Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)
- Conditions
- Endometrial Neoplasms
- Interventions
- Radiation: External Beam Radiotherapy (EBRT)Radiation: Brachytherapy
- Registration Number
- NCT04634877
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 990
-
Has a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and:
- Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and
- Is at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology.
-
Is disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging.
-
Has not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC).
-
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
-
Submission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants.
-
Has adequate organ function within 7 days of randomization.
-
Has recurrent endometrial carcinoma or carcinosarcoma.
-
Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.
-
Has FIGO (2009) Surgical Stage I/II EC of endometrioid histology without a known aberrant p53 expression or p53 mutation.
-
Is known to have a deoxyribonucleic acid (DNA) polymerase epsilon catalytic subunit A (POLE) mutation.
-
Has FIGO Stage IVB disease of any histology even if there is no evidence of disease after surgery.
-
Has residual tumor whether measurable or non-measurable after surgery.
-
Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
- Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.
-
Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
-
Has received a live vaccine within 30 days before the first dose of study intervention.
- Note: killed vaccines are allowed.
-
Has a known intolerance to study intervention (or any of the excipients).
-
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
-
Has any contraindication to the use of carboplatin or paclitaxel.
-
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
-
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
-
Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
-
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
-
Has an active infection requiring systemic therapy.
-
Has a known history of HIV infection.
-
Has a known history of Hepatitis B or known active Hepatitis C virus infection.
-
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
-
Has had an allogenic tissue/solid organ transplant.
-
Has not recovered adequately from surgery and/or any complications from the surgery.
-
Is breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab + Chemotherapy Cisplatin (as radiosensitizer) Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Placebo + Chemotherapy Placebo for pembrolizumab Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Pembrolizumab + Chemotherapy Pembrolizumab Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Pembrolizumab + Chemotherapy External Beam Radiotherapy (EBRT) Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Placebo + Chemotherapy Cisplatin (as radiosensitizer) Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Pembrolizumab + Chemotherapy Brachytherapy Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Placebo + Chemotherapy External Beam Radiotherapy (EBRT) Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Placebo + Chemotherapy Brachytherapy Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Pembrolizumab + Chemotherapy Carboplatin Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Pembrolizumab + Chemotherapy Paclitaxel Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Pembrolizumab + Chemotherapy Cisplatin Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Pembrolizumab + Chemotherapy Docetaxel Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Placebo + Chemotherapy Carboplatin Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Placebo + Chemotherapy Paclitaxel Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Placebo + Chemotherapy Docetaxel Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation. Placebo + Chemotherapy Cisplatin Participants receive placebo to pembrolizumab intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 6 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 6 cycles. During the Q3W dosing period of placebo, participants receive concurrent standard of care (SoC) chemotherapy for 4 or 6 cycles. Participants optionally receive radiotherapy starting within 6 weeks of completion of SoC chemotherapy. The SoC chemotherapy regimen includes carboplatin AUC 5 or 6 IV Q3W plus paclitaxel 175 mg/m\^2 IV Q3W. In the event of severe hypersensitivity to, or an AE requiring discontinuation of, carboplatin or paclitaxel, cisplatin or docetaxel may be substituted after investigator consults with sponsor. The SoC radiotherapy regimen may include, at the discretion of the investigator, external beam radiotherapy (EBRT) ≥4500 cGY with variable dose frequency, with or without cisplatin 50 mg/m\^2 IV on days 1 and 29 of EBRT, and/or brachytherapy radiation.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 54 months OS is defined as the time from randomization to death due to any cause.
Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence Up to approximately 42 months DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence, will be presented.
- Secondary Outcome Measures
Name Time Method Disease-Free Survival (DFS) as Assessed Radiographically by Blinded Independent Central Review (BICR) or by Histopathologic Confirmation of Suspected Disease Recurrence Up to approximately 42 months DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by BICR or by histopathologic confirmation of suspected disease recurrence, will be presented.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function Score Baseline and up to approximately 54 months The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.
Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status Up to approximately 42 months DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by tumor mutation burden (TMB) status, will be presented.
Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status Up to approximately 42 months DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by CPS-determined PD-L1 status will be presented.
Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status Up to approximately 54 months OS is defined as the time from randomization to death due to any cause. The OS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by CPS-determined PD-L1 status will be presented.
Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status Up to approximately 54 months OS is defined as the time from randomization to death due to any cause. The OS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by tumor mutation burden (TMB) status will be presented.
Number of Participants Who Experience One or More Adverse Events (AEs) Up to approximately 54 months An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) Up to approximately 52 weeks An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (QoL) Score Baseline and up to approximately 54 months The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). A higher score indicates a better overall health/quality of life status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Endometrial Cancer (EORTC QLQ-EN24) Score Baseline and up to approximately 54 months The EORTC-QLQ-EN24 is a 24-item questionnaire developed to be used in conjunction with the EORTC-QLQ-C30 to assess the quality of life of endometrial cancer patients. Participant responses are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in EORTC QLQ-E24 score will be presented.
Trial Locations
- Locations (231)
Kingston Health Sciences Centre ( Site 3003)
🇨🇦Kingston, Ontario, Canada
University of South Alabama, Mitchell Cancer Institute ( Site 3058)
🇺🇸Mobile, Alabama, United States
WK Physicians Network/Gynecologic Oncology Associates ( Site 3047)
🇺🇸Shreveport, Louisiana, United States
Instituto Cancerologico de Narino Ltda ( Site 1092)
🇨🇴San Juan De Pasto, Narino, Colombia
Institut De Cancerologie De Lorraine ( Site 2072)
🇫🇷Vandoeuvre les Nancy, Ain, France
The First Affiliated Hospital of Xiamen University ( Site 4060)
🇨🇳Xiamen, Fujian, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 4049)
🇨🇳Nanning, Guangxi, China
Hubei Cancer Hospital ( Site 4059)
🇨🇳Wuhan, Hubei, China
Obstetrics and Gynecology Hosp. Fudan University ( Site 4041)
🇨🇳Shanghai, Shanghai, China
Harbin Medical University Cancer Hospital ( Site 4033)
🇨🇳Harbin, Heilongjiang, China
Sichuan Cancer Hospital ( Site 4039)
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital ( Site 4054)
🇨🇳Tianjin, Tianjin, China
Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053)
🇨🇳Shanghai, Shanghai, China
Chernihiv Medical Center of Modern Oncology ( Site 2368)
🇺🇦Chernihiv, Chernihivska Oblast, Ukraine
CHU Liege Sart-Tilman ( Site 2044)
🇧🇪Liege, Belgium
OLV Ziekenhuis ( Site 2038)
🇧🇪Aalst, Oost-Vlaanderen, Belgium
AZ Groeninge ( Site 2036)
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Bradfordhill-Clinical Area ( Site 1070)
🇨🇱Santiago, Region M. De Santiago, Chile
Tom Baker Cancer Centre ( Site 3007)
🇨🇦Calgary, Alberta, Canada
