Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)

Solid Tumors Clinical Trial

Official title:

A Phase 2 Study of Olaparib in Combination With Pembrolizumab in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04123366
• Other study ID #: 7339-007
• Secondary ID: MK-7339-007KEYLY
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 18, 2019
• Est. completion date: July 24, 2025

Study information

• Verified date: December 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 24, 2025
• Est. primary completion date: July 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except breast or ovarian cancers whose tumor has a germline or somatic BRCA mutation) that is not eligible for curative treatment and for which standard of care therapy has failed. Participants must have progressed on or be intolerant to standard of care therapies that are known to provide clinical benefit. There is no limit on the number of prior treatment regimens.

• Has either centrally-confirmed known or suspected deleterious mutations in =1 of the specified 15 genes involved in HRR or centrally-confirmed HRD based on the Lynparza HRR-HRD assay.

• Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology and confirmed in real time by blinded independent central review (BICR). BICR must confirm the presence of radiologically measurable disease per RECIST 1.1 for the participant to be eligible for the study.

• Has a life expectancy of =3 months.

• Must have had CR or PR while on the last treatment with prior cisplatin or carboplatin, or if received only oxaliplatin had CR, PR, or stable disease (SD) while on the last treatment with prior oxaliplatin (either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor. Participant must also not have been refractory to prior platinum-containing therapy.

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 3 days of study treatment initiation.

• Male participants must agree to use contraception during the treatment period and for =90 days (3 months) after the last dose of olaparib and refrain from donating sperm during this period.

• Female participants must not be pregnant or breastfeeding, and =1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP who agrees to use contraception during the treatment period and for =120 days (3 months) after the last dose of pembrolizumab and 180 days (6 months) after the last dose of olaparib, has a highly sensitive pregnancy test within 24 hours for urine or within 72 hours for serum before the first dose of study intervention, and abstains from breastfeeding during the study intervention period and for at least 120 days after the last dose of the study intervention.

• Has adequate organ function

Exclusion Criteria:

• Has a known additional malignancy that is progressing or has required active treatment in the last 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.

• Has a history of non-infectious pneumonitis/interstitial lung disease that required treatment with steroids or currently has pneumonitis/interstitial lung disease.

• Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.

• Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Has an active infection requiring systemic therapy.

• Has active tuberculosis (Bacillus tuberculosis [TB]).

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.

• Has an active autoimmune disease that has required systemic treatment in the past 2 years.

• Has received colony-stimulating factors (e.g. granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment.

• Has a known history of human immunodeficiency virus (HIV) infection.

• Has known active hepatitis B or hepatitis C.

• Is unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption).

• Has received prior therapy with an anti-programmed death-1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), or anti-programmed death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40 [Tumor necrosis factor receptor superfamily, member 4 (TNFRSF4)], CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]).

• Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (poly[ADP ribose]) polymerization (PARP) inhibitor.

• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to administration of study treatment.

• Must have recovered from all adverse events (AEs) due to previous therapies, excluding alopecia, to =Grade 1 or Baseline.

• Has a known hypersensitivity to the study treatments and/or any of their excipients.

• Is currently receiving either strong inhibitors of cytochrome P450 (CYP)3A4 (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate inhibitors of CYP3A4 (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) that cannot be discontinued for the duration of the study. The required washout period prior to starting olaparib is 2 weeks.

• Is currently receiving either strong inducers of CYP3A4 (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate inducers of CYP3A4 (e.g. bosentan, efavirenz, modafinil) 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.

• Has received previous allogenic bone-marrow transplant or double umbilical cord transplantation (dUCBT).

• Has received a whole blood transfusion in the last 120 days prior to entry to the study.

• Has received prior radiotherapy within 2 weeks of start of study treatment.

• Is currently enrolled in and receiving study therapy, was enrolled in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks (28 days) of the first dose of study treatment.

