Clinical Trials List
Protocol NumberMK-7902-002(E7080-G000-311)
NCT Number(ClinicalTrials.gov Identfier)NCT03713593
2018-11-01 - 2025-12-31
Phase III
Terminated7
ICD-10C22
Malignant neoplasm of liver and intrahepatic bile ducts
ICD-10C22.0
Liver cell carcinoma
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants with Advanced Hepatocellular Carcinoma (LEAP-002)
-
Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
-
Sponsor
Merck Sharp & Dohme (I.A.) LLC, Taiwan Branch
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Rheun-Chuan Lee Division of Radiology
- Chien-Wei Su Digestive System Department
- San-Chi Chen Division of Hematology & Oncology
- Chien-An Liu Division of Radiology
The Actual Total Number of Participants Enrolled
4 Terminated
Audit
None
Co-Principal Investigator
- Chia-Hsun Hsieh Division of Hematology & Oncology
- 洪建福 Division of Radiology
- 陳俊瑋 Digestive System Department
- 李兆偉 Division of General Surgery
- Shi-Ming Lin Digestive System Department
- 吳宗翰 Division of General Surgery
- 呂嘉偉 Division of Radiology
- Kun-Ming Chan Division of Gastroenterological Surgery
- 潘廣澤 Division of Radiology
- Cheng-Yu Lin Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 呂宜達 Digestive System Department
- 葉宏仁 Digestive System Department
- TENG-YU LEE Digestive System Department
- 蘇德晟 Division of Radiology
- 黃儀倢 Digestive System Department
- CHUNG-HSIN CHANG Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Po-Heng Chuang Digestive System Department
- 許士超 Division of General Surgery
- 楊宏仁 Division of General Surgery
- Hsueh-Chou Lai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 簡世杰 Division of General Internal Medicine
- Chiu Hung Chiu Division of General Internal Medicine
- Hsin-Yu Kuo Division of General Internal Medicine
- 吳毅晉 Division of General Internal Medicine
- Liu Yi-Sheng Division of Radiology
- Nai-Jung Chiang Division of Hematology & Oncology
- Yih-Jyh Lin Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 林宗哲 Division of Hematology & Oncology
- 郭弘揚 未分科
- Chih-Hung Hsu Division of Hematology & Oncology
- Chien-Hung Chen Division of Hematology & Oncology
- Chiun Hsu Division of Hematology & Oncology
- 呂理駿 Division of Hematology & Oncology
- Ann-Lii Cheng Division of Hematology & Oncology
- YU-YUN SHAO Division of Hematology & Oncology
- TSUNG-HAO LIU Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
- Jee-Fu Huang Digestive System Department
- Zu-Yau Lin Digestive System Department
- 黃駿逸 Digestive System Department
- Ming-Lun Yeh Digestive System Department
- Chung-Feng Huang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
advanced stage hepatocellular carcinoma
Objectives
In first-line therapy of participants with advanced HCC following treatment with pembrolizumab plus lenvatinib versus treatment with placebo plus lenvatinib：The study will be deemed positive if either OS or PFS null hypotheses are rejected.
Test Drug
Keytruda® / Lenvima®
Active Ingredient
Lenvatinib mesilate
Pembrolizumab
Pembrolizumab
Dosage Form
Injection
Dosage
100 mg/ 4 mL ; 4 mg/capsule
Endpoints
The purpose of this test is:
o Evaluate the effect of combined treatment with test drugs (lenvatinib plus pembrolizumab).
o Test the safety of the trial drug combination treatment and your body's response.
o Evaluate the effect of combined treatment with test drugs (lenvatinib plus pembrolizumab).
o Test the safety of the trial drug combination treatment and your body's response.
Inclution Criteria
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Have a HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamel lar and mixed
hepatocellular/cholangiocarcinoma subtypes are not eligible).
• Radiologic confirmation of diagnosis is provided by the study site. Clinically confirmed
diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD)
criteria (protocol Appendix 15) , which requires:
o radiographically evident cirrhosis AND
o a liver mass that shows arterial phase hyperenhancement on triphasic CT or MRI, AND
EITHER:
▪ Is ≥20 mm with either non-peripheral portal washout or an enhancing capsule OR
▪ Is 10-19 mm with non-peripheral portal venous washout AND an enhancing
capsule
2. Have BCLC Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or
refractory to locoregional therapy, and not amenable to a curative treatment approach (see
protocol Appendix 11).
3. Have a Child-Pugh class A liver score within 7 days prior to first dose of study intervention (see
protocol Appendix 10).
4. Have a predicted life expectancy of >3 months.
5. Have at least one measurable HCC lesion based on RECIST 1.1 as confirmed by the BICR
vendor.
