Clinical Trials List
Protocol NumberMK3475-775/E7080-G000-309
NCT Number(ClinicalTrials.gov Identfier)NCT03517449
Completed
2018-06-11 - 2023-01-31
Phase III
Terminated7
ICD-10C54.1
Malignant neoplasm of endometrium
ICD-9182.0
Malignant neoplasm of corpus uteri, except isthmus
A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer
-
Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
-
Sponsor
Merck Sharp & Dohme Corp.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Huann-Cheng Horng Division of Obstetrics & Gynecology
- 沈書慧 Division of Radiology
- Chi-Mu Chuang Division of Obstetrics & Gynecology
- Yi-Jen Chen Division of Obstetrics & Gynecology
- Yen-Hou Chang Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
5 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 黃彥綾 Division of Radiology
- Cheng-Tao Lin Division of Obstetrics & Gynecology
- Chyong-Huey Lai Division of Obstetrics & Gynecology
- 周宏學 Division of Obstetrics & Gynecology
- 陳威君 Division of Obstetrics & Gynecology
- 周宏學 Division of Obstetrics & Gynecology
- Angel Chao Division of Obstetrics & Gynecology
- 黃寬仁 Division of Obstetrics & Gynecology
- Huei-Jean Huang Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 童寶玲 Division of Obstetrics & Gynecology
- 戴依柔 Division of Obstetrics & Gynecology
- 施怡倫 Division of Radiology
- Wen-Fang Cheng Division of Obstetrics & Gynecology
- YING-CHENG CHIANG Division of Obstetrics & Gynecology
- 郭冠廷 Division of Others
- 陳祈安 Division of Obstetrics & Gynecology
- 陳宇立 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Advanced Endometrial Cancer
Objectives
To demonstrate that lenvatinib in combination with pembrolizumab is superior to Treatment of Physician’s Choice (TPC) in improving progression-free survival (PFS).To demonstrate that lenvatinib in combination with pembrolizumab is superior to TPC in improving overall survival (OS).
Test Drug
Keytruda/Lenvima
Active Ingredient
Lenvatinib mesilate
Pembrolizumab
Pembrolizumab
Dosage Form
injection
capsule
capsule
Dosage
100 mg/4 mL
4 mg or 10mg
4 mg or 10mg
Endpoints
Primary Outcome Measures :
Progression Free Survival (PFS) [ Time Frame: Up to approximately 27 months ]
PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurred first.
Overall Survival (OS) [ Time Frame: Up to approximately 43 months ]
OS is defined as the time from date of randomization to date of death from any cause.
Secondary Outcome Measures :
Objective Response Rate (ORR) [ Time Frame: Up to approximately 27 months ]
ORR is defined as the percentage of participants who have best overall response of either complete response (CR) or partial response (PR), as determined by BICR per RECIST 1.1.
Health-Related Quality of Life (HRQoL) Score Using the European Organization for Research and Treatment (EORTC) Quality of Life (QoL) Questionnaire (QLQ-C30) Version 3.0 [ Time Frame: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and at the end of follow-up (up to approximately 43 months) ]
Change from baseline in HRQoL using the global score of EORTC QLQ-C30 will be determined. EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functional dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of individual symptoms, higher scores suggest increased perception of these symptoms of life.
Number of Participants With Adverse Events (AE) [ Time Frame: Up to approximately 43 months ]
The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Number of Participants With Serious Adverse Events (SAE) [ Time Frame: Up to approximately 43 months ]
The number of participants experiencing an SAE will be assessed. A SAE is an AE that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is associated with an overdose, or is another important medical event.
Number of Participants With Immune-related Adverse Events (irAE) [ Time Frame: Up to approximately 43 months ]
The number of participants experiencing an irAE will be assessed. An irAE is defined as any unfavorable and unintended immune-related sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Number of Participants With Treatment Discontinuations Due to AEs [ Time Frame: Up to approximately 43 months ]
The number of participants who discontinue study treatment due to an AE will be assessed.
Time to Treatment Failure (TTF) Due to Treatment Emergent AEs [ Time Frame: Up to approximately 43 months ]
Time to treatment failure due to toxicity, defined as the time from the date of randomization to the date that a participant discontinues study treatment due to AEs.
