Actively Recruiting
Low-dose Pembrolizumab Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer.
Led by Instituto Nacional de Cancer, Brazil · Updated on 2025-02-24
44
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Low-dose Pembrolizumab Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years and older
- Diagnosis of persistent, recurrent, or metastatic squamous cell, adenocarcinoma, or adenosquamous cervical cancer with PD-L1 CPS 21 1
- No prior systemic chemotherapy except chemotherapeutic agents used as radiosensitizers completed at least 2 weeks before treatment start
- Not pregnant or breastfeeding and agrees to contraceptive guidance if of fertile age
- Written informed consent provided
- Measurable disease by RECIST 1.1 criteria
- Archived tumor tissue sample no older than 4 years or biopsy for PD-L1 determination
- ECOG performance status of 0 to 1 within 7 days before treatment
- Adequate organ function based on specified laboratory values within 7 days before treatment
You will not qualify if you...
- Positive urine pregnancy test within 72 hours before treatment
- Active central nervous system metastases or carcinomatous meningitis unless previously treated and stable
- Other known malignancies within the past 3 years except treated basal or squamous cell skin cancer
- Immunodeficiency or chronic systemic steroid or immunosuppressive therapy within 7 days before treatment
- Active autoimmune disease requiring systemic treatment within 2 years
- History of non-infectious pneumonitis requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Known hepatitis B or active hepatitis C
- Active tuberculosis
- Prior treatment with immune checkpoint inhibitors
- Prior systemic chemotherapy for advanced cervical cancer
- Not recovered from major surgery toxicities before treatment
- Radiotherapy within 2 weeks before treatment
- Live vaccine within 30 days before treatment
- Hypersensitivity to carboplatin, paclitaxel, or cisplatin
- Participation in another investigational study within 4 weeks before treatment
- History of allogeneic organ or tissue transplantation
- Psychiatric or substance abuse disorders interfering with participation
- Any condition or abnormality that could interfere with study results or participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil, 20231050
Actively Recruiting
Research Team
A
Andreia C Melo, PhD
CONTACT
C
Cecilia F da Silva, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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