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Inability to accrue due to changing treatment landscape (PD-1 approvals)
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Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1*10^6 cells) HS-410 monotherapy. Phase 2, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. Patients who do not receive BCG will be enrolled into an open-label, non-randomized group receiving high dose (1*10^7 cells) intradermal HS-410 monotherapy.
This study is a two part study: Phase I and Phase II. The Phase 1 portion is an open-label, safety study. Patients will have previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1*10^6 cells) HS-410 monotherapy. In Phase 2, patients will be assigned to treatment groups based on whether they will receive induction BCG in the typical post-TURBT window. If the investigator plans to administer BCG, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. If patients will not receive BCG, they will be enrolled into an open-label, non-randomized group and receive high dose (1*10^7 cells) intradermal HS-410 monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: HS-410 Low Dose | Experimental | In the open label Phase 1 portion, HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections. |
|
| Phase II: HS-410 Low-Dose Plus BCG | Experimental | In the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. |
|
| Phase II: High-Dose HS-410 Plus BCG | Experimental | In the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. |
|
| Phase II: Placebo Plus BCG | Placebo Comparator | In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. |
|
| Phase II: High-Dose HS-410 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-410 | Biological | Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Safety and Tolerability | To evaluate the safety and tolerability of vesigenurtacel-L | Up to 3 years. |
| Phase 2: 1-year Disease-Free Survival | Arm 1, 2, 3: 1-year DFS in patients with NMIBC treated with BCG in combination with blinded study product (one of two doses of vesigenurtacel-L or placebo) Arm 4: 1-year DFS in patients with NMIBC treat1fv 9 with high dose vesigenurtacel-L monotherapy One-year disease-free survival will be defined as the proportion of patients who are free from recurrent disease, progressive disease, and alive one year after the date of randomization/treatment assignment | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months | Evaluate the proportion of patients with recurrence at 3, 6, 12, 18, and 24 months | Up to 2 years |
| Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Steinberg, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles | Los Angeles | California | 90095 | United States | ||
| Skyline Urology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: HS-410 Low Dose | In the open label Phase 1 portion, HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
| FG001 | Phase II: HS-410 Low-Dose Plus BCG |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2016 | Jun 27, 2019 |
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In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. |
|
| Placebo | Biological | Injection containing sterile solution but no cells |
|
| BCG | Biological | Vaccine derived from a live bacterium |
|
|
Evaluate the proportion of patients with progressive disease at 3, 6, 12, 18, and 24
| Up to 2 years |
| Disease-free Survival at 3, 6, 18, and 24 Months | Evaluate Disease Free Survival at 3, 6, 18 and 24 months | Up to 2 years |
| Overall Disease-free Survival | Evaluate overall Disease Free Survival | Up to 3 years |
| Overall Survival, Expressed as the Number of Participants Alive | Evaluate overall survival (OS) | Up to 3 years |
| Proportion of Patients Undergoing Repeat Transurethral Resection of Bladder Tumor (TURBT) by 12 and 24 Months | Up to 2 years |
| Proportion of Patients Undergoing Cystectomy by 12 and 24 Months | Evaluate the proportion of patients undergoing cystectomy by 12 and 24 months from randomization | Up to 2 years |
| Immunologic Response of PBMCs Via Intracellular Cytokine Staining (ICS) by Flow Cytometry and/or Enzyme-linked Immunosorbent Spot (ELISPOT) on CD8+ Cells After HS-410 Vaccination as Compared to Baseline. | Evaluate the proportion of patients with immunologic response of peripheral blood mononuclear cells (PBMCs) via intracellular cytokine staining (ICS) by flow cytometry and/or ELISPOT on CD8+ cells following vesigenurtacel-L vaccination | Up to 2 years |
| Immunologic Response of Peripheral Blood Mononuclear Cells (PBMCs) and Stimulation Analysis Via ICS in Baseline and Post-treatment Biopsies, if Clinically Indicated | Evaluate immunologic response of PBMCs (analysis of surface markers, CD3, CD4, CD8, CD19, CD25, CD45, CD56, FoxP3, and degranulation) and stimulation analysis via ICS of interferon gamma (IFNγ) and granzyme B (gzB) | Up to 3 years |
| Total PBMC Counts by Flow Cytometry | Evaluate total PBMC counts by flow cytometry, including lymphocyte subsets (B cells, helper T-cells, cytotoxic T-cells, natural killer (NK) cells and T-reg) | Up to 3 years |
| Tumor Antigen Expression | Evaluation of pre-treatment tumor tissue for antigen expression | At screening |
| Tumor Infiltrating Lymphocytes (TILs) | Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs | Up to 3 years |
| T Cell Receptor Sequencing of Peripheral Blood T Cells Before and During Treatment | Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs, T cell receptor sequencing of peripheral blood T cells before and during the course of treatment. | Up to 2 years |
| Safety of the Combination of the HS-410 and BCG | Phase 2 only Evaluate the safety of the combination of vesigenurtacel-L and BCG | Up to 1 year |
| Safety of the High Dose HS-410 Monotherapy | Phase 2 only Evaluate the safety of high dose vesigenurtacel-L monotherapy | Up to 3 years. |
| Sherman Oaks |
| California |
| 91411 |
| United States |
| Skyline Urology | Torrance | California | 90505 | United States |
| Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| First Urology | Jeffersonville | Indiana | 47130 | United States |
| Horizon Oncology Research | Lafayette | Indiana | 47905 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Montefiore Medical Center | The Bronx | New York | 10471 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Urology of North Texas | Dallas | Texas | 75231 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | United States |
In the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 BCG: Vaccine derived from a live bacterium |
| FG002 | Phase II: High-Dose HS-410 Plus BCG | In the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 BCG: Vaccine derived from a live bacterium |
