Nivolumab for Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Central Care Cancer Center - Great Bend, Great Bend, KS
Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8+5 More
Nivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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. Nivolumab is used to treat patients with Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8. This is a clinical trial, so there is no placebo group. Nivolumab has previously been approved by the FDA for a different condition.

Eligible Conditions

  • Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • human papillomavirus
  • Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
  • Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Study Objectives

5 Primary · 8 Secondary · Reporting Duration: Baseline up to 10 years

Week 12
PET based therapy response assessment compared to RECIST 1.1 assessment for patients who have a PET/CT scan at 12 weeks
Week 12
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
Year 10
Prognostic effect of baseline PD-L1 expression (positive versus [vs.] negative) on OS and PFS
Prognostic effect of baseline saliva and/or plasma human papillomavirus (HPV) status (positive vs. negative) on OS and PFS
Prognostic value of SUVmax of primary tumor or neck nodal metastasis of baseline FDG PET/CT for PFS
Prognostic value of maximum standardized uptake value (SUVmax) of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS
SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive vs. negative)
Year 10
Progression-free survival (PFS)
Progression-free survival (PFS) (Phase II)
Year 10
Overall survival (OS)
Overall survival (OS) (Phase III)
Month 9
Post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV deoxyribonucleic acid (DNA)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Trial Design

3 Treatment Groups

Arm B (cisplatin, IMRT, observation)
1 of 3
Arm C (nivolumab)
1 of 3
Arm A (cisplatin, IMRT, nivolumab)
1 of 3
Active Control
Experimental Treatment

636 Total Participants · 3 Treatment Groups

Primary Treatment: Nivolumab · No Placebo Group · Phase 2 & 3

Arm C (nivolumab)
Biological
Experimental Group · 1 Intervention: Nivolumab · Intervention Types: Biological
Arm A (cisplatin, IMRT, nivolumab)Experimental Group · 3 Interventions: Cisplatin, Intensity-Modulated Radiation Therapy, Nivolumab · Intervention Types: Drug, Radiation, Biological
Arm B (cisplatin, IMRT, observation)ActiveComparator Group · 3 Interventions: Cisplatin, Intensity-Modulated Radiation Therapy, Patient Observation · Intervention Types: Drug, Radiation, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~1660
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 10 years
Closest Location: Central Care Cancer Center - Great Bend · Great Bend, KS
Photo of kansas 1Photo of kansas 2Photo of kansas 3
2022First Recorded Clinical Trial
1 TrialsResearching Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
12 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,930 Previous Clinical Trials
41,293,824 Total Patients Enrolled
8 Trials studying Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
1,302 Patients Enrolled for Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Nabil F SabaPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients must not receive investigational agents within 4 weeks of enrollment or at any time while on study.
Patients with evidence of distant metastases or LMD are excluded.
Patients with a history of allergic reactions attributed to platinum-based chemotherapy agents are excluded.
Patients must not have had prior systemic therapy, radiation treatment or surgery for OPSCC.
You have had surgery for a primary tumor of the breast, and no radiation or chemotherapy was given.
Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors.
Patients must have oropharynx cancer (AJCC 8) that is p16-positive by immunohistochemistry or HPV positive by in situ hybridization
Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.