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Immunoradiotherapy for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Led By Rom Leidner, MD

Research Sponsored by Providence Health & Services

Eligibility Criteria Checklist

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

Must have

Patients with HPV status as determined by p16 immunostain

Patients with squamous cell carcinoma of the head and neck region planned for surgical resection and deemed able to safely undergo neoadjuvant anti-PD-1 and radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial is testing if immunoradiotherapy can safely shrink HNSCC tumors before surgery.

Who is the study for?

Adults with head and neck squamous cell carcinoma scheduled for surgery can join. They must have certain blood counts, be HPV status known, able to consent, and have an acceptable performance status. Pregnant women or those not using contraception are excluded, as well as individuals on high-dose steroids or with active autoimmune diseases.Check my eligibility

What is being tested?

The trial is testing if giving Nivolumab (an immunotherapy drug) combined with a short course of radiation before surgery can safely shrink tumors in patients with head and neck cancer. The study will separate participants into groups based on their HPV status.See study design

What are the potential side effects?

Nivolumab may cause immune-related side effects like inflammation in various organs, skin rash, hormone gland problems (like thyroid), fatigue, and infusion reactions. Radiation could lead to skin irritation at the treatment site and general tiredness.

Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer's HPV status has been checked.

Select...

I have squamous cell carcinoma in the head or neck and am set for surgery with pre-surgery anti-PD-1 and radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Neoadjuvant Therapy

Secondary outcome measures

Number of patients with decrease in tumor size or number of lymph nodes involved [Efficacy of Neoadjuvant Treatment]

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Chills

Hypertension

Hyperkalaemia

Hyperglycaemia

Blood alkaline phosphatase increased

Dehydration

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Musculoskeletal chest pain

Malaise

Pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Malignant pleural effusion

Sepsis

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Hypercalcaemia

Neoplasm progression

Small intestinal haemorrhage

Femur fracture

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Pericardial effusion malignant

Atrial flutter

Bronchial obstruction

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

4Treatment groups

Experimental Treatment

Group I: Treatment Cohort 4Experimental Treatment3 Interventions

Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).

Group II: Treatment Cohort 3Experimental Treatment3 Interventions

Radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).

Group III: Treatment Cohort 2Experimental Treatment3 Interventions

Nivolumab administration (3 doses) and radiation (3 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).

Group IV: Treatment Cohort 1Experimental Treatment3 Interventions

Nivolumab administration (3 doses) and radiation (5 days) therapy prior to restaging and surgical resection followed by additional administration of nivolumab (3 doses).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Surgical Resection

2018

Completed Phase 2

~420

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor

117 Previous Clinical Trials

822,513 Total Patients Enrolled

Providence Cancer Center, Earle A. Chiles Research InstituteOTHER

18 Previous Clinical Trials

456 Total Patients Enrolled

Rom Leidner, MDPrincipal InvestigatorProvidence Health and Services

2 Previous Clinical Trials

48 Total Patients Enrolled

Media Library

Surgical Resection Clinical Trial Eligibility Overview. Trial Name: NCT03247712 — Phase 1 & 2

Head and Neck Squamous Cell Carcinoma Research Study Groups: Treatment Cohort 1, Treatment Cohort 2, Treatment Cohort 3, Treatment Cohort 4

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Surgical Resection Highlights & Side Effects. Trial Name: NCT03247712 — Phase 1 & 2

Surgical Resection 2023 Treatment Timeline for Medical Study. Trial Name: NCT03247712 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please provide details of other experiments using Nivolumab?

"Currently, there are 82 Nivolumab clinical trials in their third phase of development, with a total of 718 active studies. 40285 medical centres across the world have set up research sites to investigate this drug's efficacy."

Answered by AI

What maladies has Nivolumab been known to ameliorate?

"Nivolumab is used to treat malignant neoplasms, such as unresectable melanoma and squamous cell carcinoma."

Answered by AI

What is the current capacity of enrollees for this research project?

"Currently, this trial is not open to recruitment. It was initially posted on January 15th 2018 and most recently amended on May 23rd 2022. However, there are presently 850 trials recruiting participants with malignant neoplasms and 718 studies actively looking for candidates taking Nivolumab."

Answered by AI

Is this testing protocol a pioneering endeavor?

"Since 2012, Ono Pharmaceutical Co. Ltd has sponsored the study of Nivolumab beginning with 659 patients in its first trial. Following successful Phase 1 & 2 trials, there are now 718 active studies for this drug across 2356 cities and 49 countries around the world."

Answered by AI

Is enrollment for this clinical trial still available?

"Unfortunately, the clinical trial webpage on clinicialtrials.gov reveals that this research study is not taking in any new participants at present. Although it had first been posted to the website back on January 15th 2018 and was last updated May 23rd 2022, its recruitment period has closed for now. Nonetheless, there are still 1,568 other active trials looking for patients currently."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Neoadjuvant Immunoradiotherapy Results in High Rate of Complete Pathological Response and Clinical to Pathological Downstaging in Locally Advanced Head and Neck Squamous Cell Carcinoma

Leidner, Rom, Marka Crittenden, Kristina Young, Hong Xiao, Yaping Wu, Marcus A Couey, Ashish A Patel, et al.. 2021. “Neoadjuvant Immunoradiotherapy Results in High Rate of Complete Pathological Response and Clinical to Pathological Downstaging in Locally Advanced Head and Neck Squamous Cell Carcinoma”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2021-002485.

clinicaltrials.govStudy

Neoadjuvant Immunoradiotherapy in Head & Neck Cancer

2018. "Neoadjuvant Immunoradiotherapy in Head & Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03247712.

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