Phase
Condition
Neoplasms
Endometrial Cancer
Treatment
Dostarlimab
Niraparib
Placebo matching Niraparib
Clinical Study ID
Ages > 18 Female
Study Summary
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;
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;
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;
Participant has primary Stage IIIC2 or Stage IV disease regardless of thepresence of evaluable or measurable disease;
Participant has first recurrent disease and is naïve to systemic anticancertherapy;
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:
has not had a recurrence or PD prior to first dose on the study OR
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
Connect with a study center
GSK Investigational Site
Grodno, 230030
BelarusSite Not Available
GSK Investigational Site
Minsk, 223040
BelarusSite Not Available
GSK Investigational Site
Aalst, 9300
BelgiumSite Not Available
GSK Investigational Site
Leuven, 3000
BelgiumSite Not Available
GSK Investigational Site
LiEge, 4000
BelgiumSite Not Available
GSK Investigational Site
Liège, 4000
BelgiumSite Not Available
GSK Investigational Site
Calgary, Alberta T3N 4N1
CanadaSite Not Available
GSK Investigational Site
Winnipeg, Manitoba R3E 0V9
CanadaSite Not Available
GSK Investigational Site
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
GSK Investigational Site
Sault Ste Marie, Ontario P6B 0A8
CanadaSite Not Available
GSK Investigational Site
Sault Ste. Marie, Ontario P6B 0A8
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 2M9
CanadaSite Not Available
GSK Investigational Site
Montreal, Quebec H4A 3J1
CanadaSite Not Available
GSK Investigational Site
Montréal, Quebec H2X 3E4
CanadaSite Not Available
GSK Investigational Site
QuEbec, G1J 1Z4
CanadaSite Not Available
GSK Investigational Site
Quebec, G1R 2J6
CanadaSite Not Available
GSK Investigational Site
Québec, G1J 1Z4
CanadaSite Not Available
GSK Investigational Site
Brno, 625 00
CzechiaSite Not Available
GSK Investigational Site
Prague, 128 00
CzechiaSite Not Available
GSK Investigational Site
Praha 2, 128 00
CzechiaSite Not Available
GSK Investigational Site
Aalborg, 9100
DenmarkSite Not Available
GSK Investigational Site
Copenhagen, DK-2100
DenmarkSite Not Available
GSK Investigational Site
Dk-2730 Herlev, 2730
DenmarkSite Not Available
GSK Investigational Site
Herlev, 2730
DenmarkSite Not Available
GSK Investigational Site
Odense, 5000
DenmarkSite Not Available
GSK Investigational Site
Odense C, 5000
DenmarkSite Not Available
GSK Investigational Site
Roskilde, 5000
DenmarkSite Not Available
GSK Investigational Site
Kuopio, 70210
FinlandSite Not Available
GSK Investigational Site
Tampere, 33520
FinlandSite Not Available
GSK Investigational Site
Turku, 20520
FinlandSite Not Available
GSK Investigational Site
Amberg, 92224
GermanySite Not Available
GSK Investigational Site
Bad Homburg, 61352
GermanySite Not Available
GSK Investigational Site
Dessau, 06847
GermanySite Not Available
GSK Investigational Site
Dresden, 01307
GermanySite Not Available
GSK Investigational Site
Essen, 45136
GermanySite Not Available
GSK Investigational Site
Frankfurt, 20259
GermanySite Not Available
GSK Investigational Site
Giessen, 35385
GermanySite Not Available
GSK Investigational Site
Hamburg, 20246
GermanySite Not Available
GSK Investigational Site
Hannover, 30177
GermanySite Not Available
GSK Investigational Site
Jena, 07747
GermanySite Not Available
GSK Investigational Site
Karlsruhe, 76135
GermanySite Not Available
GSK Investigational Site
Kiel, 24105
GermanySite Not Available
GSK Investigational Site
Koeln, 50935
GermanySite Not Available
GSK Investigational Site
Luebeck, 23538
GermanySite Not Available
GSK Investigational Site
Mainz, 55131
GermanySite Not Available
GSK Investigational Site
Muenchen, 81675
GermanySite Not Available
GSK Investigational Site
Offenbach, 63069
GermanySite Not Available
GSK Investigational Site
Ravensburg, 88212
GermanySite Not Available
GSK Investigational Site
Rosenheim, 83022
GermanySite Not Available
GSK Investigational Site
Tuebingen, 72076
GermanySite Not Available
GSK Investigational Site
Ulm, 89075
GermanySite Not Available
GSK Investigational Site
Wiesbaden, 65189
GermanySite Not Available
GSK Investigational Site
Athens, 115 22
GreeceSite Not Available
GSK Investigational Site
Marousi, 115 22
GreeceSite Not Available
GSK Investigational Site
Thessaloniki, 54645
GreeceSite Not Available
GSK Investigational Site
Budapest, 1122
HungarySite Not Available
GSK Investigational Site
Debrecen, 4032
HungarySite Not Available
GSK Investigational Site
