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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
Study 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 10 years
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 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
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%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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
Biospecimen Collection
2004
Completed Phase 2
~1700
Echocardiography
2013
Completed Phase 4
~11670
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,369 Total Patients Enrolled
Nabil F SabaPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had hepatitis C but am cured, or I'm being treated with no detectable virus.I had surgery for cancer return and got scans within 4 weeks before starting nivolumab.I've had a CT scan of my neck and chest within the last 4 weeks.My recent bilirubin levels are within normal range.I had surgery for cancer that came back, so I don't need to show measurable disease now.I am not on high-dose steroids or other immune-weakening drugs that will continue during treatment.My cancer has not spread to distant parts of my body or into the fluid around my brain and spinal cord.My cancer has worsened after treatment within a year of finishing radiation.I've had a CT scan of my neck and chest, or a PET/CT scan, within the last 4 weeks.I do not have significant hearing loss that would prevent me from using cisplatin.I do not have an active or history of severe autoimmune disease that could worsen.I have not had any treatment for my p16 positive throat cancer.I haven't had any cancer treatment outside this study after my last radiation and chemotherapy.My recent blood test shows normal alkaline phosphatase levels.My kidney function, measured by creatinine clearance, is good.My liver function tests are within twice the normal limit.My throat cancer is linked to HPV and I have a history of heavy smoking.I am not allergic to nivolumab or similar medications.I do not have any other serious illnesses that would stop me from receiving cancer treatment.My white blood cell count is healthy for treatment.I am not pregnant or breastfeeding and have confirmed this with a test.I have no cancer history, except for treated skin or cervical cancer, or any cancer cured over 2 years ago.I am HIV positive but have an undetectable viral load on a stable treatment.I had early-stage cancer surgery without any follow-up treatments over 5 years ago.I am fully active or restricted in physically strenuous activity but can do light work.I am fully active or can carry out light work.I am 18 years old or older.I have not had radiation therapy for tumors in my head, neck, skull base, or brain.My hepatitis B virus is under control with treatment.My total bilirubin levels are within normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (cisplatin, IMRT, nivolumab)
- Group 2: Arm B (cisplatin, IMRT, observation)
- Group 3: Arm C (nivolumab)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the main aim of this scientific investigation?
"The primary outcome of this study is progression-free survival (PFS). Secondary outcomes include PET based therapy response assessment compared to RECIST 1.1 assessment for patients who have a PET/CT scan at 12 weeks, prognostic value of maximum standardized uptake value (SUVmax) of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS, and prognostic effect of baseline PD-L1 expression (positive versus [vs.] negative) on OS and PFS."
Answered by AI
What other researchers have looked into Nivolumab?
"Nivolumab was first studied in 1997 and, since then, 1226 completed studies exist in the medical literature. At this time, there are 1476 active clinical trials underway with a significant portion of these taking place Dayton, Ohio."
Answered by AI
In how many different geographical locations is this research project being conducted?
"Currently, this study is recruiting from a pool of 100 sites. While some locations are in Dayton, Las Vegas and Mooresville, there are also many other centres participating. To limit travel burdens, patients should consider enrolling at the nearest location."
Answered by AI
Nivolumab is most often given to treat which condition?
"Nivolumab is not only used to treat metastatic ureter urothelial carcinoma, but also other malignant conditions such as metastatic hepatocellular carcinoma, melanoma of the skin, and neoplasm metastasis."
Answered by AI
Are people with the required medical conditions able to participate in this trial right now?
"The latest information on clinicaltrials.gov suggests that this study is still looking for participants. The trial was first posted on June 20th, 2019 and was last edited on November 12th, 2020."
Answered by AI
How many people are involved in this experiment?
"In order to properly conduct this clinical study, 636 eligible patients must be recruited. These individuals can come from different participating sites, such as Miami Valley Hospital in Dayton, Ohio and OptumCare Cancer Care at MountainView in Las Vegas, Nevada."
Answered by AI
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