Instituto de Oncologia de Rosario ( Site 1004)
🇦🇷Rosario, Santa Fe, Argentina
Arizona Oncology Associates PC- HOPE ( Site 3049)
🇺🇸Tucson, Arizona, United States
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010)
🇦🇷Buenos Aires, Argentina
Saint-Luc UCL ( Site 2042)
🇧🇪Bruxelles, Bruxelles-Capitale, Region De, Belgium
Universitair Ziekenhuis Gent ( Site 2037)
🇧🇪Gent, Oost-Vlaanderen, Belgium
AZ Nikolaas ( Site 2031)
🇧🇪Sint-Niklaas, Oost-Vlaanderen, Belgium
CHC - Groupe Sante ( Site 2041)
🇧🇪Liege, Belgium
Smilow Cancer Hospital at Yale New Haven ( Site 3070)
🇺🇸New Haven, Connecticut, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 1005)
🇦🇷Berazategui, Buenos Aires, Argentina
Fundacion Arturo Lopez Perez FALP ( Site 1062)
🇨🇱Santiago, Region M. De Santiago, Chile
Hopital prive du Confluent ( Site 2061)
🇫🇷Nantes, Loire-Atlantique, France
Edith Wolfson Medical Center ( Site 2306)
🇮🇱Holon, Israel
National Cancer Center Hospital East ( Site 4197)
🇯🇵Kashiwa, Chiba, Japan
University of the Ryukyus Hospital ( Site 4184)
🇯🇵Nakagami-gun, Okinawa, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 4192)
🇯🇵Sunto-gun, Shizuoka, Japan
I Can Oncology Center SA de CV ( Site 1126)
🇲🇽Monterrey, Nuevo Leon, Mexico
Soerlandet sykehus HF Kristiansand ( Site 2152)
🇳🇴Kristiansand, Vest-Agder, Norway
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2487)
🇵🇱Siedlce, Mazowieckie, Poland
National Research Ogarev Mordovia State University ( Site 2648)
🇷🇺Saransk, Mordoviya, Respublika, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2636)
🇷🇺Saint-Petersburg, Sankt-Peterburg, Russian Federation
Tomsk Scientific Research Institute of Oncology-Chemotherapy ( Site 2638)
🇷🇺Tomsk, Tomskaya Oblast, Russian Federation
Fundacion Valle del Lili ( Site 1093)
🇨🇴Cali, Valle Del Cauca, Colombia
Instituto Nacional de Cancerología E.S.E ( Site 1094)
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Kurume University Hospital ( Site 4186)
🇯🇵Kurume, Fukuoka, Japan
National Hospital Organization Kyushu Cancer Center ( Site 4193)
🇯🇵Fukuoka, Japan
Keio University Hospital ( Site 4191)
🇯🇵Tokyo, Japan
Hospital San Lucas Cardiologica del Sureste ( Site 1122)
🇲🇽Tuxtla Gutierrez, Chiapas, Mexico
Centro Oncologico Internacional. SEDNA ( Site 1121)
🇲🇽Mexico City, Mexico
Linkou Chang Gung Memorial Hospital ( Site 4091)
🇨🇳Taoyuan, Taiwan
Centro Investigación del Cáncer James Lind ( Site 1061)
🇨🇱Temuco, Araucania, Chile
Clínica Vida Fundación - Sede Poblado ( Site 1096)
🇨🇴Medellin, Antioquia, Colombia
Gunma Prefectural Cancer Center ( Site 4183)
🇯🇵Ota, Gunma, Japan
The Cancer Institute Hospital of JFCR ( Site 4196)
🇯🇵Tokyo, Japan
Christus Muguerza Clinica Vidriera ( Site 1125)
🇲🇽Monterrey, Nuevo Leon, Mexico
Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 2644)
🇷🇺Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Institut Bergonie ( Site 2067)
🇫🇷Bordeaux, Gironde, France
Institut Universitaire du Cancer Toulouse - Oncopole ( Site 2065)
🇫🇷Toulouse, Haute-Garonne, France
Hospital Hygeia ( Site 2426)
🇬🇷Marousi, Attiki, Greece
Iwate Medical University Hospital ( Site 4189)
🇯🇵Shiwa-gun, Iwate, Japan
Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2631)
🇷🇺Moscow, Moskva, Russian Federation
Castle Hill Hospital-Academic Oncology ( Site 2252)
🇬🇧Cottingham, East Riding Of Yorkshire, United Kingdom
Tampere University Hospital ( Site 2541)
