Phase 2 Cervical Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Women aged 18 years or older
• People diagnosed with cervical cancer (squamous cell, adenocarcinoma, or adenosquamous type) that has come back, persisted, or spread to other parts of the body, and whose cancer tests positive for a protein called PD-L1 (with a score of 1 or higher)
• People whose cancer cannot be treated with surgery or radiation aimed at curing the disease, and who have not previously received chemotherapy for advanced cervical cancer (chemotherapy given alongside radiation treatment may be acceptable if it was completed at least 2 weeks before the trial starts and side effects have mostly resolved)
• People who are not pregnant and not breastfeeding; women who could become pregnant must agree to use contraception during treatment and for at least 120 days after the last dose of one study drug (pembrolizumab) and 210 days after the last dose of chemotherapy
• People who are willing and able to give written consent to take part in the study
• People who have measurable cancer that can be tracked on scans, assessed according to standard medical guidelines (called RECIST 1.1)
• People who can provide either a stored tumour tissue sample from the last 4 years or agree to a new tumour biopsy, so that PD-L1 levels can be confirmed
• People who are physically well enough to carry out light activity and care for themselves — assessed using a standard scale (ECOG score of 0 or 1) within 7 days before the trial starts
• People whose blood test results show that their kidneys, liver, bone marrow, and blood clotting are working within acceptable ranges, tested within 7 days before the trial starts (confirm specific values with trial site)

Who may not be able to join:

• People with a positive pregnancy test within 72 hours before the trial starts
• People with active cancer that has spread to the brain or to the lining around the brain; people with previously treated, stable brain metastases may be considered if stability has been confirmed on at least two brain scans taken at specific timepoints (confirm with trial site)
• People who have had another cancer in the past 3 years, except for certain treated skin cancers (basal cell or squamous cell carcinoma of the skin that has been treated with the aim of cure)
• People with a diagnosis of immune system deficiency, or who have been taking high-dose steroid tablets or other immune-suppressing medicines within the 7 days before the trial starts
• People with an active autoimmune disease that has required medical treatment within the past 2 years (hormone replacement therapies such as thyroid medication or insulin are generally still permitted — confirm with trial site)
• People with a history of lung inflammation (pneumonitis) that was not caused by infection and required steroid treatment
• People with an active infection that requires antibiotic or antiviral treatment
• People with a known history of HIV infection
• People with known active or chronic hepatitis B or hepatitis C infection
• People with a known history of active tuberculosis
• People who have previously been treated with certain types of immunotherapy drugs that work on the PD-1, PD-L1, PD-L2, or similar immune checkpoint pathways (such as CTLA-4, OX40, or LAG3 inhibitors)
• People who have previously received chemotherapy specifically to treat advanced cervical cancer (chemotherapy used alongside radiation may be acceptable — confirm with trial site)
• People who have not sufficiently recovered from a major surgery before the trial start date
• People who have received radiotherapy within 2 weeks before the trial start date
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, or BCG) within 30 days before the trial start date; standard seasonal flu vaccines are generally permitted
• People who have a known allergy or serious sensitivity to carboplatin, paclitaxel, or cisplatin (the chemotherapy drugs used in this trial)
• People who are currently taking part in another clinical trial or have used an experimental treatment or device within 4 weeks before the trial start date
• People who have had an organ or tissue transplant from another person
• People with a known psychiatric condition or substance use problem that may make it difficult to follow the trial requirements
• People with any other medical condition, ongoing treatment, or abnormal test result that the treating doctor believes could affect the trial results or the person's ability to participate

Important: Always verify eligibility with the trial site directly before applying.