• The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT interval by Fredericia [QTcF] prolongation >500 msec, electrolyte disturbances), or participant has congenital long QT syndrome.

• Has either had major surgery within 2 weeks of starting study treatment or has not recovered from any effects of any major surgery.

• Has received a live vaccine within 30 days prior to the first dose of study treatment.

• Has had an allogenic tissue/solid tumor organ transplant.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• Olaparib
Oral tablet

Biological:
• Pembrolizumab
Intravenous infusion

Locations

Country	Name	City	State
Argentina	CEMIC ( Site 2701)	Buenos Aires
Argentina	Centro Medico Dra De Salvo ( Site 2702)	Buenos Aires
Argentina	Fundacion CIDEA ( Site 2704)	Ciudad de Buenos Aires	Caba
Argentina	Hospital Britanico de Buenos Aires ( Site 2705)	Ciudad de Buenos Aires	Caba
Argentina	Centro Oncologico Riojano Integral ( Site 2703)	La Rioja
Australia	Blacktown Hospital ( Site 2202)	Blacktown	New South Wales
Australia	Monash Medical Centre ( Site 2205)	Clayton	Victoria
Australia	Linear Clinical Research Ltd ( Site 2206)	Nedlands	Western Australia
Australia	Tasman Oncology Research Pty Ltd ( Site 2203)	Southport	Queensland
Canada	Moncton Hospital - Horizon Health Network ( Site 0206)	Moncton	New Brunswick
Canada	Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0201)	Montreal	Quebec
Canada	BC Cancer-Vancouver Center ( Site 0203)	Vancouver	British Columbia
Colombia	Clinica de la Costa S.A.S. ( Site 2900)	Barranquilla	Atlantico
Colombia	Fundacion Valle del Lili ( Site 2909)	Cali	Valle Del Cauca
Colombia	Hemato Oncologos S.A. ( Site 2910)	Cali	Valle Del Cauca
Colombia	Fundación Colombiana de Cancerología Clínica Vida ( Site 2902)	Medellin	Antioquia
Colombia	Fundacion Cardiovascular de Colombia ( Site 2907)	Piedecuesta	Santander
France	CHU Jean Minjoz ( Site 0606)	Besancon	Doubs
France	CHD Vendee ( Site 0604)	La Roche sur Yon	Vendee
France	Institut du Cancer de Montpellier ( Site 0610)	Montpellier	Herault
France	Centre Henri Becquerel ( Site 0607)	Rouen	Seine-Maritime
France	Institut Gustave Roussy ( Site 0602)	Villejuif	Val-de-Marne
Germany	Charite-Universitaetsmedizin Berlin-Campus Benjamin Franklin ( Site 0902)	Berlin
Germany	Universitaetsklinik Koeln ( Site 0903)	Koeln	Nordrhein-Westfalen
Germany	Universitaetsklinik der Ludwig-Maximilians-Universitaet Muenchen ( Site 0906)	Muenchen	Bayern
Guatemala	Grupo Angeles SA ( Site 3004)	Guatemala
Guatemala	Medi-K Cayala ( Site 3005)	Guatemala
Guatemala	Oncologika S.A. ( Site 3003)	Guatemala
Guatemala	Sanatorio Nuestra Senora del Pilar ( Site 3006)	Guatemala
Guatemala	Centro Medico Integral De Cancerología (CEMIC) ( Site 3002)	Quetzaltenango
Israel	Rambam Health Care Campus-Oncology Division ( Site 0801)	Haifa
Israel	Hadassah Ein Kerem Medical Center ( Site 0802)	Jerusalem
Israel	Meir Medical Center ( Site 0804)	Kfar Saba
Israel	Rabin Medical Center ( Site 0806)	Petah Tikva
Israel	Chaim Sheba Medical Center ( Site 0800)	Ramat Gan
Israel	Sourasky Medical Center ( Site 0805)	Tel Aviv
Italy	ASST Grande Ospedale Metropolitano Niguarda ( Site 0700)	Milano
Italy	Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0703)	Modena	Emilia-Romagna
Italy	Istituto Nazionale Tumori Fondazione Pascale ( Site 0705)	Napoli
Italy	Azienda Ospedaliera Universitaria Senese ( Site 0704)	Siena
Japan	Kyushu University Hospital ( Site 2506)	Fukuoka
Japan	National Cancer Center Hospital East ( Site 2500)	Kashiwa	Chiba
