Phase 2 Endometrial 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 or older who have been diagnosed with cervical cancer that has spread to nearby tissues or to other parts of the body, confirmed by a tissue test.
• People whose cancer has gotten worse after at least one previous treatment, or who were unable to tolerate a previous treatment, for advanced or spread cervical cancer.
• People who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use contraception during treatment and for at least 120 days after the last dose.
• People who are willing and able to give written consent to participate (or have a legal representative do so on their behalf).
• People who have measurable cancer that can be tracked using standard imaging measurements (called RECIST 1.1), including in some previously treated areas if the cancer has continued to grow there.
• People who are able to provide a stored or newly taken tissue sample from a tumour that has not been previously treated with radiation.
• People who are generally well enough to carry out light activities, as measured by a standard medical scoring system called ECOG, with a score of 0 or 1, assessed within 28 days before starting treatment.
• People whose blood test results show that the kidneys, liver, bone marrow, and blood clotting are functioning at an acceptable level, tested within 28 days before starting treatment (confirm specific thresholds with trial site).

Who may not be able to join:

• Women of childbearing potential who have a positive pregnancy test within 72 hours before starting treatment.
• People who have previously been treated with certain types of immunotherapy drugs that target the PD-1, PD-L1, or PD-L2 pathways.
• People who have received other systemic cancer treatments or experimental therapies within the past 4 weeks, or who have not yet recovered from side effects of previous treatments (with some exceptions for mild nerve-related side effects).
• People who have had radiation therapy within the past 2 weeks before starting the trial, or who have not recovered from radiation side effects (a shorter waiting period may apply in certain limited cases — confirm with trial site).
• People who have received a live or live-weakened vaccine within 30 days before the first dose.
• People who are currently enrolled in another clinical trial or have used an experimental treatment or device within the past 4 weeks.
• People who have a condition that weakens the immune system, or who are currently taking immune-suppressing medications or high-dose steroid medicines (above a certain daily threshold) within 7 days before the first dose.
• People who have another cancer that is currently active or has required treatment within the past 3 years (some minor skin cancers or cancers treated with curative intent may be exceptions — confirm with trial site).
• People who have active cancer spread to the brain or the lining of the brain, unless previously treated brain spread has been stable for at least 4 weeks and steroid treatment has not been needed for at least 14 days.
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or lenvatinib, or to any of their ingredients.
• People who have an active autoimmune disease that required medical treatment within the past 2 years (hormone replacement therapy for certain conditions is generally not counted as this type of treatment — confirm with trial site).
• People who have a history of or currently have serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
• People who currently have an active infection that requires treatment through a drip or tablets.
• People with a known history of HIV.
• People with a known history of active Hepatitis B or Hepatitis C infection.
• People with any other medical condition, past treatment, or abnormal test result that the treating doctor believes would interfere with the study or would not be in the person's best interest.
• People with known serious mental health conditions or substance use disorders that would make it difficult to follow the trial requirements.
• Pregnant or breastfeeding people, or those planning to become pregnant or father children during the study period and for 120 days after the last dose.
• People with high blood pressure that remains uncontrolled (above 140/90 mmHg) despite optimised medication.
• People with abnormal electrolyte (blood salt) levels that have not been corrected.
• People with significant heart problems, including certain types of heart failure, unstable chest pain, a heart attack, or a stroke within the past 6 months, or a heart rhythm problem requiring treatment at the time of screening.
• People with bleeding disorders or blood clot disorders, or those considered at high risk of serious bleeding, including those whose tumour is located close to major blood vessels.
• People with higher-than-acceptable protein levels in their urine, unless a more detailed urine test confirms levels are within an acceptable range.
• People with conditions affecting how the gut absorbs food or medication, or any other condition that may affect how the study drug lenvatinib is absorbed.
• People with a specific type of abnormal heart electrical reading (QTc interval greater than 480 ms) on a heart tracing test.

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