RecruitingPhase 1Phase 2NCT02138734

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

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

Sponsor

ImmunityBio, Inc.

Enrollment

596 participants

Start Date

Jul 21, 2014

Study Type

INTERVENTIONAL

Conditions

Non Muscle Invasive Bladder Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a new immune-boosting drug called ALT-803 (a molecule that activates natural killer cells and T cells) to the standard BCG bladder treatment can make it more effective at preventing the return of non-muscle-invasive bladder cancer (cancer that has not yet grown deep into the bladder wall). **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-grade, non-muscle-invasive bladder cancer (cancer in the bladder lining) - You have either not received BCG before, or it has been more than 3 years since your last BCG treatment - Your cancer has been completely removed or only carcinoma in situ (CIS) remains - Your blood counts and organ function are acceptable **You may NOT be eligible if...** - Your bladder cancer has grown into the muscle wall - You have previously failed BCG treatment within the last 3 years - You have upper urinary tract cancer - You have active autoimmune disease, are on immune-suppressing drugs, or are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). )

BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG+N-803 for 3 consecutive weeks at 3, 6, 12, 18, 24,30 and 36 months. An additional 6 week re-induction of BCG+N-803 for patients with eligible disease at 3 months in phase IIb is included.

BIOLOGICALBCG( 50mg/Instillation)

BCG will be administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG for 3 consecutive weeks at 3, 6, 12, 18, 24, 30 and 36 months. An additional 6 week re-induction of BCG for patients with eligible disease at 3 months in phase IIb is included.

Locations(80)

Indriyani Hospital & Cancer Institute

Pune, Maharashtra, India

Onco Life Cancer Center

Pune, India

Inamdar Hospital Pune

Pune, India

Integrated Medical Professionals

New York, New York, United States

NYU Langone Health

New York, New York, United States

Associated Urological Specialists

Chicago, Illinois, United States

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, United States

Rush University

Chicago, Illinois, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Adult & Pediatric Urology

Omaha, Nebraska, United States

Associated Urologists of North Carolina

Raleigh, North Carolina, United States

Urology Group of New Mexico (AccumetRx Clinical Research)

Albuquerque, New Mexico, United States

Hoag Cancer Center

Irvine, California, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Skyline Sherman Oaks

Sherman Oaks, California, United States

Skyline Urology

Torrance, California, United States

Eastern Connecticut Hematology & Oncology Associates

Norwich, Connecticut, United States

Memorial Healthcare System

Hollywood, Florida, United States

Advanced Urology Institute

Oxford, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

Florida Urology Partners

Riverview, Florida, United States

UroPartners

Glenview, Illinois, United States

Urology of Indiana

Carmel, Indiana, United States

Kansas University Medical Center

Westwood, Kansas, United States

Comprehensive Urology

Royal Oak, Michigan, United States

Specialty Clinical Research of St. Louis

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Winthrop University Hospital

Mineola, New York, United States

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, United States

Associated Medical Professionals of NY

Syracuse, New York, United States

Central Ohio Urology Group

Gahanna, Ohio, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Lowcountry Urology Clinics

North Charleston, South Carolina, United States

Erlanger Health

Chattanooga, Tennessee, United States

Arkansas Urology

Little Rock, Arkansas, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

University of California San Diego

San Diego, California, United States

The Urology Group

Cincinnati, Ohio, United States

Moffitt Cancer Center

Tampa, Florida, United States

Alaska Clinical Research Center

Anchorage, Alaska, United States

UCLA Department of Urology

Los Angeles, California, United States

Urology Partners of North Texas

Arlington, Texas, United States

B J Medical College & Civil Hospital, Asarwa, Ahmedaba

Ahmedabad, India

Urology San Antonio

San Antonio, Texas, United States

HCG Bangalore

Bengaluru, India

Potomac Urology

Alexandria, Virginia, United States

Binayak Multispecialty Hospital

Kolkata, India

Chittaranjan National Cancer Institute

Kolkata, India

Pi Health Cancer Hospital

Hyderabad, Telangana, India

HCG Cancer Centre

Visakhapatnam, Andhra Pradesh, India

Darakh Nursing Home and Kidney Stone Centre

Aurangabad, Maharashtra, India

Kidney Centre Jasleen Hospital

Nagpur, Maharashtra, India

Erode Cancer Centre

Erode, Tamilnadu. India, India

Swami Harshankaranand JI Hospital and Research Centre

Sunderpur, Varanasi, India

Basavatarakam Indo American Cancer Hospital & Research Institute

Banjara Hills, India

SP Medical College and Hospital

Bikaner, India

Guru Govnid Singh Medical College and Hospital

Farīdkot, India

Muljibhai Patel Urological Hospital

Gujrāt, India

KR Hospital

Mysuru, India

KMC Manipal

Nagar, India

Jasleen Hospital

Nagpur, India

Urocare Hospital

Rajkot, India

All India Institute of Medical Sciences, Raipur

Rajpura, India

Uttar Pradesh University of Medical Sciences

Uttar, India

HCG cancer Centre, Vizag

Visakhapatnam, India

Apollo Vizag

Visakhapatnam, India

SunningHill Hospital

Sandton, South Africa

Urology Associates

Nashville, Tennessee, United States

Texas Oncology

Austin, Texas, United States

Houston Metro Urology

Houston, Texas, United States

Virginia Urology

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Urology of Virginia

Virginia Beach, Virginia, United States

HCG Manavata Cancer Centre

Mumbai, Nashik, India

University of Washington School of Medicine

Seattle, Washington, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of California, Davis

Sacramento, California, United States

Urology Austin, PLLC, Research Department

Austin, Texas, United States

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