Japan	Aichi Cancer Center Hospital ( Site 2504)	Nagoya	Aichi
Japan	Okayama University Hospital ( Site 2505)	Okayama
Japan	Hokkaido University Hospital ( Site 2502)	Sapporo	Hokkaido
Japan	Japanese Foundation for Cancer Research ( Site 2503)	Tokyo
Japan	National Cancer Center Hospital ( Site 2501)	Tokyo
Korea, Republic of	Seoul National University Bundang Hospital ( Site 2403)	Seongnam-si	Kyonggi-do
Korea, Republic of	Samsung Medical Center ( Site 2401)	Seoul
Korea, Republic of	Seoul National University Hospital ( Site 2402)	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System ( Site 2400)	Seoul
Latvia	Daugavpils Regional Hospital ( Site 2104)	Daugavpils
Latvia	Liepaja Regional Hospital ( Site 2101)	Liepaja
Latvia	P. Stradina Clinical University Hospital ( Site 2102)	Riga
Latvia	Riga East Clinical University Hospital ( Site 2103)	Riga
Mexico	CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 3103)	Ciudad de Mexico
Mexico	Preparaciones Oncologicas ( Site 3102)	León	Guanajuato
Mexico	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 3101)	Madero	Tamaulipas
Mexico	Unidad Biomedica Avanzada Monterrey S. A. ( Site 3108)	Monterrey	Nuevo Leon
Mexico	Clinica Integral Internacional de Oncologia S. de R.L. de C.V. ( Site 3107)	Puebla
Mexico	Centro Medico Zambrano Hellion ( Site 3105)	San Pedro Garza Garcia	Nuevo Leon
Mexico	Hospital H+ Queretaro ( Site 3104)	Santiago de Queretaro	Queretaro
Peru	Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 3206)	Arequipa	Ariqipa
Peru	Hospital Nacional Daniel Alcides Carrion ( Site 3207)	Bellavista	Qallaw
Peru	Hospital Nacional Adolfo Guevara Velasco ( Site 3205)	Cuzco	Qusqu
Peru	Clinica San Gabriel ( Site 3202)	Lima
Peru	Hospital Nacional Arzobispo Loayza ( Site 3208)	Lima
Peru	Hospital Nacional Cayetano Heredia ( Site 3203)	Lima
Peru	Instituto Nacional de Enfermedades Neoplasicas ( Site 3201)	Lima
Peru	Oncosalud ( Site 3200)	Lima
Poland	Uniwersyteckie Centrum Kliniczne ( Site 1809)	Gdansk	Pomorskie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (	Warszawa	Mazowieckie
Puerto Rico	Hematology and Oncology Institute ( Site 0504)	Manati
Puerto Rico	Ad-Vance Medical Research LLC ( Site 0505)	Ponce
Puerto Rico	Pan American Center for Oncology Trials LLC ( Site 0501)	Rio Piedras
Puerto Rico	FDI Clinical Research ( Site 0500)	San Juan
Romania	Spitalul Judetean de Urgenta Alba Iulia ( Site 1107)	Alba Iulia	Alba
Romania	Medisprof ( Site 1102)	Cluj Napoca	Cluj
Romania	Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1101)	Cluj-Napoca	Cluj
Romania	S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)	Craiova	Dolj
Romania	Policlinica Oncomed SRL ( Site 1104)	Timisoara	Timis
South Africa	Universitas Annex National Hospital ( Site 1902)	Bloemfontein	Free State
South Africa	The Oncology Centre ( Site 1904)	Durban	Kwazulu-Natal
South Africa	Wits Clinical Research ( Site 1906)	Parktown-Johannesburg	Gauteng
South Africa	Mary Potter Oncology Centre, Little Company of Mary Hospital ( Site 1900)	Pretoria	Gauteng
South Africa	Cancercare Rondebosch Oncology ( Site 1901)	Rondebosch	Western Cape
South Africa	Vaal Triangle Oncology Centre ( Site 1905)	Vereeniging	Gauteng
Spain	Hospital Clinic i Provincial ( Site 1302)	Barcelona
Spain	Hospital General Universitario Gregorio Maranon ( Site 1300)	Madrid
Spain	Hospital Quiron de Madrid ( Site 1301)	Pozuelo de Alarcon	Madrid
Sweden	Skanes Universitetssjukhus Lund. ( Site 2001)	Lund	Skane Lan
Sweden	Karolinska Universitetssjukhuset Solna ( Site 2000)	Solna	Stockholms Lan
Sweden	Akademiska Sjukhuset ( Site 2002)	Uppsala	Uppsala Lan