Demographics
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 within
7 days prior to first dose of study intervention.
7. Participant is male or female.
8. Participant is ≥18 years of age, at the time of signing the informed consent.
Male Participants
9. Male participants are eligible to participate if they agree to the following during the intervention
period and for at least 30 days after the last dose of lenvatinib:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a
long term and persistent basis) and agree to remain abstinent
OR
• Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary
to medical cause [Appendix 5]) as detailed below:
- Agree to use a male condom plus partner use of an additional contraceptive method when
having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men
with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal
intercourse or use a male condom during each episode of penile-vaginal penetration.
• Contraceptive use by men should be consistent with local regulations regarding the methods of
contraception for those participating in clinical studies.
Please note that 30 days after lenvatinib is stopped, if the participant is on pembrolizumab/placebo only, no male contraception measures are needed.
Female Participants
10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least
one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
OR
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate
of <1% per year), with low user dependency, or be abstinent from heterosexual
intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent
basis), as described in Protocol Appendix 5 during the intervention period and for at least
120 days post pembrolizumab/placebo or 30 days post lenvatinib, whichever occurs last.
The investigator should evaluate the potential for contraceptive method failure (ie,
noncompliance, recently initiated) in relationship to the first dose of study intervention.
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as
required by local regulations) within 24 hours before the first dose of study intervention.
- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum
pregnancy test is required. In such cases, the participant must be excluded from
participation if the serum pregnancy result is positive.
• Additional requirements for pregnancy testing during and after study intervention are located in
Appendix 2.
• The investigator is responsible for review of medical history, menstrual history, and recent
sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
• Contraceptive use by women should be consistent with local regulations regarding the methods
of contraception for those participating in clinical studies.
Informed Consent
11. The participant (or legally acceptable representative if applicable) provides written informed
consent/assent for the study.
Additional Categories
12. Participants with past or ongoing HCV infection will be eligible for the study. The treated
participants must have completed their treatment at least 1 month prior to starting study
intervention.
13. Participants with controlled hepatitis B will be eligible as long as they meet the following
criteria:
• Antiviral therapy for HBV must be given for at least 4 weeks and HBV viral load must be less than 100 IU/mL prior to first dose of study drug. Participants on active HBV therapy
with viral loads under 100 IU/mL should stay on the same therapy throughout study
treatment.
• Participants who are positive for anti-hepatitis B core antibody HBc, negative for hepatitis B
surface antigen (HBsAg), and negative or positive for anti-hepatitis B surface antibody
(HBs), and who have an HBV viral load under 100 IU/mL, do not require HBV anti-viral
prophylaxis.
14. 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 Cycle 1 Day 1.
15. Have adequate organ function as defined in the following table. Specimens must be collected
within 7 days prior to the start of study intervention.
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Have a HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamel lar and mixed
hepatocellular/cholangiocarcinoma subtypes are not eligible).
• Radiologic confirmation of diagnosis is provided by the study site. Clinically confirmed
diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD)
criteria (protocol Appendix 15) , which requires:
o radiographically evident cirrhosis AND
o a liver mass that shows arterial phase hyperenhancement on triphasic CT or MRI, AND
EITHER:
▪ Is ≥20 mm with either non-peripheral portal washout or an enhancing capsule OR
▪ Is 10-19 mm with non-peripheral portal venous washout AND an enhancing
capsule
2. Have BCLC Stage C disease, or BCLC Stage B disease not amenable to locoregional therapy or
refractory to locoregional therapy, and not amenable to a curative treatment approach (see
protocol Appendix 11).
3. Have a Child-Pugh class A liver score within 7 days prior to first dose of study intervention (see
protocol Appendix 10).
4. Have a predicted life expectancy of >3 months.
5. Have at least one measurable HCC lesion based on RECIST 1.1 as confirmed by the BICR
vendor.
Demographics
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 within
7 days prior to first dose of study intervention.
7. Participant is male or female.
8. Participant is ≥18 years of age, at the time of signing the informed consent.
Male Participants
9. Male participants are eligible to participate if they agree to the following during the intervention
period and for at least 30 days after the last dose of lenvatinib:
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a
long term and persistent basis) and agree to remain abstinent
OR
• Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary
to medical cause [Appendix 5]) as detailed below:
- Agree to use a male condom plus partner use of an additional contraceptive method when
having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men
with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal
intercourse or use a male condom during each episode of penile-vaginal penetration.
• Contraceptive use by men should be consistent with local regulations regarding the methods of
contraception for those participating in clinical studies.
Please note that 30 days after lenvatinib is stopped, if the participant is on pembrolizumab/placebo only, no male contraception measures are needed.