Model-Predicted Area Under the Concentration time Curve of Lenvatinib Based on Starting Dose From Time 0 to Infinity (AUC 0-∞) [ Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycle 2 Day 1: predose and 0.5 - 4 hours and 6-10 hours postdose; Cycle length = 21 days ]
Model-Predicted Apparent Total Body Clearance (Cl/F) of Lenvatinib [ Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycle 2 Day 1: predose and 0.5 - 4 hours and 6-10 hours postdose; Cycle length = 21 days ]
Model-Predicted Apparent Total Body Volume of Distribution (Vd/F) of Lenvatinib [ Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycle 2 Day 1: predose and 0.5 - 4 hours and 6-10 hours postdose; Cycle length = 21 days ]
Progression Free Survival (PFS) [ Time Frame: Up to approximately 27 months ]
PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurred first.
Overall Survival (OS) [ Time Frame: Up to approximately 43 months ]
OS is defined as the time from date of randomization to date of death from any cause.
Secondary Outcome Measures :
Objective Response Rate (ORR) [ Time Frame: Up to approximately 27 months ]
ORR is defined as the percentage of participants who have best overall response of either complete response (CR) or partial response (PR), as determined by BICR per RECIST 1.1.
Health-Related Quality of Life (HRQoL) Score Using the European Organization for Research and Treatment (EORTC) Quality of Life (QoL) Questionnaire (QLQ-C30) Version 3.0 [ Time Frame: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and at the end of follow-up (up to approximately 43 months) ]
Change from baseline in HRQoL using the global score of EORTC QLQ-C30 will be determined. EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functional dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of individual symptoms, higher scores suggest increased perception of these symptoms of life.
Number of Participants With Adverse Events (AE) [ Time Frame: Up to approximately 43 months ]
The number of participants experiencing an AE will be assessed. An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Number of Participants With Serious Adverse Events (SAE) [ Time Frame: Up to approximately 43 months ]
The number of participants experiencing an SAE will be assessed. A SAE is an AE that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is associated with an overdose, or is another important medical event.
Number of Participants With Immune-related Adverse Events (irAE) [ Time Frame: Up to approximately 43 months ]
The number of participants experiencing an irAE will be assessed. An irAE is defined as any unfavorable and unintended immune-related sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Number of Participants With Treatment Discontinuations Due to AEs [ Time Frame: Up to approximately 43 months ]
The number of participants who discontinue study treatment due to an AE will be assessed.
Time to Treatment Failure (TTF) Due to Treatment Emergent AEs [ Time Frame: Up to approximately 43 months ]
Time to treatment failure due to toxicity, defined as the time from the date of randomization to the date that a participant discontinues study treatment due to AEs.
Model-Predicted Area Under the Concentration time Curve of Lenvatinib Based on Starting Dose From Time 0 to Infinity (AUC 0-∞) [ Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycle 2 Day 1: predose and 0.5 - 4 hours and 6-10 hours postdose; Cycle length = 21 days ]
Model-Predicted Apparent Total Body Clearance (Cl/F) of Lenvatinib [ Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycle 2 Day 1: predose and 0.5 - 4 hours and 6-10 hours postdose; Cycle length = 21 days ]
Model-Predicted Apparent Total Body Volume of Distribution (Vd/F) of Lenvatinib [ Time Frame: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours postdose; Cycle 1 Day 15: predose and 2-12 hours postdose; Cycle 2 Day 1: predose and 0.5 - 4 hours and 6-10 hours postdose; Cycle length = 21 days ]
Inclution Criteria
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following
criteria apply:
1. Histologically confirmed diagnosis of endometrial carcinoma.
2. Documented evidence of advanced, recurrent or metastatic EC.
3. Radiographic evidence of disease progression after 1 prior systemic,
platinum-based chemotherapy regimen for recurrent, metastatic or primary
unresectable disease.
- Participants who progress <1 year after completion of prior adjuvant or
neoadjuvant platinum-based chemotherapy are eligible without further
systemic treatment.
