Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invas… (NCT05241340) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer
United States33 participantsStarted 2022-02-15
Plain-language summary
This is a prospective, single-institution, single-arm, phase II clinical trial that tests a novel strategy of neoadjuvant Sasanlimab, an immune checkpoint inhibitor (ICI), in combination with stereotactic body radiation therapy as an in-situ vaccination in patients, who are ineligible to receive cisplatin-based chemotherapy and undergoing radical cystectomy for muscle-invasive bladder cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Capable of giving signed informed consent
✓. Age ≥ 18 years
✓. ECOG Eastern Cooperative Oncology Group performance status 0-2
✓. Muscle-invasive bladder cancer (cT2-4a, cN0, cM0)
✓. Decline/refuse OR Ineligible to receive cisplatin-based Neoadjuvant Chemotherapy due to at least one of the following criteria:
✓. Adequate Bone Marrow Function (without hematopoietic growth factor support within 14 days prior to study screening), defined as:
✓. Adequate renal function defined by an estimated creatinine clearance ≥30 mL/min according to the Cockcroft Gault formula or by 24-hour urine collection for creatinine clearance.
Exclusion criteria
✕. Lymphadenopathy (\>1cm short-axis measurement on CT/MRI Imaging or biopsy proven)
✕. Metastatic disease
✕. Prior systemic chemotherapy for bladder cancer (however, may have had intra-vesical chemotherapy such as gemcitabine, docetaxel or mitomycin-C)
✕. Prior treatment with systemic anti-cancer investigational agent
✕. Other malignancy within 2 years prior to study screening, or active malignancy except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance without any plans for treatment intervention (e.g., surgery, radiation, or castration) or other concurrent malignancy felt by the investigator has a very low likelihood to become metastatic
What they're measuring
1
Composite outcome for Feasibility and Safety
Timeframe: From date of registration to date of death due to any cause, assessed up to 4 weeks after radical cystectomy
2
Clinical benefit rate defined as pathologic complete response (pT0)