigational Site

    Sassuolo, 41049, Italy

  • GSK Investigational Site

    Trento, 38122, Italy

  • GSK Investigational Site

    Udine, 33100, Italy

  • GSK Investigational Site

    Amsterdam, 1105 AZ, Netherlands

  • GSK Investigational Site

    Eindhoven, 5623 EJ, Netherlands

  • GSK Investigational Site

    Enschede, 7512 KZ, Netherlands

  • GSK Investigational Site

    Groningen, 9713 GZ, Netherlands

  • GSK Investigational Site

    Maastricht, 6229 HX, Netherlands

  • GSK Investigational Site

    Rotterdam, 3015 GD, Netherlands

  • GSK Investigational Site

    Bergen, 5053, Norway

  • GSK Investigational Site

    Oslo, 0379, Norway

  • GSK Investigational Site

    Stavanger, 4011, Norway

  • GSK Investigational Site

    Troms, 9019, Norway

  • GSK Investigational Site

    Trondheim, 7006, Norway

  • GSK Investigational Site

    Bialystok, 15-027, Poland

  • GSK Investigational Site

    Gdynia, 81-519, Poland

  • GSK Investigational Site

    Lodz, 93-513, Poland

  • GSK Investigational Site

    Olsztyn, 10-228, Poland

  • GSK Investigational Site

    Poznan, 60-569, Poland

  • GSK Investigational Site

    Szczecin, 70-111, Poland

  • GSK Investigational Site

    Warsaw, 04-141, Poland

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Donostia / San Sebastian, 20014, Spain

  • GSK Investigational Site

    Madrid, 28027, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Málaga, 29010, Spain

  • GSK Investigational Site

    Málaga, 41014, Spain

  • GSK Investigational Site

    Murcia, 14004, Spain

  • GSK Investigational Site

    Valencia, 46010, Spain

  • GSK Investigational Site

    Linköping, SE-581 85, Sweden

  • GSK Investigational Site

    Lund, 222 42, Sweden

  • GSK Investigational Site

    Stockholm, SE-171 76, Sweden

  • GSK Investigational Site

    Uppsala, 751 85, Sweden

  • GSK Investigational Site

    Adapazarı, 54290, Turkey (Türkiye)

  • GSK Investigational Site

    Ankara, 06230, Turkey (Türkiye)

  • GSK Investigational Site

    Istanbul, 34093, Turkey (Türkiye)

  • GSK Investigational Site

    Istanbul, 34098, Turkey (Türkiye)

  • GSK Investigational Site

    Istanbul, 34147, Turkey (Türkiye)

  • GSK Investigational Site

    Chernihiv, 14029, Ukraine

  • GSK Investigational Site

    Kharkiv, 61024, Ukraine

  • GSK Investigational Site

    Brighton, BN2 5BE, United Kingdom

  • GSK Investigational Site

    Cambridge, CB2 0QQ, United Kingdom

  • GSK Investigational Site

    London, NW1 2PG, United Kingdom

  • GSK Investigational Site

    London, SE1 9RT, United Kingdom

  • GSK Investigational Site

    Truro, TR1 3LJ, United Kingdom

  • GSK Investigational Site

    Phoenix, Arizona, 85016, United States

  • GSK Investigational Site

    Scottsdale, Arizona, 85016, United States

  • GSK Investigational Site

    Tucson, Arizona, 85704, United States

  • GSK Investigational Site

    Tucson, Arizona, 85710, United States

  • GSK Investigational Site

    Newport Beach, California, 92663, United States

  • GSK Investigational Site

    Palo Alto, California, 94304, United States

  • GSK Investigational Site

    Deerfield Beach, Florida, 33442, United States

  • GSK Investigational Site

    Jacksonville, Florida, 32207, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.