Transitional Cell CarcinomaPhase 2/3BONDNCT01438112
Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer
A Phase 2/3 study testing CG0070 Adenovirus Vector in people with Transitional Cell Carcinoma and Bladder Cancer, run by CG Oncology, Inc. at 7 sites in United States.
Trial summary
The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Cell Carcinoma, Bladder Cancer, Carcinoma in Situ
- What is being tested?
- CG0070 Adenovirus Vector
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2014to Jun 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be considered high risk, with pathologically confirmed high grade disease (HG) WHO 2004
- Patients must have pathologically-proven unresectable, primary, secondary or concurrent carcinoma in situ disease, defined by having either Ta and/or T1 with CIS, or CIS
- Patients must have no evidence of muscle invasive disease
- Patient need to sign a specific informed consent acknowledging that a delay of cystectomy may lead to an increase chance of progression and/or metastasis with serious or sometimes fatal consequences.
- Patients must have received at least two or more prior courses of intravesical therapy. BCG must have been one of the prior therapies administered. Patients can have either failed BCG induction therapy within a six month period or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical therapy must include six weekly treatments (allowable range of instillations per course is 4-9). The second course of BCG can consist of three weekly treatments
- 18 years of age or older
Show all 17Show fewer
- Residual disease at accrual
- Pathologically diagnosed transitional cell (urothelial) bladder cancer (further details in 10.) patients where radical cystectomy with curative intent is indicated for superficial bladder cancer that is resistant to treatment.
- Patients must be able to enter into the study within five weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection of bladder tumor (TURBT) procedure or other diagnostic scanning such as CT and PET procedures.
- Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible.
- No evidence of urethral or renal pelvis TCC by upper tract radiological imaging (e.g., intravenous pyelogram, CT urogram, or retrograde pyelogram) within the past 2 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <2.
- Not pregnant or lactating
- Patients with child bearing potential must agree to use adequate contraception
- Agree to study specific informed consent and HIPAA authorization for release of personal health information
- Adequate baseline CBC, renal and hepatic function. Renal parameters as detailed above. Absolute lymphocyte count ≥ 1,000/μL before all doses of CG0070
- Patient to provide a tumor specimen for determination of RB pathway status
Who cannot join
- Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable
- No bladder cancer residual disease, such as patients that are rendered disease free by TURBT
- History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs.
- Known infection with HIV, HBV or HCV.
- Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study
- Any underlying medical condition that, in the Investigator's opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or surgical resection. Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study
Show all 18Show fewer
- Systemic treatment on any investigational clinical trial within 28 days prior to registration.
- Concurrent treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted). Use of a short course (i.e., ≤ 1 day) of a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for CT scans.
- Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry.
- History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine)
- History of partial cystectomy in the setting of bladder cancer primary tumor.
- History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs.
- History of stage III or greater cancer, excluding urothelial cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer, must have been adequately treated and have been disease-free for ≥ 3 years at the time of registration.
- Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis)
- Progressive viral or bacterial infection
- All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study
- Any underlying medical condition that, in the Investigator's opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or not permit adequate surgical resection.
- Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Chicago, Department of Surgery, Section of Urology
Chicago, Illinois, 60637
University of California, San Diego- Moores Cancer Center
La Jolla, California, 92093
UCLA Institute of Urological Oncology
Los Angeles, California, 90024
Vanderbilt University Medical Center Department of Urologic Surgery
Nashville, Tennessee, 37232
BCG Oncology
Phoenix, Arizona, 85032-2129
University of California, Davis- Cancer Center
Sacramento, California, 95817
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: An Integrated Phase II/III, Open Label, Randomized and Controlled Study of the Safety and Efficacy of CG0070 Adenovirus Vector Expressing GM-CSF in Patients With NMIBC With Carcinoma In Situ Disease Who Have Failed BCG
The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs.
