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

NCT06050954 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-11-09

No results posted yet for this study

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.

Conditions

  • Metastatic Urothelial Carcinoma

Interventions

DRUG

Pembrolizumab (200mg)

200mg Pembrolizumab every six weeks via IV infusion.

DRUG

Pembrolizumab (400mg)

400mg Pembrolizumab every six weeks via IV infusion.

DIAGNOSTIC_TEST

Monitoring

active surveillance and monitoring via continued serial ctDNA testing and radiographic assessments at regular intervals.

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Benjamin Miron · Fox Chase Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2027-01-31
Completion
2032-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06050954 on ClinicalTrials.gov