Ovarian Cancer Clinical Trial
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)
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] â‰¥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.
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.
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 (â‰¥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.
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There are 182 Locations for this study
Phoenix Arizona, 85016, United States
Greenbrae California, 94904, United States
Monterey California, 93940, United States
Rancho Mirage California, 92270, United States
New Haven Connecticut, 06511, United States
Gainesville Florida, 32610, United States
Sarasota Florida, 34239, United States
Tampa Florida, 33612, United States
Marietta Georgia, 30060, United States
Park Ridge Illinois, 60068, United States
Fort Wayne Indiana, 46845, United States
Indianapolis Indiana, 46260, United States
Edgewood Kentucky, 41017, United States
Shreveport Louisiana, 71103, United States
Baltimore Maryland, 21202, United States
Worcester Massachusetts, 01605, United States
Hackensack New Jersey, 07601, United States
Buffalo New York, 14263, United States
New York New York, 10032, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27103, United States
Canton Ohio, 44710, United States
Cleveland Ohio, 44109, United States
Portland Oregon, 97213, United States
Pittsburgh Pennsylvania, 15219, United States
Sioux Falls South Dakota, 57104, United States
Germantown Tennessee, 38138, United States
Dallas Texas, 75231, United States
The Woodlands Texas, 77380, United States
Fairfax Virginia, 22031, United States
Westmead New South Wales, 2145, Australia
Brisbane Queensland, 4120, Australia
Melbourne Victoria, 3002, Australia
Subiaco Western Australia, 6008, Australia
Bruxelles Bruxelles-Capitale, Region De, 1000, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Kortrijk West-Vlaanderen, 8500, Belgium
GoiÃ¢nia Goias, 74605, Brazil
Natal Rio Grande Do Norte, 59075, Brazil
Lages Santa Catarina, 88501, Brazil
SÃ£o Paulo Sao Paulo, 01323, Brazil
SÃ£o Paulo Sao Paulo, 04014, Brazil
Rio de Janeiro , 20220, Brazil
Calgary Alberta, T2N 4, Canada
Abbotsford British Columbia, V2S 0, Canada
Victoria British Columbia, V8R 6, Canada
Kingston Ontario, K7L 2, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H3T 1, Canada
MontrÃ©al Quebec, H4A 3, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Quebec , G1J 1, Canada
Temuco Araucania, 47800, Chile
Temuco Araucania, 48101, Chile
Puerto Montt Los Lagos, 55002, Chile
Santiago Region M. De Santiago, 75100, Chile
Santiago Region M. De Santiago, 76303, Chile
Santiago Region M. De Santiago, 82414, Chile
Santiago Region M. De Santiago, 83300, Chile
Santiago Region M. De Santiago, 84203, Chile
Hefei Anhui, 23000, China
Beijing Beijing, 10014, China
Beijing Beijing, 10073, China
Fuzhou Fujian, 35001, China
Lanzhou Gansu, 73003, China
Guangzhou Guangdong, 51028, China
Zhanjiang Guangdong, 52400, China
Nanning Guangxi, 53002, China
Haikou Hainan, 57031, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41000, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Nanjing Jiangsu, , China
Nanchang Jiangxi, 33000, China
Changchun Jilin, 13002, China
Jinan Shandong, 25011, China
Linyi Shandong, 27600, China
Shanghai Shanghai, 20001, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20120, China
Chengdu Sichuan, 61006, China
