Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer

The purpose of this study is to examine the safety and tolerability of treatment with concurrent Sacituzumab Govitecan (SG) and adaptive radiation therapy. The main objective is to establish the safety, tolerability, and feasibility of bladder preservation therapy treatment with concurrent SG and adaptive image-guided radiation therapy for participants with localized MIBC. Participants will receive the study drug, SG, through an IV once weekly on days 1 and 8 of each 21-day treatment cycle. The first cycle of SG will begin 21 days prior to the scheduled start of radiation therapy. The second a

Trial Details

NCT ID
NCT05833867
Phase
PHASE1
Sponsor
Shilpa Gupta, MD
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Sacituzumab govitecan
  • Adaptive Radiotherapy
Locations (sample)
  • Cleveland, Ohio, United States|41.4995,-81.69541

Key Eligibility Criteria

  • Participants must have histologically or cytologically confirmed muscle-invasive bladder cancer (MIBC) (T2-T4aN0M0). Participants with mixed urothe…
  • Participants must have received no prior systemic chemotherapy for this disease. Participants must refuse conventional radio-sensitizing chemothera…
  • Performance status: ECOG Performance status ≤ 2
  • Participants must have normal organ and marrow function as defined below:

For full eligibility, visit ClinicalTrials.gov.

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