Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Corbus Pharmaceuticals Inc.
With
CSPC Megalith Biopharmaceutical Co.,Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histological and/or cytological confirmed diagnosis of OPSCC arising from tonsils, base of tongue, soft palate and posterior pharyngeal wall, with evidence of metastatic or recurrent disease not amenable to standard therapy with curative intent.
Either second or third-line OPSCC patients who have progressed on or after receiving SOC therapy (that must have included platinum chemotherapy and an anti-PD-(L)1 antibody administered sequentially or together) OR received platinum chemotherapy and/or anti-PD-(L)1 therapy in the neoadjuvant or adjuvant setting or as part of definitive chemoradiation therapy, provided disease recurrence occurred less than 6 months after completion of the relevant systemic therapy.
ECOG PS of 0-1
Measurable disease as per RECIST v1.1, with at least one measurable lesion not previously irradiated unless unequivocal progression has been documented after radiation.
Life expectancy of greater than 12 weeks at time of enrollment, as per Investigator's assessment.
Signed informed consent
You may not be if
Persistent CTCAE Grade \>1 clinically significant toxicities related to prior antineoplastic therapies, excluding alopecia.
Significant active or chronic corneal disorders
Pre-existing Grade ≥2 peripheral neuropathy
Any other significant co-morbidities, disease, metabolic dysfunction, physical examination, or clinical laboratory finding that contraindicates the use of the investigational drug or may represent an unacceptable risk from treatment complications or may affect adherence to the study procedures or the interpretation of the results.
