Ireland
--:--IST
Latest
Clinical Trials in Mexico / NCT03811015
Active, not recruiting Phase 3

Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer

NCT03811015 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2019-08-16
Last updated
2026-09-29

Condition(s) studied

Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Investigational drug(s) / intervention(s)

Biospecimen CollectionCisplatin →Computed TomographyEchocardiography TestFludeoxyglucose F-18Intensity-Modulated Radiation TherapyNivolumab →Patient ObservationPositron Emission Tomography

Biospecimen Collection: Undergo blood sample collection

Cisplatin: Given IV

Computed Tomography: Undergo CT or PET/CT

Echocardiography Test: Undergo ECHO

Fludeoxyglucose F-18: Receive FDG

Intensity-Modulated Radiation Therapy: Undergo IMRT

Nivolumab: Given IV

Patient Observation: Undergo observation

Positron Emission Tomography: Undergo PET/CT

Study summary

This phase III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * STEP 1: Age \>= 18 years * STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * STEP 1: Patients must have oropharynx cancer (American Joint Committee on Cancer \[AJCC\] 8) that is p16-positive by immunohistochemistry OR p16 equivocal by IHC and HPV positive by in situ hybridization with the following criteria: \>= 10 pack-years, stage T1-2N2-N3 or T3-4N0-3 (less than 10 pack-years is considered a non-smoker) OR \< 10 pack-years, stage T4N0-N3 or T1-3N2-3 * STEP 1: Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition. * STEP 1: Patients with a history of allergic reactions attributed to platinum-based chemotherapy agents are excluded. * STEP 1: Patients must not have had prior systemic therapy, radiation treatment or surgery for p16 positive oropharyngeal squamous cell carcinoma (OPSCC). * NOTE: Patients who had resection of T1 or T2 carcinoma with no radiation or chemotherapy are eligible if surgery was done 5 years prior to enrollment * STEP 1: Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors. * STEP 1: Patients must not receive investigational agents within 4 weeks of enrollment or at any time while on study. * STEP 1: Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded. * STEP 1: Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded. * STEP 1: Patients with a history of prior or second malignancy are excluded, with the exception of curatively treated non-melanoma skin cancer, or curatively treated cervical cancer; additionally, patients curatively treated for malignancy who remain disease-free at \> 2 years of follow up, are not excluded. * STEP 1: Absolute neutrophil count (ANC) \>= 1500/mm\^3 (must be obtained =\< 2 weeks prior to randomization). * STEP 1: Hemoglobin (Hgb) \>= 8.0 g/dL (must be obtained =\< 2 weeks prior to randomization). * STEP 1: Platelet count \>= 100,000/mm\^3 (must be obtained =\< 2 weeks prior to randomization). * STEP 1: Creatinine clearance of \>= 60 ml/min (must be obtained =\< 2 weeks prior to randomization). Creatinine clearance may be measured or calculated. If calculating, creatinine clearance, use the Cockcroft-Gault formula. * STEP 1: Total bilirubin within 1.5 times the normal limits (must be obtained =\< 2 weeks prior to randomization). * STEP 1: Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) within 2.0 times the normal limits (must be obtained =\< 2 weeks prior to randomization). * STEP 1: Alkaline phosphatase within 2.0 times the normal limits (must be obtained =\< 2 weeks prior to randomization). * STEP 1: Patients must not be pregnant or breast-feeding as chemotherapy, radiation, and immunotherapy may have possible teratogenicity effects; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A patient of childbearing potential is any patient, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * STEP 1: Patients of childbearing potential must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment. Patients must also not donate ova during this same time period. * STEP 1: Patients must have measurable disease * STEP 1: Patients must have tumor measurements with CT of neck and CT of chest (or CT of neck and FDG PET/CT if standard of care) within 4 weeks prior to Step 1 randomization. * STEP 1: Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. * STEP 1: Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event). * STEP 1: 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 * STEP 1: Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * STEP 1: 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 * STEP 1: Patients with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) must have no detectable viral load on a stable antiviral regimen * STEP 1: Patients must not be receiving any other investigational agents. * STEP 1: Patient must not have a baseline clinically significant hearing loss, which in the opinion of the investigator would preclude the use of cisplatin * STEP 2: Patients must have progression per RECIST criteria AND tissue-proven progression on Arm B treatment within 12 months after completion of radiation therapy. * STEP 2: ECOG performance status of 0 or 1. * STEP 2: Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition. * STEP 2: Patients must not have received non-protocol anti-cancer therapy after completion of radiation and chemotherapy. * STEP 2: ANC \>= 1500/mm\^3 (must be obtained =\< 2 weeks prior to registration). * STEP 2: Hgb \>= 8.0 g/dL (must be obtained =\< 2 weeks prior to registration). * STEP 2: Platelet count \>= 100,000/mm\^3 (must be obtained =\< 2 weeks prior to registration). * STEP 2: Creatinine within institutional limits of normal (must be obtained =\< 2 weeks prior to registration) * STEP 2: Total bilirubin within 1.5 times the normal limits (must be obtained =\< 2 weeks prior to registration). * STEP 2: SGOT (AST) or SGPT (ALT) within 2.0 times the normal limits (must be obtained =\< 2 weeks prior to registration). * STEP 2: Alkaline phosphatase within 1.5 times the normal limits (must be obtained =\< 2 weeks prior to registration). * STEP 2: Patients must not be pregnant or breast-feeding as chemotherapy, radiation, and immunotherapy may have possible teratogenicity effects; in addition, complications from pregnancy may interfere with the ability of patients to have an uninterrupted therapy. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A patient of childbearing potential is any patient, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * STEP 2: Patients of childbearing potential must use an accepted and effective method of contraception or abstain from sexual intercourse for at least one week prior to the start of treatment, and continue for 5 months after the last dose of protocol treatment. Patients must also not donate ova during this same time period. * STEP 2: Patients must have measurable disease at the time of documented progression * NOTE: For patients that have undergone salvage surgery for disease recurrence, measurable disease is not required at the time of registration to Step 2 * STEP 2: Patients must have tumor measurements with CT of neck and CT of chest (or CT of neck and FDG PET/CT if standard of care) within 4 weeks prior to Step 2 registration * NOTE: Patients that have undergone salvage surgery for disease recurrence prior to Step 2 are not required to have measurable disease post-resection, but must have CT of neck and CT of chest (or CT of neck and FDG PET/CT if standard of care) after salvage surgery and within 4 weeks prior to step 2 registration to establish a baseline prior to nivolumab

