Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

Inclusion Criteria:

- 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)

- 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 or 210 days after the last dose of chemotherapy

- Has measurable disease per RECIST 1.1 as assessed by the local site
investigator/radiology

- 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

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within
14 days prior to randomization

- Has adequate organ function

Exclusion Criteria:

- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization

- 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.

- 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.

- 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

- 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

- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis

- 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 known history of active tuberculosis (TB; Bacillus tuberculosis)

- 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)

- Has received prior systemic chemotherapy for treatment of cervical cancer.

- Has not recovered adequately from toxicity and/or complications from surgery prior to
randomization

- 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.

- Has received a live vaccine within 30 days prior to randomization

- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

- Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin,
paclitaxel, or bevacizumab

- 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

- 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

- Has had an allogeneic tissue/solid organ transplant