RecruitingPhase 2NCT06670911

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

A Phase II Trial of Low-dose Pembrolizumab Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer - ACCESS I


Sponsor

Instituto Nacional de Cancer, Brazil

Enrollment

44 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a lower dose of pembrolizumab (an immunotherapy drug) combined with standard chemotherapy (cisplatin and paclitaxel) is an effective and safe first-line treatment for women with advanced cervical cancer that expresses a protein called PD-L1. **You may be eligible if...** - You are a woman aged 18 or older - You have persistent, recurrent, or metastatic cervical cancer (squamous cell, adenocarcinoma, or adenosquamous type) - Your tumor tests positive for PD-L1 (CPS ≥ 1) - You have not received prior chemotherapy for metastatic disease - You cannot have curative surgery or radiation - You have measurable tumors on scans and are in good health (ECOG 0–1) **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your tumor does not express PD-L1 (CPS < 1) - You have had prior chemotherapy for metastatic cervical cancer - Your blood counts or organ function are outside acceptable ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow-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).


Locations(1)

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, Brazil

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NCT06670911