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Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab

NCT04266730 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-23

No results posted yet for this study

Summary

This is a single center, open-label phase I clinical trial designed to determine the safety of personalized and adjusted neoantigen peptide vaccine (PANDA-VAC) administered concurrently with pembrolizumab in subjects with advanced squamous non-small cell lung cancer (NSCLC) or squamous cell carcinoma of head and neck (SCCHN).

Conditions

  • Squamous Cell Lung Cancer
  • Squamous Non-small Cell Lung Cancer
  • Squamous Cell Carcinoma of Head and Neck

Interventions

BIOLOGICAL

PANDA-VAC

The primary therapeutic neoantigen vaccine product, Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine (PANDA-VAC), will be comprised of 6 peptides at a dose of 300 micrograms (µg) per peptide admixed with local adjuvant Stabilized polyriboinosinic/polyribocytidylic acid (Poly-ICLC).

DRUG

Pembrolizumab

Pembrolizumab will be administered at 200 mg IV dose every three weeks. The subject may transition to 400 mg every six weeks if, after the first scan done after start of treatment, they have a partial response or better or after two scans with stable disease or better.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jared Weiss, MD · UNC Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-05-20
Primary Completion
2027-06-01
Completion
2033-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04266730 on ClinicalTrials.gov