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Pembrolizumab + Olaparib for Head and Neck Cancer

Phase 2

Recruiting

Led By Siddharth Sheth, DO MPH

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

Biopsy confirmed American Joint Committee on Cancer 8th Edition stage III-IV B oral cavity squamous cell carcinoma (SCC), p16-negative oropharyngeal SCC, stage III-IVB hypopharyngeal SCC, stage III-IVB laryngeal SCC -OR- HPV-associated oropharyngeal SCC (p16 positive or HPV-associated) T4 or N3, T1-3 N2 or T3N0-1 with >10 pack-year tobacco history

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Must not have

Subjects unable to swallow orally administered medication prior to initiation of study treatment

Systemic glucocorticoids for any purpose other than to modulate symptoms from an event of clinical interest of suspected immunologic etiology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years from start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether using pembrolizumab and olaparib together before and after chemoradiation therapy is more effective in treating locally advanced head and neck squamous cell carcinoma than chemoradiation therapy alone.

Who is the study for?

This trial is for adults over 18 with certain types of head and neck squamous cell carcinoma (HNSCC) that haven't been treated yet. Participants need to be in good physical condition, able to follow the study plan, and have a tumor assessable by imaging. They can't join if they've had other cancer treatments recently, can't swallow pills, are ineligible for cisplatin therapy, or have severe medical issues.

What is being tested?

The trial tests pembrolizumab plus olaparib before and after standard chemoradiation therapy for advanced HNSCC. These drugs are approved separately but not together; this study examines their combined effectiveness when paired with chemo and radiation.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects like inflammation in organs or skin reactions. Olaparib could lead to blood cell count changes, nausea, fatigue or respiratory issues. Cisplatin might result in kidney problems, hearing loss or nerve damage.

Eligibility Criteria

Inclusion Criteria

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

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I have advanced stage mouth or throat cancer, not caused by HPV unless I have a heavy smoking history.

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I am fully active or can carry out light work.

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I have at least one cancer lesion that can be monitored through scans.

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I haven't had treatments aimed at curing my cancer and haven't been in a drug/device trial recently.

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I am over 18 years old.

Exclusion Criteria

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

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I cannot swallow pills before starting the study treatment.

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I am taking steroids only for immune-related symptoms, not for other reasons.

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I do not have any severe, uncontrolled health issues.

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I cannot receive cisplatin as per my treatment plan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years from start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from start of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

One Year Progression Free Survival (PFS)

Secondary study objectives

Correlate Combined Positive Score (CPS) and one-year progression free survival (PFS)

Distant Metastasis-Free Survival (DMFS)

General Cancer Associated Patient Reported Outcomes (PRO)

+8 more

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

Systemic infection

Clostridium difficile colitis

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: Single ArmExperimental Treatment4 Interventions

The participants will receive neoadjuvant and adjuvant pembrolizumab and olaparib combination plus standard of care (chemoradiation therapy) as defined in the protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Cisplatin

2013

Completed Phase 3

~3120