Clinical Trials List
Protocol NumberMK-7902-001 (E7080-G000-313)
NCT Number(ClinicalTrials.gov Identfier)NCT03884101
Completed
2019-02-01 - 2026-12-31
Phase III
Recruiting6
ICD-10C54.1
Malignant neoplasm of endometrium
ICD-10C54.2
Malignant neoplasm of myometrium
ICD-10C54.3
Malignant neoplasm of fundus uteri
ICD-10C54.9
Malignant neoplasm of corpus uteri, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9182.0
Malignant neoplasm of corpus uteri, except isthmus
A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
-
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
- Chi-Mu Chuang Division of Obstetrics & Gynecology
- Huann-Cheng Horng Division of Obstetrics & Gynecology
- 吳華席 Division of Obstetrics & Gynecology
- Yi-Jen Chen Division of Obstetrics & Gynecology
- 沈書慧 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chyong-Huey Lai Division of Obstetrics & Gynecology
- Huei-Jean Huang Division of Obstetrics & Gynecology
- Min-Yu Chen Division of Obstetrics & Gynecology
- 周宏學 Division of Obstetrics & Gynecology
- Cheng-Tao Lin Division of Obstetrics & Gynecology
- 黃彥綾 Division of Radiology
- Ting-Chang Chang Division of Obstetrics & Gynecology
- Angel Chao Division of Obstetrics & Gynecology
- 黃寬仁 Division of Obstetrics & Gynecology
- 陳威君 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Lian-Shung Yeh Division of Obstetrics & Gynecology
- Yao-Ching Hung Division of Obstetrics & Gynecology
- Wei-Chun Chang Division of Obstetrics & Gynecology
- Yin-Yi Chang Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Wen-Fang Cheng Division of Obstetrics & Gynecology
- YING-CHENG CHIANG Division of Obstetrics & Gynecology
- 施怡倫 Division of Obstetrics & Gynecology
- CHI-HAU CHEN CHI-HAU CHEN Division of Obstetrics & Gynecology
- - - Division of Obstetrics & Gynecology
- 陳祈安 Division of Obstetrics & Gynecology
- 陳宇立 Division of Obstetrics & Gynecology
- 郭冠廷 Division of Obstetrics & Gynecology
- 童寶玲 Division of Obstetrics & Gynecology
- 戴依柔 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced or Recurrent Endometrial Carcinoma
Objectives
The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS)
Test Drug
KEYTRUDA®/LENVIMA®
Active Ingredient
Lenvatinib mesilate
Pembrolizumab
Pembrolizumab
Dosage Form
injection
capsule
capsule
Dosage
100 mg/4 mL/vial
10mg/capsule；4 mg/capsule
10mg/capsule；4 mg/capsule
Endpoints
Primary Outcome Measures :
-Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) [ Time Frame: Up to approximately 31 months ]
Progression-free survival based on RECIST 1.1 as assessed by BICR. Progression-free survival is measured from the time of randomization to the first documented disease progression or death due to any cause, whichever occurs first.
-Overall Survival (OS) [ Time Frame: Up to approximately 45 months ]
Overall survival is measured from the time of randomization up to death due to any cause.
Secondary Outcome Measures :
-Objective response rate (ORR ) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR) [ Time Frame: Up to approximately 31 months ]
The ORR (either confirmed complete response [CR] or partial response [PR]) based on RECIST 1.1 and assessed by BICR will be determined in mismatch repair proficient (pMMR) participants and in all-comer participants who have measurable disease at study entry.
-Mean change from baseline in the global health status/quality of life score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR and in all-comer participants [ Time Frame: Baseline and designated time points up to 27 months ]
The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of quality of life (QoL): one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms.
-Percentage of participants experiencing an adverse event (AE) [ Time Frame: Up to approximately 27 months (through 90 days after the last dose of study treatment) ]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
-Percentage of participants experiencing a serious adverse event (SAE) [ Time Frame: Up to approximately 28 months (through 120 days after the last dose of study treatment) ]
An SAE is an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital birth defect, or is another important medical event.
-Percentage of participants experiencing an immune-related AE (irAE) [ Time Frame: Up to approximately 27 months (through 90 days after the last dose of study treatment) ]
Immune-related AEs will be monitored in both arms.
