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

NCT04266730 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: LCCC1804
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lung cancer; head and neck cancer; neoantigen; vaccine; pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Number of adverse events in participants as a measure of safety of personalized and dose adjusted antitumor peptide vaccine (PANDA-VAC) administered concomitantly with pembrolizumab.

  Safety will be assessed by events occurring after initial treatment for subjects with advanced squamous non-small cell lung cancer, and head and neck squamous cell carcinoma. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  8 weeks

Secondary Outcomes (3)

• Response rate in subjects with advanced squamous non-small cell lung cancer, and head and neck squamous cell carcinoma treated with PANDA-VAC and pembrolizumab

  2 years

• Overall survival of subjects with advanced squamous non-small cell lung cancer, and head and neck squamous cell carcinoma treated with PANDA-VAC and pembrolizumab

  10 years

• Progression-free survival of subjects with advanced squamous non-small cell lung cancer, and head and neck squamous cell carcinoma treated with PANDA-VAC and pembrolizumab

  10 years

Study Arms (1)

PANDA-VAC combined with pembrolizumab

EXPERIMENTAL

The final primary therapeutic neoantigen vaccine product will comprise 6 peptides at a dose of 300 μg per peptide and Poly-ICLC at a dose of 500 μg formulated in an aqueous solution containing \<5% DMSO in isotonic dextrose for a total volume of 750 μL. The vaccine will be administered subcutaneously via 3 equal volume (250 μL) injections, one in an arm and one in each leg. The product will be administered on the following schedule: Days 1 and 4 of Week 1, Day 1 of Week 2, Day 1 of Week 3, Day 1 of Week 4, Day 1 of Week 11, and Day 1 of Week 21.

Biological: PANDA-VAC; Drug: Pembrolizumab

Interventions

PANDA-VAC BIOLOGICAL

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).

Also known as: Personalized and adaptive neoantigen dose-adjusted vaccine

PANDA-VAC combined with pembrolizumab

Pembrolizumab DRUG

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.

PANDA-VAC combined with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must sign an institutional review board (IRB) approved informed consent to undergo tissue procurement and HIPAA authorization for release of personal health information.
• Subject must have a previously treated, histologically confirmed squamous non-small cell lung cancer and head and neck squamous cell carcinoma where cure is either not possible or curative modality therapy is declined by the subject.
• Subject has adequate archival tumor tissue for sequencing for vaccine generation.
• Subject has Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• Subject has adequate bone marrow function as demonstrated by:
• Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
• Absolute lymphocyte count (ALC) ≥1.0 x 10\^9/L
• Hemoglobin \>8 g/dL (use of transfusion to reach this threshold prior to study initiation is acceptable)
• Platelet count ≥100 x 10\^9/L
• Subject has radiographically measurable according to RECIST 1.1 and iRECIST.
• Subjects must per RECIST 1.1 have stable disease, mixed response, oligoprogressive state (defined as disease progression at a limited number of anatomic sites, with continued response or stable disease at other sites of disease) or non-threatening progression (progression that fits a clinical pattern where the treating physician believes that PD-1 therapy post-progression is appropriate (e.g. multiple sub-centimeter nodules that do not compromise the bronchus)) on a PD-1, PDL-1 or PD-1/L containing regimen.
• Subject must meet the following criteria:
• For squamous non-small cell lung cancer (NSCLC):
• Tumor expressing PD-L1 (Tumor Proportion Score/TPS ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
• Subjects with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations.

You may not qualify if:

• Subject is currently participating in or has participated in a study of an investigational agent within 4 weeks of study pembrolizumab treatment initiation.
• Subject has active infection requiring systemic therapy.
• Subject is pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on the study).
• Subject has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for at least five years.
• Subject has active central nervous system (CNS) metastases. Treated metastases without evidence of progression will be allowed. Asymptomatic, subcentimeter metastases not requiring treatment will be allowed. Any leptomeningeal disease will be excluded.
• Subject is currently using systemic corticosteroids at doses ≥10mg prednisone daily or its equivalent, or other immunosuppressive medications including, but not limited to methotrexate, azathioprine, calcineurin inhibitor, and TNF-α blockers.
• Subject has known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
• Subject has a history of primary immunodeficiency.
• Subject has a history of organ transplant, bone marrow transplant or hematopoietic stem cell transplantation.
• Subject has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Subject has received a live attenuated vaccines within 30 days of on study pembrolizumab dosing. Inactivated vaccines, such as the injectable influenza vaccine, are permitted.
• Subject has any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study results.
• Subject is not a good candidate for treatment with pembrolizumab and PANDA-VAC per investigator's discretion.
• Eligibility Criteria for Vaccination:
• Subject must sign written informed consent to enroll in the PANDA-VAC therapy trial.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Lung Neoplasms; Head and Neck Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jared Weiss, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start (Estimated): May 20, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2033
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)