Pembrolizumab/placebo plus paclitaxel with or without bevacizumab for platinum-resistant recurrent ovarian cancer.
- Conditions
- Platinum-resistant Recurrent Ovarian CancerMedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-005027-37-IT
- Lead Sponsor
- MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 616
A participant will be eligible for inclusion in the study if the participant meets the following criteria:
1. Has histologically confirmed epithelial (including high-grade serous or predominantly serous, low-grade serous, any-grade endometrioid,
malignant mixed Müllerian tumors [carcinosarcoma], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma.
2. Has received 1 or 2 prior lines of systemic therapy for OC, including at least 1 prior platinum-based therapy.
– Participants must have received at least 4 cycles of platinum-based therapy in first line.
– Adjuvant ± neoadjuvant therapy is considered 1 line
– Participants may have received a prior PARPi; this will not be considered a separate line of therapy if received in maintenance
– Participants may have received a prior 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
3. Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC
(ie, platinum-resistant disease).
4. Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using).
5. Is female, and at least 18 years of age, at the time of signing the informed consent.
6. Has an ECOG performance status of 0 to 1 assessed within 3 days before randomization.
For other inclusion criteria please refer to the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 384
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 232
The participant must be excluded from the study if the participant meets the following criteria:
1. Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
2. Has primary platinum-refractory disease, defined as disease that has progressed per RECIST 1.1 while receiving first-line platinum-based
therapy.
3. Has prior disease progression on weekly paclitaxel alone.
4. Has uncontrolled hypertension.
5. Has current, clinically relevant bowel obstruction (including subocclusive disease) including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.
6. Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.
7. Has received >2 prior lines of systemic therapy for OC.
8. Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
9. Has received prior radiation therapy within 2 weeks of start of study intervention.
10. Has not recovered adequately from surgery and/or any complications from the surgery.
11. Has received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks before randomization.
12. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
13. 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.
14. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
15. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
16. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days before the first dose of study intervention.
17. Has severe hypersensitivity (=Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients.
18. Has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
19. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung
disease.
20. Has an active infection requiring systemic therapy.
21. Has a known history of HIV infection.
For other exclusion criteria please refer to the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method