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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05116189
Other study ID # 3475-B96
Secondary ID MK-3475-B96KEYNO
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 13, 2021
Est. completion date August 31, 2027

Study information

Verified date February 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 616
Est. completion date August 31, 2027
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. - Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-PD-1/anti-PD-L1 therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy. - Has provided documented informed consent for the study. - Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease). - Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using). - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before randomization. - For a female participant, 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 uses a contraceptive method that is highly effective (with a failure rate of <1% per year). - Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by the local site investigator. - Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided. - Have adequate organ function. Exclusion Criteria: - Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma. - Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy. - Has prior disease progression on weekly paclitaxel alone. - Has received >2 prior lines of systemic therapy for OC. - Has received prior systemic anticancer therapy including investigational agents or maintenance therapy (including bevacizumab maintenance therapy), within 4 weeks before randomization. - Has received prior radiation therapy within 2 weeks of start of study intervention. - Has not recovered adequately from surgery and/or any complications from the surgery. - Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor,[GM-CSF] or recombinant erythropoietin) within 4 weeks before randomization. - Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. - Has received investigational agent or has used an investigational device within 4 weeks prior to study intervention. - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. - Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Has severe hypersensitivity (=Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients. - Has an active autoimmune disease that has required systemic treatment in the past 2 years. - Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. - Has an active infection requiring systemic therapy. - Has a known history of human immunodeficiency virus (HIV) infection. - Has a known history of Hepatitis B or known active Hepatitis C virus infection. - Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study. - Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. - Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study. - Has had an allogenic tissue/solid organ transplant. For bevacizumab treatment - Has uncontrolled hypertension. - Has current, clinically relevant bowel obstruction including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam. - Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.

Study Design


Intervention

Biological:
Pembrolizumab
IV infusion
Drug:
Paclitaxel
IV infusion
Bevacizumab
IV infusion
Other:
Placebo for pembrolizumab
IV infusion
Drug:
Docetaxel
IV infusion

