Phase 2 Ovarian Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who are willing and able to sign a written consent form agreeing to take part in the trial.
• People who are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with an advanced cancer confirmed through laboratory testing of a tissue sample.
• People who are unable to tolerate standard cancer treatment, have chosen not to have it, or are not considered suitable for it.
• People who have at least one cancer lesion that can be measured using standard imaging guidelines (called RECIST).
• People who are able to safely have a small tissue sample (biopsy) taken from a tumour that has not previously been treated with radiation, at least 4 weeks after their last cancer treatment.
• People who are expected to live for at least 12 weeks.
• People who are considered physically well enough to carry out light activity and care for themselves, based on a standard medical scoring system (ECOG score of 0 or 1).
• People whose liver, kidneys, and other organs are functioning well enough, as confirmed by blood tests.

For people with ovarian cancer specifically:

• People with a laboratory-confirmed diagnosis of recurring ovarian, fallopian tube, or peritoneal cancer.

For people with T-cell lymphoma (TCL/CTCL) specifically:

• People with a laboratory-confirmed diagnosis of T-cell lymphoma.
• People who are at disease stage IB through IV and whose cancer has not responded to at least one previous systemic (whole-body) treatment.
• People who have not had large cell transformation of their CTCL.
• People who have not previously had an allogeneic (donor) stem cell transplant, are more than 90 days out from an autologous (own cells) stem cell transplant, are more than 4 weeks past their last systemic treatment, and more than 2 weeks past their last skin-directed treatment.
• People who are on stable, low-dose steroid medication (no more than 20 mg prednisone or equivalent per day, unchanged for the past 4 weeks) and/or low-to-medium strength topical steroids.
• People who have previously received certain specific treatments including brentuximab vedotin, bexarotene, extracorporeal photopheresis, methotrexate, mogamulizumab, romidepsin, vorinostat, or systemic therapy combined with localised radiation or skin-directed therapy (confirm with trial site).

For people with melanoma specifically:

• People with a laboratory-confirmed diagnosis of melanoma that cannot be surgically removed or has spread to other parts of the body.
• People (in Part A of the study) who have previously been treated with a type of immunotherapy called anti-PD-1 therapy, either alone or in combination with other treatments.
• People (in Part A) with a specific genetic change in their cancer known as a BRAF V600 mutation who have also previously received targeted combination therapy in addition to anti-PD-1/PD-L1 therapy.
• People (in Part B of the study) who have not previously received any lines of treatment for their melanoma.

For all solid tumour types:

• People with locally advanced, unresectable, recurring, or metastatic solid tumours that have not previously been treated with immune checkpoint inhibitor therapy, and whose cancer is considered likely to respond to that type of treatment, based on the treating doctor's judgement.
• People who have already received standard treatment appropriate for their cancer type and stage, or whom the treating doctor considers unlikely to tolerate or benefit from standard treatment.
• People with a known activating gene mutation in their cancer who have already received targeted therapy for that mutation.

Who may not be able to join:

• People who need to take more than 10 mg of prednisolone (or an equivalent steroid dose) daily while on the trial, except as a pre-medication before treatment.
• People with active cancer that has spread to the brain or the lining of the brain and spinal cord.
• People with a known or suspected allergic reaction to either of the trial drugs (BI-1808 or pembrolizumab).
• People who have a condition called cardiac or renal amyloid light-chain amyloidosis (a disease involving abnormal protein deposits in the heart or kidneys).
• People who have received chemotherapy or certain targeted cancer medicines within 4 weeks before the first trial dose.
• People who have received radiotherapy within 2 weeks before the first trial dose, or within 1 week for limited palliative radiation to non-brain areas (people who have previously had radiation-related lung inflammation are not eligible).
• People who have received immunotherapy within 4 weeks before the first trial dose.
• People who have not yet recovered from side effects of previous cancer treatments to an acceptable level.
• People who have previously experienced severe (Grade 3 or higher) immune-related side effects from prior immunotherapy treatments such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies.
• People who have a history of non-infectious lung inflammation that required steroid treatment, or who currently have lung inflammation.
• People who have an active, known, or suspected autoimmune disease (a condition where the immune system attacks the body's own tissues).
• People who are pregnant, breastfeeding, or capable of becoming pregnant — unless a pregnancy test before enrolment is negative and highly effective contraception is used for 4 weeks before joining, throughout the trial, and for 12 months after the last dose of BI-1808.
• Male participants whose partner(s) could become pregnant, unless they agree to use effective contraception (condom plus spermicide gel) during the trial and for 12 months after completing treatment.
• People who have recently had major surgery and have not yet fully recovered.
• People with serious non-cancer medical conditions, including severe active infections currently being treated with antibiotics, antifungal, or antiviral medicines.
• People with chronic graft-versus-host disease (a condition that can occur after a donor stem cell transplant).
• People who have had an organ or tissue transplant from a donor.
• People with a known HIV infection, a history of hepatitis B or C, or a positive test result for HIV, hepatitis B, or hepatitis C.
• People with a history of active tuberculosis.
• People who have received a live vaccine within 30 days before the first trial dose.
• People with uncontrolled or significant heart disease.
• People with a known psychiatric condition or substance use disorder that could prevent them from being able to follow the trial requirements.
• People with any other condition, treatment history, or abnormal test result that, in the treating doctor's opinion, could affect the trial results, interfere with participation, or make participation not in the person's best interest.
• People who are currently taking part in, or planning to join, another interventional clinical trial, or who have used an experimental drug or device within 4 weeks before the first trial dose.
• People who have another type of cancer, with the exception of certain early-stage or skin cancers that have been adequately treated (confirm with trial site), or male participants with low-risk, stable prostate cancer meeting specific criteria (confirm with trial site).
• People with a primary or acquired immune deficiency disorder, or who have taken immunosuppressive medication within 7 days before the first trial dose.
• People with problematic fluid build-up in the abdomen or around the lungs that requires surgical treatment or additional medication.

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