Clinical Trials List
Protocol NumberMK-7339-001/ENGOT-ov43/GOG-3036
NCT Number(ClinicalTrials.gov Identfier)NCT03740165
2019-02-01 - 2026-11-30
Phase III
Recruiting8
ICD-10C56.1
Malignant neoplasm of right ovary
ICD-10C56.2
Malignant neoplasm of left ovary
ICD-10C56.9
Malignant neoplasm of unspecified ovary
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9183.0
Malignant neoplasm of ovary
A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
-
Sponsor
Merck Sharp & Dohme Corp.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/11/06
Investigators and Locations
Co-Principal Investigator
- Yi-Jen Chen Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Yang Chou 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
- 陳子健 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳祈安 Division of Obstetrics & Gynecology
- 童寶玲
- - -
- 施怡倫 Division of Radiology
- YING-CHENG CHIANG
- Wen-Fang Cheng Division of Obstetrics & Gynecology
- 戴依柔
- 郭冠廷 Division of Others
- 陳宇立
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wei-Chun Chang Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Epithelial Ovarian Cancer (EOC)
Objectives
Objective: To compare the progressionfree survival (PFS) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) Objective: To compare the overall survival (OS)
Test Drug
KEYTRUDA®/LYNPARZA®
Active Ingredient
4-[(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2H)-one
Pembrolizumab (Humanized anti-PD-1 mAb)
Pembrolizumab (Humanized anti-PD-1 mAb)
Dosage Form
injection
Film-coated Tablet
Film-coated Tablet
Dosage
100 mg/ 4 mL/ vial
100 mg/tablet, 150 mg/tablet
100 mg/tablet, 150 mg/tablet
Endpoints
Primary Outcome Measures :
-Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]≥10) Tumors [ Time Frame: Up to approximately 57 months ]
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1-positive (CPS≥10) tumors.
-PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants [ Time Frame: Up to approximately 57 months ]
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants.
-Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]≥10) Tumors [ Time Frame: Up to approximately 57 months ]
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1-positive (CPS≥10) tumors.
-PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants [ Time Frame: Up to approximately 57 months ]
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants.
Inclution Criteria
Type of Participant and Disease Characteristics
1. Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade
predominantly serous, endometrioid, carcinosarcoma, mixed mullerian with highgrade serous component, clear cell, or low-grade serous OC), primary peritoneal
cancer, or fallopian tube cancer.
Note: Enrollment of participants with low-grade serous OC will be capped at 4% of
the total population.
2. Participant has just completed primary debulking surgery or is eligible for primary or
interval debulking surgery. Participant must be randomized within 56 days of
primary debulking surgery.
3. Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be
administered in the adjuvant or neoadjuvant setting.
4. Participant that is a candidate for neoadjuvant chemotherapy has a CA-125
(kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than 25 [Vergote,
I., et al 2010].
5. Participant is able to provide a newly obtained core or excisional biopsy of a tumor
lesion for prospective testing of BRCA1/2 and PD-L1 status prior to randomization.
Note: Newly obtained tissue may be obtained at any time prior to the administration
of systemic cytotoxic treatment for the treatment of current ovarian cancer.
Formalin-fixed paraffin-embedded (FFPE) tumor blocks are preferred to slides. If
submitting unstained cut slides, freshly cut slides should be submitted to the testing
laboratory within 14 days from the date the slides are cut.
Demographics
6. Participant is female and at least 18 years of age on the day of signing informed
consent.
7. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in
period and within 7 days prior to randomization.
Female participants:
8. A female participant is eligible to participate if she is not pregnant (see Appendix 3),
not breastfeeding, and at least 1 of the following conditions applies:
a.) Not a woman of childbearing potential (WOCBP) as defined in Appendix 3
OR
b.) A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during
the treatment period and for at least 120 days following the last dose of
pembrolizumab (or pembrolizumab placebo) and olaparib (or olaparib placebo)
and at least 210 days following the last dose of chemotherapy or bevacizumab (if
administered).
Informed Consent
9. The participant (or legally acceptable representative if applicable) provides written
informed consent for the study. The participant may also provide consent for future
biomedical research; however, the participant may participate in the main study
without participating in future biomedical research.
Laboratory Values
10. Participant has adequate organ function as defined in Table 1; all screening laboratory
tests should be performed within 7 days of initiating chemotherapy in the lead-in
period. Hematological parameters must be reassessed and adequate after the lead-in
period and within 7 days prior to randomization.
1. Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade
predominantly serous, endometrioid, carcinosarcoma, mixed mullerian with highgrade serous component, clear cell, or low-grade serous OC), primary peritoneal
cancer, or fallopian tube cancer.
Note: Enrollment of participants with low-grade serous OC will be capped at 4% of
the total population.