-Percentage of participants discontinuing from study treatment due to an AE(s) [ Time Frame: Up to approximately 24 months (through the last dose of study treatment) ]
Discontinuations related to AEs will be monitored in both arms.
-Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) [ Time Frame: Up to approximately 31 months ]
Progression-free survival based on RECIST 1.1 as assessed by BICR. Progression-free survival is measured from the time of randomization to the first documented disease progression or death due to any cause, whichever occurs first.
-Overall Survival (OS) [ Time Frame: Up to approximately 45 months ]
Overall survival is measured from the time of randomization up to death due to any cause.
Secondary Outcome Measures :
-Objective response rate (ORR ) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR) [ Time Frame: Up to approximately 31 months ]
The ORR (either confirmed complete response [CR] or partial response [PR]) based on RECIST 1.1 and assessed by BICR will be determined in mismatch repair proficient (pMMR) participants and in all-comer participants who have measurable disease at study entry.
-Mean change from baseline in the global health status/quality of life score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) in pMMR and in all-comer participants [ Time Frame: Baseline and designated time points up to 27 months ]
The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of quality of life (QoL): one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms.
-Percentage of participants experiencing an adverse event (AE) [ Time Frame: Up to approximately 27 months (through 90 days after the last dose of study treatment) ]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
-Percentage of participants experiencing a serious adverse event (SAE) [ Time Frame: Up to approximately 28 months (through 120 days after the last dose of study treatment) ]
An SAE is an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital birth defect, or is another important medical event.
-Percentage of participants experiencing an immune-related AE (irAE) [ Time Frame: Up to approximately 27 months (through 90 days after the last dose of study treatment) ]
Immune-related AEs will be monitored in both arms.
-Percentage of participants discontinuing from study treatment due to an AE(s) [ Time Frame: Up to approximately 24 months (through the last dose of study treatment) ]
Discontinuations related to AEs will be monitored in both arms.
Inclution Criteria
1. Have Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma
with disease that is either measurable or non-measurable per RECIST 1.1 but
radiographically apparent, as assessed by BICR.
Notes about prior therapy:
May have received prior chemotherapy only if administered concurrently with
radiation
May have received prior radiation (see also section 5.2)
May have received prior hormonal therapy for treatment of endometrial
carcinoma, provided that it was discontinued ≥1 week prior to randomization
2. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy
of a tumor lesion that was not previously irradiated, for determination of MMR status.
Note: FFPE tissue blocks are preferred to slides. Newly obtained biopsies are preferred to
archived tissue. If submitting unstained cut slides, newly cut slides should be submitted
to the testing laboratory within 14 days from the date slides are cut (details pertaining to
tumor tissue submission can be found in the Laboratory Manual).
Demographics
3. Have an ECOG performance status of 0 or 1, as assessed within 7 days prior to the first
dose of study intervention.
4. Be female and at least 18 years of age on the day of signing consent.
Female Participants
5. Not be pregnant (Appendix 5) or breastfeeding, and at least one of the following
conditions applies:
a. Not be a WOCBP as defined in Appendix 5 or
b. A WOCBP must agree to follow the contraceptive guidance in Appendix 5 during the
treatment period and for at least 120 days after the last dose of pembrolizumab or
lenvatinib and 180 days after the last dose of chemotherapy.
Informed Consent
6. The participant (or legally acceptable representative if applicable) provides written
informed consent for the study.
Additional Categories
7. Have adequately controlled BP with or without antihypertensive medications, defined as
BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week prior
to randomization.
8. Have adequate organ function as indicated by the following laboratory values (Table 3)
within 7 days prior to the first dose of study intervention:
with disease that is either measurable or non-measurable per RECIST 1.1 but
radiographically apparent, as assessed by BICR.
Notes about prior therapy:
May have received prior chemotherapy only if administered concurrently with
radiation
May have received prior radiation (see also section 5.2)
May have received prior hormonal therapy for treatment of endometrial
carcinoma, provided that it was discontinued ≥1 week prior to randomization
2. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy
of a tumor lesion that was not previously irradiated, for determination of MMR status.
