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ACTIVE NOT RECRUITING

NCT02138734

PHASE1/PHASE2

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

Sponsor: ImmunityBio, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

369

Start Date

2014-07-21

Completion Date

2039-03-04

Last Updated

2026-03-31

Healthy Volunteers

Conditions

Non-muscle Invasive Bladder Cancer

Interventions

BIOLOGICAL

BCG (50mg/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.

BIOLOGICAL

BCG (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.

Inclusion Criteria 1. Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology). 1. Cohort A: Histologically confirmed CIS (with or without Ta/T1 disease); Cohort B: Histologically confirmed high-grade papillary disease (Ta/T1 only). 2. Patients are eligible if the diagnostic biopsy was done within 3 months of treatment start and a cystoscopy demonstrating no resectable disease was done within 6 calendar weeks (inclusive of 48 days) of treatment start (residual CIS is acceptable; patients with T1 disease must undergo repeat resection if muscularis propria is not present in each biopsy sample). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment. 3. Upper tract imaging within 6 months prior to study entry must not be suspicious for upper tract malignancy. 2. Currently eligible for intravesical BCG therapy. 3. Age ≥ 18 years. 4. Performance status: ECOG performance status of 0, 1, or 2. 5. BCG-naive disease as defined as either of the following: 1. Have not received prior intravesical BCG; or 2. Previously received BCG, but stopped receiving more than 3 years before date of randomization. 6. Laboratory tests performed within 21 days of treatment start: 1. Absolute lymphocyte count ≥ Institutional lower limit of normal 2. Absolute neutrophil count (AGC/ANC) ≥ 1,000/μL 3. Platelets ≥ 100,000/µL \[Patients may be transfused to meet this requirement\] 4. Hemoglobin ≥ 8 g/dL \[Patients may be transfused to meet this requirement\] 5. Calculated glomerular filtration rate (GFR\*) \>40 mL/min or Serum creatinine ≤ 1.5 x ULN 6. Total bilirubin ≤ 2.0 X ULN 7. AST, ALT, ALP ≤ 3.0 X ULN 7. Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction. PFT \> 50% FEV1 if clinically indicated by the investigator. 8. Negative serum pregnancy test if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized). 9. Female participants of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study. 10. Provide signed informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations. * using the following Cockcroft-Gault equation to calculate the eGFR for this study: eGFR in mL/min = {(140-age in years) x (weight in kg) x F}/(serum creatinine in mg/dL x 72) Where F =1 if male; and 0.85 if female Exclusion Criteria 1. Prior BCG treatment or known hypersensitivity to BCG. Patients who have received more than a single-dose post-operative treatment of mitomycin-C or gemcitabine following the most recent screening TURBT/biopsy are excluded. 2. Concurrent use of other investigational agents (not including FDA-authorized drugs for the prevention and treatment of COVID-19). 3. History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer or any other cancer within the past 5 years, except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 1 or 2 cancer from which the patient is currently in complete remission, or stable prostate cancer (under active surveillance or hormone control). 4. Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV or other clinical signs of severe cardiac dysfunction. 5. Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry. 6. History or evidence of uncontrollable CNS disease. 7. Known HIV-positive. 8. Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy. 9. Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions. 10. Ongoing chronic systemic steroid therapy required (\>10 mg oral prednisone daily or equivalent). 11. Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug. 12. Psychiatric illness/social situations that would limit compliance with study requirements. 13. Other illness that in the opinion of the investigator would exclude the patient from participating in this study.

Locations (108)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Alaska Clinical Research Center

Anchorage, Alaska, United States

Mayo Clinic

Phoenix, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

Hoag Memorial Hospital Presbyterian

Irvine, California, United States

University of Southern California

Los Angeles, California, United States

UCLA Department of Urology

Los Angeles, California, United States

University of California, Irvine Medical Center

Orange, California, United States

University of California, Davis

Sacramento, California, United States

Golden State Urology

Sacramento, California, United States

University of California San Diego

San Diego, California, 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

Mayo Clinic

Jacksonville, 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

Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Georgia Urology

Atlanta, Georgia, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Associated Urological Specialists

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Rush University

Chicago, Illinois, United States

UroPartners, LLC.