Read the detailed description
After the phase I/II CG0070 trial review, it became apparent that the use of CG0070 oncolytic vaccine as an intravesical agent for oncolytic lysis of tumor cells, together with the transcription of GM-CSF on site, may have distinct advantages. This first study showed excellent tumor response rates of 48-77% depending on the dose schedule administered. All of these patients had residual non-muscle invasive bladder cancer who have previously failed BCG therapy at the time of treatment.
With the addition of a transduction agent such as DDM, the intravesical instillation of CG0070 enabled uniform distribution of viral particles and exposure to the tumor during those 30-60 minutes instillations as contrast to the intra-tumor injection, intra-arterial or intravenous injection of viral particles in other oncolytic viral trials. Some or most of these delivering methodologies have obvious intrinsic imperfections and potential toxicity. This unique opportunity of an relatively easy intravesical tumor exposure is difficult to duplicate in other solid tumor models.
The replication of CG0070 in the majority of patients during the first phase I/II trial indicated tumor lysis with release of tumor specific or tumor associated antigens that have been stably expressed, in abundant quantities during tumor cell death. Release of tumor antigens have been the key elements, together with sufficient on-site GM-CSF, in stimulating strong cross-presentation and confirmation signals to the antigen presenting cells such as dendritic cells interacting with CD4+ and CD8+ T cells. This concept of a "real time" vaccine like regimen is expected to compare favorably with other forms of cancer immunotherapy treatment such as BCG in this patient population.
It is with this thought that CG0070 may find a success in this setting because of a reasonably and proven complete response rate in residual and failed BCG bladder cancer patients in the first phase I/II study (some cases with only one instillation). Of importance as well, is the demonstration in the study data of a strong GM-CSF expression during its replication phase. Those patients with carcinoma in situ disease and those with RB pathway dysfunction were particularly responsive.
It is therefore, desirable to formulate a protocol to encompass the specialty of this oncolytic vaccine and the unique intravesical delivery to prove the efficacy by a randomized controlled study. This opportunity allows a study on the CG0070's beneficial effects, if any, on the standard of care for carcinoma in situ non muscle invasive bladder cancer patients after they failed BCG therapy. The prognosis of this group presently depends mainly on early radical cystectomy, which carries a high morbidity and decrease of quality of life generally viewed as unacceptable for this group of older patients.
- Conditions
- Transitional Cell Carcinoma, Bladder Cancer, Carcinoma in Situ, Carcinoma in Situ Concurrent With Papillary Tumors
- Being tested
- CG0070 Adenovirus Vector, Control Arm: Quadruple Choice
- Keywords
- cancer, bladder cancer, transitional cell, virus, oncolytic, GM-CSF, adenovirus, intravesical, neoadjuvant, cystectomy, gene therapy, oncolytic virus, carcinoma in situ, carcinoma in situ concurrent with papillary tumors
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Carcinoma in Situ, Neoplasms, Virus Diseases, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG0070 Adenovirus VectorBiological
Also called oncolytic virus, CG0070, GM-CSF expression, adenoviral vector
CG0070 adenoviral vector with GM-CSF expression given intravesically 1x10e12 viral particles for each instillations, weekly times six
Control Arm: Quadruple ChoiceOther
Also called Mitomycin C, Interferon, Valrubicin, Gemcitabine
Quadruple Choice Treatment Options: (same as listed above)
| Study group | Role | What they receive |
|---|---|---|
| CG0070 oncolytic virus | Experimental | Interventions: CG0070 oncolytic virus intravesical instillations weekly X6 with each instillation lasting 45 minutes after prior transduction agent of DDM intravesically for 15 minutes Receives: Biological: CG0070 Adenovirus Vector |
| Chemotherapy or Interferon | Active comparator | Quadruple Choice as interventions
1. Mitomycin C
2. Interferon
3. Valrubicin
4. Gemcitabine Receives: Other: Control Arm: Quadruple Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Proportion (CR)
'CR' Proportion is confirmed by negative biopsy, cystoscopy, cytology weekly times 2 with the first assessment three months after first intravesical treatment and then assessed again at 9 month. Two consecutive positive urine cytologies to confirm a persistent or recurrent disease if visual and biopsy is negative. Random biopsy mandatory at the first assessment in the trigone, bladder dome, right, left , anterior and posterior of the bladder wall.
