Details
Description
To assess the efficacy of intermittent CPI therapy, defined as the proportion of patients who remain off therapy for at least 36 weeks Secondary Objective(s)To determine the clinical outcome (TFI, ORR, PFS, OS) in advanced urothelialcarcinoma with intermittent CPI therapy. To assess response to re-initiation of CPI therapy
Inclusion Criteria
Exclusion Criteria
Details
Title A Phase II Study of Intermittent Checkpoint Inhibitor Therapy in Patients with Advanced Urothelial Carcinoma
IRB CASE6819
CC 20-162
Hospital Fairview, Hillcrest, Main Campus
Stage Advanced-Metastatic
Phase Phase 2
Disease Bladder
Description
Primary ObjectiveInclusion Criteria
- Men and women ≥ 18 years of age.
- Histological confirmation of urothelial carcinoma (any histology)
- Advanced or metastatic urothelial carcinoma.
- Has received at least 24 weeks (+/- 4 weeks) on CPI therapy per standard of care (SOC) for advanced urothelial carcinoma
- Karnofsky Performance Score (KPS) ≥70% (for more information on KPS, please see: http://www.npcrc.org/files/news/karnofsky_performance_scale.pdf)
- Willing and able to provide informed consent.
- Laboratory criteria for study entry must meet the following criteria:
- Serum creatinine ≤ 2 x ULN OR CrCl ≥ 30 mL/min (measured or calculated using the Cockcroft-Gault formula).
- Hb ≥ 8.0g/dL
- AST and ALT ≤ 3.0 x ULN
- Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Exclusion Criteria
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Patients are excluded if they have known HIV/AIDS.
- Major surgery (eg, cystectomy) less than 28 days prior to the first dose of study drug.
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 7 days prior to the first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
- Known medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.
- Pregnant women are excluded from this study because animal studies have demonstrated that PD-1/PD-L1 inhibitors can cause fetal harm when administered to pregnant women. Breastfeeding women are excluded from this study because PD-1/PD-L1 inhibitors may be excreted in human milk and the potential for serious adverse reactions in nursing infants