🇫🇮Tampere, Pirkanmaa, Finland
Lviv State Regional Oncological Center ( Site 2361)
🇺🇦Lviv, Lvivska Oblast, Ukraine
Geniko Panepistimako Nosokomeio ARETEIO ( Site 2423)
🇬🇷Athens, Attiki, Greece
Ehime University Hospital ( Site 4187)
🇯🇵Toon, Ehime, Japan
Hokkaido University Hospital ( Site 4194)
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Cancer Center ( Site 4195)
🇯🇵Akashi, Hyogo, Japan
Saitama Medical University International Medical Center ( Site 4182)
🇯🇵Hidaka, Saitama, Japan
Osaka International Cancer Institute ( Site 4188)
🇯🇵Osaka, Japan
Hospital Angeles Roma ( Site 1123)
🇲🇽Ciudad de Mexico, Mexico
University Hospital of North Norway ( Site 2153)
🇳🇴Tromso, Troms, Norway
Oslo Universitetssykehus Radiumhospitalet ( Site 2151)
🇳🇴Oslo, Norway
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2646)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2641)
🇷🇺Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Norton Cancer Institute - St. Matthews ( Site 3056)
🇺🇸Louisville, Kentucky, United States
AHN West Penn Hospital ( Site 3060)
🇺🇸Pittsburgh, Pennsylvania, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042)
🇺🇸New York, New York, United States
Northside Hospital ( Site 3036)
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital ( Site 3044)
🇺🇸Chicago, Illinois, United States
Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078)
🇺🇸Philadelphia, Pennsylvania, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076)
🇺🇸Mineola, New York, United States
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006)
🇦🇷Caba, Buenos Aires, Argentina
VCU Massey Cancer Center ( Site 3068)
🇺🇸Richmond, Virginia, United States
Abington Hospital - Asplundh Cancer Center ( Site 3073)
🇺🇸Willow Grove, Pennsylvania, United States
Hospital Britanico de Buenos Aires ( Site 1002)
🇦🇷Buenos Aires, Caba, Argentina
CHR Verviers ( Site 2035)
🇧🇪Verviers, Liege, Belgium
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080)
🇺🇸Fargo, North Dakota, United States
Sanford Gynecology Oncology ( Site 3045)
🇺🇸Sioux Falls, South Dakota, United States
Hospital Aleman ( Site 1001)
🇦🇷Buenos Aires, Argentina
CEMIC ( Site 1009)
🇦🇷Buenos Aires, Argentina
Centro Oncologico Riojano Integral ( Site 1007)
🇦🇷La Rioja, Argentina
Medizinische Universitat Graz ( Site 2004)
🇦🇹Graz, Steiermark, Austria
Medizinische Universitaet Innsbruck ( Site 2001)
🇦🇹Innsbruck, Tirol, Austria
C.I.U. Hopital Ambroise Pare ( Site 2039)
🇧🇪Mons, Hainaut, Belgium
AZ Maria Middelares Gent ( Site 2032)
🇧🇪Gent, Oost-Vlaanderen, Belgium
McGill University Health Centre ( Site 3005)
🇨🇦Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3
🇨🇦Quebec City, Quebec, Canada
The First Affiliated Hospital ( Site 4043)
🇨🇳Guangzhou, Guangdong, China
Beijing Cancer Hospital ( Site 4048)
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital, Zhejiang University-Gynecology ( Site 4002)
🇨🇳Hangzhou, Zhejiang, China
Yunnan Province Cancer Hospital-Gynecology Department ( Site 4055)
🇨🇳Kunming, Yunnan, China
Aalborg Universitetshospital ( Site 2511)
🇩🇰Aalborg, Nordjylland, Denmark
Odense Universitetshospital ( Site 2512)
🇩🇰Odense, Syddanmark, Denmark
Kuopio University Hospital ( Site 2543)
🇫🇮Kuopio, Pohjois-Savo, Finland
Centre Francois Baclesse ( Site 2062)
🇫🇷Caen, Calvados, France
General Hospital of Patras. St Andrews ( Site 2421)
