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Clinical Trial 21026

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT04398524

Phase: Phase II
Principal Investigator: Muzaffar, Jameel

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Study Title

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.


Primary Objectives: 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. Secondary Objectives: To characterize the safety profile of ISA101b plus cemiplimab. To assess preliminary efficacy of ISA101b plus cemiplimab as measured by multiple criteria.



Immunotherapy; Therapy (NOS)


Cemiplimab (); ISA101b (); REGN2810 (Cemiplimab)

Inclusion Criteria

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • Provide informed consent signed by study patient
  • 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 total dose of 800mg of pembrolizumab (e.g. 4 doses of 200 mg of 2 doses of 400 mg) or 960 mg of nivolumab (e.g. 4 doses of 240 mg or 2 doses of 480 mg) or equivalent anti-PD-1 antibody with or without chemotherapy for 1st or 2nd line recurrent/ 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), and anti PD-1 therapy should have been the last treatment regimen that the patient received before entry into the current trial.
  • 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.
  • Additional criteria may apply

  • Exclusion Criteria

    Exclusion Criteria:

  • Invasive surgery (defined as surgical intervention requiring general or spinal anesthesia and hospital admission) within 4 weeks prior to start of study treatment.
  • Patients who, after progressing on anti-PD-1, received additional anti-cancer therapy (chemotherapy, radiotherapy, experimental TKI's, immunotherapy, anti-EGFR antibodies, surgery). The following palliative treatments are allowed: Palliative radiotherapy (but NOT for target lesions; Palliative surgery; bone resorptive therapy such as bisphosphonates and denosumab but only if patients have been on stable doses for > 4 weeks prior to first dose of test treatment
  • 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.
  • Additional criteria may apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.