Personalized Cancer Vaccine for Solid Tumors with Molecular Residual Disease
This study is testing a personalized cancer vaccine strategy for people with certain solid tumors, including muscle-invasive bladder cancer, gastroesophageal adenocarcinoma, melanoma, and non-small cell lung cancer. The vaccine, called a synthetic long peptide personalized cancer vaccine, is given along with another drug called Poly ICLC. Researchers want to see if these personalized vaccines are safe and can help the body's immune system fight cancer by clearing tiny amounts of cancer cells that might remain after treatment (called molecular residual disease). The study will also use a test called Signatera to detect these remaining cancer cells. You may be able to join if you are at least 18 years old and have one of the specified cancer types.
- Study design
- This is a Phase 1 interventional study aiming to enroll 64 participants. It is designed to evaluate the safety, feasibility, and immune response to the personalized cancer vaccine.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored from the first vaccine dose through 30 days after the last dose, which is estimated to be 13 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06529822
Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease
Recruiting
PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~64 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Synthetic long peptide personalized cancer vaccinePoly ICLCSignatera assay
At a glance
Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as measured by treatment-emergent adverse events (TEAEs)
Measured over From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)
+5 more outcomes measured
Conditions
Where it's being run
3 sites across 3 statesFlorida1
Missouri1
Ohio1
Study leadership
- William Gillanders, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
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.
Exclusion
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 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.
What this trial measures
- Safety as measured by treatment-emergent adverse events (TEAEs)From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)
- Safety as measured by treatment-related adverse events (TRAEs)From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)
-At least possibly related to vaccine therapy
- Safety as measured by serious adverse events (SAEs)From 1st vaccine dose through 30 days following last dose of vaccine (estimated to be 13 months)
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
- Feasibility as measured by the success of enrolling patients with molecular residual diseaseThrough 30 months
The trial will be feasible if 8 patients with molecular residual disease are enrolled in 30 months
- Feasibility as measured by the expected time frame for vaccine creationThrough 24 weeks
The trial will be feasible if the vaccine is created within 24 weeks from signing of treatment consent to vaccine availability.
- Feasibility as measured by the rate of successful vaccine deliveryThrough 1st vaccine dose (estimated to be 24 weeks)
The trial will be feasible if at least 50% of patients receive the vaccine