2. Participant has just completed primary debulking surgery or is eligible for primary or
interval debulking surgery. Participant must be randomized within 56 days of
primary debulking surgery.
3. Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be
administered in the adjuvant or neoadjuvant setting.
4. Participant that is a candidate for neoadjuvant chemotherapy has a CA-125
(kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than 25 [Vergote,
I., et al 2010].
5. Participant is able to provide a newly obtained core or excisional biopsy of a tumor
lesion for prospective testing of BRCA1/2 and PD-L1 status prior to randomization.
Note: Newly obtained tissue may be obtained at any time prior to the administration
of systemic cytotoxic treatment for the treatment of current ovarian cancer.
Formalin-fixed paraffin-embedded (FFPE) tumor blocks are preferred to slides. If
submitting unstained cut slides, freshly cut slides should be submitted to the testing
laboratory within 14 days from the date the slides are cut.
Demographics
6. Participant is female and at least 18 years of age on the day of signing informed
consent.
7. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in
period and within 7 days prior to randomization.
Female participants:
8. A female participant is eligible to participate if she is not pregnant (see Appendix 3),
not breastfeeding, and at least 1 of the following conditions applies:
a.) Not a woman of childbearing potential (WOCBP) as defined in Appendix 3
OR
b.) A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during
the treatment period and for at least 120 days following the last dose of
pembrolizumab (or pembrolizumab placebo) and olaparib (or olaparib placebo)
and at least 210 days following the last dose of chemotherapy or bevacizumab (if
administered).
Informed Consent
9. The participant (or legally acceptable representative if applicable) provides written
informed consent for the study. The participant may also provide consent for future
biomedical research; however, the participant may participate in the main study
without participating in future biomedical research.
Laboratory Values
10. Participant has adequate organ function as defined in Table 1; all screening laboratory
tests should be performed within 7 days of initiating chemotherapy in the lead-in
period. Hematological parameters must be reassessed and adequate after the lead-in
period and within 7 days prior to randomization.
Exclusion Criteria
Medical Conditions
1. Participant has mucinous, germ cell, or borderline tumor of the ovary.
2. Participant has a known or suspected deleterious mutation (germline or somatic) in
either BRCA1 or BRCA2.
3. Participant has a history of non-infectious pneumonitis that required treatment with
steroids or currently has pneumonitis.
4. Participant either has myelodysplastic syndrome (MDS)/acute myeloid leukemia
(AML) or has features suggestive of MDS/AML.
5. Participant has a known additional malignancy that is progressing or has required
active treatment in the last 3 years.
6. Participant has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following
chemotherapy administered during the lead-in period.
7. Participant has known active central nervous system metastases and/or carcinomatous
meningitis. Participants with brain metastases may participate provided they were
previously treated (except with chemotherapy) and are radiologically stable, clinically
stable, and no steroids were used for the management of symptoms related to brain
metastases within 14 days prior to randomization. Stable brain metastases should be
established prior to the first dose of study medication.
8. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic
steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other
form of immunosuppressive therapy within 7 days prior to randomization.
9. Participant has an active autoimmune disease that has required systemic treatment in
the past 2 years (ie, with use of disease modifying agents, corticosteroids or
immunosuppressive drugs).
10. Participant has a known history of active tuberculosis (TB; Bacillus Tuberculosis).
11. Participant has an active infection requiring systemic therapy.
12. Participant has a history or current evidence of any condition (eg, cytopenia,
transfusion-dependent anemia, or thrombocytopenia), therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
participant’s involvement for the full duration of the study, or is not in the best
interest of the participant to be involved, in the opinion of the treating investigator.
13. Participant has received colony-stimulating factors (eg, granulocyte colony
stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor
[GM-CSF] or recombinant erythropoietin) within 2 weeks prior to randomization.
14. Participant is considered to be of poor medical risk due to a serious, uncontrolled
medical disorder, non-malignant systemic disease or active, uncontrolled infection.
Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent
(within 3 months) myocardial infarction, uncontrolled major seizure disorder,
unstable spinal cord compression, superior vena cava syndrome, or extensive
interstitial bilateral lung disease on high-resolution computed tomography scan.
15. Participant has had surgery to treat borderline tumors, early stage EOC, or fallopian
tube cancer <6 months prior to screening.
16. Participant has a known psychiatric or substance abuse disorder that would interfere
with the ability to cooperate with the requirements of the study.
17. Participant has a known history of human immunodeficiency virus (HIV) infection.
HIV testing is required at screening only if mandated by local health authority. Refer
to Appendix 7 for country-specific requirements.
18. Participant 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. Testing for hepatitis B or hepatitis C is required at
screening only if mandated by local health authority. Refer to Appendix 7 for
country-specific requirements.
