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

Sponsor
Instituto Nacional de Cancer, Brazil
Study ID
NCT06670911
Phase
PHASE2
Status
Recruiting
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Conditions

  • Persistent, Recurrent, or Metastatic Cervical Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low-dose Pembrolizumab Plus Chemotherapy (Paclitaxel plus Carboplatin or Cisplatin) — DRUG
    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).

Study Details

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).

Key Dates

Start date
Feb 20, 2025
Status verified
Feb 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low-dose Pembrolizumab Plus Chemotherapy
    pembrolizumab 100mg intravenous infusion plus chemotherapy every 3 weeks. Chemotherapy may consist of paclitaxel 175 mg/m² + carboplatina AUC 5 or paclitaxel 175 mg/m² + cisplatin 50 mg/m² for patients who have not been previously exposed to cisplatin.

Primary Outcome Measure

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator [ Time Frame: Up to approximately 46 months ]

Central Contacts