Measured: 9 months (Phase II)
Durable Complete Response Proportion (DCR)
DCR proportion of DCR lasting 12 months or longer will be conducted after a follow up period of 15 months for each patient. The first complete response assessment will be at 3 month.
Measured: 15 months (Phase III)
Secondary outcomes (4)
Progression rate to muscle invasive disease
The Progression rate to muscle invasive disease rate is based on analysis from comparing disease status at the time of enrollment versus disease status (for those patients with muscle invasion) at the time of cystectomy or TURBT
Measured: Throughout the study with expected average of 12 months
Complete Response Survival
The Complete Response Survival time to events of patients who have achieved a complete response at the 3 month assessment will be compared with a log rank test.
Measured: 15 months
Safety Events
The number and percentage of patients experiencing one or more adverse events will be summarized by relationship to study drug, and severity.
Measured: Expected average of two years throughout the study
Cystectomy Free Survival
The Cystectomy Free Survival time to events of patients will be compared with a log rank test.
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startMar 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Change in study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- CG Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex W Yeung, MBBS, Study chair, CG Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438112
- Sponsor's protocol ID
- 12154
- Acronym
- BOND
- Status last verified
- Apr 2021
- First submitted
- 19 Sep 2011
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Phase II/III, Open Label, Randomized and Controlled Study of the Safety and Efficacy of CG0070 Adenovirus Vector Expressing GM-CSF in Patients With NMIBC With Carcinoma In Situ Disease Who Have Failed BCG
- ClinicalTrials.gov ID
- NCT01438112
- Acronym / sponsor ID
- BOND / 12154
- Conditions
- Transitional Cell Carcinoma, Bladder Cancer, Carcinoma in Situ, Carcinoma in Situ Concurrent With Papillary Tumors
- Keywords
- cancer, bladder cancer, transitional cell, virus, oncolytic, GM-CSF, adenovirus, intravesical
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in study design
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CG Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs.
Detailed description
After the phase I/II CG0070 trial review, it became apparent that the use of CG0070 oncolytic vaccine as an intravesical agent for oncolytic lysis of tumor cells, together with the transcription of GM-CSF on site, may have distinct advantages. This first study showed excellent tumor response rates of 48-77% depending on the dose schedule administered. All of these patients had residual non-muscle invasive bladder cancer who have previously failed BCG therapy at the time of treatment.
With the addition of a transduction agent such as DDM, the intravesical instillation of CG0070 enabled uniform distribution of viral particles and exposure to the tumor during those 30-60 minutes instillations as contrast to the intra-tumor injection, intra-arterial or intravenous injection of viral particles in other oncolytic viral trials. Some or most of these delivering methodologies have obvious intrinsic imperfections and potential toxicity. This unique opportunity of an relatively easy intravesical tumor exposure is difficult to duplicate in other solid tumor models.
The replication of CG0070 in the majority of patients during the first phase I/II trial indicated tumor lysis with release of tumor specific or tumor associated antigens that have been stably expressed, in abundant quantities during tumor cell death. Release of tumor antigens have been the key elements, together with sufficient on-site GM-CSF, in stimulating strong cross-presentation and confirmation signals to the antigen presenting cells such as dendritic cells interacting with CD4+ and CD8+ T cells. This concept of a "real time" vaccine like regimen is expected to compare favorably with other forms of cancer immunotherapy treatment such as BCG in this patient population.
It is with this thought that CG0070 may find a success in this setting because of a reasonably and proven complete response rate in residual and failed BCG bladder cancer patients in the first phase I/II study (some cases with only one instillation). Of importance as well, is the demonstration in the study data of a strong GM-CSF expression during its replication phase. Those patients with carcinoma in situ disease and those with RB pathway dysfunction were particularly responsive.
