Phase 2 Bladder Cancer Trial, Terminated

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:

• People who have been diagnosed with an advanced or spreading solid tumour, confirmed by a tissue or cell sample.
• People who have at least one tumour that can be measured on a scan (using standard measurement guidelines) and has not previously been treated with radiation.
• People who have a tumour tissue sample available from within the past year, with no cancer treatment received between that sample and joining the study.
• People who have not previously received PD-1 or PD-L1 treatments (except for one specific group — see Combination F below).
• Combination A (a specific treatment group): In the early phase, people with a type of lung cancer called NSCLC whose cancer has grown despite standard treatment, or where no standard treatment exists. In the later phase, people with NSCLC, melanoma, a head and neck cancer called SCCHN, a type of breast cancer called TNBC, small cell lung cancer (SCLC), or previously untreated NSCLC. Untreated NSCLC must show a specific protein marker called PD-L1. Certain lung cancer gene changes (EGFR, ALK, ROS1) are not permitted in this group.
• Combination B (a specific treatment group): In the early phase, people with advanced solid tumours (NSCLC, SCCHN, or melanoma) that have progressed despite standard treatment or where no standard treatment is available. In the later phase, people with NSCLC, melanoma, or SCCHN, with up to two prior treatments for advanced disease. Certain lung cancer gene changes (EGFR, ALK, ROS1) are not permitted.
• Combination C (a specific treatment group): People with ovarian cancer, SCCHN, NSCLC, stomach cancer, platinum-resistant ovarian cancer, or a rare joint tumour condition called TGCT/PVNS that cannot be surgically removed or would need very extensive surgery. Up to two prior treatments for advanced disease are allowed. Prior treatment with drugs targeting a specific protein pathway (CSF-1/CSF-1R) is not allowed. Certain lung cancer gene changes (EGFR, ALK, ROS1) are not permitted.
• Combination D (a specific treatment group): People with NSCLC, melanoma, SCCHN, or bladder cancer, with up to two prior treatments for advanced disease. Certain lung cancer gene changes (EGFR, ALK, ROS1) are not permitted.
• Combination F (a specific treatment group): People with returning or spreading SCCHN who have received between one and three prior systemic treatments for advanced or spreading disease, including at least two doses of a PD-1 or PD-L1 treatment. The cancer must have shown signs of growing on scans, no earlier than six weeks after starting the most recent cancer treatment. A tumour must be present that a doctor can safely inject directly.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People expected to live for at least three more months.
• People whose blood counts, kidney function, and liver function are within acceptable levels.
• People who have recovered from side effects of any previous cancer treatment.
• People who test negative for pregnancy on a blood test at the screening stage.
• People who are capable of having children (male or female) and who agree to use at least one highly effective form of contraception throughout the study and for at least 90 days after the last dose.
• People who have read, understood, and signed the consent form for the study.

Who may not be able to join:

• People who have received a certain type of cancer treatment called a monoclonal antibody within 28 days before joining, or a targeted therapy or chemotherapy within 14 days before joining. For Combination F, PD-1 or PD-L1 treatment within 14 days before joining is also not permitted.
• People who have used medications that suppress the immune system within the past 7 days.
• People with an active autoimmune disease (where the immune system attacks the body) that has required steroids or immune-suppressing drugs within the past 7 days.
• People with a known or suspected allergic reaction to any of the study drugs.
• People who have had major surgery within 4 weeks, or radiation therapy within 14 days, before joining.
• People with brain tumours that are causing symptoms and require steroid treatment.
• People who have previously received very high-dose chemotherapy that required a stem cell rescue procedure.
• People who have previously received a stem cell transplant from another person, or an organ transplant.
• People who have experienced any of the following within the past 6 months: a heart attack, uncontrolled chest pain, heart bypass surgery, significant heart failure symptoms, a stroke, or a mini-stroke.
• People who have had a blood clot in the lungs causing symptoms within the past 6 months.
• People with a known HIV infection or AIDS-related illness.
• People who currently have an active infection requiring treatment with medication.
• People who test positive for active or chronic hepatitis B or hepatitis C infection.
• People who have received a live vaccine within 4 weeks before joining.
• People who have been diagnosed with another cancer within the past 5 years — except for certain treated skin cancers, very early-stage breast or cervical cancer, or low-grade prostate cancer (confirm specifics with trial site).
• People who are currently taking part in, or have taken part in, another clinical trial involving an experimental drug within the past 4 weeks.
• People who still have side effects from a previous treatment that are above a mild level (above Grade 1 on a standard medical scale).
• People with other serious ongoing medical conditions.
• Combination C only: People who have existing swelling around the eye area.
• Combination C only: People with low calcium levels, significant bone disease, or a bone fracture that occurred within the past 12 weeks.

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