Ashkelon, 78278
IsraelSite Not Available
GSK Investigational Site
Beer Sheva, 84101
IsraelSite Not Available
GSK Investigational Site
Beer-Sheva, 84101
IsraelSite Not Available
GSK Investigational Site
Haifa, 3436212
IsraelSite Not Available
GSK Investigational Site
Jerusalem, 91120
IsraelSite Not Available
GSK Investigational Site
Petach Tikva, 4941492
IsraelSite Not Available
GSK Investigational Site
Rehovot, 76100
IsraelSite Not Available
GSK Investigational Site
Tel Aviv, 64239
IsraelSite Not Available
GSK Investigational Site
Carpi (MO), Emilia-Romagna 41012
ItalySite Not Available
GSK Investigational Site
Roma, Lazio 00128
ItalySite Not Available
GSK Investigational Site
Candiolo (TO), Piemonte 10060
ItalySite Not Available
GSK Investigational Site
Biella, 13875
ItalySite Not Available
GSK Investigational Site
Candiolo, 10060
ItalySite Not Available
GSK Investigational Site
Carpi MO, 41012
ItalySite Not Available
GSK Investigational Site
Lecce, 73100
ItalySite Not Available
GSK Investigational Site
Milano, 20133
ItalySite Not Available
GSK Investigational Site
Naples, 00144
ItalySite Not Available
GSK Investigational Site
Ponderano, 13875
ItalySite Not Available
GSK Investigational Site
Rome, 00128
ItalySite Not Available
GSK Investigational Site
Sassuolo, 41049
ItalySite Not Available
GSK Investigational Site
Trento, 38122
ItalySite Not Available
GSK Investigational Site
Udine, 33100
ItalySite Not Available
GSK Investigational Site
Amsterdam, 1105 AZ
NetherlandsSite Not Available
GSK Investigational Site
Eindhoven, 5623 EJ
NetherlandsSite Not Available
GSK Investigational Site
Enschede, 7512 KZ
NetherlandsSite Not Available
GSK Investigational Site
Groningen, 9713 GZ
NetherlandsSite Not Available
GSK Investigational Site
Maastricht, 6229 HX
NetherlandsSite Not Available
GSK Investigational Site
Rotterdam, 3015 GD
NetherlandsSite Not Available
GSK Investigational Site
Bergen, 5021
NorwaySite Not Available
GSK Investigational Site
Oslo, 0310
NorwaySite Not Available
GSK Investigational Site
Stavanger, 4011
NorwaySite Not Available
GSK Investigational Site
Troms, 9019
NorwaySite Not Available
GSK Investigational Site
Tromso, 9019
NorwaySite Not Available
GSK Investigational Site
Trondheim, 7006
NorwaySite Not Available
GSK Investigational Site
Bialystok, 15-207
PolandSite Not Available
GSK Investigational Site
Gdynia, 81-519
PolandSite Not Available
GSK Investigational Site
Lodz, 93-513
PolandSite Not Available
GSK Investigational Site
Olsztyn, 10-228
PolandSite Not Available
GSK Investigational Site
Poznan, 60-569
PolandSite Not Available
GSK Investigational Site
Szczecin, 70-111
PolandSite Not Available
GSK Investigational Site
Warszawa, 00-909
PolandSite Not Available
GSK Investigational Site
Barcelona, 08036
SpainSite Not Available
GSK Investigational Site
Cordoba, 14004
SpainSite Not Available
GSK Investigational Site
MAlaga, 41014
SpainSite Not Available
GSK Investigational Site
Madrid, 28027
SpainSite Not Available
GSK Investigational Site
Murcia, 14004
SpainSite Not Available
GSK Investigational Site
Málaga, 29010
SpainSite Not Available
GSK Investigational Site
San SebastiAn, 20014
SpainSite Not Available
GSK Investigational Site
San Sebastián, 20014
SpainSite Not Available
GSK Investigational Site
Sevilla, 41014
SpainSite Not Available
GSK Investigational Site
Valencia, 46010
SpainSite Not Available
GSK Investigational Site
Linkoping, SE-581 85
SwedenSite Not Available
GSK Investigational Site
Linköping, SE-581 85
SwedenSite Not Available
GSK Investigational Site
Lund, 222 42
SwedenSite Not Available
GSK Investigational Site
Stockholm, SE-171 76
SwedenSite Not Available
GSK Investigational Site
Uppsala, SE-751 85
SwedenSite Not Available
GSK Investigational Site
Adapazari, 54290
TurkeySite Not Available
GSK Investigational Site
Ankara, 06230
TurkeySite Not Available
GSK Investigational Site
Istanbul, 34098
TurkeySite Not Available
GSK Investigational Site
Chernihiv, 14029
UkraineSite Not Available
GSK Investigational Site
Kharkiv, 61024
UkraineSite Not Available
GSK Investigational Site
Brighton, BN2 5BE
United KingdomSite Not Available
GSK Investigational Site
Cambriddge, CB2 2XY
United KingdomSite Not Available
GSK Investigational Site
Cambridge, CB2 0QQ
United KingdomSite Not Available
GSK Investigational Site
London, SE1 9RT
United KingdomSite Not Available
GSK Investigational Site
Truro, TR1 3LJ
United KingdomSite Not Available
GSK Investigational Site
Mesa, Arizona 85284
United StatesSite Not Available
GSK Investigational Site
Phoenix, Arizona 85016
United StatesSite Not Available
GSK Investigational Site
