Infiltrating Bladder Urothelial CarcinomaNCT02944357
Gemcitabine Hydrochloride, Cisplatin, and AGS-003-BLD in Treating Patients With Muscle-Invasive Bladder Cancer Undergoing Surgery
A study testing Cisplatin, Gemcitabine Hydrochloride and Radical Cystectomy in people with Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and who are undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma
- What is being tested?
- Cisplatin, Gemcitabine Hydrochloride and Radical Cystectomy
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 5 Sep 2017
- Phase
- Interventional
- 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
- PRE-REGISTRATION INCLUSION CRITERIA: Diagnosis or clinical signs of urothelial carcinoma with clinical stage T2 or greater disease without lymph node involvement where neoadjuvant chemotherapy of cisplatin and gemcitabine are indicated
- PRE-REGISTRATION INCLUSION CRITERIA: Scheduled for a transurethral resection of bladder tumor (TURBT)
- PRE-REGISTRATION INCLUSION CRITERIA: Be a candidate for radical cystectomy
- PRE-REGISTRATION INCLUSION CRITERIA: Signed and dated informed consent document for study participation
- PRE-REGISTRATION INCLUSION CRITERIA: Willing to submit tissue for required correlative research
- REGISTRATION INCLUSION CRITERIA
Show all 24Show fewer
- TURBT successfully completed
- Verification received from Argos Therapeutics that ribonucleic acid (RNA) successfully collected from TURBT procedure
- Be a candidate for radical cystectomy
- Diagnosis of urothelial carcinoma with stage T2 or greater disease without lymph node involvement where neoadjuvant chemotherapy of cisplatin and gemcitabine are indicated
- Absolute neutrophil count (ANC) >= 1500/uL
- Platelet count >= 100,000/uL
- Total bilirubin =< 1.5 x institutional upper normal limit (UNL) or =< 3 x institutional UNL if known Gilbert's syndrome
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x UNL
- Alkaline phosphatase =< 5 x UNL
- Hemoglobin >= 9.0 g/dL
- International normalized ratio (INR) and partial thromboplastin time (PTT) =< 3.0 x UNL; NOTE: anticoagulation is allowed if target INR =< 3.0 x UNL on a stable dose of warfarin or on a stable dose of low molecular weight heparin for > 2 weeks at time of registration
- Calculated creatinine clearance must be >= 50 ml/min using the applicable Cockcroft-Gault formula
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Ability to provide written informed consent
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Willing to provide tissue and blood samples for correlative research purposes
- Negative serum pregnancy test for female subjects with reproductive potential =< 7 days prior to registration, for women of childbearing potential only
- Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
Who cannot join
- RE-REGISTRATION EXCLUSION CRITERIA
- Requirement for systemic chronic immunosuppressive drugs or systemic chronic corticosteroids for active autoimmune disorder(s) or other conditions (e.g.: rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)
- Known inability to undergo neoadjuvant gemcitabine and cisplatin combination treatment due to pre-existing medical conditions in the opinion of the treating physician or investigator
- Immunotherapy =< 28 days prior to pre-registration (e.g. intravesical Bacillus Calmette-Guerin [BCG])
- Any of the following prior therapies:
- Systemic chemotherapy for bladder cancer at any time; NOTE: intravesical chemotherapy is allowed
Show all 24Show fewer
- Systemic chemotherapy for other malignancies =< 3 years prior to pre-registration
- REGISTRATION EXCLUSION CRITERIA
- Lymph node positive urothelial carcinoma
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator
- Treatment with oral/systemic corticosteroids =< 14 days prior to registration, with the exception of topical or inhaled steroids or steroids given for the purpose of antiemetics during chemotherapy
- New York Heart Association classification III or IV congestive heart failure
- Central nervous system (CNS) metastases or seizure disorder
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) with the exception of intravesical therapy at the time of TURBT
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Clinically significant infections including human immunodeficiency virus (HIV), syphilis, and active hepatitis B or C
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Prior history of malignancy =< 3 years prior to registration, except for adequately treated non-melanoma skin cancer, adequately treated early stage breast cancer, adequately treated cervical cancer and non-metastatic prostate cancer under clinical control as deemed by treating physician or investigator
- History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- History of major surgery or traumatic injury =< 28 days prior to registration or other major anticipated procedures requiring general anesthesia during study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Gemcitabine and Cisplatin Plus AGS-003-BLD in Patients With Muscle-Invasive Bladder Cancer Undergoing Neoadjuvant Cisplatin-Based Chemotherapy
This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and who are undergoing surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Giving gemcitabine hydrochloride, cisplatin, and AGS-003-BLD before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed by surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the immunogenicity of AGS-003-BLD in subjects with muscle invasive bladder cancer.
SECONDARY OBJECTIVES:
- To assess 1-year disease-free survival rate of patients with muscle-invasive bladder cancer who receive cisplatin/gemcitabine chemotherapy plus AGS-003-BLD.
II. To determine the time to first metastatic lesion. III. To explore the disease-free and overall survival of patients treated with this treatment combination.
IV. To evaluate the pathologic complete response (pCR) rate and identify any activity of this treatment combination.
- To evaluate toxicities and tolerability associated with this treatment combination.
VI. To assess the success rate of tumor procurement and AGS-003-BLD production of >= 5 doses.
TERTIARY OBJECTIVES:
- To evaluate the relationships between pathologic complete response with the change in CD28+ T cell levels.
II. To evaluate the change in frequency of CD11a highPD-1+ CD8+ T cells (and their expression of Bim) in peripheral blood.
OUTLINE:
NEOADJUVANT PHASE: Patients receive gemcitabine hydrochloride intravenously (IV) on days 1 and 8, AGS-003-BLD intradermally (ID) on day 1, and cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive AGS-003-BLD ID on day 1. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients undergo cystectomy during course 8.
ADJUVANT PHASE: Patients continue AGS-003-BLD ID on day 1 of course 9. Treatment repeats every 12 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
- Conditions
- Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma
- Being tested
- Cisplatin, Gemcitabine Hydrochloride, Radical Cystectomy, Tumor Cell-Derived Vaccine Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given IV
Also called dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011
Given IV
Radical CystectomyProcedure or surgery
Also called Complete Cystectomy
Undergo cystectomy
Tumor Cell-Derived Vaccine TherapyBiological
Given AGS-003-BLD ID
| Study group | Role | What they receive |
|---|---|---|
| Treatment (gemcitabine hydrochloride, cisplatin, AGS-003-BLD) | Experimental | NEOADJUVANT PHASE: Patients receive gemcitabine hydrochloride IV on days 1 and 8, AGS-003-BLD ID on day 1, and cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive AGS-003-BLD ID on day 1. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients undergo cystectomy during course 8.
ADJUVANT PHASE: Patients continue AGS-003-BLD ID on day 1 of course 9. Treatment repeats every 12 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cisplatin; Drug: Gemcitabine Hydrochloride; Procedure: Radical Cystectomy; Biological: Tumor Cell-Derived Vaccine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
Measured: Baseline, before systemic therapy with chemotherapy
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
Measured: Prior to 1st dose of AGS-003-Bladder therapy
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
Measured: Treatment visit 7 (Cycle 3) After 3rd dose of AGS-003-Bladder therapy, up to 7 days
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
Measured: Treatment visit 15 (Cycle 6) - After the 5th dose of neoadjuvant AGS-003-Bladder therapy, up to 14 days
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
Measured: Treatment visit 20 (Cycle 8) - After the 8th dose (3rd adjuvant) of AGS-003 - Bladder therapy, up to 12 weeks
Secondary outcomes (8)
1-year survival rate
Measured: 1 year
2-year disease-free survival rate
Measured: 2 years
2-year survival rate
Measured: 2 years
Disease-free survival rate
Measured: 1 year
Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Measured: Up to 2 years
Manufacturing success rate and successful manufacture of > 5 doses and administration of 1 or more doses of AGS-003-BLD
Descriptive statistics (frequency table) and histogram will be used to summarize the success rate.
Measured: Up 2 years
Proportion of pathologic complete responses
Descriptive statistics (frequency table) and histogram will be used to summarize the pathologic complete response rate.
Measured: Up to 2 years
Time to first metastatic lesion
Will be estimated using the Kaplan-Meier method.
Measured: Time from randomization to first recognition of metastases, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infiltrating Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian Costello, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944357
- Sponsor's protocol ID
- MC1452
- Other IDs
- NCI-2016-01517, MC1452, P30CA015083
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Gemcitabine and Cisplatin Plus AGS-003-BLD in Patients With Muscle-Invasive Bladder Cancer Undergoing Neoadjuvant Cisplatin-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT02944357
- Acronym / sponsor ID
- MC1452
- Conditions
- Infiltrating Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2016 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 25 Oct 2016 (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.
This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and who are undergoing surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Giving gemcitabine hydrochloride, cisplatin, and AGS-003-BLD before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed by surgery.
Detailed description
PRIMARY OBJECTIVES:
- To assess the immunogenicity of AGS-003-BLD in subjects with muscle invasive bladder cancer.
SECONDARY OBJECTIVES:
- To assess 1-year disease-free survival rate of patients with muscle-invasive bladder cancer who receive cisplatin/gemcitabine chemotherapy plus AGS-003-BLD.
II. To determine the time to first metastatic lesion. III. To explore the disease-free and overall survival of patients treated with this treatment combination.
IV. To evaluate the pathologic complete response (pCR) rate and identify any activity of this treatment combination.
- To evaluate toxicities and tolerability associated with this treatment combination.
VI. To assess the success rate of tumor procurement and AGS-003-BLD production of >= 5 doses.
TERTIARY OBJECTIVES:
- To evaluate the relationships between pathologic complete response with the change in CD28+ T cell levels.
II. To evaluate the change in frequency of CD11a highPD-1+ CD8+ T cells (and their expression of Bim) in peripheral blood.