- Participants who progress ≥1 year after completion of prior adjuvant or
neoadjuvant platinum-based chemotherapy must receive 1 additional
cytotoxic systemic treatment prior to enrollment in this study.
4. Available historical or fresh tumor biopsy specimen for determination of
MMR status.
5. At least 1 measurable target lesion according to RECIST 1.1 and confirmed
by BICR, including the following criteria:
- Non-nodal lesion that measures ≥1.0 cm in the longest diameter
- Lymph node (LN) lesion that measures as ≥1.5 cm in the short axis
- The lesion is suitable for repeat measurement using computed
tomography/magnetic resonance imaging (CT/MRI). Lesions that have
had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of subsequent growth.
6. ECOG performance status of 0 or 1 within 3 days of starting study
treatment.
7. Female participants age ≥18 years and considered an adult per local
regulations at the time of informed consent.
8. A female participant is eligible to participate if she is not pregnant (see
Appendix 2), not breastfeeding, and at least one of the following conditions
applies:
a.) Not a WOCBP as defined in Appendix 2
OR
b.) A WOCBP who agrees to follow the contraceptive guidance in
Appendix 2 during the treatment period and for at least 120 days after the
last dose of study treatment.
9. The participant provides written informed consent for the study.
10. Adequately controlled blood pressure (BP) with or without antihypertensive
medications, defined as BP ≤150/90 mm Hg at Screening and no change in
antihypertensive medications within 1 week before C1D1.
11. Have adequate organ function as defined in Table 1. Specimens must be
collected within 3 days prior to the start of study treatment.
Participants are eligible to be included in the study only if all of the following
criteria apply:
1. Histologically confirmed diagnosis of endometrial carcinoma.
2. Documented evidence of advanced, recurrent or metastatic EC.
3. Radiographic evidence of disease progression after 1 prior systemic,
platinum-based chemotherapy regimen for recurrent, metastatic or primary
unresectable disease.
- Participants who progress <1 year after completion of prior adjuvant or
neoadjuvant platinum-based chemotherapy are eligible without further
systemic treatment.
- Participants who progress ≥1 year after completion of prior adjuvant or
neoadjuvant platinum-based chemotherapy must receive 1 additional
cytotoxic systemic treatment prior to enrollment in this study.
4. Available historical or fresh tumor biopsy specimen for determination of
MMR status.
5. At least 1 measurable target lesion according to RECIST 1.1 and confirmed
by BICR, including the following criteria:
- Non-nodal lesion that measures ≥1.0 cm in the longest diameter
- Lymph node (LN) lesion that measures as ≥1.5 cm in the short axis
- The lesion is suitable for repeat measurement using computed
tomography/magnetic resonance imaging (CT/MRI). Lesions that have
had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of subsequent growth.
6. ECOG performance status of 0 or 1 within 3 days of starting study
treatment.
7. Female participants age ≥18 years and considered an adult per local
regulations at the time of informed consent.
8. A female participant is eligible to participate if she is not pregnant (see
Appendix 2), not breastfeeding, and at least one of the following conditions
applies:
a.) Not a WOCBP as defined in Appendix 2
OR
b.) A WOCBP who agrees to follow the contraceptive guidance in
Appendix 2 during the treatment period and for at least 120 days after the
last dose of study treatment.
9. The participant provides written informed consent for the study.
10. Adequately controlled blood pressure (BP) with or without antihypertensive
medications, defined as BP ≤150/90 mm Hg at Screening and no change in
antihypertensive medications within 1 week before C1D1.
11. Have adequate organ function as defined in Table 1. Specimens must be
collected within 3 days prior to the start of study treatment.
Exclusion Criteria
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
1. Carcinosarcoma (malignant mixed Műllerian tumor), endometrial
leiomyosarcoma and endometrial stromal sarcomas.
2. Participants with CNS metastases are not eligible, unless they have
completed local therapy (eg, whole brain radiation therapy [WBRT],
surgery or radiosurgery) and have discontinued the use of corticosteroids
for this indication for at least 4 weeks before starting treatment in this study.
Any signs (eg, radiologic) or symptoms of brain metastases must be stable
for at least 4 weeks before starting study treatment.
