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Neoadjuvant chemotherapy followed by trimodal therapy consisting of TURBT followed by concurrent chemotherapy with radiation therapy

Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)

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Leslie Ballas, MD

Anirban Mitra, MD, PhD

Michael Ahdoor, MD

Charles Rosser, MD

This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +/- IO and is therefore a viable option in patients who are risk of systemic disease spread.

Trimodal therapy (TMT) is accepted as an NCCN category 1 alternative to radical cystectomy (with neoadjuvant chemotherapy) in patients with cT2N0M0 muscle-invasive urothelial cell bladder cancer (MIBC). Not all patients with MIBC have pure urothelial cell carcinoma; urothelial carcinoma with variant histology (VH) described any morphologic variant of conventional urothelial carcinoma that is believed to be derived from urothelial carcinoma and is typically admixed with conventional urothelial carcinoma in the same tumor. Variant histologies described include squamous differentiation, glandular differentiation, micropapillary, sarcomatoid, small cell/neuroendocrine, plasmacytoid and nested variant. This is a rare tumor type and understudied. For patients with variant histologies there is limited data on the use of trimodal therapy. There are a couple single institution retrospective studies and data from the NCDB, but no prospective data.

Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology

IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology

To estimate progression free (\<=T2) survival rates from TMT

To estimate the metastasis-free survival of TMT

To estimate the rate of salvage cystectomy following TMT

To investigate blood and urine correlatives of clinical outcomes (Signatera and Oncuria)

To evaluate the feasibility of initiating TMT within 45 days of completion of NAC - Feasibility will be defined as at least 17 study participants initiating TMT within 45 days of NAC

To estimate 3-year bladder intact event free survival (BIEFS) in patients undergoing TMT for MIBC with VH-TMT

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology	NCT06417190	Muscle-Invasive... Tumor	Trimodal therap...	18 Years -	Cedars-Sinai Medical Center
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology	NCT06417190	Muscle-Invasive... Tumor	Trimodal therap...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for trimodal therapy (tmt) within 45 days of neoadjuvant chemotherapy (nac)