A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

Last updated: November 26, 2024
Sponsor: Tesaro, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Neoplasms

Endometrial Cancer

Treatment

Dostarlimab

Niraparib

Placebo matching Niraparib

Clinical Study ID

NCT03981796
213361
4010-03-001
GOG-3031
ENGOT-EN6
  • Ages > 18
  • Female

Study Summary

This is a 2 part study. Part 1 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo; and Part 2 is to evaluate the efficacy and safety of dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo in participants with recurrent or primary advanced (Stage III or IV) endometrial cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Part 1 and Part 2:

  • Female participant is at least 18 years of age.

  • Participant has histologically or cytologically proven endometrial cancer withrecurrent or advanced disease.

  • Participant must have primary Stage III or Stage IV disease or first recurrentendometrial cancer with a low potential for cure by radiation therapy or surgeryalone or in combination and meet at least one of the following criteria;

  1. Participant has primary Stage IIIA to IIIC1 disease with presence of evaluableor measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)version (v).1.1 based on Investigator's assessment. Lesions that are equivocalor can be representative of post-operative change should be biopsied andconfirmed 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 percentcarcinosarcoma, clear cell, or serous histology) regardless of presence ofevaluable or measurable disease on imaging;

  3. Participant has primary Stage IIIC2 or Stage IV disease regardless of thepresence of evaluable or measurable disease;

  4. Participant has first recurrent disease and is naïve to systemic anticancertherapy;

  5. Participant has received prior neo-adjuvant/adjuvant systemic anticancertherapy and had a recurrence or progression of disease (PD) >=6 months aftercompleting 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 andcontrolled hypertension (systolic BP lesser than or equal to [<=] 140 millimeter ofmercury [mmHg] and diastolic BP <=90 mmHg).

  • Participants must be able to take medication orally, by mouth (PO).

Exclusion

Exclusion Criteria:

Part 1 and Part 2:

  • Participant has received neo-adjuvant/adjuvant systemic anticancer therapy forprimary 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 anticancertherapy 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 thehalf-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-endometrialinvasive malignancy who has been disease-free for <3 years or who received anyactive treatment in the last 3 years for that malignancy. Non-melanoma skin canceris allowed.

  • Participant has known uncontrolled central nervous system metastases, carcinomatosismeningitis, or both.

  • Participant has not recovered (that is [i.e.], to Grade <=1 or to Baseline) fromcytotoxic therapy induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulatingfactors (including granulocyte colony-stimulating factor [G-CSF], granulocytemacrophage 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 majorsurgery prior to starting therapy.

  • Participant is currently participating and receiving study treatment or hasparticipated in a study of an investigational agent and received study treatment orused an investigational device within 4 weeks of the first dose of treatment.

  • Participant is considered a poor medical risk due to a serious, uncontrolled medicaldisorder, nonmalignant systemic disease, or active infection requiring systemictherapy.

  • Participant has received, or is scheduled to receive, a live vaccine within 30 daysbefore first dose of study treatment, during study treatment, and for up to 180 daysafter 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

Study Design

Total Participants: 785
Treatment Group(s): 6
Primary Treatment: Dostarlimab
Phase: 3
Study Start date:
July 15, 2019
Estimated Completion Date:
November 26, 2026

Connect with a study center

  • GSK Investigational Site

    Grodno, 230030
    Belarus

    Site Not Available

  • GSK Investigational Site

    Minsk, 223040
    Belarus

    Site Not Available

  • GSK Investigational Site

    Aalst, 9300
    Belgium

    Site Not Available

  • GSK Investigational Site

    Leuven, 3000
    Belgium

    Site Not Available

  • GSK Investigational Site

    LiEge, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Liège, 4000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Calgary, Alberta T3N 4N1
    Canada

    Site Not Available

  • GSK Investigational Site

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • GSK Investigational Site

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • GSK Investigational Site

    Sault Ste Marie, Ontario P6B 0A8
    Canada

    Site Not Available

  • GSK Investigational Site

    Sault Ste. Marie, Ontario P6B 0A8
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • GSK Investigational Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • GSK Investigational Site