Glenview, Illinois, United States

Urology of Indiana

Carmel, Indiana, United States

Kansas University Medical Center

Westwood, Kansas, United States

Wichita Urology

Wichita, Kansas, United States

University of Kentucky Markey Cancer Center

Lexington, Kentucky, United States

Mary Bird Perkins Cancer Center

Metairie, Louisiana, United States

Anne Arundel Urology

Annapolis, Maryland, United States

Greater Boston Urology

Plymouth, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Comprehensive Urology

Royal Oak, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Minnesota Urology

Woodbury, Minnesota, United States

Specialty Clinical Research of St. Louis

St Louis, Missouri, United States

Adult & Pediatric Urology

Omaha, Nebraska, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Summit Health

Florham Park, New Jersey, United States

Urology Group of New Mexico (AccumetRx Clinical Research)

Albuquerque, New Mexico, United States

Winthrop University Hospital

Mineola, New York, United States

Integrated Medical Professionals

New York, New York, United States

NYU Langone Health

New York, 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

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Associated Urologists of North Carolina

Raleigh, North Carolina, United States

Dayton Physicians Network

Centerville, Ohio, United States

The Urology Group

Cincinnati, Ohio, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Central Ohio Urology Group

Gahanna, Ohio, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Lowcountry Urology Clinics

North Charleston, South Carolina, United States

Erlanger Health

Chattanooga, Tennessee, United States

Urology Associates, PC

Nashville, Tennessee, United States

Urology Partners of North Texas

Arlington, Texas, United States

Texas Oncology

Austin, Texas, United States

Urology Austin, PLLC

Austin, Texas, United States

Houston Metro Urology

Houston, Texas, United States

Urology San Antonio

San Antonio, Texas, United States

Potomac Urology

Alexandria, Virginia, United States

Virginia Urology

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Urology of Virginia

Virginia Beach, Virginia, United States

University of Washington School of Medicine

Seattle, Washington, United States

Spokane Urology

Spokane, Washington, United States

HCG Cancer Centre

Visakhapatnam, Andhra Pradesh, India

Adyar Cancer Institute

Adyār, Chennai, India

HCG Aastha Cancer Centre

Ahmedabad, Gujarat, India

Darakh Nursing Home and Kidney Stone Centre

Aurangabad, Maharashtra, India

Kidney Centre Jasleen Hospital

Nagpur, Maharashtra, India

Indriyani Hospital & Cancer Institute

Pune, Maharashtra, India

HCG Manavata Cancer Centre

Mumbai, Nashik, India

BLK-Max Super Specialty Hospital

New Delhi, National Capital Territory of Delhi, India

All India Institute of Medical Sciences,

Bhubaneswar, Odisha, India

Sri Guru Ram Das Institute of Medical Sciences and Research

Amritsar, Punjab, India

Urocare Hospital

Guntur, Rajkort, India

Erode Cancer Centre

Erode, Tamilnadu. India, India

Pi Health Cancer Hospital

Hyderabad, Telangana, India

Max Super Specialty Hospital

Ghaziabad, Uttar Pardesh, India

Pushpanjali Hospital & Research Centre

Agra, Uttar, India

Swami Harshankaranand JI Hospital and Research Centre

Sunderpur, Varanasi, India

Govt. Medical College, Kolkata

Kolkata, West Bengal, India

B J Medical College & Civil Hospital, Asarwa, Ahmedaba

Ahmedabad, India

Basavatarakam Indo American Cancer Hospital & Research Institute

Banjara Hills, India

HCG Bangalore

Bengaluru, India

SP Medical College and Hospital

Bikaner, India

Guru Govnid Singh Medical College and Hospital

Farīdkot, India

Muljibhai Patel Urological Hospital

Gujrāt, India

Binayak Multispecialty Hospital

Kolkata, India

Chittaranjan National Cancer Institute

Kolkata, India

KR Hospital

Mysuru, India

KMC Manipal

Nagar, India

Jasleen Hospital

Nagpur, India

Onco Life Cancer Center

Pune, India

Inamdar Hospital Pune

Pune, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (108)