PANDA-VAC + Pembrolizumab for Lung Cancer

(PANDA-VAC Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jared Weiss, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Jared Weiss, MD

Principal Investigator

UNC Chapel Hill

Eligibility Criteria

This trial is for adults with advanced squamous non-small cell lung cancer or head and neck squamous cell carcinoma who have stable disease or limited progression on certain immune therapies. They must have good organ function, measurable disease, and be able to consent to biopsies. Pregnant women, those with autoimmune diseases requiring treatment in the past 2 years, active infections, or other cancers needing treatment are excluded.

Inclusion Criteria

I am fully active and can carry on all pre-disease activities without restriction.

I am 18 years old or older.

I agree to a biopsy for vaccine study if my cancer shows certain responses after 7 vaccinations.

Exclusion Criteria

I am currently being treated for an infection.

My doctor thinks pembrolizumab and PANDA-VAC are not suitable for me.

You have a history of a weakened immune system from birth.

Treatment Details

Interventions

• PANDA-VAC (Cancer Vaccine)
• Pembrolizumab (PD-1 Inhibitor)

Trial Overview The trial tests a personalized vaccine (PANDA-VAC) given alongside Pembrolizumab to see if it's safe for patients with specific types of advanced cancer. It's an early-phase study where all participants receive both treatments and are closely monitored.

Participant Groups

Group I: PANDA-VAC combined with pembrolizumab Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Dr. Shelley Earp

UNC Lineberger Comprehensive Cancer Center

Chief Medical Officer since 2018

MD from Johns Hopkins Medical School

Dr. Robert L. Ferris

UNC Lineberger Comprehensive Cancer Center

Chief Executive Officer

PhD in Immunology and MD from Johns Hopkins Medical School; Bachelor's in Chemistry from UNC-Chapel Hill