🇬🇷Patras, Achaia, Greece
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2122)
🇮🇹Milano, Italy
Hôpital Privé Des Côtes d'Armor ( Site 2063)
🇫🇷Plérin, Cotes-d Armor, France
Asan Medical Center ( Site 4061)
🇰🇷Seoul, Korea, Republic of
Turku University Hospital ( Site 2542)
🇫🇮Turku, Varsinais-Suomi, Finland
Centre Antoine Lacassagne ( Site 2073)
🇫🇷Nice, Alpes-Maritimes, France
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2105)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Institut Regional du Cancer de Montpellier - ICM ( Site 2069)
🇫🇷Montpellier, Herault, France
Universitätsklinikum Bonn-Gynaecological oncology ( Site 2103)
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Chaim Sheba Medical Center ( Site 2301)
🇮🇱Ramat Gan, Israel
Fondazione Policlinico Universitario Agostino Gemelli ( Site 2124)
🇮🇹Roma, Lazio, Italy
IRCCS Ospedale San Raffaele ( Site 2130)
🇮🇹Milano, Italy
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
🇩🇪Dresden, Sachsen, Germany
Hadassah Medical Center. Ein Kerem ( Site 2303)
🇮🇱Jerusalem, Israel
Rabin Medical Center ( Site 2305)
🇮🇱Petah Tikva, Israel
Aichi Cancer Center Hospital ( Site 4190)
🇯🇵Nagoya, Aichi, Japan
National Hospital Organization Shikoku Cancer Center ( Site 4181)
🇯🇵Matsuyama, Ehime, Japan
Istituto di Candiolo - IRCCS ( Site 2125)
🇮🇹Candiolo, Piemonte, Italy
Niigata Cancer Center Hospital ( Site 4185)
🇯🇵Niigata, Japan
Instituto Nacional de Cancerologia ( Site 1124)
🇲🇽Cdmx, Distrito Federal, Mexico
Investigacion Onco Farmaceutica S de RL de CV ( Site 1127)
🇲🇽La Paz, Baja California Sur, Mexico
National Cancer Center ( Site 4065)
🇰🇷Goyang-si, Kyonggi-do, Korea, Republic of
Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2481)
🇵🇱Warszawa, Mazowieckie, Poland
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2486)
🇵🇱Olsztyn, Warminsko-mazurskie, Poland
Krasnoyarsk Regional Clinical oncology dispensary ( Site 2643)
🇷🇺Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
Bialostockie Centrum Onkologii ( Site 2483)
🇵🇱Bialystok, Podlaskie, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2482)
🇵🇱Gliwice, Slaskie, Poland
Swietokrzyskie Centrum Onkologii SPZOZ ( Site 2485)
🇵🇱Kielce, Swietokrzyskie, Poland
Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 2484)
🇵🇱Poznan, Wielkopolskie, Poland
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 2634)
🇷🇺Moscow, Moskva, Russian Federation
Nizhegorodsky Regional Oncology Dispensary-chemotherapy department (Branch№1) ( Site 2639)
🇷🇺Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
Samara Regional Clinical Oncology Center-Chemotherapy Dapartment ( Site 2649)
🇷🇺Samara, Samarskaya Oblast, Russian Federation
LISOD - Israeli Oncological Hospital MedX-ray International Group, LLC ( Site 2364)
🇺🇦Kiev, Kyivska Oblast, Ukraine
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 2366)
🇺🇦Chernivtsi, Chernivetska Oblast, Ukraine
Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2355)
🇹🇷Adana, Turkey
Cukurova Uni. Tip Fakultesi ( Site 2353)
🇹🇷Adana, Turkey
Bristol Haematology and Oncology Centre ( Site 2244)
🇬🇧Bristol, Bristol, City Of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 2248)
🇬🇧London, London, City Of, United Kingdom
Royal Marsden Hospital Sutton-Surrey ( Site 2241)
🇬🇧Sutton, London, City Of, United Kingdom
Baskent Universitesi Ankara Hastanesi ( Site 2354)
