Printed from Voxsanity (voxsanity.com.au) — NCT06529822 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Bladder Cancer Trial, Recruiting
NCT06529822
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
This trial has four groups (called cohorts). The criteria below are organised by group.
Cohort 1 – Bladder or Upper Urinary Tract Cancer
- Adults aged 18 or older
- General health that is reasonably well-maintained, as assessed by the treating doctor using a standard scale (ECOG score of 2 or below, or Karnofsky score of 60% or above)
- A confirmed diagnosis of muscle-invasive bladder cancer or cancer of the upper urinary tract (renal pelvis and/or ureter), confirmed by tissue testing
- If the cancer shows a mixed cell type, the main cell type must be the transitional cell type
- The cancer must have been completely removed by surgery with no cancer left at the surgical edges (called R0 resection), and must fall within specific staging categories based on standard cancer staging guidelines (confirm exact staging with trial site)
- Full recovery from surgery, as determined by the treating doctor
- A positive ctDNA blood test result using a specific test called Signatera, which detects tiny traces of cancer in the blood
- Imaging scans confirming no remaining cancer or spread to other parts of the body
- Blood and organ function test results that meet specific minimum levels for white blood cells, neutrophils, platelets, haemoglobin, liver enzymes, bilirubin, and kidney function (confirm exact values with trial site)
- People who are able to become pregnant, and men, must agree to use adequate contraception before joining, throughout the study, and for 5 months after finishing the study treatments; if pregnancy is suspected during the study, the treating doctor must be informed immediately
- No other experimental treatments being received outside of this trial
- Willingness and ability to read and sign a consent form; a legally authorised representative may do this on behalf of the participant
Cohort 2 – Stomach or Oesophageal (Gastroesophageal) Cancer
- Adults aged 18 or older
- General health meeting the same standard scale as Cohort 1 (ECOG score of 2 or below)
- A confirmed diagnosis of gastroesophageal adenocarcinoma (a type of cancer affecting the stomach or oesophagus), at Stage II or III
- The cancer must have been completely removed by surgery with no cancer left at the surgical edges (R0 resection), with full recovery from surgery and enrolment within 52 weeks of surgery
- The cancer must fall within specific staging categories based on standard cancer staging guidelines (confirm exact staging with trial site)
- Full recovery from surgery, as determined by the treating doctor
- A positive ctDNA blood test result using the Signatera test
- Imaging scans confirming no remaining cancer or spread to other parts of the body
- Blood and organ function test results meeting the same minimum levels as Cohort 1 (confirm exact values with trial site)
- People who are able to become pregnant, and men, must agree to use adequate contraception before joining, throughout the study, and for 5 months after finishing; if pregnancy is suspected during the study, the treating doctor must be informed immediately
- No other experimental treatments being received outside of this trial
- Willingness and ability to sign a consent form; a legally authorised representative may do this on behalf of the participant
Cohort 3 – Melanoma (Skin Cancer)
- Adults aged 18 or older
- General health meeting a slightly stricter standard (ECOG score of 1 or below)
- A confirmed diagnosis of melanoma at Stage IIB, IIC, IIIB, or IIIC, based on standard cancer staging guidelines
- Complete removal of the cancer by surgery (R0 resection) within the past 36 months, with full recovery from surgery
- Already planning to receive, or having already received, a type of cancer treatment called adjuvant immunotherapy for one year
- A positive ctDNA blood test result using the Signatera test, taken within 28 days before joining the trial
- Imaging scans confirming no remaining cancer or spread to other parts of the body
- Blood and organ function test results meeting the same minimum levels as Cohorts 1 and 2 (confirm exact values with trial site)
- Willingness and ability to sign a consent form; a legally authorised representative may do this on behalf of the participant
Cohort 4 – Non-Small Cell Lung Cancer
- Adults aged 18 or older
- General health meeting the same stricter standard as Cohort 3 (ECOG score of 1 or below)
- A confirmed diagnosis of non-small cell lung cancer at Stage II, IIIA, or IIIB, with complete surgical removal of the cancer (R0 resection) within 9 months of surgery
- Already planning to receive, or having already received, adjuvant immunotherapy for one year
