A Pilot Study of a Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins0 sitesMay 3, 2023

ConditionsPancreatic Cancer Metastatic Colorectal Cancer Metastatic

InterventionsNeoantigen Vaccine with Poly-ICLC adjuvant Retifanlimab

DrugsNeoantigen Vaccine with Poly-ICLC adjuvant Retifanlimab

Overview

Phase: Phase 1
Intervention: Neoantigen Vaccine with Poly-ICLC adjuvant
Conditions: Pancreatic Cancer Metastatic
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary Endpoint: Percentage of patients who receive at least one dose of personalized neoantigen vaccine
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

May 3, 2023

End Date

May 3, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years.
•Have histologically or cytologically - proven cancer of the pancreas or colon.
•Have tumor lesions amenable to repeated biopsy, and patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
•Measurable disease as per RECIST 1.
•Have sufficient and accessible tissue for NGS and immune-phenotyping.
•Have not received any prior systemic therapy in the metastatic setting for PDA or CRC. Patients who have received adjuvant chemotherapy \>12 months prior to the diagnosis of metastatic disease may be eligible.
•ECOG performance status
•Life expectancy of greater than 6 months.
•Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
•Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.

Exclusion Criteria

•Is a candidate for definitive surgical resection.
•Is unwilling or unable to undergo standard of care therapy.
•Known history or evidence of brain metastases and/or leptomeningeal spread.
•Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
•Receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment.
•Has active autoimmune disease that has required systemic treatment in the past 5 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
•Known history or concurrent interstitial lung disease.
•Has a pulse oximetry \< 95% on room air.
•Requires the use of home oxygen.
•Infection with HIV or hepatitis B or C.

Arms & Interventions

Neoantigen Vaccine with Poly-ICLC adjuvant and Retifanlimab

All participants receive this intervention.

Intervention: Neoantigen Vaccine with Poly-ICLC adjuvant

Neoantigen Vaccine with Poly-ICLC adjuvant and Retifanlimab

All participants receive this intervention.

Intervention: Retifanlimab

Outcomes

Primary Outcomes

Percentage of patients who receive at least one dose of personalized neoantigen vaccine

Time Frame: 9 months

Percentage of patients that receive at least one dose of personalized neoantigen vaccine in the maintenance setting among the total number of patients who achieved disease response (eligible for vaccine generation).

Number of participants experiencing study drug-related toxicities

Time Frame: 2 years

Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.