Note: FFPE tissue blocks are preferred to slides. Newly obtained biopsies are preferred to
archived tissue. If submitting unstained cut slides, newly cut slides should be submitted
to the testing laboratory within 14 days from the date slides are cut (details pertaining to
tumor tissue submission can be found in the Laboratory Manual).
Demographics
3. Have an ECOG performance status of 0 or 1, as assessed within 7 days prior to the first
dose of study intervention.
4. Be female and at least 18 years of age on the day of signing consent.
Female Participants
5. Not be pregnant (Appendix 5) or breastfeeding, and at least one of the following
conditions applies:
a. Not be a WOCBP as defined in Appendix 5 or
b. A WOCBP must agree to follow the contraceptive guidance in Appendix 5 during the
treatment period and for at least 120 days after the last dose of pembrolizumab or
lenvatinib and 180 days after the last dose of chemotherapy.
Informed Consent
6. The participant (or legally acceptable representative if applicable) provides written
informed consent for the study.
Additional Categories
7. Have adequately controlled BP with or without antihypertensive medications, defined as
BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week prior
to randomization.
8. Have adequate organ function as indicated by the following laboratory values (Table 3)
within 7 days prior to the first dose of study intervention:
Exclusion Criteria
1. Has carcinosarcoma (malignant mixed Műllerian tumor), endometrial leiomyosarcoma or
other high grade sarcomas, or endometrial stromal sarcomas.
2. Participants with central nervous system (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 CNS metastases must be stable for at least 4 weeks before starting study
treatment.
3. Has a known additional malignancy (other than endometrial carcinoma) that is
progressing or has required active treatment in the last 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or carcinoma in situ (eg, ductal carcinoma in situ, cervical carcinoma in situ) that
have undergone potentially curative therapy are not excluded.
4. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition
that might affect the absorption of lenvatinib.
5. Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
6. Has 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.
7. Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to
randomization.
8. Has significant cardiovascular impairment within 12 months of the first dose of study
intervention 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.
9. Has an active infection (any infection requiring systemic treatment).
10. Has not recovered adequately from any toxicity and/or complications from major surgery
prior to randomization.
11. Has a known history of human immunodeficiency virus (HIV) infection.
Note: HIV testing is required at screening only when mandated by local health authority.
12. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is
detected) infection.
Note: Testing for Hepatitis B and Hepatitis C is required at screening only when
mandated by local health authority.
13. Has a history of (non-infectious) pneumonitis that required treatment with steroids, or has
current pneumonitis.
14. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the participant's participation
for the full duration of the study, or is not in the best interest of the participant to
participate, in the opinion of the treating investigator.
15. Has a known psychiatric or substance abuse disorder that would interfere with
cooperation with the requirements of the study.
16. 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 randomization.
17. Has an 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.
18. Is pregnant or breastfeeding or expecting to conceive children within the projected
duration of the study, starting with the screening visit through 120 days after the last dose
of pembrolizumab or lenvatinib and 180 days after the last dose of chemotherapy.
Prior/Concomitant Therapy
19. Has received prior systemic chemotherapy in any setting for the treatment of endometrial
carcinoma (note: prior chemotherapy administered concurrently with radiation is
permitted).
20. Has received prior radiotherapy within 4 weeks prior to randomization. Participants must
have recovered from all radiation-related toxicities, not require corticosteroids, and not
have had radiation pneumonitis. A 2-week washout is permitted for palliative radiation to
non-CNS disease and vaginal brachytherapy.
21. Has received prior hormonal therapy for the treatment of endometrial carcinoma within 1
week of randomization.
22. Has received prior therapy with any treatment targeting VEGF-directed angiogenesis, an
anti-PD-1, anti-PD-L1, or anti PD L2 agent, or with an agent directed to another
stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
23. Has received a live vaccine within 30 days prior to the first dose of study intervention.
Examples of live vaccines include, but are not limited to, the following: measles, mumps,
rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine.
Seasonal influenza vaccines for injection are generally killed virus vaccines and are
allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated
vaccines and are not allowed.
24. Has known intolerance to study intervention (or any of the excipients).
25. Has had an allogenic tissue/solid organ transplant.
Prior/Concurrent Clinical Study Experience
26. 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 randomization.