Locations

Country Name City State
Australia Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202) Brisbane Queensland
Australia Epworth Freemasons ( Site 0204) Melbourne Victoria
Australia St. John of God Subiaco Hospital ( Site 0203) Subiaco Western Australia
Australia Westmead Hospital-Department of Gynaecological Oncology ( Site 0201) Westmead New South Wales
Belgium Institut Jules Bordet-Medicine Oncology ( Site 0302) Bruxelles Bruxelles-Capitale, Region De
Belgium UZ Gent-Medical oncology ( Site 0301) Gent Oost-Vlaanderen
Belgium AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305) Kortrijk West-Vlaanderen
Belgium UZ Leuven ( Site 0303) Leuven Vlaams-Brabant
Brazil Hospital Araújo Jorge ( Site 0401) Goiânia Goias
Brazil ANIMI - Unidade de Tratamento Oncologico ( Site 0408) Lages Santa Catarina
Brazil Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404) Natal Rio Grande Do Norte
Brazil Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402) Rio de Janeiro
Brazil BP - A Beneficencia Portuguesa de São Paulo ( Site 0403) São Paulo Sao Paulo
Brazil Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405) São Paulo Sao Paulo
Canada BC Cancer Abbotsford ( Site 0512) Abbotsford British Columbia
Canada Tom Baker Cancer Center ( Site 0511) Calgary Alberta
Canada Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog Kingston Ontario
Canada CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501) Montreal Quebec
Canada Jewish General Hospital ( Site 0505) Montreal Quebec
Canada McGill University Health Centre ( Site 0502) Montréal Quebec
Canada Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 Quebec
Canada Saskatoon Cancer Center ( Site 0510) Saskatoon Saskatchewan
Canada Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508) Toronto Ontario
Canada BC Cancer Victoria ( Site 0513) Victoria British Columbia
Chile Clínica Puerto Montt ( Site 0601) Puerto Montt Los Lagos
Chile Bradfordhill ( Site 0605) Santiago Region M. De Santiago
Chile Clínica Vespucio-Hemato - Ocology ( Site 0607) Santiago Region M. De Santiago
Chile Instituto de Radiomedicina-hemato-oncologia ( Site 0604) Santiago Region M. De Santiago
Chile Oncovida ( Site 0603) Santiago Region M. De Santiago
Chile Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609) Santiago Region M. De Santiago
Chile CIDO SpA-Oncology ( Site 0608) Temuco Araucania
Chile James Lind Centro de Investigación del Cáncer ( Site 0602) Temuco Araucania
China Beijing Cancer hospital ( Site 0711) Beijing Beijing
China Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702) Beijing Beijing
China The First Hospital of Jilin University ( Site 0710) Changchun Jilin
China Hunan Cancer Hospital ( Site 0704) Changsha Hunan
China Xiangya Hospital Central South University-Gynecology ( Site 0705) Changsha Hunan
China West China Second University Hospital Sichuan University ( Site 0740) Chengdu Sichuan
China Fujian Provincial Cancer Hospital ( Site 0713) Fuzhou Fujian
China Zhujiang Hospital ( Site 0739) Guangzhou Guangdong
China Hainan General Hospital ( Site 0736) Haikou Hainan
China The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741) Hangzhou Zhejiang
China Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709) Hefei Anhui
China Shandong Cancer Hospital-Oncology Department ( Site 0733) Jinan Shandong
China Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714) Kunming Yunnan
China Lanzhou university second hospital ( Site 0734) Lanzhou Gansu
China LinYi Cancer Hospital ( Site 0731) Linyi Shandong
China Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716) Nanchang Jiangxi
China Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Nanjing Jiangsu
China Zhongda Hospital Southeast University ( Site 0723) Nanjing Jiangsu
China Guangxi Medical University Affiliated Tumor Hospital ( Site 0717) Nanning Guangxi
China Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701) Shanghai Shanghai
China Obstetrics & Gynecology Hospital of Fudan University ( Site 0715) Shanghai Shanghai
China Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744) Shanghai Shanghai
China Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737) Tianjin Tianjin
China Tianjin Medical University Cancer Institute and Hospital ( Site 0720) Tianjin Tianjin
China The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706) Wenzhou Zhejiang
China Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708) Wuhan Hubei
China Wuhan Union Hospital-Medical Oncology ( Site 0735) Wuhan Hubei
China Affiliated Hospital of Guangdong Medical University ( Site 0743) Zhanjiang Guangdong
China Henan Cancer Hospital ( Site 0718) Zhengzhou Henan
Colombia Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809) Barranquilla Atlantico
Colombia Clínica Universitaria Colombia ( Site 0806) Bogotá Distrito Capital De Bogota
Colombia Hemato Oncologos SA ( Site 0801) Cali Valle Del Cauca
Colombia Fundación Colombiana de Cancerología Clínica Vida ( Site 0808) Medellin Antioquia
Colombia Oncologos del Occidente ( Site 0807) Pereira Risaralda
Denmark Aalborg Universitetshospital, Syd ( Site 0901) Aalborg Nordjylland
Finland Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001) Turku Varsinais-Suomi
France Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi Brest Bretagne
France Centre François Baclesse-Recherche clinique ( Site 2904) Caen Calvados
France Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907) Limoges Haute-Vienne
France Centre de Cancérologie du Grand Montpellier ( Site 2908) Montpellier Languedoc-Roussillon
France Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905) Nantes Loire-Atlantique
France Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901) Rennes Ille-et-Vilaine
France Institut Curie - site Saint-Cloud ( Site 2909) Saint-Cloud Hauts-de-Seine
Germany Charité Campus Virchow-Klinikum ( Site 1201) Berlin
Germany Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203) Bonn Nordrhein-Westfalen
Germany Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur Dresden Sachsen
Germany Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204) Düsseldorf Nordrhein-Westfalen
Germany Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205) Erlangen Bayern
Germany Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214) Hamburg
Germany Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207) Krefeld Nordrhein-Westfalen
Germany Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213) Leipzig Sachsen
Germany CaritasKlinikum Saarbrücken St. Theresia ( Site 1211) Saarbrücken Saarland
Ireland St. James's Hospital-Cancer clinical trials office ( Site 2821) Dublin
Israel Emek Medical Center-Gyn-Onc ( Site 1406) Afula
Israel Soroka Medical Center ( Site 1404) Be'er Sheva
Israel Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402) Haifa
Israel Shaare Zedek Medical Center ( Site 1405) Jerusalem
Israel Rabin Medical Center ( Site 1401) Petah-Tikva
Israel Sheba Medical Center ( Site 1407) Ramat Gan
Israel Sourasky Medical Center ( Site 1403) Tel Aviv
Italy IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501) Bologna Emilia-Romagna
Italy Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504) Brescia
Italy ASST Grande Ospedale Metropolitano Niguarda ( Site 1505) Milan Milano
Italy Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503) Milan Lombardia
Italy Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502) Milano
Italy Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508) Monza Lombardia
Italy Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507) Torino Piemonte
Japan National Cancer Center Hospital ( Site 1612) Chuo-ku Tokyo
Japan Saitama Medical University International Medical Center ( Site 1601) Hidaka-shi Saitama
Japan National Cancer Center Hospital East ( Site 1609) Kashiwa Chiba
Japan Nippon Medical School Musashi Kosugi Hospital ( Site 1614) Kawasaki Kanagawa
Japan Japanese Foundation for Cancer Research ( Site 1605) Koto Tokyo
Japan Kurume University Hospital ( Site 1607) Kurume Fukuoka
Japan National Hospital Organization Shikoku Cancer Center ( Site 1603) Matsuyama Ehime
Japan Shizuoka Cancer Center ( Site 1611) Nagaizumi Shizuoka
Japan Aichi Cancer Center Hospital ( Site 1610) Nagoya Aichi
Japan Osaka International Cancer Institute ( Site 1602) Osaka
Japan Hokkaido University Hospital ( Site 1604) Sapporo Hokkaido
Japan Iwate Medical University Hospital ( Site 1613) Shiwa-gun Yahaba-cho Iwate
Japan Ehime University Hospital ( Site 1606) Toon Ehime
Korea, Republic of Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304) Seoul
Korea, Republic of Gangnam Severance Hospital ( Site 2301) Seoul
Korea, Republic of Seoul National University Hospital ( Site 2302) Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303) Seoul
Mexico Investigación Oncofarmacéutica-Investigación clínica ( Site 1706) La Paz Baja California Sur
Mexico COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703) Mexico City Distrito Federal
Mexico INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701) Mexico City Distrito Federal
Mexico iCan Oncology Center Centro Medico AVE ( Site 1704) Monterrey Nuevo Leon
Mexico Centro de Investigacion Clinica de Oaxaca ( Site 1705) Oaxaca
Netherlands Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801) Leiden Zuid-Holland
Netherlands Radboudumc ( Site 1802) Nijmegen Gelderland
Netherlands Erasmus Medisch Centrum-Medical Oncology ( Site 1803) Rotterdam Zuid-Holland
Netherlands Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804) Utrecht
New Zealand Auckland City Hospital ( Site 1901) Auckland
Norway Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001) Tromsø Troms
Poland Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106) Bialystok Podlaskie
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104) Bialystok Podlaskie
Poland Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi Gdansk Pomorskie
Poland Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21 Gliwice Slaskie
Poland Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107) Kielce Swietokrzyskie
Poland Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit Poznan Wielkopolskie
Poland Szpital Kliniczny im. Ksieznej Anny Mazowieckiej ( Site 2103) Warsaw Mazowieckie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit Warszawa Mazowieckie
Russian Federation Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary Chelyabinsk Chelyabinskaya Oblast
Russian Federation SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216) Ekaterinburg Sverdlovskaya Oblast
Russian Federation Moscow City Oncology Hospital #62 ( Site 2214) Krasnogorsk D-t Moskovskaya Oblast
Russian Federation Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211) Moscow Moskva
Russian Federation Ogarev Mordovia State University ( Site 2209) Saransk Mordoviya, Respublika
