Immunotherapy Plus Capivasertib for Metastatic Bladder Cancer

You may not qualify if:

• Patients who have undergone major surgery within 4 weeks, or major radiation therapy within 2 weeks, prior to starting treatment. Prior palliative radiotherapy is permitted if completed at least 48 hours before study entry
• Receipt of another investigational agent within the past 4 weeks. Participation in observational studies is allowed
• Persistent toxicities (CTCAE Grade ≥2) from previous anticancer therapy, except for alopecia. Patients with irreversible toxicity not reasonably expected to be exacerbated by study intervention (as deemed by the investigator, such as hearing loss) may be included.
• Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow capivasertib, or prior significant bowel resection that may impair adequate absorption, distribution, metabolism, or excretion of capivasertib.
• Active tuberculosis infection, as determined by clinical evaluation, imaging, or tuberculosis testing per local practice
• Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor
• Known or suspected hypersensitivity to study drugs or any of their components
• Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to study intervention. Patients with previously treated CNS metastases may be eligible if they have recovered from acute effects of radiation or surgery, discontinued corticosteroids for at least 4 weeks, and are neurologically stable
• Diagnosis of any other malignancy within the past 3 years, except adequately treated basal or squamous cell skin cancer, other Stage 0 or 1 cancers, or incidental prostate cancer found at cystoprostatectomy
• Moderate to severe symptoms from metastatic cancer, including moderate to severe pain, impaired organ function, or spinal cord compression
• Active autoimmune disease likely to worsen with ICI therapy. Patients with vitiligo, psoriasis, or thyroid disorders controlled without immunosuppressive therapy are eligible
• Known severe hypersensitivity reactions (Grade \>3) to monoclonal antibodies, history of anaphylaxis, or uncontrolled asthma
• History or concurrent condition of interstitial lung disease or severely impaired lung function, as judged by the investigator
• Any of the following cardiac risks:
• Mean resting corrected QT interval (QTc) \>470 milliseconds (ms) from triplicate ECGs at screening
• +20 more criteria