- A positive ctDNA blood test result using the Signatera test, taken within 28 days before joining the trial
- Imaging scans confirming no remaining cancer or spread to other parts of the body
- Blood and organ function test results meeting the same minimum levels as the other cohorts (confirm exact values with trial site)
- Willingness and ability to sign a consent form; a legally authorised representative may do this on behalf of the participant
Who may not be able to join:
The following exclusion criteria apply across all cohorts, with some differences noted per group:
Applicable to all cohorts:
- Currently receiving other experimental treatments, or planning to receive other experimental treatments (note: people who previously received chemotherapy or immunotherapy around the time of surgery are generally still eligible — confirm with trial site)
- A known allergy or history of a serious reaction to any vaccine, such as severe allergic reactions, hives, or breathing difficulties
- A mental health condition or personal circumstances that the treating doctor believes would make it difficult to follow the study requirements
- A current or past autoimmune disease (a condition where the immune system attacks the body's own tissues) that requires immune-suppressing treatment — a long list of specific conditions applies, including inflammatory bowel disease, rheumatoid arthritis, lupus, multiple sclerosis, and others; some exceptions apply for people using only inhaled or locally applied steroids, or short-term low-dose steroids (confirm eligibility with trial site)
- Known HIV-positive status
- A history of active Hepatitis B or Hepatitis C infection confirmed by specific blood tests
- Side effects from previous cancer treatments that have not fully resolved (above a minor level), with the exception of hair loss; all prior cancer treatments must have been completed more than 28 days before starting the vaccine (except for standard adjuvant immunotherapy)
- A history of another cancer that the trial doctors believe could interfere with assessing this trial's safety or effectiveness (cases that do not meet this concern may still be considered — confirm with trial site)
- Having received a live vaccine within 30 days before joining the trial
- Having received immune-suppressing medication or treatment within 30 days before joining the trial
- Active autoimmune disease (excluding diabetes or a skin condition called vitiligo), a history of organ transplant or bone marrow transplant from a donor, or other known reasons that would prevent participation in immunotherapy
- A severe allergic reaction (Grade 3 or higher) to checkpoint inhibitor drugs or their ingredients
- Current lung inflammation (pneumonitis), a history of non-infectious lung inflammation that required steroid treatment, or a significant history of scarring or inflammation of the lung tissue
- A positive tuberculosis test result within 3 months before starting treatment
- Currently pregnant or breastfeeding; people who are able to become pregnant must have a negative pregnancy test before joining (timing of test differs slightly between cohorts — confirm with trial site)
Additional exclusion criteria for Cohort 3 (Melanoma) only:
- A history of stem cell transplant from a donor, or a solid organ transplant
- A history of severe immune-related side effects (Grade 3 or higher) from previous checkpoint inhibitor treatment that the treating doctor believes would prevent further immunotherapy or vaccine treatment
- Untreated or unstable cancer that has spread to the brain
Additional exclusion criteria for Cohort 4 (Non-Small Cell Lung Cancer) only:
- Specific gene changes in the tumour (EGFR, ALK, RET, or ROS1) for which targeted drug therapy is planned — the trial site can advise whether this applies in a specific case
- A history of stem cell transplant from a donor, or a solid organ transplant
- A history of severe immune-related side effects (Grade 3 or higher) from previous checkpoint inhibitor treatment that the treating doctor believes would prevent further immunotherapy or vaccine treatment
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: William Gillanders, M.D., Washington University School of Medicine
Phone: 314-747-0072
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
20 March 2025
Est. completion
31 January 2030
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Safety as measured by treatment-emergent adverse events (TEAEs); Safety as measured by treatment-related adverse events (TRAEs); Safety as measured by serious adverse events (SAEs); Feasibility as measured by the success of enrolling patients with molecular residual disease; Feasibility as measured by the expected time frame for vaccine creation; Feasibility as measured by the rate of successful vaccine delivery
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.