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Chemotherapy Agent

Immunotherapy for HPV-Positive Throat Cancer

Phase 3
Recruiting
Led By Nabil F Saba
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalents) or other immunosuppressive medications which are expected to continue during nivolumab administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 10 years
Awards & highlights

Summary

This trial is testing whether maintenance immunotherapy after initial radiation and chemotherapy treatment improves overall and progression-free survival for patients with HPV positive oropharyngeal cancer.

Who is the study for?
Adults with intermediate-risk HPV-positive oropharyngeal cancer that has spread locally but not to distant sites. Participants must have adequate organ function, no prior treatments for this cancer, and cannot be pregnant or breastfeeding. They should not have a history of severe allergic reactions to chemotherapy agents like cisplatin or immune conditions that require steroids.Check my eligibility
What is being tested?
The trial is testing if adding maintenance immunotherapy (nivolumab) after standard treatment with radiation and chemotherapy (cisplatin) improves survival in patients compared to just the standard treatment alone. It's looking at overall survival and progression-free survival as key outcomes.See study design
What are the potential side effects?
Possible side effects include typical chemotherapy-related issues such as nausea, fatigue, hair loss, and increased risk of infection. Nivolumab may cause immune system-related side effects affecting various organs, infusion reactions, skin rash, hormone gland problems (like thyroid), and can worsen pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I am not on high-dose steroids or other immune-weakening drugs that will continue during treatment.
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My cancer has not spread to distant parts of my body or into the fluid around my brain and spinal cord.
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I do not have an active or history of severe autoimmune disease that could worsen.
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I have not had any treatment for my p16 positive throat cancer.
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I haven't had any cancer treatment outside this study after my last radiation and chemotherapy.
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My throat cancer is linked to HPV and I have a history of heavy smoking.
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I am not allergic to nivolumab or similar medications.
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I am HIV positive but have an undetectable viral load on a stable treatment.
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I had early-stage cancer surgery without any follow-up treatments over 5 years ago.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I have not had radiation therapy for tumors in my head, neck, skull base, or brain.
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My hepatitis B virus is under control with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 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
Negative (standardized qualitative) 12 week post therapy (cisplatin + RT) FDG PET/CT associated with PFS for patients who have a PET/CT
Negative (standardized qualitative) 12 week post therapy (cisplatin + radiation therapy [RT]) FDG positron emission tomography/computed tomography (PET/CT) associated with OS for patients who have a PET/CT
Overall survival (OS)
Secondary outcome measures
PET/CT scan
Post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV deoxyribonucleic acid (DNA)
Prognostic effect of baseline PD-L1 expression (positive versus [vs.] negative) on OS and PFS
+5 more

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%
Neutropenia
21%
Pyrexia
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
9%
Hypothyroidism
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Dry mouth
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Cardiac failure
2%
Malignant pleural effusion
2%
Sepsis
2%
Atrial fibrillation
2%
General physical health deterioration
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Cancer pain
1%
Confusional state
1%
Circulatory collapse
1%
Bronchial obstruction
1%
Pneumothorax
1%
Atrial flutter
1%
Ileus
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Pericardial effusion
1%
Femur fracture
1%
Pancytopenia
1%
Colitis
1%
Small intestinal obstruction
1%
Hypercalcaemia
1%
Syncope
1%
Pericardial effusion malignant
1%
Superior vena cava syndrome
1%
Gastrointestinal haemorrhage
1%
Lung cancer metastatic
1%
Performance status decreased
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm C (nivolumab)Experimental Treatment6 Interventions
Patients receive nivolumab IV over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.
Group II: Arm A (cisplatin, IMRT, nivolumab)Experimental Treatment8 Interventions
Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions. Within 4 weeks after completion of concurrent therapy, patients receive nivolumab IV once weekly over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.
Group III: Arm B (cisplatin, IMRT, observation)Active Control8 Interventions
Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions, and then go on observation. Patients will be offered the option to cross-over to Arm C if they have clearly documented progression within 12 months from the end of cisplatin/radiation therapy. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2210
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Nivolumab
2014
Completed Phase 3
~4740

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for oropharyngeal cancer include immunotherapy, chemotherapy, and radiation therapy. Immunotherapy, such as nivolumab, uses monoclonal antibodies to help the immune system recognize and attack cancer cells, interfering with their growth and spread. Chemotherapy, like cisplatin, works by killing cancer cells or stopping them from dividing. Radiation therapy uses high-energy rays to destroy cancer cells and shrink tumors. These treatments are crucial for oropharyngeal cancer patients as they target the cancer through different mechanisms, potentially improving overall survival and disease-free survival.
Immunotherapy of head and neck squamous cell carcinoma (HNSCC). Immune checkpoint blockade.Profile of pembrolizumab in the treatment of head and neck squamous cell carcinoma: design development and place in therapy.Novel therapy for nasopharyngeal carcinoma--where are we.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,958,765 Total Patients Enrolled
Nabil F SabaPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Cisplatin (Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03811015 — Phase 3
Oropharyngeal Cancer Research Study Groups: Arm A (cisplatin, IMRT, nivolumab), Arm B (cisplatin, IMRT, observation), Arm C (nivolumab)
Oropharyngeal Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03811015 — Phase 3
Cisplatin (Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03811015 — Phase 3
~210 spots leftby Jan 2027