A Phase II Study of Cemiplimab, an Anti-PD-1 Monoclonal Antibody, and ISA101b Vaccine in Patients with Recurrent/Metastatic HPV16 Positive Oropharyngeal Cancer who have Experienced Disease Progression with Prior Anti-PD-1 Therapy
This study will assess the ability of ISA101b plus cemiplimab to improve Overall Response Rate in subjects who have progressed on prior anti-PD-1 therapy.
To estimate the clinical benefit of ISA101b plus cemiplimab after progression on prior anti-PD-1 therapy, as assessed by objective response rate (ORR) according to RECIST 1.1.
To characterize the safety profile of ISA101b plus cemiplimab.
To assess preliminary efficacy of ISA101b plus cemiplimab as measured by multiple criteria.
Provide informed consent signed by study patient or legally acceptable representative
Willing and able to comply with site visits and study-related procedures and requirements.
Histologically confirmed recurrent or metastatic HPV16 positive OPC. Patients with squamous cell carcinoma of occult primary site, presenting with lymph node(s) limited only to the neck, are also eligible. Patients should have HPV16 positivity confirmed before being considered a candidate for this study.
HPV16 positive disease as determined by a specified central reference laboratory investigational use only assay.
Patients who have received a minimum of 4 doses of pembrolizumab or nivolumab or equivalent anti-PD-1 antibody with or without chemotherapy for 1st or 2nd line metastatic HPV16 positive OPC. The last dose of anti-PD-1 must have been no more than 6 months prior to the first dose of study drug. Progressive disease (PD) must have been diagnosed during or after anti-PD-1 therapy (but not longer than 6 months after the last dose).
At least one measurable lesion by CT or MRI per RECIST version 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented disease progression in that site.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Major surgery within 14 days of first administration of enrollment.
Radiation therapy after progression on prior anti-PD-1 antibody.
Any intervening anti-cancer therapy since last dose of anti-PD-1 including induction chemotherapy.
Patients who, after progressing on anti-PD-1, required subsequent chemotherapy within the last 4 weeks prior to enrollment in order to control disease.
Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. The following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.
Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression.
Encephalitis, meningitis, organic brain disease (e.g. Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study therapy.
Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (in the past 5 years). A history of radiation pneumonitis in the radiation field is permitted.
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