Tianjin Tianjin, 30005, China
Tianjin Tianjin, 30006, China
Kunming Yunnan, 65010, China
Hangzhou Zhejiang, 31000, China
Wenzhou Zhejiang, 32500, China
Medellin Antioquia, 05003, Colombia
Barranquilla Atlantico, 08002, Colombia
BogotÃ¡ Distrito Capital De Bogota, 11122, Colombia
Pereira Risaralda, 66000, Colombia
Cali Valle Del Cauca, 76001, Colombia
Aalborg Nordjylland, 9000, Denmark
Turku Varsinais-Suomi, 20521, Finland
Brest Bretagne, 29200, France
Caen Calvados, 14076, France
Limoges Haute-Vienne, 87042, France
Saint-Cloud Hauts-de-Seine, 92210, France
Rennes Ille-et-Vilaine, 35042, France
Montpellier Languedoc-Roussillon, 34070, France
Nantes Loire-Atlantique, 44277, France
Erlangen Bayern, 91054, Germany
Bonn Nordrhein-Westfalen, 53127, Germany
DÃ¼sseldorf Nordrhein-Westfalen, 40225, Germany
Krefeld Nordrhein-Westfalen, 47805, Germany
SaarbrÃ¼cken Saarland, 66113, Germany
Dresden Sachsen, 01307, Germany
Leipzig Sachsen, 04103, Germany
Berlin , 13353, Germany
Hamburg , 22307, Germany
Dublin , D08 E, Ireland
Afula , 18341, Israel
Be'er Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Petah-Tikva , 49100, Israel
Ramat Gan , 52656, Israel
Tel Aviv , 64239, Israel
Bologna Emilia-Romagna, 40138, Italy
Milan Lombardia, 20133, Italy
Monza Lombardia, 20900, Italy
Milan Milano, 20162, Italy
Torino Piemonte, 10128, Italy
Brescia , 25123, Italy
Milano , 20141, Italy
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 277-8, Japan
Matsuyama Ehime, 791-0, Japan
Toon Ehime, 791-0, Japan
Kurume Fukuoka, 830-0, Japan
Sapporo Hokkaido, 060-8, Japan
Shiwa-gun Yahaba-cho Iwate, 028-3, Japan
Kawasaki Kanagawa, 211-8, Japan
Hidaka-shi Saitama, 350-1, Japan
Nagaizumi Shizuoka, 411-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Koto Tokyo, 135-8, Japan
Osaka , 541-8, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06273, Korea, Republic of
La Paz Baja California Sur, 23040, Mexico
Mexico City Distrito Federal, 04700, Mexico
Mexico City Distrito Federal, 14070, Mexico
Monterrey Nuevo Leon, 64710, Mexico
Oaxaca , 68020, Mexico
Nijmegen Gelderland, 6525 , Netherlands
Leiden Zuid-Holland, 2333 , Netherlands
Rotterdam Zuid-Holland, 3015 , Netherlands
Utrecht , 3584 , Netherlands
Auckland , 1023, New Zealand
TromsÃ¸ Troms, 9038, Norway
Warsaw Mazowieckie, 00-31, Poland
Warszawa Mazowieckie, 02-78, Poland
Bialystok Podlaskie, 15-02, Poland
Bialystok Podlaskie, 15-27, Poland
GdaÅ„sk Pomorskie, 80-21, Poland
Gliwice Slaskie, 44-10, Poland
Kielce Swietokrzyskie, 25-73, Poland
Poznan Wielkopolskie, 61-84, Poland
Chelyabinsk Chelyabinskaya Oblast, 45408, Russian Federation
Saransk Mordoviya, Respublika, 43000, Russian Federation
Krasnogorsk D-t Moskovskaya Oblast, 14342, Russian Federation
Moscow Moskva, 11547, Russian Federation
Ekaterinburg Sverdlovskaya Oblast, 62090, Russian Federation
SarÃ§am Adana, 01250, Turkey
Fatih Istanbul, 34098, Turkey
Bornova Izmir, 35100, Turkey
Adana , 01250, Turkey
Ankara , 06100, Turkey
Ankara , 34180, Turkey
Istanbul , 34093, Turkey
Istanbul , 34440, Turkey
East Sussex Brighton And Hove, BN2 5, United Kingdom
Cambridge Cambridgeshire, CB2 2, United Kingdom
Truro Cornwall, TR1 3, United Kingdom
Kendal Cumbria, LA9 7, United Kingdom
Dundee Dundee City, DD1 9, United Kingdom
Leicester England, , United Kingdom
London London, City Of, W12 0, United Kingdom
Cardiff , CF14 , United Kingdom
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