🇹🇷Ankara, Turkey
Changhua Christian Hospital ( Site 4095)
🇨🇳Changhua, Taiwan
Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 2350)
🇹🇷Ankara, Turkey
MacKay Memorial Hospital ( Site 4092)
🇨🇳Taipei, Taiwan
Ege University Medical Faculty ( Site 2351)
🇹🇷Izmir, Turkey
I.E.U. Medical Point Hastanesi ( Site 2356)
🇹🇷Izmir, Turkey
Beatson West of Scotland Cancer Centre ( Site 2247)
🇬🇧Glasgow, Glasgow City, United Kingdom
UCLH NHS Foundation Trust ( Site 2242)
🇬🇧London, London, City Of, United Kingdom
Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 2249)
🇬🇧Leicester, United Kingdom
University of Alabama - Birmingham ( Site 3061)
🇺🇸Birmingham, Alabama, United States
HonorHealth Research Institute - Biltmore ( Site 3043)
🇺🇸Phoenix, Arizona, United States
Duke Cancer Center ( Site 3072)
🇺🇸Durham, North Carolina, United States
Legacy Good Samaritan Medical Center ( Site 3033)
🇺🇸Portland, Oregon, United States
Azienda Ospedaliera Spedali Civili di Brescia ( Site 2135)
🇮🇹Brescia, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 2132)
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Federico II ( Site 2123)
🇮🇹Napoli, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2127)
🇮🇹Napoli, Italy
Istituto Oncologico Veneto IRCCS-Oncologia 2 ( Site 2134)
🇮🇹Padova, Italy
Seoul National University Bundang Hospital ( Site 4063)
🇰🇷Seongnam-si, Kyonggi-do, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 4062)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center ( Site 4064)
🇰🇷Seoul, Korea, Republic of
UT Southwestern Medical Center ( Site 3063)
🇺🇸Dallas, Texas, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 3071)
🇺🇸Indianapolis, Indiana, United States
Mount Sinai Cancer Center ( Site 3081)
🇺🇸Miami Beach, Florida, United States
UCSD Moores Cancer Center ( Site 3053)
🇺🇸La Jolla, California, United States
University Of Colorado ( Site 3051)
🇺🇸Aurora, Colorado, United States
Montefiore Medical Center ( Site 3065)
🇺🇸Bronx, New York, United States
Parkview Cancer Institute ( Site 3067)
🇺🇸Fort Wayne, Indiana, United States
University of Massachusetts Medical School ( Site 3037)
🇺🇸Worcester, Massachusetts, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
🇺🇸Columbus, Ohio, United States
Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003)
🇦🇷Mar del Plata, Buenos Aires, Argentina
UZ Leuven ( Site 2040)
🇧🇪Leuven, Vlaams-Brabant, Belgium
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 3006)
🇨🇦Montreal, Quebec, Canada
Oncocentro ( Site 1065)
🇨🇱Vina del Mar, Valparaiso, Chile
Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)
🇨🇱Santiago, Region M. De Santiago, Chile
Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 4034)
🇨🇳Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 4036)
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital ( Site 4040)
🇨🇳Chongqing, Chongqing, China
Xiangya Hospital Central-South University ( Site 4035)
🇨🇳Changsha, Hunan, China
Jiangxi Maternal and Child Health Hospital ( Site 4051)
🇨🇳Nanchang, Jiangxi, China
Nanjing Drum Tower Hospital ( Site 4037)
🇨🇳Nanjing, Jiangsu, China
Hunan Cancer Hospital ( Site 4050)
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 4045)
🇨🇳XI An, Shaanxi, China
The First Bethune Hospital of Jilin University ( Site 4057)
🇨🇳Changchun, Jilin, China
Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001)