3. Active malignancy (except for endometrial cancer, definitively treated
in-situ carcinomas [e.g. breast, cervix, bladder], or basal or squamous cell
carcinoma of the skin) within the past 24 months.
4. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other
condition that might affect the absorption of lenvatinib.
5. Radiographic evidence of major blood vessel invasion/infiltration. The
degree of tumor invasion/infiltration of major blood vessels should be
considered because of the potential risk of severe hemorrhage associated
with tumor shrinkage/necrosis following lenvatinib therapy.
6. Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to
the first dose of study drug.
7. Significant cardiovascular impairment within 12 months of the first dose of
study drug: such as history of congestive heart failure greater than New
York Heart Association (NYHA) Class II, unstable angina, myocardial
infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia
associated with hemodynamic instability.
8. Active infection (any infection requiring systemic treatment).
9. Participants who have not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.
10. Participants known to be positive for Human Immunodeficiency Virus
(HIV). No HIV testing is required unless mandated by local heath authority.
11. Known active Hepatitis B (eg, HBsAg reactive) or Hepatitis C (eg, HCV
RNA [qualitative] is detected). No testing for hepatitis B or C is required
unless mandated by local health authority.
12. Has a history of (non-infectious) pneumonitis that required treatment with
steroids, or has current pneumonitis.
13. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
participant's participation for the full duration of the trial, or is not in the
best interest of the participant to participate, in the opinion of the treating
investigator.
14. Has known psychiatric or substance abuse disorders that would interfere
with cooperation with the requirements of the trial.
15. 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 to the
first dose of study drug.
16. Active autoimmune disease (with the exception of psoriasis) that has
required systemic treatment in the 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.
17. Females who are breastfeeding or pregnant at Screening or Baseline (as
documented by a positive beta-human chorionic gonadotropin [β-hCG] (or
hCG) test with a minimum sensitivity of 25 IU/L or equivalent units of
β-hCG [or hCG]). A separate baseline assessment is required if a negative
screening pregnancy test was obtained more than 72 hours before the first
dose of study drug.
18. Greater than 1 prior systemic anticancer regimen (other than adjuvant or
neoadjuvant) for advanced, recurrent, or metastatic endometrial cancer.
19. Prior anticancer treatment within 28 days (or 5 times the half-life time,
whichever is shorter). All acute toxicities related to prior treatments must
be resolved to Grade ≤1, except for alopecia and Grade ≤2 peripheral
neuropathy.
20. Prior treatment with any treatment targeting VEGF-directed angiogenesis,
any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
21. Participants who received prior treatment with an agent directed to a
stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
other than an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, and who
discontinued from that treatment due to a Grade 3 or higher immune-related
adverse event (irAE).
22. Prior radiation therapy within 21 days prior to start of study treatment with
the exception of palliative radiotherapy to bone lesions, which is allowed if
completed 2 weeks prior to study treatment start.
23. Received a live vaccine within 30 days of planned start of study treatment
(C1D1). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow
fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine.
Seasonal influenza vaccines for injection are generally killed virus vaccines
and are allowed; however, intranasal influenza vaccines (e.g., FluMist®)
are live attenuated vaccines and are not allowed.
24. Known intolerance to study treatment (or any of the excipients).
25. Is currently participating in or has participated in a study of an
investigational agent or has used an investigational device within 4 weeks
prior to the first dose of study treatment.
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.
26. Participants with proteinuria >1+ on urine dipstick testing will undergo
24-h urine collection for quantitative assessment of proteinuria.
Participants with urine protein ≥1 g/24 h will be ineligible.
27. Prolongation of QTc interval to >480 ms.
28. Left ventricular ejection fraction (LVEF) below the institutional normal
range as determined by multigated acquisition scan (MUGA) or
echocardiogram (ECHO).
Participants are excluded from the study if any of the following criteria apply:
1. Carcinosarcoma (malignant mixed Műllerian tumor), endometrial
leiomyosarcoma and endometrial stromal sarcomas.
