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

Conditions

• Gastroesophageal Adenocarcinoma
• Melanoma
• Muscle-Invasive Bladder Carcinoma
• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Synthetic long peptide personalized cancer vaccine — BIOLOGICAL
  Neoantigen vaccines will be provided on a patient-specific basis
• Poly ICLC — DRUG
  Poly-ICLC will be supplied by Oncovir, Inc.
• Signatera assay — DEVICE
  Signatera is a clinically validated, personalized, tumor-informed, multiplex-PCR and next-generation sequencing (NGS) based clinical trial assay targeting 16 tumor-specific mutations. It is intended for the detection of ctDNA isolated from anticoagulated peripheral whole blood from post-surgical patients previously diagnosed with localized or advanced solid tumors to aid physician assessment and treatment decision-making, together with other clinical factors

Study Details

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.

Key Dates

First listed

Jul 31, 2024

Start date

Mar 20, 2025

Status verified

Jul 2026

Primary completion

Jan 31, 2030

Completion

Jun 30, 2034

Study Design

Enrollment

64 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Muscle Invasive Bladder Cancer (PCV)
  The 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.
• Experimental: Cohort 2: Gastroesophageal Adenocarcinoma (GEC)
  The 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.
• Experimental: Cohort 3: Melanoma
  The 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.
• Experimental: Cohort 4: Non-Small Cell Lung Cancer
  The 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.

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) ]

Central Contacts

• William Gillanders, M.D.
  314-747-0072
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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