Note: Participants who have entered the Follow-up Phase of an investigational study may
participate as long as it has been ≥4 weeks from the last dose of the investigational agent
and randomization.
Diagnostic Assessments
27. Participants with proteinuria >1+ on urine dipstick testing will undergo 24-hr urine
collection for quantitative assessment of proteinuria. Participants with urine protein ≥1
g/24 hr will be ineligible.
28. Has prolongation of QTc interval to >480 ms (corrected by Fridericia Formula).
29. Has left ventricular ejection fraction (LVEF) below the institutional normal range as
determined by multigated acquisition (MUGA) or echocardiogram (ECHO).
other high grade sarcomas, or endometrial stromal sarcomas.
2. Participants with central nervous system (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 CNS metastases must be stable for at least 4 weeks before starting study
treatment.
3. Has a known additional malignancy (other than endometrial carcinoma) that is
progressing or has required active treatment in the last 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or carcinoma in situ (eg, ductal carcinoma in situ, cervical carcinoma in situ) that
have undergone potentially curative therapy are not excluded.
4. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition
that might affect the absorption of lenvatinib.
5. Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
6. Has 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.
7. Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to
randomization.
8. Has significant cardiovascular impairment within 12 months of the first dose of study
intervention 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.
9. Has an active infection (any infection requiring systemic treatment).
10. Has not recovered adequately from any toxicity and/or complications from major surgery
prior to randomization.
11. Has a known history of human immunodeficiency virus (HIV) infection.
Note: HIV testing is required at screening only when mandated by local health authority.
12. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]
reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is
detected) infection.
Note: Testing for Hepatitis B and Hepatitis C is required at screening only when
mandated by local health authority.
13. Has a history of (non-infectious) pneumonitis that required treatment with steroids, or has
current pneumonitis.
14. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the participant's participation
for the full duration of the study, or is not in the best interest of the participant to
participate, in the opinion of the treating investigator.
15. Has a known psychiatric or substance abuse disorder that would interfere with
cooperation with the requirements of the study.
16. 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 randomization.
17. Has an 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.
18. Is pregnant or breastfeeding or expecting to conceive children within the projected
duration of the study, starting with the screening visit through 120 days after the last dose
of pembrolizumab or lenvatinib and 180 days after the last dose of chemotherapy.
Prior/Concomitant Therapy
19. Has received prior systemic chemotherapy in any setting for the treatment of endometrial
carcinoma (note: prior chemotherapy administered concurrently with radiation is
permitted).
20. Has received prior radiotherapy within 4 weeks prior to randomization. Participants must
have recovered from all radiation-related toxicities, not require corticosteroids, and not
have had radiation pneumonitis. A 2-week washout is permitted for palliative radiation to
non-CNS disease and vaginal brachytherapy.
21. Has received prior hormonal therapy for the treatment of endometrial carcinoma within 1
week of randomization.
22. Has received prior therapy with any treatment targeting VEGF-directed angiogenesis, an
anti-PD-1, anti-PD-L1, or anti PD L2 agent, or with an agent directed to another
stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
23. Has received a live vaccine within 30 days prior to the first dose of study intervention.
Examples of live vaccines include, but are not limited to, the following: measles, mumps,
rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine.
Seasonal influenza vaccines for injection are generally killed virus vaccines and are
allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated
vaccines and are not allowed.
24. Has known intolerance to study intervention (or any of the excipients).
25. Has had an allogenic tissue/solid organ transplant.
Prior/Concurrent Clinical Study Experience
26. 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 randomization.
Note: Participants who have entered the Follow-up Phase of an investigational study may
participate as long as it has been ≥4 weeks from the last dose of the investigational agent
and randomization.
Diagnostic Assessments
27. Participants with proteinuria >1+ on urine dipstick testing will undergo 24-hr urine
collection for quantitative assessment of proteinuria. Participants with urine protein ≥1
g/24 hr will be ineligible.
28. Has prolongation of QTc interval to >480 ms (corrected by Fridericia Formula).
29. Has left ventricular ejection fraction (LVEF) below the institutional normal range as
determined by multigated acquisition (MUGA) or echocardiogram (ECHO).
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
720 participants