    Montréal, Quebec H2X 3E4
    Canada

    Site Not Available

  • GSK Investigational Site

    QuEbec, G1J 1Z4
    Canada

    Site Not Available

  • GSK Investigational Site

    Quebec, G1R 2J6
    Canada

    Site Not Available

  • GSK Investigational Site

    Québec, G1J 1Z4
    Canada

    Site Not Available

  • GSK Investigational Site

    Brno, 625 00
    Czechia

    Site Not Available

  • GSK Investigational Site

    Prague, 128 00
    Czechia

    Site Not Available

  • GSK Investigational Site

    Praha 2, 128 00
    Czechia

    Site Not Available

  • GSK Investigational Site

    Aalborg, 9100
    Denmark

    Site Not Available

  • GSK Investigational Site

    Copenhagen, DK-2100
    Denmark

    Site Not Available

  • GSK Investigational Site

    Dk-2730 Herlev, 2730
    Denmark

    Site Not Available

  • GSK Investigational Site

    Herlev, 2730
    Denmark

    Site Not Available

  • GSK Investigational Site

    Odense, 5000
    Denmark

    Site Not Available

  • GSK Investigational Site

    Odense C, 5000
    Denmark

    Site Not Available

  • GSK Investigational Site

    Roskilde, 5000
    Denmark

    Site Not Available

  • GSK Investigational Site

    Kuopio, 70210
    Finland

    Site Not Available

  • GSK Investigational Site

    Tampere, 33520
    Finland

    Site Not Available

  • GSK Investigational Site

    Turku, 20520
    Finland

    Site Not Available

  • GSK Investigational Site

    Amberg, 92224
    Germany

    Site Not Available

  • GSK Investigational Site

    Bad Homburg, 61352
    Germany

    Site Not Available

  • GSK Investigational Site

    Dessau, 06847
    Germany

    Site Not Available

  • GSK Investigational Site

    Dresden, 01307
    Germany

    Site Not Available

  • GSK Investigational Site

    Essen, 45136
    Germany

    Site Not Available

  • GSK Investigational Site

    Frankfurt, 20259
    Germany

    Site Not Available

  • GSK Investigational Site

    Giessen, 35385
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 20246
    Germany

