St Louis, MONCT06529822Now EnrollingIRB Ready

Muscle-Invasive Bladder Carcinoma Clinical Trial in St Louis, MO

Access cutting-edge muscle-invasive bladder carcinoma treatment through this phase 1 clinical trial at a research site in St Louis. Study-provided care at no cost to qualified participants.

Sponsored by Washington University School of Medicine

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Expert Care in St Louis

Access muscle-invasive bladder carcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related muscle-invasive bladder carcinoma treatment provided free

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Check if you qualify for this muscle-invasive bladder carcinoma clinical trial in St Louis, MO

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Why Participate?

  • No-Cost Study Care

  • Local to St Louis

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit St Louis site if eligible
  4. 4Begin participation

About This Muscle-Invasive Bladder Carcinoma Study in St Louis

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.

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

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: pT2-4aN0M0 or pT0-4aN+M0.
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 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.

Exclusion Criteria

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 7 days of study entry. Inclusion Criteria Cohort #2:
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 52 weeks following surgery with curative intent. 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:
Esophageal and Esophagogastric junction adenocarcinoma T1 N1-3 M0 or T2-4 N0-2M0.
Gastric adenocarcinoma T1-2 N1-3 M0 or T3-4 N0-3 M0.
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. Exclusion Criteria Cohort #2:
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 of study entry. Inclusion Criteria Cohort #3:
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. Exclusion Criteria Cohort #3:
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 7 days of study entry. Inclusion Criteria Cohort #4:
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. Exclusion Criteria Cohort #4:
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 7 days of study entry.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT06529822) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Muscle-Invasive Bladder Carcinoma Treatment Options in St Louis, MO

If you're searching for muscle-invasive bladder carcinoma treatment options in St Louis, MO, this clinical trial (NCT06529822) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced muscle-invasive bladder carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all muscle-invasive bladder carcinoma clinical trials near you to find additional studies recruiting in your area.

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