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AzTrials

Muscle-Invasive Bladder CarcinomaPhase 1NCT06529822

Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease

A Phase 1 study testing Synthetic long peptide personalized cancer vaccine, Poly ICLC and Signatera or Altera testing in people with Muscle-Invasive Bladder Carcinoma and Gastroesophageal Adenocarcinoma, run by Washington University School of Medicine at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Synthetic long peptide personalized cancer vaccine, Poly ICLC and Signatera or Altera testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
3 sitesUnited States
Study dates
20 Mar 2025to 30 Jun 2034
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Age ≥ 18 years.
  • ECOG performance status ≤ 2 (Karnofsky ≥ 60%).
  • Histologically confirmed muscle-invasive bladder cancer (MIBC) or upper tract urothelial carcinoma (renal pelvis and/or ureter).
  • Patients with carcinomas showing mixed histologies are required to have a dominant transitional cell pattern.
  • Complete surgical resection of MIBC (R0) or upper tract urothelial carcinoma (renal pelvis and/or ureter). Tumor, nodes, metastases (TNM) classification (based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th ed.) at pathological examination of surgical resection specimen as follows: ypT0N0M0, pT2-4N0M0, or pT0-4aN+M0.
  • Patient must have fully recovered from surgical resection in the opinion of the treating MD.
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  • ctDNA positive result as identified by Signatera.
  • Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.
  • Adequate bone marrow and organ function as defined below:
  • WBC ≥ 1.5 K/cumm
  • Absolute neutrophil count ≥ 1.0 K/cumm
  • Platelets ≥ 50 K/cumm
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  • Creatinine clearance > 30 mL/min by Cockcroft-Gault
  • The effects of synthetic long peptide personalized cancer vaccines and Hiltonol on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after completion of study interventions. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
  • No concurrent investigational therapies outside of this protocol are allowed.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
  • Age ≥ 18 years.
  • ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
  • Histologically confirmed gastroesophageal adenocarcinoma
  • Stage II or III gastroesophageal adenocarcinoma (GEC).
  • Complete surgical resection of GEC (R0). Full recovery from surgery and enrollment within 3 yearsfollowing surgery with curative intent. Eligible patients must have had clinical tumor, nodes, metastases (TNM) classification (based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th ed.) documented at initial diagnosis after completion of diagnostic staging and prior to initiation of definitive anti-cancer therapy as follows:
  • Esophageal and esophagogastric junction adenocarcinoma: cT1 cN1-3 cM0 or cT2-4 cN0-2 cM0
  • Gastric adenocarcinoma: cT1-2 cN1-3 cM0 or cT3-4 cN0-3 cM0
  • Patient must have fully recovered from surgical resection in the opinion of the treating MD.
  • ctDNA positive result as identified by Signatera.
  • Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.
  • Adequate bone marrow and organ function as defined below:
  • WBC ≥ 1.5 K/cumm
  • Absolute neutrophil count ≥ 1.0 K/cumm
  • Platelets ≥ 50 K/cumm
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  • Creatinine clearance > 30 mL/min by Cockcroft-Gault
  • The effects of synthetic long peptide personalized cancer vaccines and Hiltonol and on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after completion of study interventions. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
  • No concurrent investigational therapies outside of this protocol are allowed.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
  • Age ≥ 18 years.
  • ECOG performance status ≤ 1.
  • Histologically or cytologically confirmed diagnosis of Melanoma. Stage IIB/C or IIIB-C (per AJCC 8th edition). Completed R0 resection within 36 months prior to enrollment and have fully recovered from surgery.
  • Planning to receive or have received adjuvant immunotherapy for 1 year.
  • Availability of a SignateraTM ctDNA report within 28 days prior to enrollment demonstrating ctDNA-positivity (MRD+). Note: Patients may be pre-screened prior to obtaining ctDNA results to facilitate assay design.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
  • Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.
  • Adequate bone marrow and organ function as defined below:
  • WBC ≥ 1.5 K/cumm
  • Absolute neutrophil count ≥ 1.0 K/cumm
  • Platelets ≥ 50 K/cumm
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  • Creatinine clearance > 30 mL/min by Cockcroft-Gault
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
  • Age ≥ 18 years.
  • ECOG performance status ≤ 1.
  • Histological diagnosis of non-small cell lung carcinoma, stages II, IIIA or IIIB with complete R0 resection. Completed R0 resection within 9 months of surgery.
  • Planned to receive or have received adjuvant immunotherapy for 1 year.
  • Availability of a SignateraTM ctDNA report within 28 days prior to enrollment demonstrating ctDNA-positivity (MRD+). Note: Patients may be pre-screened prior to obtaining ctDNA results to facilitate assay design.
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
  • Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.
  • Adequate bone marrow and organ function as defined below:
  • WBC ≥ 1.5 K/cumm
  • Absolute neutrophil count ≥ 1.0 K/cumm
  • Platelets ≥ 50 K/cumm
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  • Creatinine clearance > 30 mL/min by Cockcroft-Gault
  • Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Who cannot join

