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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.

Must not have

Subject has active infection requiring systemic therapy.

Subject has active autoimmune disease that has required systemic treatment in the past 2 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I have an autoimmune disease treated with medication in the last 2 years.

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I am taking 10mg or more of prednisone daily or similar medications.

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I have another cancer that is growing and needs treatment.

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My cancer has spread to my brain.

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I have had an organ, bone marrow, or stem cell transplant.

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I have HIV, hepatitis C, or active hepatitis B.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

0 / 14Eligibility criteria met