Inclusion Criteria:
- Has high-risk locally advanced cervical cancer (LACC): The International Federation of
Gynecology and Obstetrics (FIGO) 2014 Stage IB2-IIB (with node-positive disease) or
FIGO 2014 Stages III-IVA
- Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous
carcinoma of the cervix
- Has not previously received any definitive surgical, radiation, or systemic therapy
for cervical cancer and is immunotherapy-naïve
- Female participants must not be pregnant or breastfeeding, and agree to use highly
effective contraception during the treatment period and for at least 120 days after
the last dose of pembrolizumab or placebo and 180 days following the end of
chemoradiotherapy
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7
days prior to the first dose of study treatment
- Has provided a tissue sample from a core or excisional biopsy of a tumor lesion
- Has radiographically evaluable disease, either measurable or non-measurable per RECIST
1.1, as assessed by the local site investigator/radiology
- Has adequate organ within 7 days prior to the start of study treatment
Exclusion Criteria:
- Has excluded subtypes of LACC
- Has FIGO 2014 Stage IVB disease
- Has undergone a previous hysterectomy defined as removal of the entire uterus or will
have a hysterectomy as part of their initial cervical cancer therapy
- Has bilateral hydronephrosis, unless at least one side has been stented or resolved by
positioning of nephrostomy
- Has anatomy or tumor geometry or any other reason or contraindication that cannot be
treated with intracavitary brachytherapy or a combination of intracavitary and
interstitial brachytherapy
- Has received a live vaccine within 30 days prior to the first dose of study treatment
- Has received treatment with systemic immunostimulatory agents such as bacterial or
viral vaccines, colony stimulating factors, interferons, interleukins and vaccine
combinations within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior
to Cycle 1, Day 1
- Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1),
anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death
receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or
co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4
(CTLA-4), OX-40, CD137)
- Has received prior systemic anticancer therapy including investigational agents within
4 weeks prior to randomization
- 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
- Has any contraindication to the use of cisplatin.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years
- Has severe hypersensitivity to pembrolizumab and/or any of its excipients
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- 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 a history or current evidence of any condition, therapy, lab abnormality, or other
circumstance that may increase the risk associated with study participation or study
treatment administration or may interfere with the interpretation of study results,
and in the judgment of the investigator or Sponsor, would make the participant
inappropriate for entry into this 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
- Is pregnant or breastfeeding or expecting to conceive children within the projected
duration of the study, starting with the screening visit through 120 days after the
last dose of pembrolizumab or placebo and 180 days following the end of
chemoradiotherapy
- Has had an allogenic tissue/solid organ transplant
