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 at the time of signing the consent form
• People with a laboratory-confirmed diagnosis of squamous, adenocarcinoma, or adenosquamous cervical cancer that has come back or spread to other parts of the body
• People who have received up to 2 previous rounds of chemotherapy for advanced, metastatic, or recurrent cervical cancer
• People who have previously received a checkpoint inhibitor (an immune-boosting cancer drug) for advanced or recurrent cervical cancer, whether in the first or second round of treatment
• People who have previously received bevacizumab or a similar drug targeting blood vessel growth for recurrent or metastatic cervical cancer
• People who have had previous radiation therapy (this does not count as a line of treatment)
• People who received chemotherapy alongside radiation (such as cisplatin) — this does count as one line of treatment
• People who are not pregnant, not breastfeeding, and either cannot become pregnant or are using a highly reliable form of contraception (with a failure rate of less than 1% per year) or are consistently abstinent — and who agree to continue this for at least 120 days after the last dose of one study drug (pembrolizumab) or 30 days after the last dose of the other (lenvatinib), whichever comes later
• People who have had a negative pregnancy test within 24 hours before the first dose of the study treatment
• People who have had a PD-L1 test carried out on a tissue sample from the original or returning tumour
• People whose cancer got worse after receiving at least 2 doses of an anti-PD-1/L1 drug, with that worsening confirmed by a second scan at least 4 weeks later, and with disease progression documented within 12 weeks of the last dose
• People whose side effects from previous cancer treatments have mostly recovered to a mild level (Grade 1 or lower), or who have hormone-related side effects being well managed, or who have mild-to-moderate nerve-related side effects (Grade 2 or lower)
• People who have a measurable tumour that can be tracked on scans, as defined by standard measurement guidelines (RECIST 1.1)
• People who can provide a stored or freshly collected tumour tissue sample that has not been previously treated with radiation
• People who are in good enough general health to carry out light activity (performance score of 0 or 1 on a standard scale, assessed within 7 days before the first dose)
• People whose blood, liver, and kidney function meet the required levels (tested within 10 days before starting treatment)
• People with a history of Hepatitis B who have been on antiviral treatment for at least 4 weeks and have an undetectable level of the virus before joining
• People with a history of Hepatitis C who have completed curative antiviral treatment at least 4 weeks before joining and have an undetectable virus level at screening
• People whose blood pressure is at or below 150/90 mmHg, with no changes to blood pressure medication in the week before joining
• People who are able to understand the study and are willing to sign a written consent form

Who may not be able to join:

• People with a positive pregnancy test within 72 hours before enrolment
• People who have received any systemic cancer treatment (including experimental treatments) within 2 weeks before being assigned to the trial
• People who have had radiation therapy within 2 weeks before starting the study, or who have ongoing side effects from radiation that require steroid treatment
• People who have received a live or live-weakened vaccine within 30 days before the first dose
• People who have used an experimental drug or device within 4 weeks before starting the study
• People with an immune deficiency condition, or who are taking steroid medication at a dose above 10 mg of prednisone (or equivalent) daily, or any other immune-suppressing treatment within 7 days before the first dose
• People with another cancer that is still active or has required treatment within the past 5 years (note: certain treated skin cancers and non-bladder carcinoma in situ may still be eligible — confirm with trial site)
• People with active cancer that has spread to the brain or the lining around the brain, unless previously treated, stable on scans for at least 4 weeks, and not requiring steroids for at least 14 days
• People with a known severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients
• People with an active autoimmune disease that has required systemic treatment within the past 2 years (routine hormone or supplement replacement is generally acceptable — confirm with trial site)
• People with a history of serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition
• People with an active infection that requires treatment through medication given by mouth or injection
• People with a known history of HIV infection
• People with both active Hepatitis B and active Hepatitis C at the same time
• People who have had major surgery within 3 weeks before the first dose, or whose surgical wound has not healed adequately
• People with a psychiatric condition or substance use disorder that would make it difficult to follow the requirements of the trial
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and up to 120 days after the last dose
• People who have received an organ or tissue transplant from another person
• People with a pre-existing severe fistula (an abnormal passage or opening in the body, Grade 3 or higher) in the digestive tract or elsewhere
• People with high levels of protein in the urine (1 gram or more per 24 hours)
• People whose heart pumping function is below the normal range as measured by a heart scan
• People whose scans show the tumour is wrapping around or growing into a major blood vessel, or where the tumour has developed a hollow cavity
• People with a significantly prolonged heart electrical interval on an ECG (QTcF greater than 480 ms)
• People with serious heart or blood vessel problems in the 12 months before joining, such as severe heart failure, unstable chest pain, a heart attack, a stroke, or an irregular heartbeat that caused dangerous changes in blood flow
• People with a digestive condition that affects how well the body absorbs medication, which could interfere with one of the study drugs (lenvatinib)
• People who have coughed up significant amounts of bright red blood within 3 weeks before the first dose

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