🇨🇳Shanghai, Shanghai, China
Women s Hospital School of Medicine Zhejiang University ( Site 4032)
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 4056)
🇨🇳Wenzhou, Zhejiang, China
Vseobecna fakultni nemocnice v Praze ( Site 2391)
🇨🇿Praha, Praha 2, Czechia
Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394)
🇨🇿Brno, Brno-mesto, Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 2393)
🇨🇿Praha, Praha 10, Czechia
Fakultni nemocnice Olomouc ( Site 2392)
🇨🇿Olomouc, Czechia
Herlev Hospital ( Site 2514)
🇩🇰Herlev, Hovedstaden, Denmark
Rigshospitalet University Hospital ( Site 2515)
🇩🇰Copehagen, Hovedstaden, Denmark
Roskilde Sygehus ( Site 2513)
🇩🇰Roskilde, Sjaelland, Denmark
CHU Besancon - Hopital Jean Minjoz ( Site 2068)
🇫🇷Besancon, Doubs, France
Hopital Cochin ( Site 2070)
🇫🇷Paris, Ile-de-France, France
Gustave Roussy ( Site 2071)
🇫🇷Villejuif, Ile-de-France, France
Klinikum Ludwigsburg ( Site 2111)
🇩🇪Ludwigsburg, Baden-Wurttemberg, Germany
Centre Hospitalier Lyon Sud ( Site 2064)
🇫🇷Pierre Benite, Rhone, France
SLK-Kliniken Heilbronn GmbH ( Site 2116)
🇩🇪Heilbronn, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen ( Site 2113)
🇩🇪Tübingen, Baden-Wurttemberg, Germany
Medizinische Hochschule Hannover-Department of Obstetrics and Gynecology ( Site 2109)
🇩🇪Hannover, Niedersachsen, Germany
Perifereiako Geniko Nosokomeio ALEXANDRA ( Site 2425)
🇬🇷Athens, Attiki, Greece
Athens University Hospital ATTIKON ( Site 2424)
🇬🇷Chaidari, Attiki, Greece
Euromedica General Clinic of Thessaloniki ( Site 2422)
🇬🇷Thessaloniki, Greece
Rambam Medical Center ( Site 2307)
🇮🇱Haifa, Israel
Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 2121)
🇮🇹Roma, Abruzzo, Italy
Arkhangelsk Clinical Oncological Dispensary ( Site 2637)
🇷🇺Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 2645)
🇷🇺Ufa, Baskortostan, Respublika, Russian Federation
Hospital Josep Trueta ( Site 2184)
🇪🇸Girona, Gerona, Spain
Hospital Vall D Hebron ( Site 2182)
🇪🇸Barcelona, Spain
Clinica Universitaria de Navarra ( Site 2181)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Clinic i Provincial ( Site 2185)
🇪🇸Barcelona, Spain
Blod-och Tumorsjukdomar ( Site 2221)
🇸🇪Uppsala, Uppsala Lan, Sweden
Hospital Universitario Reina Sofia ( Site 2183)
🇪🇸Cordoba, Spain
Universitetssjukhuset i Linkoping. ( Site 2222)
🇸🇪Linkoping, Ostergotlands Lan, Sweden
Hospital Universitario La Paz ( Site 2186)
🇪🇸Madrid, Spain
Karolinska Universitetssjukhuset Solna ( Site 2220)
🇸🇪Solna, Stockholms Lan, Sweden
Taichung Veterans General Hospital ( Site 4094)
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital ( Site 4093)
🇨🇳Taipei, Taiwan
Medipol Universite Hastanesi ( Site 2352)
🇹🇷Istanbul, Turkey
The Municipal Enterprise Volyn Regional Medical Oncology Centre ( Site 2362)
🇺🇦Lutsk, Volynska Oblast, Ukraine
SO Grigoriev Institute for Medical Radiology and Oncology of NAMS of Ukraine ( Site 2363)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
MNE "Khmelnytskyi regional antitumor center" ( Site 2365)
🇺🇦Khmelnitskyi, Khmelnytska Oblast, Ukraine
The Christie Hospital NHS Foundation Trust ( Site 2243)
🇬🇧Manchester, United Kingdom
Hospital Clinico San Carlos ( Site 2187)
🇪🇸Madrid, Spain
University of Iowa Hospital and Clinics ( Site 3046)
🇺🇸Iowa City, Iowa, United States
Universitätsklinikum Schleswig-Holstein ( Site 2101)
🇩🇪Lübeck, Schleswig-Holstein, Germany