Female Participants
10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least
one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
OR
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate
of <1% per year), with low user dependency, or be abstinent from heterosexual
intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent
basis), as described in Protocol Appendix 5 during the intervention period and for at least
120 days post pembrolizumab/placebo or 30 days post lenvatinib, whichever occurs last.
The investigator should evaluate the potential for contraceptive method failure (ie,
noncompliance, recently initiated) in relationship to the first dose of study intervention.
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as
required by local regulations) within 24 hours before the first dose of study intervention.
- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum
pregnancy test is required. In such cases, the participant must be excluded from
participation if the serum pregnancy result is positive.
• Additional requirements for pregnancy testing during and after study intervention are located in
Appendix 2.
• The investigator is responsible for review of medical history, menstrual history, and recent
sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
• Contraceptive use by women should be consistent with local regulations regarding the methods
of contraception for those participating in clinical studies.
Informed Consent
11. The participant (or legally acceptable representative if applicable) provides written informed
consent/assent for the study.
Additional Categories
12. Participants with past or ongoing HCV infection will be eligible for the study. The treated
participants must have completed their treatment at least 1 month prior to starting study
intervention.
13. Participants with controlled hepatitis B will be eligible as long as they meet the following
criteria:
• Antiviral therapy for HBV must be given for at least 4 weeks and HBV viral load must be less than 100 IU/mL prior to first dose of study drug. Participants on active HBV therapy
with viral loads under 100 IU/mL should stay on the same therapy throughout study
treatment.
• Participants who are positive for anti-hepatitis B core antibody HBc, negative for hepatitis B
surface antigen (HBsAg), and negative or positive for anti-hepatitis B surface antibody
(HBs), and who have an HBV viral load under 100 IU/mL, do not require HBV anti-viral
prophylaxis.
14. 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 Cycle 1 Day 1.
15. Have adequate organ function as defined in the following table. Specimens must be collected
within 7 days prior to the start of study intervention.
Exclusion Criteria
Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Has had esophageal or gastric variceal bleeding within the last 6 months. All participants will be
screened for esophageal or gastric varices unless such screening has been performed in the past 3
months before first dose of treatment. If varices are present, they should be treated according to
institutional standards before starting study intervention; esophageal or gastric varices that require
interventional treatment within 28 days prior to first dose of study drug are excluded.
2. Bleeding or thrombotic disorders or use of factor X inhibitors or anticoagulants requiring
therapeutic international normalized ratio (INR) monitoring, eg, warfarin or similar agents.
Treatment with low molecular weight heparin is permitted.
3. Has clinically apparent ascites on physical examination that is not controlled with medication.
Note: ascites detectable on imaging studies only are allowed.
4. Portal vein invasion (Vp4), inferior vena cava, or cardiac involvement of HCC based on
imaging.
5. Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to
therapy within 3 days. Participants on rifaximin or lactulose during screening to control their
hepatic encephalopathy are not allowed.
6. Has medical contraindications that preclude all forms of contrast enhanced imaging (CT or
MRI).
7. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might
affect the absorption of lenvatinib.
8. Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
9. Clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the
first dose of study drug.
10. 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 stroke, or
cardiac arrhythmia associated with hemodynamic instability.
11. Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention.
Note: If participant received major surgery, they must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting study treatment.
12. Has had a minor surgery (ie, simple excision) within 7 days prior to the first dose of study
intervention (Cycle 1 Day 1).
13. Has serious nonhealing wound, ulcer, or bone fracture.
Prior/Concomitant Therapy
14. Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic
investigational anticancer agents for advanced/unresectable HCC.
Note: Participants who have received local hepatic injection chemotherapy are eligible.
15. Has received prior therapy with 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, or CD137).
16. Has received locoregional therapy to liver (transcatheter chemoembolization, transcatheter
embolization, hepatic arterial infusion, radiation, radioembolization, or ablation) within 4 weeks
prior to the first dose of study intervention.
Note: Participant must show evidence of disease progression after locoregional therapy to be
eligible.
17. Has received prior radiotherapy to a non-liver region within 2 weeks of start of study
intervention. 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 (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
18. 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, Bacillus Calmette– Guérin (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.
Prior/Concurrent Clinical Study Experience
19. 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 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.
Diagnostic Assessments
20. 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.
21. Has a known additional malignancy that is progressing or has required active treatment within
the past 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or
carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially
curative therapy are not excluded.
22. Has a known history of, or any evidence of, CNS metastases and/or carcinomatous meningitis
as assessed by local site investigator.
23. Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of their excipients.
24. 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.
25. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
26. Participants with proteinuria >1+ on urine dipstick testing will undergo 24-hour urine collection
for quantitative assessment of proteinuria. Participants with urine protein ≥1 g/24 hours will be
ineligible.
