Loading clinical trials...

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

WITHDRAWNPHASE1

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

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

NCT04799431•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 1.1.
•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 0.
•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.
+2 more criteria

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.
+14 more criteria

Key Dates

Start Date

May 3, 2023

Primary Completion Date

May 3, 2023

Completion Date

May 3, 2023

Last Updated

May 9, 2023

Conditions

Pancreatic Cancer MetastaticColorectal Cancer Metastatic

Interventions

Neoantigen Vaccine with Poly-ICLC adjuvant

DRUG

Retifanlimab

DRUG

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer

NCT05759728

Colorectal Cancer Metastatic

View study

RECRUITINGEARLY_PHASE1

COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer

NCT07328087

Colorectal Cancer MetastaticColorectal Cancer Stage III+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer

COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer

STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer

Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients

Holistic Acupuncture for Patients With Chemotherapy Induced Nausea

A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.