A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT02138734|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2014
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-muscle Invasive Bladder Cancer||Biological: BCG+ALT-803 Biological: BCG||Phase 1 Phase 2|
The study includes a dose escalation phase (phase Ib) and an expansion phase (phase IIb).
In the phase Ib, patients will be treated with intravesical ALT-803 in combination with BCG. The purpose of the phase Ib portion of the study is to evaluate the safety, identify the Maximum Tolerated Dose (MTD) of ALT-803 and determine the Recommended Dose (RD) level of ALT-803 in combination with BCG for the phase IIb expansion.
In the phase IIb expansion, patients will be randomized to receive either intravesical ALT-803 in combination with BCG or BCG alone.
The purpose of the phase IIb portion of the study is to compare disease response, recurrence and survival rates, safety and quality of life between the two treatment groups.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single arm phase Ib; two-arm phase IIb, 1:1 randomization and stratification by bladder tumor disease stage.|
|Masking:||None (Open Label)|
|Official Title:||A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||October 2019|
(Phase Ib and IIb) for BCG-naive patients
BCG and ALT-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+ALT-803 for 3 consecutive weeks at 3, 6, 12, & 18 months.
An additional 6 week re-induction of BCG+ALT-803 for patients with eligible disease at 3 months in phase IIb is included.
Active Comparator: BCG alone
(Phase IIb) for BCG-naive patients
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 months.
An additional 6 week re-induction of BCG for patients with eligible disease at 3 months in phase IIb is included.
- Safety Profile [ Time Frame: 48 months ]For phase Ib and IIb Number and severity of treatment related AEs that occur or worsen after the first dose of study treatment.
- MTD Determination [ Time Frame: 9 months ]For phase Ib Determine the maximum tolerated dose (MTD)
- Time to Recurrence [ Time Frame: 48 months ]For phase IIb Assess time from first treatment to evidence of disease.
- RD Designation [ Time Frame: 9 months ]For phase Ib designate the recommended dose (RD) level for Phase IIb.
- Clinical Benefit [ Time Frame: 24 months ]For phase Ib and IIb Assess disease response rate.
- Pharmacokinetics [ Time Frame: 24 months ]For phase Ib Area under the plasma concentration-time curve from time zero to infinity (AUC).
- Biomarkers [ Time Frame: 24 months ]For phase Ib Measures the serum and urine levels of IL-2, IL-4, IL-6, IL-10, IFN-gamma and TNF-alpha in treated patients.
- Molecular Alterations [ Time Frame: 24 months ]For phase Ib Measures the molecular changes (angiogenesis, apoptosis and proliferative index) and immune cell infiltration (assessed by immunohistochemistry for immune cells) in treated patients.
- Immune Cell Assessment [ Time Frame: 24 months ]For phase Ib Determine the percentage of specific immune cell subsets.
- Immunogenicity [ Time Frame: 24 months ]For phase Ib and IIb Measures the serum level of anti-ALT-803 in patient samples.
- Survival [ Time Frame: 24 months ]For phase Ib and IIb All enrolled patients will be followed for 2 years to determine survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138734
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Alaska|
|Alaska Clinical Research Center|
|Anchorage, Alaska, United States, 99503|
|United States, California|
|UCLA Department of Urology|
|Los Angeles, California, United States, 90024|
|University of California, Davis|
|Sacramento, California, United States, 95817|
|Skyline Sherman Oaks|
|Sherman Oaks, California, United States, 91411|
|Torrance, California, United States, 90505|
|United States, Connecticut|
|Eastern Connecticut Hematology & Oncology Associates|
|Norwich, Connecticut, United States, 06360|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Hawaii|
|University of Hawaii Cancer Center|
|Honolulu, Hawaii, United States, 96813|
|United States, Kansas|
|Kansas University Medical Center|
|Westwood, Kansas, United States, 66205|
|United States, Michigan|
|Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|United States, New York|
|Winthrop University Hospital|
|Mineola, New York, United States, 11501|
|United States, Washington|
|University of Washington School of Medicine|
|Seattle, Washington, United States, 98109|
|Study Director:||Amy Rock, PhD||Altor BioScience|