Turkey Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704) Adana
Turkey Ankara University Hospital Cebeci ( Site 2701) Ankara
Turkey Baskent Universitesi Ankara Hastanesi ( Site 2707) Ankara
Turkey Ege University Medicine of Faculty ( Site 2702) Bornova Izmir
Turkey Istanbul Universitesi Cerrahpasa ( Site 2709) Fatih Istanbul
Turkey Bezmialem Vakf Üniversitesi-Oncology ( Site 2705) Istanbul
Turkey T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Istanbul
Turkey cukurova universty ( Site 2706) Sarçam Adana
United Kingdom Addenbrooke's Hospital ( Site 2808) Cambridge Cambridgeshire
United Kingdom Velindre Cancer Centre ( Site 2805) Cardiff
United Kingdom Ninewells Hospital and Medical School ( Site 2826) Dundee Dundee City
United Kingdom Brighton and Sussex University Hospitals NHS Trust ( Site 2803) East Sussex Brighton And Hove
United Kingdom Westmorland General Hospital ( Site 2815) Kendal Cumbria
United Kingdom Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812) Leicester England
United Kingdom Hammersmith Hospital-Medical Oncology ( Site 2818) London London, City Of
United Kingdom The Royal Cornwall Hospital ( Site 2804) Truro Cornwall
United States Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015) Baltimore Maryland
United States Roswell Park Cancer Institute ( Site 0039) Buffalo New York
United States Aultman Hospital-Oncology Clinical Trials ( Site 0009) Canton Ohio
United States Novant Health Presbyterian Medical Center ( Site 0029) Charlotte North Carolina
United States MetroHealth Medical Center-Cancer Care Center ( Site 0047) Cleveland Ohio
United States Texas Oncology - Dallas (Presbyterian) ( Site 0065) Dallas Texas
United States Duke Cancer Institute ( Site 0038) Durham North Carolina
United States Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040) Edgewood Kentucky
United States Inova Schar Cancer Institute ( Site 0019) Fairfax Virginia
United States Parkview Research Center at Parkview Regional Medical Center ( Site 0027) Fort Wayne Indiana
United States University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054 Gainesville Florida
United States The West Clinic, PLLC dba West Cancer Center ( Site 0058) Germantown Tennessee
United States Marin Cancer Care ( Site 0055) Greenbrae California
United States John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007) Hackensack New Jersey
United States St. Vincent Hospital and Health Care Center, Inc ( Site 0032) Indianapolis Indiana
United States Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005) Marietta Georgia
United States Pacific Cancer Care ( Site 0028) Monterey California
United States Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004) New Haven Connecticut
United States Columbia University Medical Center ( Site 0010) New York New York
United States Advocate Medical Group-Oncology ( Site 0049) Park Ridge Illinois
United States HonorHealth ( Site 0041) Phoenix Arizona
United States University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024) Pittsburgh Pennsylvania
United States Providence Portland Medical Center ( Site 0048) Portland Oregon
United States Eisenhower Medical Center ( Site 0067) Rancho Mirage California
United States Sarasota Memorial Hospital ( Site 0018) Sarasota Florida
United States WK Physicians Network / Hematology Oncology Associates ( Site 0034) Shreveport Louisiana
United States Sanford Cancer Center ( Site 0064) Sioux Falls South Dakota
United States Moffitt Cancer Center ( Site 0033) Tampa Florida
United States Texas Oncology - The Woodlands_Lee ( Site 0043) The Woodlands Texas
United States Novant Health Forsyth Medical Center ( Site 0057) Winston-Salem North Carolina
United States University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003) Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Denmark,  Finland,  France,  Germany,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Russian Federation,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator 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 presented. Up to ~38 months
Secondary Overall Survival (OS) OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants. Up to ~64 months
Secondary PFS per RECIST 1.1 by Blinded Independent Central Review (BICR) PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review 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 blinded independent central review will be presented. Up to ~38 months
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 an AE will be reported. Up to ~64 months
Secondary Number of Participants who Discontinue Study Treatment due to an 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 due to an AE will be reported. Up to ~64 months
Secondary Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented. Baseline and up to ~64 months
Secondary Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30 TTD is defined as the time from Baseline to the first onset of a =10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome. Up to ~64 months
Secondary Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome. Baseline and up to ~64 months
Secondary TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale TTD is defined as the time from Baseline to the first onset of a =10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome. Up to ~64 months
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