    Site Not Available

  • GSK Investigational Site

    Hannover, 30177
    Germany

    Site Not Available

  • GSK Investigational Site

    Jena, 07747
    Germany

    Site Not Available

  • GSK Investigational Site

    Karlsruhe, 76135
    Germany

    Site Not Available

  • GSK Investigational Site

    Kiel, 24105
    Germany

    Site Not Available

  • GSK Investigational Site

    Koeln, 50935
    Germany

    Site Not Available

  • GSK Investigational Site

    Luebeck, 23538
    Germany

    Site Not Available

  • GSK Investigational Site

    Mainz, 55131
    Germany

    Site Not Available

  • GSK Investigational Site

    Muenchen, 81675
    Germany

    Site Not Available

  • GSK Investigational Site

    Offenbach, 63069
    Germany

    Site Not Available

  • GSK Investigational Site

    Ravensburg, 88212
    Germany

    Site Not Available

  • GSK Investigational Site

    Rosenheim, 83022
    Germany

    Site Not Available

  • GSK Investigational Site

    Tuebingen, 72076
    Germany

    Site Not Available

  • GSK Investigational Site

    Ulm, 89075
    Germany

    Site Not Available

  • GSK Investigational Site

    Wiesbaden, 65189
    Germany

    Site Not Available

  • GSK Investigational Site

    Athens, 115 22
    Greece

    Site Not Available

  • GSK Investigational Site

    Marousi, 115 22
    Greece

    Site Not Available

  • GSK Investigational Site

    Thessaloniki, 54645
    Greece

    Site Not Available

  • GSK Investigational Site

    Budapest, 1122
    Hungary

    Site Not Available

  • GSK Investigational Site

    Debrecen, 4032
    Hungary

    Site Not Available

  • GSK Investigational Site

    Ashkelon, 78278
    Israel

    Site Not Available

  • GSK Investigational Site

    Beer Sheva, 84101
    Israel

    Site Not Available

  • GSK Investigational Site

    Beer-Sheva, 84101
    Israel

    Site Not Available

  • GSK Investigational Site

    Haifa, 3436212
    Israel

    Site Not Available

  • GSK Investigational Site

    Jerusalem, 91120
    Israel

    Site Not Available

  • GSK Investigational Site

    Petach Tikva, 4941492
    Israel

    Site Not Available

  • GSK Investigational Site

    Rehovot, 76100
    Israel

    Site Not Available

  • GSK Investigational Site

    Tel Aviv, 64239
    Israel

    Site Not Available

  • GSK Investigational Site

    Carpi (MO), Emilia-Romagna 41012
    Italy

    Site Not Available

  • GSK Investigational Site

    Roma, Lazio 00128
    Italy

    Site Not Available

  • GSK Investigational Site

    Candiolo (TO), Piemonte 10060
    Italy

    Site Not Available

  • GSK Investigational Site

    Biella, 13875
    Italy

    Site Not Available

  • GSK Investigational Site

    Candiolo, 10060
    Italy

    Site Not Available

  • GSK Investigational Site

    Carpi MO, 41012
    Italy

    Site Not Available

  • GSK Investigational Site

    Lecce, 73100
    Italy

    Site Not Available

  • GSK Investigational Site

    Milano, 20133
    Italy

    Site Not Available

  • GSK Investigational Site

    Naples, 00144
    Italy

    Site Not Available

  • GSK Investigational Site

    Ponderano, 13875
    Italy

    Site Not Available

  • GSK Investigational Site

    Rome, 00128
    Italy

    Site Not Available

  • GSK Investigational Site

    Sassuolo, 41049
    Italy

    Site Not Available

  • GSK Investigational Site

    Trento, 38122
    Italy

    Site Not Available

  • GSK Investigational Site

    Udine, 33100
    Italy

    Site Not Available

  • GSK Investigational Site

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Eindhoven, 5623 EJ
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Enschede, 7512 KZ
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Groningen, 9713 GZ
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • GSK Investigational Site

    Bergen, 5021
    Norway

    Site Not Available

  • GSK Investigational Site

    Oslo, 0310
    Norway

    Site Not Available

  • GSK Investigational Site

    Stavanger, 4011
    Norway

    Site Not Available

  • GSK Investigational Site

    Troms, 9019
    Norway

    Site Not Available

  • GSK Investigational Site

    Tromso, 9019
    Norway

    Site Not Available

  • GSK Investigational Site

    Trondheim, 7006
    Norway

    Site Not Available

  • GSK Investigational Site

    Bialystok, 15-207
    Poland

    Site Not Available

  • GSK Investigational Site

    Gdynia, 81-519
    Poland

    Site Not Available

  • GSK Investigational Site

    Lodz, 93-513
    Poland

    Site Not Available

  • GSK Investigational Site

    Olsztyn, 10-228
    Poland

    Site Not Available

  • GSK Investigational Site

    Poznan, 60-569
    Poland

    Site Not Available

  • GSK Investigational Site

    Szczecin, 70-111
    Poland

    Site Not Available

  • GSK Investigational Site

    Warszawa, 00-909
    Poland

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08036
    Spain

    Site Not Available

  • GSK Investigational Site

    Cordoba, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    MAlaga, 41014
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28027
    Spain

    Site Not Available

  • GSK Investigational Site

    Murcia, 14004
    Spain

    Site Not Available

  • GSK Investigational Site

    Málaga, 29010
    Spain

    Site Not Available

  • GSK Investigational Site

    San SebastiAn, 20014
    Spain

    Site Not Available

  • GSK Investigational Site

    San Sebastián, 20014
    Spain

    Site Not Available

  • GSK Investigational Site

    Sevilla, 41014
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46010
    Spain