27. Prolongation of corrected QT (QTc) interval to >480 ms (corrected by Fridericia
Formula).
28. Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by
multigated acquisition scan (MUGA) or echocardiogram (ECHO).
29. Has an active infection requiring systemic therapy, with the exception of HBV, HCV.
30. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is
required unless mandated by local health authority.
31. Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and HCV infection
(anti-HCV Ab (+) and detectable HCV RNA) at study entry.
32. Has known active tuberculosis (Bacillus tuberculosis).
33. 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.
34. Has a known psychiatric or substance abuse disorder that would interfere with the participants
ability to cooperate with the requirements of the study.
Other Exclusions
35. Is pregnant or breastfeeding or expecting to conceive or father children within the projected
duration of the study, starting with the screening visit through 120 days after the last dose of
study intervention.
36. Has had an allogenic tissue/solid organ transplant.
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Has had esophageal or gastric variceal bleeding within the last 6 months. All participants will be
screened for esophageal or gastric varices unless such screening has been performed in the past 3
months before first dose of treatment. If varices are present, they should be treated according to
institutional standards before starting study intervention; esophageal or gastric varices that require
interventional treatment within 28 days prior to first dose of study drug are excluded.
2. Bleeding or thrombotic disorders or use of factor X inhibitors or anticoagulants requiring
therapeutic international normalized ratio (INR) monitoring, eg, warfarin or similar agents.
Treatment with low molecular weight heparin is permitted.
3. Has clinically apparent ascites on physical examination that is not controlled with medication.
Note: ascites detectable on imaging studies only are allowed.
4. Portal vein invasion (Vp4), inferior vena cava, or cardiac involvement of HCC based on
imaging.
5. Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to
therapy within 3 days. Participants on rifaximin or lactulose during screening to control their
hepatic encephalopathy are not allowed.
6. Has medical contraindications that preclude all forms of contrast enhanced imaging (CT or
MRI).
7. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might
affect the absorption of lenvatinib.
8. Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
9. Clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the
first dose of study drug.
10. 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 stroke, or
cardiac arrhythmia associated with hemodynamic instability.
11. Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention.
Note: If participant received major surgery, they must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting study treatment.
12. Has had a minor surgery (ie, simple excision) within 7 days prior to the first dose of study
intervention (Cycle 1 Day 1).
13. Has serious nonhealing wound, ulcer, or bone fracture.
Prior/Concomitant Therapy
14. Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic
investigational anticancer agents for advanced/unresectable HCC.
Note: Participants who have received local hepatic injection chemotherapy are eligible.
15. Has received prior therapy with 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, or CD137).
16. Has received locoregional therapy to liver (transcatheter chemoembolization, transcatheter
embolization, hepatic arterial infusion, radiation, radioembolization, or ablation) within 4 weeks
prior to the first dose of study intervention.
Note: Participant must show evidence of disease progression after locoregional therapy to be
eligible.
17. Has received prior radiotherapy to a non-liver region within 2 weeks of start of study
intervention. 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 (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
18. 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, Bacillus Calmette– Guérin (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.
Prior/Concurrent Clinical Study Experience
19. 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 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.
Diagnostic Assessments
20. 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.
21. Has a known additional malignancy that is progressing or has required active treatment within
the past 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or
carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially
curative therapy are not excluded.
22. Has a known history of, or any evidence of, CNS metastases and/or carcinomatous meningitis
as assessed by local site investigator.
23. Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of their excipients.
24. 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.
25. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
26. Participants with proteinuria >1+ on urine dipstick testing will undergo 24-hour urine collection
for quantitative assessment of proteinuria. Participants with urine protein ≥1 g/24 hours will be
ineligible.
27. Prolongation of corrected QT (QTc) interval to >480 ms (corrected by Fridericia
Formula).
28. Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by
multigated acquisition scan (MUGA) or echocardiogram (ECHO).
29. Has an active infection requiring systemic therapy, with the exception of HBV, HCV.
30. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is
required unless mandated by local health authority.
31. Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and HCV infection
(anti-HCV Ab (+) and detectable HCV RNA) at study entry.
32. Has known active tuberculosis (Bacillus tuberculosis).
33. 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.
34. Has a known psychiatric or substance abuse disorder that would interfere with the participants
ability to cooperate with the requirements of the study.
Other Exclusions
35. Is pregnant or breastfeeding or expecting to conceive or father children within the projected
duration of the study, starting with the screening visit through 120 days after the last dose of
study intervention.
36. Has had an allogenic tissue/solid organ transplant.
The Estimated Number of Participants
-
Taiwan
45 participants
-
Global
750 participants
