Clinical Trial

Low-dose Pembrolizumab Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer.

Study acronym: ACCESS-I
Recruiting Phase 2
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Record status
This record was last updated February 24, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a phase II single-arm study of low-dose pembrolizumab (100mg, fixed-dose) plus chemotherapy in women aged 18 years or older with histologically confirmed persistent, recurrent, or metastatic cervical cancer who are ineligible for curative-intent treatment (surgery and/or radiation therapy) and who have not been previously treated with systemic chemotherapy, with the exception of chemotherapeutic agents used as radiosensitizers (cisplatin or carboplatin concurrent with radiation therapy).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-10-31; most recent amendment 2025-02-20.
Status change: Not Yet Recruiting → Recruiting 2025-02-05
Trial Details
NCT Number NCT06670911
Lead Sponsor Instituto Nacional de Cancer, Brazil
Conditions Persistent, Recurrent, or Metastatic Cervical Cancer
Enrollment 44 participants
Start Date 2025-02-20
Primary Completion 2026-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2025-02-24