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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeslie Ballas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET.

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Disqualifiers

Evidence of diffuse cis on pathology

Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral)

Prior radiotherapy to the pelvis

History of systemic therapy for MIBS

Trial design

Design model

Single group

Treatments tested in this trial

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

    Drug

    Single-arm, open-label

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of initiating TMT

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

Time frame
45 days

Secondary outcomes

1

3-year bladder intact event free survival (BIEFS)

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

Time frame
3 year

Other outcomes

1

Progression free (<=T2) survival rates

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

Time frame
3 year
2

Metastasis-free survival

To estimate the metastasis-free survival of TMT

Time frame
3 year
3

Rate of salvage cystectomy

To estimate the rate of salvage cystectomy following TMT

Time frame
3 year
4

Blood and urine correlatives of clinical outcomes

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

Time frame
3 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leslie Ballas

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution