Sponsors

Lead Sponsor

Dana-Farber Cancer Institute

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or unknown primary that is HPV 16 positive as determined by ISH and p16 positive as determined by IHC.
•Stage 3 or 4 disease without evidence of distant metastases
•At least one evaluable or uni- or bi-dimensionally measurable lesion by RECIST 1.1 criteria
•18 years of age or older
•No previous surgery, radiation therapy or chemotherapy for SSCHN is allowed at time of study entry
•ECOG Performance Status of 0 or 1
•No active alcohol addiction
•Adequate bone marrow, hepatic and renal function as defined in the protocol
•Women of child-bearing potential must have a negative pregnancy test within 7 days of starting treatment

Exclusion Criteria

•Pregnant or breast feeding women or women and men of childbearing potential not willing to use adequate contraception while on treatment and for at least 3 months after
•Previous or current malignancies at other sites
•Symptomatic peripheral neuropathy of grade 2 or greater
•Symptomatic altered hearing greater than grade 2
•Other serious illnesses or medical conditions
•Patients that have experienced an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry
•Concurrent treatment with any other anticancer therapy
•Participation in an investigational trial within 30 days of study entry

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What this study is about

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Sponsors

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Trial snapshot

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