2. Participants with CNS metastases are not eligible, unless they have
completed local therapy (eg, whole brain radiation therapy [WBRT],
surgery or radiosurgery) and have discontinued the use of corticosteroids
for this indication for at least 4 weeks before starting treatment in this study.
Any signs (eg, radiologic) or symptoms of brain metastases must be stable
for at least 4 weeks before starting study treatment.
3. Active malignancy (except for endometrial cancer, definitively treated
in-situ carcinomas [e.g. breast, cervix, bladder], or basal or squamous cell
carcinoma of the skin) within the past 24 months.
4. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other
condition that might affect the absorption of lenvatinib.
5. Radiographic evidence of major blood vessel invasion/infiltration. The
degree of tumor invasion/infiltration of major blood vessels should be
considered because of the potential risk of severe hemorrhage associated
with tumor shrinkage/necrosis following lenvatinib therapy.
6. Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to
the first dose of study drug.
7. Significant cardiovascular impairment within 12 months of the first dose of
study drug: such as history of congestive heart failure greater than New
York Heart Association (NYHA) Class II, unstable angina, myocardial
infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia
associated with hemodynamic instability.
8. Active infection (any infection requiring systemic treatment).
9. Participants who have not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.
10. Participants known to be positive for Human Immunodeficiency Virus
(HIV). No HIV testing is required unless mandated by local heath authority.
11. Known active Hepatitis B (eg, HBsAg reactive) or Hepatitis C (eg, HCV
RNA [qualitative] is detected). No testing for hepatitis B or C is required
unless mandated by local health authority.
12. Has a history of (non-infectious) pneumonitis that required treatment with
steroids, or has current pneumonitis.
13. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
participant's participation for the full duration of the trial, or is not in the
best interest of the participant to participate, in the opinion of the treating
investigator.
14. Has known psychiatric or substance abuse disorders that would interfere
with cooperation with the requirements of the trial.
15. 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 to the
first dose of study drug.
16. Active autoimmune disease (with the exception of psoriasis) that has
required systemic treatment in the 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.
17. Females who are breastfeeding or pregnant at Screening or Baseline (as
documented by a positive beta-human chorionic gonadotropin [β-hCG] (or
hCG) test with a minimum sensitivity of 25 IU/L or equivalent units of
β-hCG [or hCG]). A separate baseline assessment is required if a negative
screening pregnancy test was obtained more than 72 hours before the first
dose of study drug.
18. Greater than 1 prior systemic anticancer regimen (other than adjuvant or
neoadjuvant) for advanced, recurrent, or metastatic endometrial cancer.
19. Prior anticancer treatment within 28 days (or 5 times the half-life time,
whichever is shorter). All acute toxicities related to prior treatments must
be resolved to Grade ≤1, except for alopecia and Grade ≤2 peripheral
neuropathy.
20. Prior treatment with any treatment targeting VEGF-directed angiogenesis,
any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
21. Participants who received prior treatment with an agent directed to a
stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
other than an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, and who
discontinued from that treatment due to a Grade 3 or higher immune-related
adverse event (irAE).
22. Prior radiation therapy within 21 days prior to start of study treatment with
the exception of palliative radiotherapy to bone lesions, which is allowed if
completed 2 weeks prior to study treatment start.
23. Received a live vaccine within 30 days of planned start of study treatment
(C1D1). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow
fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine.
Seasonal influenza vaccines for injection are generally killed virus vaccines
and are allowed; however, intranasal influenza vaccines (e.g., FluMist®)
are live attenuated vaccines and are not allowed.
24. Known intolerance to study treatment (or any of the excipients).
25. Is currently participating in or has participated in a study of an
investigational agent or has used an investigational device within 4 weeks
prior to the first dose of study treatment.
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.
26. Participants with proteinuria >1+ on urine dipstick testing will undergo
24-h urine collection for quantitative assessment of proteinuria.
Participants with urine protein ≥1 g/24 h will be ineligible.
27. Prolongation of QTc interval to >480 ms.
28. Left ventricular ejection fraction (LVEF) below the institutional normal
range as determined by multigated acquisition scan (MUGA) or
echocardiogram (ECHO).
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
780 participants
