Bladder CancerPhase 1NCT01498172
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
A Phase 1 study testing MAGE-A3 ASCI and BCG in people with Bladder Cancer, run by Patrice Jichlinski at 1 site in Switzerland.
Trial summary
In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell responses both systemically and locally in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- MAGE-A3 ASCI and BCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Feb 2015
- Phase
- Phase 1
- 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
- Male or female patient with histological confirmation of NMIBC
- Full recovery from surgery (TUR) from 1 to 6 weeks
- Karnofsky performance status of 60% or more
- Laboratory parameters for vital functions should be in the normal range
- Women of childbearing potential must use adequate contraception and have negative pregnancy test before and during the whole period of study treatment administration
- Male patients should avoid behaviors leading to child conception up to 2 months after administration of study treatment
Who cannot join
- Muscle invasive bladder cancer
- Metastatic disease to the central nervous system, for which other therapeutic options, including radiotherapy, may be available
- Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
- Any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases(Patients with vitiligo are not excluded to participate in the trial)
- History of severe allergic reactions to vaccines or unknown allergens
- Patients require concomitant chronic treatment with systemic corticosteroids or any other immunosuppressive agents.
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- The use of prednisone, or equivalent, <0.125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
- Lack of availability for immunological and clinical follow-up assessment
- For female patients of childbearing potential: positive urine or serum pregnancy test or lactating
- Known positive HIV test, HBV, HCV.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
About this study
Official title: BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Patients With Non Muscle Invasive Bladder Cancer
In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell responses both systemically and locally in the bladder.
- Conditions
- Bladder Cancer
- Being tested
- MAGE-A3 ASCI, BCG
- Keywords
- Non muscle invasive bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGE-A3 ASCIBiological
5 doses every 3 weeks
BCGBiological
Also called Oncotice
1 intravesical dose /week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| NMIBC at intermediate risk of progression | Experimental | Not described Receives: Biological: MAGE-A3 ASCI; Biological: BCG |
| NMIBC at high risk of progression | Experimental | Not described Receives: Biological: MAGE-A3 ASCI; Biological: BCG |
| NMIBC at low risk of progression | Experimental | Not described Receives: Biological: MAGE-A3 ASCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
Measured: 6 months
Secondary outcomes (3)
Flow cytometric analysis of type and number of immune cell types in urine
Measured: 6 months
Measurement of titers of antibodies against recMAGE-A3 in serum
Measured: 6 months
Assessment of disease recurrence by control cystoscopy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrice Jichlinski
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Center for Cancer Research of Lausanne, GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Patrice Jichlinski, University of Lausanne Hospitals
- Investigators
- Patrice Jichlinski, MD, Principal investigator, University Hospital Lausanne (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498172
- Sponsor's protocol ID
- URO-68/11
- Status last verified
- Feb 2015
- First submitted
- 6 Dec 2011
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Patients With Non Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT01498172
- Acronym / sponsor ID
- URO-68/11
- Conditions
- Bladder Cancer
- Keywords
- Non muscle invasive bladder cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Patrice JichlinskiUniversity, hospital or other
- Collaborators
- Ludwig Center for Cancer Research of Lausanne, GlaxoSmithKline
- Study start
- Jan 2012
- Primary completion
- Feb 2015 (actual)
- First posted
- 23 Dec 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.
In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI), may enhance innate and vaccine-specific T cell responses both systemically and locally in the bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMIBC at intermediate risk of progression | Experimental | Biological: MAGE-A3 ASCI, Biological: BCG |
| NMIBC at high risk of progression | Experimental | Biological: MAGE-A3 ASCI, Biological: BCG |
| NMIBC at low risk of progression | Experimental | Biological: MAGE-A3 ASCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patient with histological confirmation of NMIBC
- Full recovery from surgery (TUR) from 1 to 6 weeks
- Karnofsky performance status of 60% or more
- Laboratory parameters for vital functions should be in the normal range
- Women of childbearing potential must use adequate contraception and have negative pregnancy test before and during the whole period of study treatment administration
Key exclusion criteria (12 listed)
- Muscle invasive bladder cancer
- Metastatic disease to the central nervous system, for which other therapeutic options, including radiotherapy, may be available
- Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
- Any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases(Patients with vitiligo are not excluded to participate in the trial)
- History of severe allergic reactions to vaccines or unknown allergens
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 |
|---|---|---|
| MAGE-A3 ASCI5 doses every 3 weeks | Biological | NMIBC at high risk of progression, NMIBC at intermediate risk of progression, NMIBC at low risk of progression |
| BCGAlso: Oncotice1 intravesical dose /week for 6 weeks | Biological | NMIBC at high risk of progression, NMIBC at intermediate risk of progression |
Primary outcome
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
Time frame: 6 months
3 secondary outcomes
Flow cytometric analysis of type and number of immune cell types in urine
Time frame: 6 months
Measurement of titers of antibodies against recMAGE-A3 in serum
Time frame: 6 months
Assessment of disease recurrence by control cystoscopy
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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.
Patrice Jichlinski, MD principal investigator
University Hospital Lausanne (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MAGE-A3 ASCI and BCG in people with Bladder Cancer, run by Patrice Jichlinski at 1 site in Switzerland.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability (time frame: 6 months). 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 4 Feb 2015.