| FG003 | Phase II: Placebo Plus BCG | In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. Placebo: Injection containing sterile solution but no cells BCG: Vaccine derived from a live bacterium |
| FG004 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: HS-410 Low Dose | In the open label Phase 1 portion, HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
| BG001 | Phase II: HS-410 Low-Dose Plus BCG | In the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 BCG: Vaccine derived from a live bacterium |
| BG002 | Phase II: High-Dose HS-410 Plus BCG | In the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 BCG: Vaccine derived from a live bacterium |
| BG003 | Phase II: Placebo Plus BCG | In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. Placebo: Injection containing sterile solution but no cells BCG: Vaccine derived from a live bacterium |
| BG004 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1: Safety and Tolerability | To evaluate the safety and tolerability of vesigenurtacel-L | Posted | Count of Participants | Participants | Up to 3 years. |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Phase 2: 1-year Disease-Free Survival | Arm 1, 2, 3: 1-year DFS in patients with NMIBC treated with BCG in combination with blinded study product (one of two doses of vesigenurtacel-L or placebo) Arm 4: 1-year DFS in patients with NMIBC treat1fv 9 with high dose vesigenurtacel-L monotherapy One-year disease-free survival will be defined as the proportion of patients who are free from recurrent disease, progressive disease, and alive one year after the date of randomization/treatment assignment | Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected. | Posted | Count of Participants | Participants | One year |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months | Evaluate the proportion of patients with recurrence at 3, 6, 12, 18, and 24 months | Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected. | Posted | Number | participants | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months | Evaluate the proportion of patients with progressive disease at 3, 6, 12, 18, and 24 | Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected. | Posted | Number | participants | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival at 3, 6, 18, and 24 Months | Evaluate Disease Free Survival at 3, 6, 18 and 24 months | Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected. | Posted | Number | participants | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Disease-free Survival | Evaluate overall Disease Free Survival | Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected. | Posted | Number | participants | Up to 3 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival, Expressed as the Number of Participants Alive | Evaluate overall survival (OS) | Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected. | Posted | Number | participants | Up to 3 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Undergoing Repeat Transurethral Resection of Bladder Tumor (TURBT) by 12 and 24 Months | Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected. | Posted | Number | participants | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Undergoing Cystectomy by 12 and 24 Months | Evaluate the proportion of patients undergoing cystectomy by 12 and 24 months from randomization | Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected. | Posted | Number | participants | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Immunologic Response of PBMCs Via Intracellular Cytokine Staining (ICS) by Flow Cytometry and/or Enzyme-linked Immunosorbent Spot (ELISPOT) on CD8+ Cells After HS-410 Vaccination as Compared to Baseline. | Evaluate the proportion of patients with immunologic response of peripheral blood mononuclear cells (PBMCs) via intracellular cytokine staining (ICS) by flow cytometry and/or ELISPOT on CD8+ cells following vesigenurtacel-L vaccination | Data were not collected as pre-specified in Outcome Measure 10 due to study termination by the Sponsor. | Posted | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunologic Response of Peripheral Blood Mononuclear Cells (PBMCs) and Stimulation Analysis Via ICS in Baseline and Post-treatment Biopsies, if Clinically Indicated | Evaluate immunologic response of PBMCs (analysis of surface markers, CD3, CD4, CD8, CD19, CD25, CD45, CD56, FoxP3, and degranulation) and stimulation analysis via ICS of interferon gamma (IFNγ) and granzyme B (gzB) | Data were not collected as pre-specified in Outcome Measure 11 due to study termination by the Sponsor. | Posted | Up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Total PBMC Counts by Flow Cytometry | Evaluate total PBMC counts by flow cytometry, including lymphocyte subsets (B cells, helper T-cells, cytotoxic T-cells, natural killer (NK) cells and T-reg) | Data were not collected as pre-specified in Outcome Measure 12 due to study termination by the Sponsor. | Posted | Up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Antigen Expression | Evaluation of pre-treatment tumor tissue for antigen expression | Data were not collected as pre-specified in Outcome Measure 13 due to study termination by the Sponsor. | Posted | At screening |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Infiltrating Lymphocytes (TILs) | Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs | Data were not collected as pre-specified in Outcome Measure 14 due to study termination by the Sponsor. | Posted | Up to 3 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | T Cell Receptor Sequencing of Peripheral Blood T Cells Before and During Treatment | Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs, T cell receptor sequencing of peripheral blood T cells before and during the course of treatment. | Data were not collected as pre-specified in Outcome Measure 15 due to study termination by the Sponsor. | Posted | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety of the Combination of the HS-410 and BCG | Phase 2 only Evaluate the safety of the combination of vesigenurtacel-L and BCG | Data were not collected as pre-specified in Outcome Measure 16 due to study termination by the Sponsor. | Posted | Up to 1 year |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Safety of the High Dose HS-410 Monotherapy | Phase 2 only Evaluate the safety of high dose vesigenurtacel-L monotherapy | Data were not collected as pre-specified in Outcome Measure 17 due to study termination by the Sponsor. | Posted | Up to 3 years. |
|
