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VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer

NCT02371447 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-04-13

No results posted yet for this study

Summary

This phase I/II trial will assess the safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after TURB (transurethral resection of the bladder) and standard BCG therapy. In phase I part of the trial, a 3+3 dose de-escalation design will be applied to determine the recommended phase II dose (RP2D). In phase II part of the trial, a maximum of 39 patients will be treated at RP2D to further assess the preliminary efficacy of VPM1002BC.The efficacy and tolerability of VPM1002BC will be compared to results previously reported for BCG in a similar population. The quality of life will be also investigated as a secondary endpoint. Additional immunology assessments are foreseen as exploratory analyses to investigate the immunogenicity of VPM1002BC.

The Phase II of the trial has been opened on 27.07.2016.

Conditions

Interventions

DRUG

VPM1002BC

Phase 1: Induction: 6 intravesical instillations of VPM1002BC in 6-12 weeks (dose de-escalation in cohorts of 3-6 patients) Phase 2: Induction: VPM1002BC at RP2D established in phase I, 6 intravesical instillations in 6-12 weeks (n=39 including patients treated at RPD2 in phase I)

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Cyrill Rentsch, MD, PhD · University Hospital, Basel, Switzerland

  • Andreas Wicki, MD, PhD · University Hospital, Basel, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-08
Primary Completion
2019-10-22
Completion
2023-03-07

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT02371447 on ClinicalTrials.gov