Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: IV infusion
Paclitaxel: IV infusion
Bevacizumab: IV infusion
Placebo for pembrolizumab: IV infusion
Docetaxel: IV infusion
Study 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.
Eligibility
Primary outcome measure(s)
- 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 Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1) — Up to ~38 months
PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data. - PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants — Up to ~38 months
PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Trial sites (187)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth ( Site 0041) | Phoenix | Arizona | |
| Marin Cancer Care ( Site 0055) | Greenbrae | California | |
| Pacific Cancer Care ( Site 0028) | Monterey | California | |
| Eisenhower Medical Center ( Site 0067) | Rancho Mirage | California | |
| Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004) | New Haven | Connecticut | |
| University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054 | Gainesville | Florida | |
| Sarasota Memorial Hospital ( Site 0018) | Sarasota | Florida | |
| Moffitt Cancer Center ( Site 0033) | Tampa | Florida | |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005) | Marietta | Georgia | |
| Advocate Medical Group-Oncology ( Site 0049) | Park Ridge | Illinois | |
| Parkview Research Center at Parkview Regional Medical Center ( Site 0027) | Fort Wayne | Indiana | |
| St. Vincent Hospital and Health Care Center, Inc ( Site 0032) | Indianapolis | Indiana | |
| Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040) | Edgewood | Kentucky | |
| WK Physicians Network / Hematology Oncology Associates ( Site 0034) | Shreveport | Louisiana | |
| Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015) | Baltimore | Maryland | |
| University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003) | Worcester | Massachusetts | |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007) | Hackensack | New Jersey | |
| Roswell Park Cancer Institute ( Site 0039) | Buffalo | New York | |
| Columbia University Medical Center ( Site 0010) | New York | New York | |
| Novant Health Presbyterian Medical Center ( Site 0029) | Charlotte | North Carolina | |
| Duke Cancer Institute ( Site 0038) | Durham | North Carolina | |
| Novant Health Forsyth Medical Center ( Site 0057) | Winston-Salem | North Carolina | |
| Aultman Hospital-Oncology Clinical Trials ( Site 0009) | Canton | Ohio | |
| MetroHealth Medical Center-Cancer Care Center ( Site 0047) | Cleveland | Ohio | |
| Providence Portland Medical Center ( Site 0048) | Portland | Oregon | |
| University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024) | Pittsburgh | Pennsylvania | |
| Sanford Cancer Center ( Site 0064) | Sioux Falls | South Dakota | |
| The West Clinic, PLLC dba West Cancer Center ( Site 0058) | Germantown | Tennessee | |
| Texas Oncology - Dallas (Presbyterian) ( Site 0065) | Dallas | Texas | |
| Texas Oncology - The Woodlands_Lee ( Site 0043) | The Woodlands | Texas | |
| Inova Schar Cancer Institute ( Site 0019) | Fairfax | Virginia | |
| Westmead Hospital-Department of Gynaecological Oncology ( Site 0201) | Westmead | New South Wales | |
| Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202) | Brisbane | Queensland | |
| Epworth Freemasons ( Site 0204) | Melbourne | Victoria | |
| St. John of God Subiaco Hospital ( Site 0203) | Subiaco | Western Australia | |
| Institut Jules Bordet-Medicine Oncology ( Site 0302) | Brussels | Bruxelles-Capitale, Region de | |
| UZ Gent-Medical oncology ( Site 0301) | Ghent | Oost-Vlaanderen | |
| UZ Leuven ( Site 0303) | Leuven | Vlaams-Brabant | |
| AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305) | Kortrijk | West-Vlaanderen | |
| Hospital Araújo Jorge ( Site 0401) | Goiânia | Goiás |
+ 147 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in Italy
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05116189 on ClinicalTrials.gov ↗ ← All trials in Italy