Turkey	Baskent University Adana Training Hospital ( Site 1509)	Adana
Turkey	Ankara Sehir Hastanesi ( Site 1508)	Ankara
Turkey	Gazi Universitesi Tip Fakultesi ( Site 1507)	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1502)	Ankara
Turkey	Akdeniz Universitesi Tip Fakultesi ( Site 1503)	Antalya
Turkey	Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1500)	Edirne
Turkey	Göztepe Prof. Dr. Süleyman Yalçin Sehir Hastanesi ( Site 1505)	Istanbul
Turkey	Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1504)	Istanbul
Turkey	Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1501)	Izmir
Turkey	Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1510)	Konya
Turkey	Inonu Universitesi Medical Fakultesi ( Site 1506)	Malatya
Ukraine	Cherkasy Regional Oncology Dispensary ( Site 1702)	Cherkasy	Cherkaska Oblast
Ukraine	Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1700)	Dnipro	Dnipropetrovska Oblast
Ukraine	Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (	Ivano-Frankivsk	Ivano-Frankivska Oblast
Ukraine	Communal non profit enterprise Regional Clinical Oncology Center ( Site 1704)	Kharkiv	Kharkivska Oblast
Ukraine	Khmelnitskiy Regional Onkology Dispensary ( Site 1705)	Khmelnitskiy	Khmelnytska Oblast
Ukraine	Kirovograd Regional oncology Dispensary ( Site 1716)	Kropyvnytsky	Kirovohradska Oblast
Ukraine	Medical Centre Consilium Medical ( Site 1712)	Kyiv	Kyivska Oblast
Ukraine	Podillya Regional Center of Oncology ( Site 1708)	Vinnytsia	Vinnytska Oblast
Ukraine	Medical center of the Limited Liability Company Yulis ( Site 1714)	Zaporizhzhia	Zaporizka Oblast
Ukraine	Zhytomyr Regional Oncology Center ( Site 1710)	Zhytomyr	Zhytomyrska Oblast
United States	Winship Cancer Institute of Emory University ( Site 0057)	Atlanta	Georgia
United States	The Kirklin Clinic ( Site 0086)	Birmingham	Alabama
United States	University Hospitals Cleveland Medical Center ( Site 0016)	Cleveland	Ohio
United States	Parkland Health & Hospital System ( Site 0091)	Dallas	Texas
United States	University of Texas, Southwestern Medical Center ( Site 0004)	Dallas	Texas
United States	Inova Schar Cancer Institute ( Site 0008)	Fairfax	Virginia
United States	Northeast Georgia Medical Center ( Site 0026)	Gainesville	Georgia
United States	University of Florida ( Site 0078)	Gainesville	Florida
United States	Banner MD Anderson Cancer Center ( Site 0049)	Gilbert	Arizona
United States	Banner MD Anderson Cancer Center ( Site 0092)	Greeley	Colorado
United States	University of Texas-MD Anderson Cancer Center ( Site 0087)	Houston	Texas
United States	Norton Cancer Institute - St. Matthews ( Site 0024)	Louisville	Kentucky
United States	Northwest Georgia Oncology Centers PC ( Site 0047)	Marietta	Georgia
United States	The University of Oklahoma Health Sciences Center ( Site 0050)	Oklahoma City	Oklahoma
United States	New York Cancer and Blood Specialists-Research Department ( Site 0080)	Port Jefferson Station	New York
United States	UC Davis Comprehensive Cancer Center ( Site 0039)	Sacramento	California
United States	San Francisco Oncology Associates ( Site 0085)	San Francisco	California
United States	University of California San Francisco ( Site 0015)	San Francisco	California
United States	Atlantic Health System ( Site 0046)	Summit	New Jersey
United States	Northwest Medical Specialties, PLLC ( Site 0007)	Tacoma	Washington
