Cervical cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Pembrolizumab, Paclitaxel, Cisplatin, Carboplatin, Bevacizumab
INN of investigational material : Pembrolizumab, Paclitaxel, Cisplatin, Carboplatin, Bevac
disease progression, unacceptable adverse event(s), or received 35 administrations of pembrolizumab (approximately 2 years).
control material(s)
Generic name etc : Paclitaxel, Cisplatin, Carboplatin,
Sponsors
MSD K.K.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Has persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment (such as with surgery and/or radiation). 2) Not pregnant or breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP), b.) A WOCBP must agree to use effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab/placebo and 210 days after the last dose of chemotherapy/bevacizumab 3) Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology 4) Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for prospective determination of Programmed Cell Death-Ligand 1 (PD-L1) status prior to randomization 5) Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 14 days prior to randomization 6) Has adequate organ function
Exclusion criteria
Exclusion criteria: 1) A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization 2) Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable. 3) Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have undergone potentially curative therapy are not excluded. 4) Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization 5) Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed 6) Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis 7) Has an active infection requiring systemic therapy 8) Has a known history of human immunodeficiency virus (HIV) infection 9) Has a known history of Hepatitis B or known active Hepatitis C virus infection 10) Has a known history of active tuberculosis (TB; Bacillus tuberculosis) 11) Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137) 12) Has received prior systemic chemotherapy for treatment of cervical cancer. 13) Has not recovered adequately from toxicity and/or complications from major surgery prior to randomization 14) Has received prior radiotherapy within 2 weeks prior to randomization. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. 15) Has received a live vaccine within 30 days prior to randomization 16) Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients. 17) Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab 18) Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization 19) Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days following last dose of pembrolizumab/placebo and 210 days following last dose of chemotherapy/bevacizumab 20) Has had an allogeneic tissue/solid organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - PFS - OS - To compare PFS per RECIST 1.1 as assessed by investigator - To compare OS | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Objective response rate (ORR) - Duration of response (DOR) - 12-month PFS rate - Participants experiencing adverse events (AEs), serious AEs, and immune-related Aes, Participants discontinuing study treatment due to AEs - The EORTC QLQ-C30 global score | — |
Countries
Japan, North America
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed