Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Oropharyngeal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Nivolumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

RT of 45 or 50 Gy in 25 daily fractions, 6 fractions per week. Nivolumab will be administered at 240 mg every 2 weeks during radiotherapy, and at 480 mg every 4 weeks for 6 doses after radiotherapy.

A fully human anti-programmed death 1 (PD-1) monoclonal antibody

Nivolumab Injection

45-50 Gy accelerated fractionation in 25 daily fractions, 6 fractions per week

Radiotherapy (RT)

Robert Ferris, MD, PhD

This clinical trial will evaluate a new combination of treatments for Oropharyngeal Squamous Cell cancers (OPSCC), and compare it to the current standard of care (concurrent, platinum-based chemoradiotherapy). Chemoradiotherapy is efficacious, but also associated with significant toxicities and is only suitable for patients with good performance status and without severe comorbidities. The purpose of this trial is to demonstrate equivalent oncologic outcome with fewer adverse effects and improved quality of life when compared to the standard of care.

This study aims to enroll 135 patients (male and female, age 18+) who are newly diagnosed with resectable, squamous cell carcinoma or undifferentiated carcinoma of the oropharynx. Survival rate and treatment response of OPSCC varies based on HPV infection status and genotype; therefore, in this study, only patients who are HPV seropositive and have HPV type 16 will be enrolled. All patients will receive the same treatment, i.e. there is no active control group.

In this trial, patients will undergo transoral surgery followed by de-intensified adjuvant radiotherapy plus nivolumab. The radiotherapy will consist of 45 or 50 Gy (depending on tumor volume) in 25 daily fractions, 6 fractions per week. Nivolumab will be administered at a fixed dose of 240 mg over 30 minutes IV every 2 weeks during radiotherapy, and at 480 mg over 60 minutes IV every 4 weeks for 6 doses after radiotherapy. The first dose will be given prior to the first fraction of radiation (Day 1) on Day -3 (+/- 2 days), and continued every 2 weeks (+/- 2 days). Nivolumab will thus be given in weeks 2 and 4 of radiotherapy. Adjuvant nivolumab will then be given for a total of 6 additional doses after the completion of radiotherapy every 4 weeks (+/- 7 days), starting in the second or third week after the completion of radiotherapy. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment. Relevant outcome measures include disease free survival (2 year post surgery); percutaneous gastronomy dependence (1-year postsurgery); acute and late toxicity; patient-reported Quality of Life measures, locoregional control and distant metastatic control.

Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer

Phase II Trial of Adjuvant De-Escalated Radiation + Concurrent and Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer

Determination of tumor TP53 mutation as measured in serum and/or tissue samples. The presence of TP53 mutations results in a protein that is less able to control cell proliferation as it is unable to trigger apoptosis in cells with damaged DNA.

Determination of tumor genomics, measured in serum and/or tissue samples. This measure will explore the of DNA sequence and gene expression differences in tumor cells and gene abnormalities may that drive the drives disease growth.

Determination of cytokines present in plasma samples. The presence of cytokines in tissues can associated positively or negatively in the development of disease.

Determination of antigen-specific cellular immune response to Human papillomavirus (HPV) measured in serum and/or tissue samples.

Determination of oral HPV DNA present/measured in oral tissue samples.

The length of time (months) from of beginning of study treatment without local, regional or distant disease recurrence until the appearance of new metastatic lesions.

Presence /absence of enteral feeding tube

The FACT-H\&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true 27 statements are for them, using the past 7 days as the timeframe. Responses range from not at all (0), to very much (4) on a 5-point scale.

Identification of disease growth that is present within the area in which it was first located.

Identification of disease that has spread (metastasized) to areas farther away from where it was first located.

MDASI-HN measures treatment related symptom burden in head and neck cancer patients. The 20-item MDASI measures both severity and burden of symptoms and their effect on patients' daily activities, using a numeric rating scale of 0-10. This instrument includes 13 core symptoms and 9 head and neck specific items. Higher scores indicate superior perception of function.

The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. It evaluates the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. This instrument has been psychometrically validated in head and neck cancer patients. Higher scores indicate superior perception of swallowing function.

The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from "never" to "always"). "Always" response is scored 4 points, a "Never" response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. The patient's values are compared to published norms.