  • Receiving any other investigational agents, or planning to receive other investigational agents as part of neoadjuvant therapy. Patients who have received perioperative neoadjuvant chemotherapy and immunotherapy, including enfortumab vedotin plus pembrolizumab (EV+P), are allowed.
  • Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
  • A psychiatric illness or social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record.
  • Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease taking inhaled corticosteroids that does not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allow if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for > 7 consecutive days. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if eligible.
  • Known HIV-positive status.
  • History of positive test for Hepatitis B virus surface antigen (HBsAg) and/or positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection
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  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia. For treatment enrollment the patient must have completed all prior cancer treatments > 28 days prior to vaccine administration with the exception of adjuvant SOC immunotherapy.
  • Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial per discussion with the PI.
  • Currently receiving any other investigational agents.
  • Live vaccine administered within 30 days prior to enrollment.
  • Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 30 days of enrollment.
  • Active autoimmune disease (excluding diabetes mellitus and/or vitiligo), solid organ or allogeneic bone marrow transplant, or other known contraindications to receiving immunotherapy.
  • Severe hypersensitivity (grade ≥ 3) to checkpoint inhibitors and/or any of its excipients.
  • Current pneumonitis, a history of (non-infectious) pneumonitis requiring steroids, or history of clinically significant interstitial lung disease.
  • Active tuberculosis test within 3 months prior to treatment initiation.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum/urine pregnancy test within 14 days of prior to the first dose of vaccine.
  • Receiving any other investigational agents or planning to receive other investigational agents as part of neoadjuvant therapy. Patients who have received perioperative neoadjuvant chemotherapy and immunotherapy are allowed.
  • Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
  • A psychiatric illness or social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record.
  • Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease taking inhaled corticosteroids that does not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allow if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for > 7 consecutive days. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if eligible.
  • Known HIV-positive status.
  • History of positive test for Hepatitis B virus surface antigen (HBsAg) and/or positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia. For treatment enrollment the patient must have completed all prior cancer treatments > 28 days prior to vaccine administration with the exception of adjuvant SOC immunotherapy.
  • Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial per discussion with the PI.
  • Currently receiving any other investigational agents.
  • Live vaccine administered within 30 days prior to enrollment.
  • Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 30 days of enrollment.
  • Active autoimmune disease (excluding diabetes mellitus and/or vitiligo), solid organ or allogeneic bone marrow transplant, or other known contraindications to receiving immunotherapy.
  • Severe hypersensitivity (grade ≥ 3) to checkpoint inhibitors and/or any of its excipients.
  • Current pneumonitis, a history of (non-infectious) pneumonitis requiring steroids, or history of clinically significant interstitial lung disease.
  • Active tuberculosis test within 3 months prior to treatment initiation.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum/urine pregnancy test within 14 days prior to the first dose of the vaccine.
  • Receiving any other investigational agents or planning to receive other investigational agents in the neoadjuvant or adjuvant setting.
  • Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
  • A psychiatric illness or social situation that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record.
  • Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease, taking inhaled corticosteroids that do not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allowed if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for > 7 consecutive days. Systemic steroids must be discontinued at least 7 days prior to the first dose of SLP-01. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if they are eligible for this investigational treatment.
  • History of allogeneic stem cell transplant of solid organ transplant.
  • History of grade ≥3 immune-related adverse events with prior checkpoint inhibitors that, in the investigator's opinion, preclude further IO or vaccine therapy.
  • Untreated or unstable CNS metastases.
  • Known HIV-positive status.
  • History of positive test for Hepatitis B virus surface antigen (HBsAg) and/or positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum/urine pregnancy test within 14 days prior to first dose of vaccine.
  • Receiving any other investigational agents or planning to receive other investigational agents in the neoadjuvant or adjuvant setting.
  • Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
  • A psychiatric illness or social situation that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record.
  • Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease, taking inhaled corticosteroids that do not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allowed if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for > 7 consecutive days. Systemic steroids must be discontinued at least 7 days prior to the first dose of SLP-01. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if they are eligible for this investigational treatment.
  • Known EGFR activating mutations (exon 19 deletion or L858R) or ALK, RET, or ROS1 gene rearrangements in subjects for whom adjuvant targeted therapy is planned.
  • History of allogeneic stem cell transplant or solid organ transplant.
  • History of grade ≥3 immune-related adverse events with prior checkpoint inhibitors that, in the investigator's opinion, preclude further IO or vaccine therapy.
  • Known HIV-positive status.
  • History of positive test for Hepatitis B virus surface antigen (HBsAg) and/or positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum/urine pregnancy test within 14 days prior to the first dose of vaccine.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

William Gillanders, M.D. contact

314-747-0072

gillanders@wustl.edu

United States3 sites, 3 recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Elshad Hasanov, M.D., Ph.D., 614-293-6196

    Elshad Hasanov, M.D., Ph.D.

    Not yet recruiting

  • AdventHealth

    Orlando, Florida, 32804

    Guru P Sonpavde, M.D., 407-609-9065

    Guru P Sonpavde, M.D.

    Not yet recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    William Gillanders, M.D., 314-747-0072, gillandersw@wustl.edu

    William Gillanders, M.D.

