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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

596

Participants

Timeline

Start Date

July 21, 2014

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2038

Conditions
Non-muscle Invasive Bladder Cancer
Interventions
BIOLOGICAL

BCG+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."

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."

Trial Locations (80)

2191

NOT_YET_RECRUITING

SunningHill Hospital, Sandton

10016

RECRUITING

Integrated Medical Professionals, New York

RECRUITING

NYU Langone Health, New York

11501

COMPLETED

Winthrop University Hospital, Mineola

12601

RECRUITING

Premier Medical Group of the Hudson Valley, Poughkeepsie

13210

RECRUITING

Associated Medical Professionals of NY, Syracuse

19004

RECRUITING

MidLantic Urology, Bala-Cynwyd

19141

RECRUITING

Thomas Jefferson University Hospital, Philadelphia

22311

RECRUITING

Potomac Urology, Alexandria

23235

RECRUITING

Virginia Urology, Richmond

23298

RECRUITING

Virginia Commonwealth University, Richmond

23462

RECRUITING

Urology of Virginia, Virginia Beach

27278

ACTIVE_NOT_RECRUITING

University of North Carolina Chapel Hill, Chapel Hill

27612

RECRUITING

Associated Urologists of North Carolina, Raleigh

29406

RECRUITING

Lowcountry Urology Clinics, North Charleston

33021

RECRUITING

Memorial Healthcare System, Hollywood

33060

COMPLETED

Clinical Research Center of Florida, Pompano Beach

33578

NOT_YET_RECRUITING

Florida Urology Partners, Riverview

33612

ACTIVE_NOT_RECRUITING

Moffitt Cancer Center, Tampa

34484

RECRUITING

Advanced Urology Institute, Oxford

35294

COMPLETED

University of Alabama at Birmingham, Birmingham

37209

RECRUITING

Urology Associates, Nashville

37403

RECRUITING

Erlanger Health, Chattanooga

43230

RECRUITING

Central Ohio Urology Group, Gahanna

44195

RECRUITING

The Cleveland Clinic Foundation, Cleveland

45212

RECRUITING

The Urology Group, Cincinnati

46032

RECRUITING

Urology of Indiana, Carmel

48201

RECRUITING

Karmanos Cancer Institute, Detroit

48703

RECRUITING

Comprehensive Urology, Royal Oak

60026

RECRUITING

UroPartners, Glenview

60415

RECRUITING

Associated Urological Specialists, Chicago

60611

RECRUITING

Northwestern University-Feinberg School of Medicine, Chicago

60612

RECRUITING

Rush University, Chicago

63141

RECRUITING

Specialty Clinical Research of St. Louis, St Louis

66205

COMPLETED

Kansas University Medical Center, Westwood

68114

COMPLETED

Adult & Pediatric Urology, Omaha

72211

COMPLETED

Arkansas Urology, Little Rock

76017

RECRUITING

Urology Partners of North Texas, Arlington

77027

RECRUITING

Houston Metro Urology, Houston

78229

RECRUITING

Urology San Antonio, San Antonio

78705

RECRUITING

Texas Oncology, Austin

78745

RECRUITING

Urology Austin, PLLC, Research Department, Austin

87109

COMPLETED

Urology Group of New Mexico (AccumetRx Clinical Research), Albuquerque

90095

ACTIVE_NOT_RECRUITING

UCLA Department of Urology, Los Angeles

90505

COMPLETED

Skyline Urology, Torrance

91411

COMPLETED

Skyline Sherman Oaks, Sherman Oaks

92618

RECRUITING

Hoag Cancer Center, Irvine

95817

COMPLETED

University of California, Davis, Sacramento

96813

COMPLETED

University of Hawaii Cancer Center, Honolulu

98195

COMPLETED

University of Washington School of Medicine, Seattle

99503

COMPLETED

Alaska Clinical Research Center, Anchorage

151203

RECRUITING

Guru Govnid Singh Medical College and Hospital, Farīdkot

221005

RECRUITING

Swami Harshankaranand JI Hospital and Research Centre, Sunderpur

334003

RECRUITING

SP Medical College and Hospital, Bikaner

410506

RECRUITING

Onco Life Cancer Center, Pune

411040

COMPLETED

Inamdar Hospital Pune, Pune

412105

RECRUITING

Indriyani Hospital & Cancer Institute, Pune

422002

RECRUITING

HCG Manavata Cancer Centre, Mumbai

431001

RECRUITING

Darakh Nursing Home and Kidney Stone Centre, Aurangabad

440012

RECRUITING

Kidney Centre Jasleen Hospital, Nagpur

COMPLETED

Jasleen Hospital, Nagpur

492099

RECRUITING

All India Institute of Medical Sciences, Raipur, Rajpura

500032

RECRUITING

Pi Health Cancer Hospital, Hyderabad

530040

RECRUITING

HCG Cancer Centre, Visakhapatnam

ACTIVE_NOT_RECRUITING

HCG cancer Centre, Vizag, Visakhapatnam

560027

RECRUITING

HCG Bangalore, Bengaluru

570001

RECRUITING

KR Hospital, Mysuru

576104

RECRUITING

KMC Manipal, Nagar

638012

COMPLETED

Erode Cancer Centre, Erode

700050

RECRUITING

Binayak Multispecialty Hospital, Kolkata

Unknown

RECRUITING

University of California San Diego, San Diego

RECRUITING

B J Medical College & Civil Hospital, Asarwa, Ahmedaba, Ahmedabad

RECRUITING

Basavatarakam Indo American Cancer Hospital & Research Institute, Banjara Hills

RECRUITING

Muljibhai Patel Urological Hospital, Gujrāt

RECRUITING

Chittaranjan National Cancer Institute, Kolkata

RECRUITING

Urocare Hospital, Rajkot

RECRUITING

Uttar Pradesh University of Medical Sciences, Uttar

RECRUITING

Apollo Vizag, Visakhapatnam

06360

COMPLETED

Eastern Connecticut Hematology & Oncology Associates, Norwich

03756

RECRUITING

Dartmouth-Hitchcock Medical Center, Lebanon

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY