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MK3475-B96 - A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

Studio Clinico

Patologia: Tumori dell’ovaio

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


Fase di studio: III

Linee di trattamento: Prima linea, Seconda linea

Criteri di inclusione: 

  • 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 or bevacizumab; 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

Criteri di esclusione: 

  • 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 RECIST 1.1 while receiving first-line platinum-based therapy.
  • Has prior disease progression on weekly paclitaxel alone.
  • 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.
  • Has received >2 prior lines of systemic therapy for OC.
  • Has received prior systemic anticancer therapy including investigational agents 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.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of 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

Trattamento sperimentale: 


Trattamento di controllo: 


Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
N.B.: Arruolamento pazienti non ancora attivo


ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS
N.B.: Arruolamento pazienti non ancora attivo


Grande Ospedale Metropolitano Niguarda
Piazza Ospedale Maggiore 3 - 20162 Milano - MI
N.B.: Arruolamento pazienti non ancora attivo


IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Dr. Francesco Raspagliesi
Telefono: 0223902719


Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Prof.ssa Nicoletta Colombo
Telefono: 0257489543


A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB
N.B.: Arruolamento pazienti non ancora attivo


AO - Ordine Mauriziano
Largo Turati 62 - 10128 Torino - TO
N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Dr.ssa Annamaria Ferrero
Telefono: 0115082682

Informazioni Generali


Numero di iscrizione a registro: 2020-005027-37

Data di inserimento: 12.05.2022


Merck Sharp & Dohme LLC



Principal Investigator ITALIA

Istituto Europeo di Oncologia - IEO

Riferimento: Prof.ssa Nicoletta Colombo

Telefono: 0257489543


Localita: Milano


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