| Title |
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 |
| Protocole ID |
MK-3475-B96 (KEYNOTE-B96, ENGOT-ov65) |
| ClinicalTrials.gov ID |
NCT05116189 |
| Cancer Type(s) |
Ovary |
| Phase |
Phase III |
| Stage |
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| Study Type |
Clinical |
| Drug |
Pembrolizumab versus placebo en association avec le paclitaxel avec ou sans bevacizumab |
| Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
 PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
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| City |
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| Principal Investigator |
Dr. Suzanne Fortin
|
| Coordinator |
Audrey Lamoureux
514-252-3400 poste 6258
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| Status |
Recruiting |
| Activation Date |
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| Eligibility 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 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
|
| 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 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.
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Groupe d'étude en oncologie du Québec