Study on Durvalumab and Monalizumab for Non-Muscle-Invasive Bladder Cancer

Inclusion Criteria

• Must be 18 years or older.
• Willing to follow the study protocol, including treatments and visits.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Diagnosed with non-muscle-invasive bladder cancer:
  • Group A: Cancer in situ (CIS) with or without high-grade papillary cancer.
  • Group B: High-grade papillary cancer without CIS.
• Mixed variant histology is allowed, but pure variant histology is not.
• Persistent disease after completing BCG therapy, with specific conditions on timing and dosage.
• High-grade recurrence within certain timeframes after BCG therapy.
• May have had one prior line of chemotherapy after BCG.
• Deemed unfit for or refuse radical cystectomy.
• All visible tumors must be removed before joining the study.
• Must provide tumor tissue samples for study purposes.
• Adequate organ function based on specific blood test results.
• Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
• Men must agree to use contraception.
• Must have a life expectancy of at least 12 weeks.

Exclusion Criteria

• Previous treatment with certain immune therapies.
• Prior cancer in the ureters or prostatic urethra within 24 months.
• Evidence of cancer spread to other parts of the body.
• Weigh less than 30 kg.
• History of organ transplantation.
• Recent history of other cancers, with some exceptions.
• Participation in another clinical trial recently.
• Active or recent autoimmune or inflammatory disorders requiring treatment.
• Immunodeficiency or recent use of immunosuppressive therapy.
• Psychiatric or substance abuse issues affecting study participation.
• Active infections like tuberculosis or herpes zoster.
• History of lung diseases like pneumonitis.
• HIV positive unless well-controlled.
• Active hepatitis infection.
• Allergy to study drugs.
• Recent live vaccinations.
• Recent major surgery.
• Uncontrolled health conditions like heart failure or hypertension.
• Pregnant or breastfeeding women, or those not using birth control.
• Unresolved side effects from previous cancer treatments.
• Concurrent cancer treatments.
• History of certain brain conditions.
• Recent use of immunosuppressive medication, with some exceptions.