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Cancer Vaccine

PANDA-VAC + Pembrolizumab for Lung Cancer (PANDA-VAC Trial)

Phase 1

Waitlist Available

Led By Jared Weiss, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

Age ≥18 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

PANDA-VAC Trial Summary

This trial is designed to see if it is safe to give a new vaccine to people with squamous cell lung cancer or head and neck cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site from PANDA-VAC and typical immune therapy-related issues from Pembrolizumab such as fatigue, skin rash, diarrhea, liver inflammation, hormonal gland problems like thyroid dysfunction.

PANDA-VAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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My cancer hasn't worsened significantly on my current immunotherapy treatment.

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I have had treatment for lung or head and neck cancer, which cannot be cured.

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I am a man who either had a vasectomy or will use contraception.

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My blood tests show my bone marrow is working well.

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My cancer is a specific type of lung or head and neck cancer.

PANDA-VAC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

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

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

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

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

PANDA-VAC Trial Design

1Treatment groups

Experimental Treatment

Group I: PANDA-VAC combined with pembrolizumabExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 7Eligibility criteria met