19. Participant is either unable to swallow orally administered medication or has a
gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel
obstruction, malabsorption).
20. Participant has current, clinically relevant bowel obstruction (including sub-occlusive
disease), abdominal fistula or gastrointestinal perforation, related to underlying EOC.
Note: This applies only to participants who will receive bevacizumab.
21. Participant has a history of hemorrhage, hemoptysis or active gastrointestinal
bleeding within 6 months prior to randomization.
Note: This applies only to participants who will receive bevacizumab.
22. A WOCBP who has a positive urine pregnancy test within 72 hours before the first
dose of chemotherapy in the lead-in period and within 72 hours prior to
randomization (see Appendix 3), is pregnant or breastfeeding, or is expecting to
conceive children within the projected duration of the study, starting with screening
through 120 days following the last dose of pembrolizumab (or pembrolizumab
placebo) and olaparib (or olaparib placebo) and at least 210 days following the last
dose of chemotherapy or bevacizumab (if administered).
Prior/Concomitant Therapy
23. Participant has received prior treatment for advanced or metastatic OC, including
radiation or systemic anti-cancer therapy (eg, chemotherapy, hormonal therapy,
immunotherapy, investigational therapy).
Note: Treatment with 1 cycle of standard of care chemotherapy (lead-in dose) for
EOC, fallopian tube cancer, or primary peritoneal cancer prior randomization in the
study is allowed.
24. Participant 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, CD137).
25. Participant has received prior therapy with either olaparib or any other PARP
inhibitor.
26. Is a participant for whom intraperitoneal chemotherapy is planned as first-line
therapy.
27. Participant has received a live vaccine within 30 days prior to the first dose of study
treatment. 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.
28. Participant has severe hypersensitivity (≥Grade 3) to the study treatments and/or any
of their excipients.
29. Participant is currently receiving either strong (eg, itraconazole, telithromycin,
clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir,
saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin,
erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450
(CYP)3A4 that cannot be discontinued for the duration of the study. The required
washout period prior to starting olaparib is 2 weeks.
30. Participant is currently receiving either strong (eg, phenobarbital, enzalutamide,
phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's
Wort) or moderate (eg. bosentan, efavirenz, modafinil) inducers of CYP3A4 that
cannot be discontinued for the duration of the study. The required washout period
prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents.
31. Participant has received whole blood transfusions in the last 120 days prior to
randomization.
Prior/Concurrent Clinical Study Experience
32. Participant is currently participating or has participated in a study of an
investigational agent or has used an investigational device within 4 weeks of the first
dose of study treatment.
Diagnostic Assessments
33. Participant has resting electrocardiogram (ECG) indicating uncontrolled, potentially
reversible cardiac conditions, as judged by the investigator (eg, unstable ischemia,
uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation
>500 ms, electrolyte disturbances, etc.), or participant has congenital long QT
syndrome.
Other Exclusions
34. Participant has had an allogenic tissue/solid organ transplant, has received previous
allogenic bone-marrow transplant, or has received double umbilical cord
transplantation.
35. Participant either had major surgery within 2 weeks of randomization or has not
recovered from any effects of any major surgery.
Note: Participants can be randomly assigned to study treatment within 2 weeks of
primary debulking, provided they have adequately recovered.
36. Participant, in the judgement of the investigator, is unlikely to comply with the study
procedures, restrictions, and requirements of the study.
1. Participant has mucinous, germ cell, or borderline tumor of the ovary.
2. Participant has a known or suspected deleterious mutation (germline or somatic) in
either BRCA1 or BRCA2.
3. Participant has a history of non-infectious pneumonitis that required treatment with
steroids or currently has pneumonitis.
4. Participant either has myelodysplastic syndrome (MDS)/acute myeloid leukemia
(AML) or has features suggestive of MDS/AML.
5. Participant has a known additional malignancy that is progressing or has required
active treatment in the last 3 years.
6. Participant has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following
chemotherapy administered during the lead-in period.
7. Participant has known active central nervous system metastases and/or carcinomatous
meningitis. Participants with brain metastases may participate provided they were
previously treated (except with chemotherapy) and are radiologically stable, clinically
stable, and no steroids were used for the management of symptoms related to brain
metastases within 14 days prior to randomization. Stable brain metastases should be
established prior to the first dose of study medication.
8. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic
steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other
form of immunosuppressive therapy within 7 days prior to randomization.
9. Participant has an active autoimmune disease that has required systemic treatment in
the past 2 years (ie, with use of disease modifying agents, corticosteroids or
immunosuppressive drugs).
10. Participant has a known history of active tuberculosis (TB; Bacillus Tuberculosis).
11. Participant has an active infection requiring systemic therapy.
12. Participant has a history or current evidence of any condition (eg, cytopenia,
transfusion-dependent anemia, or thrombocytopenia), therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
participant’s involvement for the full duration of the study, or is not in the best
interest of the participant to be involved, in the opinion of the treating investigator.
