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A Pilot Study of Circulating Tumor DNA Adaptive Risk Maintenance Approach for Bladder Cancer (CARMA) — CARMA  

Metastatic Urothelial Carcinoma Clinical Trial

Official title:
GU-216: A Pilot Study of Circulating Tumor DNA Adaptive Risk Maintenance Approach for Bladder Cancer (CARMA)

Clinical Trial Summary

Platinum-based chemotherapy remains the standard of care for advanced/metastatic unresectable bladder cancer. The JAVELIN Bladder 100 and HCRN GU14-182 trials showed that maintenance immune checkpoint inhibition(ICI) for those that achieved disease control could prolong progression-free survival (overall survival benefit in JAVELIN may have been related to the lack of guaranteed crossover at time of progression). Of note, both of these studies showed consistency with regards to the magnitude of the PFS benefit which was ~40% vs ~20% at 6-months with maintenance ICI compared to BSC/placebo. Maintenance avelumab is now category 1 on the NCCN guidelines. However, some patients prefer prolonged chemotherapy responses and literature supports a treatment break without effecting longevity. The underlying risk resides in the selection of patients with some (currently difficult to diagnose) progressing rapidly. This trial proposes to use ctDNA to stratify chemo-responsive patients to active surveillance (i.e. a ctDNA responder referred to here as "ctDNA-") vs SOC maintenance pembrolizumab (ctDNA+). All patients will be treated with SOC chemotherapy and only patients with an objective (RECIST) response will be stratified. This is a non-randomized phase 2 study with two arms based on ctDNA 1. Pembrolizumab (ctDNA non-responder) maintenance therapy arm (SOC) 2. Active surveillance arm (ctDNA responders) with serial ctDNA and crossover 1st line chemotherapy is based on physician discretion choice as described in the protocol. Patients with metastatic Urothelial Cancer are enrolled prior to initiation of SOC chemotherapy. Based on ORR (CR + PR), it is estimated that 75 patients will need to enroll onto the protocol to find 25 responders for the two arms.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06050954
Study type Interventional
Source Fox Chase Cancer Center
Contact
Status Withdrawn
Phase Phase 2
Start date September 2023
Completion date January 2032
View Details
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