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March 4, 2026Journal of Clinical Oncology

A phase II clinical trial of neoadjuvant sasanlimab and stereotactic body radiation therapy as an in situ vaccine for cisplatin-ineligible muscle invasive bladder cancer: The RAD VACCINE MIBC clinical trial.

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Authors

RSRaj SatkunasivamFNFotis NikolosRTRenil S. Titus

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Overview

Phase II trial demonstrates meaningful pathologic complete response in bladder cancer patients ineligible for chemotherapy, suggesting new treatment potential.

Key Points

  • To evaluate the safety and efficacy of combining sasanlimab with stereotactic body radiation therapy for muscle invasive bladder cancer patients ineligible for chemotherapy.
  • Conducted a phase II clinical trial with 33 patients who were ineligible for cisplatin-based chemotherapy.
  • Administered two doses of sasanlimab with stereotactic body radiation therapy prior to radical cystectomy.
  • Evaluated the primary endpoint of pathologic complete response (pCR) and secondary endpoints including adverse events and quality of life.
  • Achieved a 44.8% pathologic complete response rate and 75.9% down-staging to pT0/Ta/T1.
  • Two-year metastasis-free survival was 72.2%, with 92.3% for pCR patients.
  • Only 9.1% of patients experienced grade ≥3 treatment-related adverse events, indicating acceptable toxicity.

Cite This Study

Satkunasivam et al. (2026) studied this question.

synapsesocial.com/papers/69a7ccc3d48f933b5eed87c0https://doi.org/10.1200/jco.2026.44.7_suppl.750
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Immune features are associated with response to neoadjuvant chemo-immunotherapy for muscle-invasive bladder cancer2024 · 29 citations
  2. 2SWOG 2427: Single arm phase II study of bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant therapy in patients with muscle invasive bladder cancer (BRIGHT).2026
  3. 3Induction ipilimumab plus nivolumab followed by consolidating chemoradiotherapy as bladder-sparing treatment in stage II/III urothelial carcinoma of the bladder: The phase 2 Indi-Blade trial.2026
  4. 4Intravesical recombinant BCG combined with chemo-immunotherapy (chemo-IO) as perioperative therapy for patients with muscle-invasive bladder cancer (MIBC): Primary analysis of SAKK 06/19.2026
  5. 5SASAN-SPARING: A phase 2 trial of sasanlimab maintenance as bladder-sparing option after neoadjuvant chemotherapy in patients with muscle invasive bladder cancer.2026