It is therefore, desirable to formulate a protocol to encompass the specialty of this oncolytic vaccine and the unique intravesical delivery to prove the efficacy by a randomized controlled study. This opportunity allows a study on the CG0070's beneficial effects, if any, on the standard of care for carcinoma in situ non muscle invasive bladder cancer patients after they failed BCG therapy. The prognosis of this group presently depends mainly on early radical cystectomy, which carries a high morbidity and decrease of quality of life generally viewed as unacceptable for this group of older patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CG0070 oncolytic virus | Experimental | Biological: CG0070 Adenovirus VectorInterventions: CG0070 oncolytic virus intravesical instillations weekly X6 with each instillation lasting 45 minutes after prior transduction agent of DDM intravesically for 15 minutes |
| Chemotherapy or Interferon | Active comparator | Other: Control Arm: Quadruple ChoiceQuadruple Choice as interventions 1. Mitomycin C 2. Interferon 3. Valrubicin 4. Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must be considered high risk, with pathologically confirmed high grade disease (HG) WHO 2004
- Patients must have pathologically-proven unresectable, primary, secondary or concurrent carcinoma in situ disease, defined by having either Ta and/or T1 with CIS, or CIS
- Patients must have no evidence of muscle invasive disease
- Patient need to sign a specific informed consent acknowledging that a delay of cystectomy may lead to an increase chance of progression and/or metastasis with serious or sometimes fatal consequences.
- Patients must have received at least two or more prior courses of intravesical therapy. BCG must have been one of the prior therapies administered. Patients can have either failed BCG induction therapy within a six month period or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical therapy must include six weekly treatments (allowable range of instillations per course is 4-9). The second course of BCG can consist of three weekly treatments
Key exclusion criteria (18 listed)
- Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable
- No bladder cancer residual disease, such as patients that are rendered disease free by TURBT
- History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs.
- Known infection with HIV, HBV or HCV.
- Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG0070 Adenovirus VectorAlso: oncolytic virus, CG0070, GM-CSF expression, adenoviral vectorCG0070 adenoviral vector with GM-CSF expression given intravesically 1x10e12 viral particles for each instillations, weekly times six | Biological | CG0070 oncolytic virus |
| Control Arm: Quadruple ChoiceAlso: Mitomycin C, Interferon, Valrubicin, GemcitabineQuadruple Choice Treatment Options: (same as listed above) | Other | Chemotherapy or Interferon |
Primary outcome
Complete Response Proportion (CR)
Time frame: 9 months (Phase II)
'CR' Proportion is confirmed by negative biopsy, cystoscopy, cytology weekly times 2 with the first assessment three months after first intravesical treatment and then assessed again at 9 month. Two consecutive positive urine cytologies to confirm a persistent or recurrent disease if visual and biopsy is negative. Random biopsy mandatory at the first assessment in the trigone, bladder dome, right, left , anterior and posterior of the bladder wall.
Durable Complete Response Proportion (DCR)
Time frame: 15 months (Phase III)
DCR proportion of DCR lasting 12 months or longer will be conducted after a follow up period of 15 months for each patient. The first complete response assessment will be at 3 month.
4 secondary outcomes
Progression rate to muscle invasive disease
Time frame: Throughout the study with expected average of 12 months
Complete Response Survival
Time frame: 15 months
Safety Events
Time frame: Expected average of two years throughout the study
Cystectomy Free Survival
Time frame: 15 month
Results and safety
The study was stopped early (reason given: Change in study design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex W Yeung, MBBS study chair
CG Oncology, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CG0070 Adenovirus Vector in people with Transitional Cell Carcinoma and Bladder Cancer, run by CG Oncology, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change in study design). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Proportion (CR) (time frame: 9 months (Phase II)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.