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Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG

NCT02015104 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-07-01

Study results available
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Summary

Background:

\- Many cancers produce two particular proteins. The immune system can target these to attack the cancer. The PANVAC vaccine puts genes for these proteins inside a virus vaccine so the body sees the proteins as foreign invaders and attacks them. Researchers will test PANVAC on people with high grade non-muscle invasive bladder cancer. They will give it to people who have not responded to the usual treatment, bacillus Calmette-Guerin (BCG) over several weeks. They want to see if PANVAC plus BCG is better than BCG alone.

Objective:

\- To compare the effects of PANVAC plus BCG therapy, to BCG therapy alone.

Eligibility:

\- Adults 18 and older with high grade non-muscle invasive bladder cancer who failed at least 1 course of BCG.

Design:

* Participants will be screened with blood and urine tests and abdominal scans.
* Participants will be randomly assigned to get BCG only or BCG plus PANVAC.
* They will have up to 10 visits over 15 weeks. Most of these are part of usual cancer care.
* They will have blood and urine tests.
* All participants will get BCG in 6 weekly injections.
* One group will also get PANVAC in 5 injections over 15 weeks.
* Between weeks 17 and 20, participants will undergo tests of the tumor area as part of their usual care. They will have cystoscopy, exam under anesthesia, and bladder biopsy. Results will be used to evaluate the different treatments.
* Participants will have quarterly follow-up visits for up to 2 years.

Conditions

Interventions

BIOLOGICAL

BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG))

TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis

BIOLOGICAL

PANVAC

A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).

Sponsors & Collaborators

  • Rutgers Cancer Institute of New Jersey

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Raju Chelluri, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-18
Primary Completion
2018-09-18
Completion
2019-05-02
FDA Drug
Yes

Countries

  • United States

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 NCT02015104 on ClinicalTrials.gov