RECRUITING

A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

Talk to us

Conditions

Non-muscle Invasive Bladder CancerantitumorBCGbladder cancercancerimmunotherapyinstillationinterleukin-15intravesicalnaivenon-muscle invasivetransitional cell carcinomaALT-803N-803

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.

Official Title

A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer

Quick Facts

Study Start:2014-07-21
Study Completion:2038-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02138734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Paula Bradshaw, MPH, MBA
CONTACT
844-413-8500
paula.bradshaw@immunitybio.com
Atessa H Kiani, BS
CONTACT
9499038749
atessa.kiani@immunitybio.com

Principal Investigator

Bobby Reddy, MD
STUDY_DIRECTOR
ImmunityBio, Inc.

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Alaska Clinical Research Center
Anchorage, Alaska, 99503
United States
Arkansas Urology
Little Rock, Arkansas, 72211
United States
Hoag Cancer Center
Irvine, California, 92618
United States
UCLA Department of Urology
Los Angeles, California, 90095
United States
University of California, Davis
Sacramento, California, 95817
United States
Skyline Sherman Oaks
Sherman Oaks, California, 91411
United States
Skyline Urology
Torrance, California, 90505
United States
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, 06360
United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States
Kansas University Medical Center
Westwood, Kansas, 66205
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Adult & Pediatric Urology
Omaha, Nebraska, 68114
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Urology Group of New Mexico (AccumetRx Clinical Research)
Albuquerque, New Mexico, 87109
United States
Winthrop University Hospital
Mineola, New York, 11501
United States
Manhattan Medical Research
New York, New York, 10016
United States
NYU Langone
New York, New York, 10016
United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27278
United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
United States
Virginia Urology
Richmond, Virginia, 23235
United States
University of Washington School of Medicine
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: ImmunityBio, Inc.

  • Bobby Reddy, MD, STUDY_DIRECTOR, ImmunityBio, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-07-21
Study Completion Date2038-12

Study Record Updates

Study Start Date2014-07-21
Study Completion Date2038-12

Terms related to this study

Keywords Provided by Researchers

  • antitumor
  • BCG
  • bladder cancer
  • cancer
  • immunotherapy
  • instillation
  • interleukin-15
  • intravesical
  • naive
  • non-muscle invasive
  • transitional cell carcinoma
  • ALT-803
  • N-803

Additional Relevant MeSH Terms

  • Non-muscle Invasive Bladder Cancer