CERVICAL: METASTATIC: FIRST LINE: IMMUNOTX: KEYNOTE 826

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

Title
Merck Sharp & Dohme Corp MK-3475-826 (CERVICAL KEYNOTE-826)
Study Title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

Site Link
Malignancy
Cervical, cervix cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
First line
Investigational Agent
Pembrolizumab
Drug Class
PD-1 antibody
PI
Adam ElNaggar, MD
Sponsor
Merck Sharp and Dohme Corp.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Persistent, recurrent, or metastatic cervical cancer (squamous cell, adenosquamous, or adenocarcinoma) not amenable to curative treatment
  • No prior treatment with systemic chemotherapy
  • Measurable disease
  • ECOG PS 0-1
  • No known CNS metastases
  • No other malignancy within 3 years (other than NMSC, in situ cancers)
  • No chronic steroid therapy
  • No autoimmune disease
  • No known HBV, HCV, HIV
Objective

Primary- PFS, OS

Secondary- ORR, DOR, 12mo PFS, Safety, QOL

Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
squamous cell, adenosquamous, or adenocarcinoma of cervix
Dosing Frequency
Control Agents
Chemo alone
Study Protocol
Randomized
Yes
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