United States	Utah Cancer Specialists ( Site 0038)	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Colombia,  France,  Germany,  Guatemala,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Peru,  Poland,  Puerto Rico,  Romania,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 in Biomarker Subgroups	ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The ORR for all participants will be presented by biomarker subgroup.	Up to ~3 years
Secondary	Duration of Response (DOR) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups	For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR for all participants who experience a CR or PR will be presented by biomarker subgroup.	Up to ~3 years
Secondary	Progression-Free Survival (PFS) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups	PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 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. The appearance of one or more lesions is also considered PD. The PFS for all participants will be presented by biomarker subgroup.	Up to ~3 years
Secondary	Overall Survival (OS) in Biomarker Subgroups	OS is the time from randomization to death due to any cause. The OS for all participants will be presented by biomarker subgroup.	Up to ~3 years
Secondary	Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.	Up to ~3 years
Secondary	Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment will be presented.	Up to ~3 years
Secondary	Objective Response Rate (ORR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations	ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR will be presented by biomarker subpopulation.	Up to ~3 years
Secondary	Duration of Response (DOR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations	For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR for all participants who experience a CR or PR will be presented by biomarker subpopulation.	Up to ~3 years
Secondary	Progression-Free Survival (PFS) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations	PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 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. The appearance of one or more lesions is also considered PD. PFS will be presented by biomarker subpopulation.	Up to ~3 years
Secondary	Overall Survival (OS) in Additional Biomarker Subpopulations	OS is the time from randomization to death due to any cause. OS will be presented by biomarker subpopulation.	Up to ~3 years
Secondary	Number of Participants with Cancer Antigen-125 (CA-125) Level of =2 × Upper Limit of Normal (ULN) Among Participants with Ovarian Cancer	The number of participants who have ovarian cancer and have a CA-125 level =2 × upper limit of normal (ULN) at 2 different assessments that are measured at least 1 week apart will be presented.	Up to ~3 years
Secondary	Number of Participants with Cancer Antigen-125 (CA-125) Level =2 × Nadir (Lowest) Value Among Participants with Ovarian Cancer Who Had Elevated CA-125 Levels =ULN at Baseline	The number of participants who have ovarian cancer with an elevated CA-125 level = ULN at Baseline and have a CA-125 level =2 × the nadir (lowest) value at 2 different assessments that are measured at least 1 week apart will be presented.	Up to ~3 years
Secondary	Number of Participants with a Change from Baseline in Prostate-Specific Antigen (PSA) Level of =50% Among Participants with Prostate Cancer	A PSA response is defined as a reduction in the PSA level of =50% from Baseline measured at 2 different times at least 3 weeks apart. The number of participants who have prostate cancer and have a change from Baseline in PSA level =50% will be presented.	Up to ~3 years

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary