Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04799431
Phase
PHASE1
Status
Withdrawn

Conditions

  • Colorectal Cancer Metastatic
  • Pancreatic Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neoantigen Vaccine with Poly-ICLC adjuvant — DRUG
    Neoantigen Vaccine with Poly-ICLC adjuvant will be administered on days 1, 8, 15 and 22. 2 to 5 subcutaneous injections will be administered in the upper thighs, arms and/or back. Drug: 0.3 mg per peptide vaccine + 0.5mg Poly-ICLC
  • Retifanlimab — DRUG
    500 mg will be administered as a 30 minute IV. Infusion (-5 min/+15min) on Day 1 of each 28 day cycle every 4 weeks.

Study Details

Phase 1 study evaluating feasibility, safety, and immune response to a personalized neoantigen vaccine combined with retifanlimab for MMR-p mCRC and mPDAC patients with measurable disease following first-line FOLFIRINOX/FOLFOXIRI (FFX).

Key Dates

Start date
May 3, 2023
Status verified
May 2023
Primary completion
May 3, 2023
Completion
May 3, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoantigen Vaccine with Poly-ICLC adjuvant and Retifanlimab
    All participants receive this intervention.

Primary Outcome Measure

Percentage of patients who receive at least one dose of personalized neoantigen vaccine [ Time Frame: 9 months ]

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