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Cetuximab, Cisplatin and BYL719 for HPV-Associated Oropharyngeal Squamous Cell Carcinoma

NCT02298595 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-11-13

No results posted yet for this study

Summary

This study evaluates the combination of BYL719, cisplatin and cetuximab as induction chemotherapy prior to minimally-invasive transoral surgery (TORS or TLM) and selective lymph node dissection (SLND), followed by risk-adapted intensity-modulated radiation therapy (IMRT) in patients with transorally resectable, Stage III-IVa, HPV-associated oropharyngeal squamous cell carcinoma (OPSCC).

Conditions

Interventions

DRUG

cisplatin

75 mg/m2 IV day 1 of each cycle

DRUG

Cetuximab

XXXX day 1, 8, and 15 of each cycle

DRUG

BYL719

200, 250, 300, or 350 mg/day by mouth every day

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Julie E. Bauman, MD, MPH

    lead OTHER

Principal Investigators

  • Julie E Bauman, MD, MPH · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-08-31
Completion
2024-08-31

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02298595 on ClinicalTrials.gov