AEs were defined as all reported events with a start date on or after Study Day 1. All AEs were collected through 30 days post last dose, up to 3 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I: HS-410 Low Dose | In the open label Phase 1 portion, HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 | 0 | 10 | 0 | 10 | 7 | 10 |
| EG001 | Phase II: HS-410 Low-Dose Plus BCG | In the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 BCG: Vaccine derived from a live bacterium | 0 | 26 | 8 | 26 | 24 | 26 |
| EG002 | Phase II: High-Dose HS-410 Plus BCG | In the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 BCG: Vaccine derived from a live bacterium | 0 | 26 | 4 | 26 | 19 | 26 |
| EG003 | Phase II: Placebo Plus BCG | In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. Placebo: Injection containing sterile solution but no cells BCG: Vaccine derived from a live bacterium | 0 | 26 | 1 | 26 | 20 | 26 |
| EG004 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 | 0 | 16 | 2 | 16 | 9 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoprostatectomy | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Prostate Cancer | Musculoskeletal and connective tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | medDRA v20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Aneurysm | Vascular disorders | medDRA v20.1 | Systematic Assessment | Mycotic Aneurysm; Disseminated BCG Mycotic Aneurysm |
|
| Transient Ischaemic Attack | Nervous system disorders | medDRA v20.1 | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | medDRA v20.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | medDRA v20.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | medDRA v20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | medDRA v20.1 | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | medDRA v20.1 | Systematic Assessment | of Larynx |
|
| Cerebrovascular Accident | Nervous system disorders | medDRA v20.1 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | medDRA v20.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | medDRA v20.1 | Systematic Assessment |
| |
| Priapism | Reproductive system and breast disorders | medDRA v20.1 | Systematic Assessment |
| |
| Disease Progression | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Bladder Perforation | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | medDRA v20.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | medDRA v20.1 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | medDRA v20.1 | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | medDRA v20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Chills | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Malaise | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Pain | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | medDRA v20.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | medDRA v20.1 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | medDRA v20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | medDRA v20.1 | Systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | medDRA v20.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | medDRA v20.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | medDRA v20.1 | Systematic Assessment |
| |
| Blood Urine Present | Investigations | medDRA v20.1 | Systematic Assessment |
| |
| Hematocrit Decreased | Investigations | medDRA v20.1 | Systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | medDRA v20.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | medDRA v20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Cerebrovascular Disorder | Nervous system disorders | medDRA v20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | medDRA v20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | medDRA v20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | medDRA v20.1 | Systematic Assessment |
| |
| Bladder Perforation | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Bladder Spasm | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Lower Urinary Tract Symptoms | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Micturition Urgency | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Breast Tenderness | Reproductive system and breast disorders | medDRA v20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Upper Airway Cough Syndrome | Respiratory, thoracic and mediastinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | medDRA v20.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | medDRA v20.1 | Systematic Assessment |
| |
| Hyperadrenalism | Endocrine disorders | medDRA v20.1 | Systematic Assessment |
| |
| Eye Haemorrhage | Eye disorders | medDRA v20.1 | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | medDRA v20.1 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | medDRA v20.1 | Systematic Assessment |
| |
| Bladder Spasm | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | medDRA v20.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori McDermott | Clinical Development | 9197948950 | 9197948950 | lmcdermott@heatbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2016 | Jun 27, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001500 | BCG Vaccine |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| OG002 | Phase II: Placebo Plus BCG | In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. Placebo: Injection containing sterile solution but no cells BCG: Vaccine derived from a live bacterium |
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
|
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
|
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
|
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
|
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
|
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
|
|
|
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
|
| OG002 | Phase II: Placebo Plus BCG | In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. Placebo: Injection containing sterile solution but no cells BCG: Vaccine derived from a live bacterium |
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
| OG002 |
| Phase II: Placebo Plus BCG |
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. Placebo: Injection containing sterile solution but no cells BCG: Vaccine derived from a live bacterium |
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG.
Placebo: Injection containing sterile solution but no cells
BCG: Vaccine derived from a live bacterium
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. Placebo: Injection containing sterile solution but no cells BCG: Vaccine derived from a live bacterium |
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|
| OG003 | Phase II: High-Dose HS-410 | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. HS-410: Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 |
|