13. Participant has received colony-stimulating factors (eg, granulocyte colony
stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor
[GM-CSF] or recombinant erythropoietin) within 2 weeks prior to randomization.
14. Participant is considered to be of poor medical risk due to a serious, uncontrolled
medical disorder, non-malignant systemic disease or active, uncontrolled infection.
Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent
(within 3 months) myocardial infarction, uncontrolled major seizure disorder,
unstable spinal cord compression, superior vena cava syndrome, or extensive
interstitial bilateral lung disease on high-resolution computed tomography scan.
15. Participant has had surgery to treat borderline tumors, early stage EOC, or fallopian
tube cancer <6 months prior to screening.
16. Participant has a known psychiatric or substance abuse disorder that would interfere
with the ability to cooperate with the requirements of the study.
17. Participant has a known history of human immunodeficiency virus (HIV) infection.
HIV testing is required at screening only if mandated by local health authority. Refer
to Appendix 7 for country-specific requirements.
18. Participant 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. Testing for hepatitis B or hepatitis C is required at
screening only if mandated by local health authority. Refer to Appendix 7 for
country-specific requirements.
19. Participant is either unable to swallow orally administered medication or has a
gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel
obstruction, malabsorption).
20. Participant has current, clinically relevant bowel obstruction (including sub-occlusive
disease), abdominal fistula or gastrointestinal perforation, related to underlying EOC.
Note: This applies only to participants who will receive bevacizumab.
21. Participant has a history of hemorrhage, hemoptysis or active gastrointestinal
bleeding within 6 months prior to randomization.
Note: This applies only to participants who will receive bevacizumab.
22. A WOCBP who has a positive urine pregnancy test within 72 hours before the first
dose of chemotherapy in the lead-in period and within 72 hours prior to
randomization (see Appendix 3), is pregnant or breastfeeding, or is expecting to
conceive children within the projected duration of the study, starting with screening
through 120 days following the last dose of pembrolizumab (or pembrolizumab
placebo) and olaparib (or olaparib placebo) and at least 210 days following the last
dose of chemotherapy or bevacizumab (if administered).
Prior/Concomitant Therapy
23. Participant has received prior treatment for advanced or metastatic OC, including
radiation or systemic anti-cancer therapy (eg, chemotherapy, hormonal therapy,
immunotherapy, investigational therapy).
Note: Treatment with 1 cycle of standard of care chemotherapy (lead-in dose) for
EOC, fallopian tube cancer, or primary peritoneal cancer prior randomization in the
study is allowed.
24. Participant 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, CD137).
25. Participant has received prior therapy with either olaparib or any other PARP
inhibitor.
26. Is a participant for whom intraperitoneal chemotherapy is planned as first-line
therapy.
27. Participant has received a live vaccine within 30 days prior to the first dose of study
treatment. 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.
28. Participant has severe hypersensitivity (≥Grade 3) to the study treatments and/or any
of their excipients.
29. Participant is currently receiving either strong (eg, itraconazole, telithromycin,
clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir,
saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin,
erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450
(CYP)3A4 that cannot be discontinued for the duration of the study. The required
washout period prior to starting olaparib is 2 weeks.
30. Participant is currently receiving either strong (eg, phenobarbital, enzalutamide,
phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's
Wort) or moderate (eg. bosentan, efavirenz, modafinil) inducers of CYP3A4 that
cannot be discontinued for the duration of the study. The required washout period
prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents.
31. Participant has received whole blood transfusions in the last 120 days prior to
randomization.
Prior/Concurrent Clinical Study Experience
32. Participant is currently participating or has participated in a study of an
investigational agent or has used an investigational device within 4 weeks of the first
dose of study treatment.
Diagnostic Assessments
33. Participant has resting electrocardiogram (ECG) indicating uncontrolled, potentially
reversible cardiac conditions, as judged by the investigator (eg, unstable ischemia,
uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation
>500 ms, electrolyte disturbances, etc.), or participant has congenital long QT
syndrome.
Other Exclusions
34. Participant has had an allogenic tissue/solid organ transplant, has received previous
allogenic bone-marrow transplant, or has received double umbilical cord
transplantation.
35. Participant either had major surgery within 2 weeks of randomization or has not
recovered from any effects of any major surgery.
Note: Participants can be randomly assigned to study treatment within 2 weeks of
primary debulking, provided they have adequately recovered.
36. Participant, in the judgement of the investigator, is unlikely to comply with the study
procedures, restrictions, and requirements of the study.
The Estimated Number of Participants
-
Taiwan
55 participants
-
Global
1284 participants
