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

NCT06670911 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-02-24

No results posted yet for this study

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).

Conditions

  • Persistent, Recurrent, or Metastatic Cervical Cancer

Interventions

DRUG

Low-dose Pembrolizumab Plus Chemotherapy (Paclitaxel plus Carboplatin or Cisplatin)

Patients will receive pembrolizumab 100mg IV every 3 weeks plus chemotherapy (paclitaxel 175 mg/m² + carboplatin AUC 5 or paclitaxel 175 mg/m² + cisplatin 50 mg/m² for cisplatin-naïve patients).

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Principal Investigators

  • Andreia c Melo, PhD · Instituto Nacional de Câncer José Gomes de Alencar da Silva - INCA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2026-04-30
Completion
2028-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670911 on ClinicalTrials.gov