The Performance Status Scale (PSS-HN) is a clinician-rated instrument consisting of 3 questions: normalcy of diet, public eating/swallowing, and understandability of speech subscales in patients with head and neck cancer. Each subscale is rated from 0 to 100, with higher scores indicating better performance.

Three swallowing outcomes will be rated by the SLP conducting the MBS study and reported by research staff: 1) laryngeal penetration (yes, no); 2) aspiration (no, sensate, silent), and 3) pharyngeal residue (no, \< 50%, \> 50%). These have been selected as universal items generally reported by swallowing clinicians that have been shown to significantly predict pneumonia in patients with oropharyngeal cancers. Prevalence of these dysphagia endpoints will be estimated at each time point.

The length of time (in months) from the start of treatment patients remain alive.

Number of patients experiencing Adverse Events and Serious Adverse Events (SAE) related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Bristol-Myers Squibb

Robert L. Ferris, MD, PhD

Principal Investigator

Symptoms and General Pathology

Rare Diseases

Neoplasm Metastasis

Recurrence

Mouth Neoplasms

Neoplastic Processes

Disease Attributes

Mouth Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Pembrolizumab

Cisplatin

Immunomodulating Agents

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent cisplatin 100 mg/m2 every 3 weeks for 3 cycles (7 weeks)

Intensity-modulated radiation therapy to 70 Gy in 33-35 fractions over 6.5 weeks plus concurrent and adjuvant pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

Pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles

Radiation therapy

Loren Mell, MD

Gerald Henderson

Alysha Zeoli

Ricklie Julian, MD

Khushbu Singh, MBBS, CCRP

Jennifer Pope, CCRP

Melissa Young, MD, PhD

Elisa Lemerond

Jimmy Caudell, MD

Melissa Butler

Douglas Adkins, MD

Aubrey Hamilton

Sarah Wilson

Trisha Wise-Draper, MD, PhD

Kathy Taylor

Mike Gibson, MD

The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

This study is a prospective, multi-institutional, open-label, randomized phase II trial that will evaluate the efficacy of concurrent and adjuvant pembrolizumab with radiation therapy (RT) versus RT plus cisplatin in intermediate/high-riskp16-positive locoregionally advanced head and neck squamous cell carcinoma (HNSCC). The primary endpoint is progression-free survival (PFS).

Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Phase II Randomized Trial of Radiotherapy With Concurrent and Adjuvant Pembrolizumab (Keytruda®) Versus Concurrent Chemotherapy in Patients With Advanced/Intermediate-Risk p16+ Head and Neck Squamous Cell Carcinoma (KEYCHAIN)

compare the outcomes with RT/pembrolizumab in patients with tumors as a function of PD-L1 expression.

time from randomization to progression/relapse or death from any cause.

time from randomization to death from any cause

Toxicities due to therapy occurring within 3 months of therapy completion based on CTCAE criteria using questionnaires

Toxicity due to therapy occurring greater than 3 months after completion of therapy based on CTCAE criteria using questionnaires

Local and regional and distant recurrence of cancer and causes of death from competing events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer	NCT03715946	Carcinoma, Squa... Oropharynx Squa...	Nivolumab Injec... Radiotherapy (R...	18 Years -	University of Pittsburgh
Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer	NCT03715946	Carcinoma, Squa... Oropharynx Squa...	Nivolumab Injec... Radiotherapy (R...	18 Years -	University of Pittsburgh
Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer	NCT03383094	Head and Neck S... Cancer Cancer of Head ... Cancer, Advance... Cancer, Metasta... Tumor Tumor Recurrenc... Tumor Neck Tumor Metastasi... Oral Cancer Oropharyngeal C... Oropharynx Canc... Oropharynx Canc... Oropharynx Canc... Oropharynx Canc...	Pembrolizumab Radiation thera... Cisplatin	18 Years -	University of California, San Diego
Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer	NCT03715946	Carcinoma, Squa... Oropharynx Squa...	Nivolumab Injec... Radiotherapy (R...	18 Years -	University of Pittsburgh

Spots Global Cancer Trial Database for p16+

Every month we try and update this database with for p16+ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for p16+

Every month we try and update this database with for p16+ cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for p16+ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.