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease

This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC.

Being tested
Synthetic long peptide personalized cancer vaccine, Poly ICLC, Signatera or Altera testing
Keywords
Personalized cancer vaccine, Solid tumor, Immunotherapy, Bladder cancer, Gastroesophageal Adenocarcinoma, GEC, Melanoma, NSCLC, Non-small cell lung cancer
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synthetic long peptide personalized cancer vaccineBiological

    Also called PCV

    Neoantigen vaccines will be provided on a patient-specific basis

  • Poly ICLCDrug

    Also called Hiltonol

    Poly-ICLC will be supplied by Oncovir, Inc.

  • Signatera or Altera testingDevice

    Testing used to identify and prioritize neoantigens.

Study groups in NCT06529822
Study groupRoleWhat they receive
Cohort 1: Muscle Invasive Bladder Cancer (PCV)ExperimentalThe schedule for vaccination will be Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169. All study injections will be given intramuscularly and co-administered with poly-ICLC by a trained healthcare provider.
Receives: Biological: Synthetic long peptide personalized cancer vaccine; Drug: Poly ICLC; Device: Signatera or Altera testing
Cohort 2: Gastroesophageal Adenocarcinoma (GEC)ExperimentalThe schedule for vaccination will be Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169. All study injections will be given intramuscularly and co-administered with poly-ICLC by a trained healthcare provider.
Receives: Biological: Synthetic long peptide personalized cancer vaccine; Drug: Poly ICLC; Device: Signatera or Altera testing
Cohort 3: MelanomaExperimentalThe schedule for vaccination will be Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169. All study injections will be given intramuscularly and co-administered with poly-ICLC by a trained healthcare provider.
Receives: Biological: Synthetic long peptide personalized cancer vaccine; Drug: Poly ICLC; Device: Signatera or Altera testing
Cohort 4: Non-Small Cell Lung CancerExperimentalThe schedule for vaccination will be Days 1, 4, 8, 15, 29, 57, 85, 113, 141, and 169. All study injections will be given intramuscularly and co-administered with poly-ICLC by a trained healthcare provider.
Receives: Biological: Synthetic long peptide personalized cancer vaccine; Drug: Poly ICLC; Device: Signatera or Altera testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as measured by treatment-emergent adverse events (TEAEs)

    Measured: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)

  2. Safety as measured by treatment-related adverse events (TRAEs)

    -At least possibly related to vaccine therapy

    Measured: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)

  3. Safety as measured by serious adverse events (SAEs)

    As defined in 21 CFR 312.32:

    Definition: an adverse event is considered "serious" if, in the view of the investigator, it results in any of the following outcomes:

    • Death
    • A life-threatening adverse event
    • Inpatient hospitalization or prolongation of existing hospitalization
    • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
    • A congenital anomaly/birth defect
    • Any other important medical event that does not fit the criteria above but, based upon appropriate medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above

    Measured: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)

  4. Feasibility as measured by the success of enrolling patients with molecular residual disease

    The trial will be feasible if 8 patients with molecular residual disease are enrolled in 30 months

    Measured: Through 30 months

  5. Feasibility as measured by the expected time frame for vaccine creation

    The trial will be feasible if the vaccine is created within 24 weeks from signing of treatment consent to vaccine availability.

    Measured: Through 24 weeks

  6. Feasibility as measured by the rate of successful vaccine delivery

    The trial will be feasible if at least 50% of patients receive the vaccine

    Measured: Through 1st vaccine dose (estimated to be 24 weeks)

Secondary outcomes (3)

  1. Immune response as measured by ELISPOT analysis

    Treatment screening, day 1, day 15, day 29, day 57, day 85, day 113, day 141, day 169, 1 year (optional), and 2 years (optional)

    Measured: Through 2 years after completion of treatment (estimated to be 2.5 years)

  2. Molecular residual disease as evaluated by ctDNA clearance using the Signatera assay

    Treatment screening, day 1, day 8, day 15, day 29, day 57, day 85, day 113, day 141, day 169, and during follow-up.

    Measured: Through completion of follow-up (estimated to be 66 months)

  3. Recurrence-free survival (RFS)

    Recurrence-free survival is defined as the rate of recurrence from treatment enrollment until disease recurrence per standard of care assessments, or until patient is off study, whichever occurs first.

    Measured: Through completion of follow-up (estimated to be 66 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start20 Mar 2025
  3. Primary completion31 Jan 2030 (estimated)
  4. Study completion30 Jun 2034 (estimated)

Resources

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
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06529822
Sponsor's protocol ID
202412028
Status last verified
Sep 2026
First submitted
26 Jul 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Synthetic long peptide personalized cancer vaccine, Poly ICLC and Signatera or Altera testing in people with Muscle-Invasive Bladder Carcinoma and Gastroesophageal Adenocarcinoma, run by Washington University School of Medicine at 3 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 72 inclusion and 52 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact William Gillanders, M.D. (314-747-0072, gillanders@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as measured by treatment-emergent adverse events (TEAEs) (time frame: From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06529822.

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 21 Sep 2026.

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