Scottsdale, Arizona 85016
United StatesSite Not Available
GSK Investigational Site
Tempe, Arizona 85284
United StatesSite Not Available
GSK Investigational Site
Tucson, Arizona 85710
United StatesSite Not Available
GSK Investigational Site
Newport Beach, California 92663
United StatesSite Not Available
GSK Investigational Site
Palo Alto, California 94304
United StatesSite Not Available
GSK Investigational Site
Deerfield Beach, Florida 33442
United StatesSite Not Available
GSK Investigational Site
Jacksonville, Florida 32207
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33176
United StatesSite Not Available
GSK Investigational Site
Orlando, Florida 32804
United StatesSite Not Available
GSK Investigational Site
Atlanta, Georgia 30342
United StatesSite Not Available
GSK Investigational Site
Augusta, Georgia 30912
United StatesSite Not Available
GSK Investigational Site
Savannah, Georgia 30912
United StatesSite Not Available
GSK Investigational Site
Hinsdale, Illinois 60521
United StatesSite Not Available
GSK Investigational Site
Zion, Illinois 60099
United StatesSite Not Available
GSK Investigational Site
Fort Wayne, Indiana 46845
United StatesSite Not Available
GSK Investigational Site
Indianapolis, Indiana 46260
United StatesSite Not Available
GSK Investigational Site
Iowa City, Iowa 52242-1009
United StatesSite Not Available
GSK Investigational Site
Lexington, Kentucky 40536
United StatesSite Not Available
GSK Investigational Site
Covington, Louisiana 70433
United StatesSite Not Available
GSK Investigational Site
New Orleans, Louisiana 70121
United StatesSite Not Available
GSK Investigational Site
Shreveport, Louisiana 71103
United StatesSite Not Available
GSK Investigational Site
Boston, Massachusetts 02114
United StatesSite Not Available
GSK Investigational Site
Springfield, Massachusetts 01199
United StatesSite Not Available
GSK Investigational Site
Detroit, Michigan 48201
United StatesSite Not Available
GSK Investigational Site
Saint Louis, Missouri 63110
United StatesSite Not Available
GSK Investigational Site
Lebanon, New Hampshire 03756
United StatesSite Not Available
GSK Investigational Site
Albuquerque, New Mexico 87131
United StatesSite Not Available
GSK Investigational Site
Rio Rancho, New Mexico 87124
United StatesSite Not Available
GSK Investigational Site
Albany, New York 12208
United StatesSite Not Available
GSK Investigational Site
Bronx, New York 10461
United StatesSite Not Available
GSK Investigational Site
Mineola, New York 10016
United StatesSite Not Available
GSK Investigational Site
New York, New York 10016
United StatesSite Not Available
GSK Investigational Site
Charlotte, North Carolina 28204
United StatesSite Not Available
GSK Investigational Site
Durham, North Carolina 27710
United StatesSite Not Available
GSK Investigational Site
Kernersville, North Carolina 27284
United StatesSite Not Available
GSK Investigational Site
Mount Airy, North Carolina 27030
United StatesSite Not Available
GSK Investigational Site
Winston-Salem, North Carolina 27103
United StatesSite Not Available
GSK Investigational Site
Cincinnati, Ohio 45219
United StatesSite Not Available
GSK Investigational Site
Cleveland, Ohio 44106
United StatesSite Not Available
GSK Investigational Site
Columbus, Ohio 43210
United StatesSite Not Available
GSK Investigational Site
Hilliard, Ohio 43210
United StatesSite Not Available
GSK Investigational Site
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
GSK Investigational Site
Tulsa, Oklahoma 74146
United StatesSite Not Available
GSK Investigational Site
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
GSK Investigational Site
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
GSK Investigational Site
Wexford, Pennsylvania 15224
United StatesSite Not Available
GSK Investigational Site
Willow Grove, Pennsylvania 19090
United StatesSite Not Available
GSK Investigational Site
Providence, Rhode Island 02905
United StatesSite Not Available
GSK Investigational Site
Knoxville, Tennessee 37920
United StatesSite Not Available
GSK Investigational Site
Austin, Texas 78731
United StatesSite Not Available
GSK Investigational Site
Dallas, Texas 75246
United StatesSite Not Available
GSK Investigational Site
Fort Worth, Texas 76104
United StatesSite Not Available
GSK Investigational Site
Charlottesville, Virginia 22903
United StatesSite Not Available
GSK Investigational Site
Roanoke, Virginia 24016
United StatesSite Not Available
GSK Investigational Site
Seattle, Washington 98109
United StatesSite Not Available
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