Primary outcome measure(s)

Trial sites (727)

FacilityCityRegionStatus
Thomas Hospital Fairhope Alabama
Mobile Infirmary Medical Center Mobile Alabama
Anchorage Associates in Radiation Medicine Anchorage Alaska
Anchorage Radiation Therapy Center Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
CTCA at Western Regional Medical Center Goodyear Arizona
Kingman Regional Medical Center Kingman Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
Mercy Hospital Fort Smith Fort Smith Arkansas
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
Kaiser Permanente-Deer Valley Medical Center Antioch California
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
PCR Oncology Arroyo Grande California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
Mercy Cancer Center - Carmichael Carmichael California
Mercy San Juan Medical Center Carmichael California
Epic Care-Dublin Dublin California
Kaiser Permanente Dublin Dublin California
Mercy Cancer Center - Elk Grove Elk Grove California
Bay Area Breast Surgeons Inc Emeryville California
Epic Care Partners in Cancer Care Emeryville California
Kaiser Permanente-Fremont Fremont California
Fresno Cancer Center Fresno California
Kaiser Permanente-Fresno Fresno California
Tibor Rubin VA Medical Center Long Beach California
Contra Costa Regional Medical Center Martinez California
Mercy Cancer Center Merced California
Kaiser Permanente-Modesto Modesto California
Providence Queen of The Valley Napa California
Alta Bates Summit Medical Center - Summit Campus Oakland California
Bay Area Tumor Institute Oakland California
Kaiser Permanente Oakland-Broadway Oakland California
Kaiser Permanente-Oakland Oakland California
VA Palo Alto Health Care System Palo Alto California

+ 687 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

More National Cancer Institute (NCI) trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03811015 on ClinicalTrials.gov ↗ ← All trials in Mexico