    Site Not Available

  • GSK Investigational Site

    Linkoping, SE-581 85
    Sweden

    Site Not Available

  • GSK Investigational Site

    Linköping, SE-581 85
    Sweden

    Site Not Available

  • GSK Investigational Site

    Lund, 222 42
    Sweden

    Site Not Available

  • GSK Investigational Site

    Stockholm, SE-171 76
    Sweden

    Site Not Available

  • GSK Investigational Site

    Uppsala, SE-751 85
    Sweden

    Site Not Available

  • GSK Investigational Site

    Adapazari, 54290
    Turkey

    Site Not Available

  • GSK Investigational Site

    Ankara, 06230
    Turkey

    Site Not Available

  • GSK Investigational Site

    Istanbul, 34098
    Turkey

    Site Not Available

  • GSK Investigational Site

    Chernihiv, 14029
    Ukraine

    Site Not Available

  • GSK Investigational Site

    Kharkiv, 61024
    Ukraine

    Site Not Available

  • GSK Investigational Site

    Brighton, BN2 5BE
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Cambriddge, CB2 2XY
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Mesa, Arizona 85284
    United States

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • GSK Investigational Site

    Scottsdale, Arizona 85016
    United States

    Site Not Available

  • GSK Investigational Site

    Tempe, Arizona 85284
    United States

    Site Not Available

  • GSK Investigational Site

    Tucson, Arizona 85710
    United States

    Site Not Available

  • GSK Investigational Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • GSK Investigational Site

    Palo Alto, California 94304
    United States

    Site Not Available

  • GSK Investigational Site

    Deerfield Beach, Florida 33442
    United States

    Site Not Available

  • GSK Investigational Site

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33176
    United States

    Site Not Available

  • GSK Investigational Site

    Orlando, Florida 32804
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • GSK Investigational Site

    Augusta, Georgia 30912
    United States

    Site Not Available

  • GSK Investigational Site

    Savannah, Georgia 30912
    United States

    Site Not Available

  • GSK Investigational Site

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • GSK Investigational Site

    Zion, Illinois 60099
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Wayne, Indiana 46845
    United States

    Site Not Available

  • GSK Investigational Site

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • GSK Investigational Site

    Iowa City, Iowa 52242-1009
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • GSK Investigational Site

    Covington, Louisiana 70433
    United States

    Site Not Available

  • GSK Investigational Site

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • GSK Investigational Site

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • GSK Investigational Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • GSK Investigational Site

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • GSK Investigational Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • GSK Investigational Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • GSK Investigational Site

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • GSK Investigational Site

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • GSK Investigational Site

    Rio Rancho, New Mexico 87124
    United States

    Site Not Available

  • GSK Investigational Site

    Albany, New York 12208
    United States

    Site Not Available

  • GSK Investigational Site

    Bronx, New York 10461
    United States

    Site Not Available

  • GSK Investigational Site

    Mineola, New York 10016
    United States

    Site Not Available

  • GSK Investigational Site

    New York, New York 10016
    United States

    Site Not Available

  • GSK Investigational Site

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • GSK Investigational Site

    Durham, North Carolina 27710
    United States

    Site Not Available

  • GSK Investigational Site

    Kernersville, North Carolina 27284
    United States

    Site Not Available

  • GSK Investigational Site

    Mount Airy, North Carolina 27030
    United States

    Site Not Available

  • GSK Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • GSK Investigational Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • GSK Investigational Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • GSK Investigational Site

    Hilliard, Ohio 43210
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • GSK Investigational Site

    Tulsa, Oklahoma 74146
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • GSK Investigational Site

    Wexford, Pennsylvania 15224
    United States

    Site Not Available

  • GSK Investigational Site

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • GSK Investigational Site

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • GSK Investigational Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78731
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75246
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • GSK Investigational Site

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • GSK Investigational Site

    Roanoke, Virginia 24016
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98109
    United States

    Site Not Available

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