Phase 3 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:

• The participant must be female.
• The participant must be at least 15 years old at the time of screening (for those under 18, physical development must be at a certain stage of puberty, known as Tanner Stage III — confirm with trial site).
• The participant must weigh more than 35 kg.
• The participant must have been diagnosed with a specific type of cervical cancer (adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma) confirmed by a tissue test, at an advanced but not yet spread (metastatic) stage — known as FIGO 2018 Stage IIIA to IVA.
• The initial tests used to determine the cancer's stage must have been done no more than 56 days before starting the combined chemotherapy and radiation treatment (CCRT).
• A preserved tumour tissue sample must be available to test for a protein called PD-L1.
• The participant must not have had their cancer get worse during or after CCRT; if cancer is still present after CCRT, there must be no other treatments available that could potentially cure it.
• The participant must be in good general health, able to carry out normal daily activities with little or no limitation, and have a life expectancy of at least 12 weeks.
• The participant must have adequate organ and bone marrow function, based on blood tests.
• The participant must be able to understand and sign an informed consent form.

Who may not be able to join:

• People diagnosed with small cell (neuroendocrine) or mucinous adenocarcinoma types of cervical cancer.
• People whose cancer has already spread to other parts of the body (metastatic disease).
• People whose treatment plan is intended to preserve fertility.
• People who have previously had an organ transplant or a stem cell transplant from a donor.
• People with a history of a primary immune system disorder, or an active or previously diagnosed autoimmune or inflammatory condition.
• People with a serious, uncontrolled ongoing illness.
• People with a history of another cancer, unless it was treated with the intent to cure and has shown no signs of returning for at least 2 years, or it was a certain type of treated skin cancer or very early-stage cancer with no current evidence of disease.
• People who still have unresolved side effects from their previous CCRT treatment (with some exceptions for side effects that are permanent and not expected to worsen).
• People with a history of, or currently having, certain abnormal connections (fistulas) between the bladder, bowel, or rectum and the vagina.
• People who have had a severe allergic reaction (anaphylaxis) to any biological therapy or vaccine.
• People who have used immune-suppressing medications within 14 days before the first dose of the study treatment (certain low-dose or localised steroid uses may be exceptions — confirm with trial site).
• People who have previously had a hysterectomy (surgical removal of the uterus, including partial removal), or for whom a hysterectomy is planned as part of their cervical cancer treatment.
• People who have received any other treatment for cervical cancer before or at the same time as this trial (other than the prior CCRT).
• People who have had major surgery within 4 weeks before the first dose of the study treatment, or who are still recovering from surgery.
• People who have previously received any immune-based therapy (such as immunotherapy) for any reason.
• People who have received a live vaccine within 30 days before the first dose of the study treatment.
• People with a known allergy or sensitivity to the study treatment or any of its ingredients.

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