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Chemotherapy

Chemo/Immunotherapy Combo for Head and Neck Cancer

Phase 2

Recruiting

Led By Thomas Lycan, DO

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible, patient refusal, other).

Patients must have normal organ and marrow function as defined: Absolute neutrophil count greater than or equal to 1,000/mcL, platelets greater than or equal to 75,000/mcL, total bilirubin less than or equal to 2 mg/dL

Must not have

History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone >20 mg/day for >1 week).

Active autoimmune disease requiring systemic immunosuppression.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new chemo/immunotherapy combo to treat head/neck squamous cell carcinoma for patients unable to take 5-fluorouracil.

Who is the study for?

This trial is for adults with advanced head/neck squamous cell carcinoma that can't be cured by surgery or radiation, and who cannot take the drug 5-fluorouracil. Participants need to have a certain level of physical fitness (ECOG 0-2) and adequate organ function. Pregnant women, individuals with untreated brain metastases, severe allergies to chemo drugs used in this study, active autoimmune diseases requiring steroids, or any serious health issues that could interfere with the trial are excluded.

What is being tested?

The study tests weekly chemotherapy (carboplatin and paclitaxel) combined with immunotherapy (pembrolizumab) on patients with metastatic head/neck cancer who can't receive standard treatment. The goal is to evaluate the effectiveness and safety of this regimen in controlling cancer progression.

What are the potential side effects?

Possible side effects include allergic reactions to chemo drugs, immune-related problems like inflammation of organs due to pembrolizumab, blood cell count changes leading to increased infection risk or bleeding problems, fatigue from treatment burden, and potential harm to an unborn child.

Eligibility Criteria

Inclusion Criteria

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

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I cannot receive 5FU treatment due to side effects, practical issues, or personal choice.

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My blood tests show normal organ function and healthy blood cell counts.

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I can take care of myself and perform daily activities.

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My cancer has returned or spread and cannot be cured with surgery or radiation.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had severe lung inflammation treated with high-dose steroids.

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I am on medication to suppress my immune system due to an autoimmune disease.

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I am not pregnant or breastfeeding.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have brain metastases that haven't been treated and are causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Response Rate

Secondary study objectives

Number of Participants with Discontinuation of Study Drug due to Adverse Effects of Any Cause

Overall Survival

Progression-Free Survival

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: Combination of Chemotherapy and ImmunotherapyExperimental Treatment3 Interventions

The intervention will be administered on an outpatient basis. The treatment regimen will consist of combination chemotherapy and immunotherapy administered as: Pembrolizumab PLUS Carboplatin PLUS Paclitaxel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Carboplatin

2014

Completed Phase 3

~6120