OUTLINE:
NEOADJUVANT PHASE: Patients receive gemcitabine hydrochloride intravenously (IV) on days 1 and 8, AGS-003-BLD intradermally (ID) on day 1, and cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive AGS-003-BLD ID on day 1. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Patients undergo cystectomy during course 8.
ADJUVANT PHASE: Patients continue AGS-003-BLD ID on day 1 of course 9. Treatment repeats every 12 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (gemcitabine hydrochloride, cisplatin, AGS-003-BLD) | Experimental | Drug: Cisplatin, Drug: Gemcitabine Hydrochloride, Procedure: Radical Cystectomy, Biological: Tumor Cell-Derived Vaccine TherapyNEOADJUVANT PHASE: Patients receive gemcitabine hydrochloride IV on days 1 and 8, AGS-003-BLD ID on day 1, and cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive AGS-003-BLD ID on day 1. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo cystectomy during course 8. ADJUVANT PHASE: Patients continue AGS-003-BLD ID on day 1 of course 9. Treatment repeats every 12 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- PRE-REGISTRATION INCLUSION CRITERIA: Diagnosis or clinical signs of urothelial carcinoma with clinical stage T2 or greater disease without lymph node involvement where neoadjuvant chemotherapy of cisplatin and gemcitabine are indicated
- PRE-REGISTRATION INCLUSION CRITERIA: Scheduled for a transurethral resection of bladder tumor (TURBT)
- PRE-REGISTRATION INCLUSION CRITERIA: Be a candidate for radical cystectomy
- PRE-REGISTRATION INCLUSION CRITERIA: Signed and dated informed consent document for study participation
- PRE-REGISTRATION INCLUSION CRITERIA: Willing to submit tissue for required correlative research
Key exclusion criteria (24 listed)
- RE-REGISTRATION EXCLUSION CRITERIA
- Requirement for systemic chronic immunosuppressive drugs or systemic chronic corticosteroids for active autoimmune disorder(s) or other conditions (e.g.: rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, organ transplant recipient, etc.)
- Known inability to undergo neoadjuvant gemcitabine and cisplatin combination treatment due to pre-existing medical conditions in the opinion of the treating physician or investigator
- Immunotherapy =< 28 days prior to pre-registration (e.g. intravesical Bacillus Calmette-Guerin [BCG])
- Any of the following prior therapies:
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 |
|---|---|---|
| CisplatinAlso: Abiplatin, Blastolem, Briplatin, CDDPGiven IV | Drug | Treatment (gemcitabine hydrochloride, cisplatin, AGS-003-BLD) |
| Gemcitabine HydrochlorideAlso: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011Given IV | Drug | Treatment (gemcitabine hydrochloride, cisplatin, AGS-003-BLD) |
| Radical CystectomyAlso: Complete CystectomyUndergo cystectomy | Procedure or surgery | Treatment (gemcitabine hydrochloride, cisplatin, AGS-003-BLD) |
| Tumor Cell-Derived Vaccine TherapyGiven AGS-003-BLD ID | Biological | Treatment (gemcitabine hydrochloride, cisplatin, AGS-003-BLD) |
Primary outcome
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Time frame: Baseline, before systemic therapy with chemotherapy
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Time frame: Prior to 1st dose of AGS-003-Bladder therapy
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Time frame: Treatment visit 7 (Cycle 3) After 3rd dose of AGS-003-Bladder therapy, up to 7 days
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Time frame: Treatment visit 15 (Cycle 6) - After the 5th dose of neoadjuvant AGS-003-Bladder therapy, up to 14 days
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
Change in the frequency of CD11a high PD-1+ CD8+ T cells
Time frame: Treatment visit 20 (Cycle 8) - After the 8th dose (3rd adjuvant) of AGS-003 - Bladder therapy, up to 12 weeks
Descriptive statistics (mean, standard deviation [sd], median, interquartile range [iqr]) will be used to summarize change from baseline in the frequency of CD11a high PD-1+ CD8+ T cells following five doses of AGS-003-BLD.
8 secondary outcomes
1-year survival rate
Time frame: 1 year
2-year disease-free survival rate
Time frame: 2 years
2-year survival rate
Time frame: 2 years
Disease-free survival rate
Time frame: 1 year
Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events
Time frame: Up to 2 years
Manufacturing success rate and successful manufacture of > 5 doses and administration of 1 or more doses of AGS-003-BLD
Time frame: Up 2 years
Proportion of pathologic complete responses
Time frame: Up to 2 years
Time to first metastatic lesion
Time frame: Time from randomization to first recognition of metastases, assessed up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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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.
Brian Costello principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cisplatin, Gemcitabine Hydrochloride and Radical Cystectomy in people with Infiltrating Bladder Urothelial Carcinoma and Stage II Bladder Urothelial Carcinoma, run by Mayo Clinic at 1 site 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 24 inclusion and 24 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: withdrawn, as of the sponsor's last update on 17 Nov 2017. 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 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in the frequency of CD11a high PD-1+ CD8+ T cells (time frame: Baseline, before systemic therapy with chemotherapy). The study lists 5 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 17 Nov 2017.