Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN
Head and Neck Squamous Cell Carcinoma · Head and Neck Cancer · Head and Neck Cancer Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT03878979 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab 480mg and surgical resection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Measured by Number of Participants With Drug-related Adverse Events |
19; 2 | — |
| PRIMARY Feasibility as Measured by Number of Participants With Successful Completion of Preoperative Treatment and no Extended Treatment-related Delays |
20; 6 | — |
| SECONDARY Major Pathologic Response Rate |
3; 2 | — |
| SECONDARY Progression Free Survival (PFS) |
NA; 23 | — |
| SECONDARY Radiographic Response Rate |
1; 1; 0; 0; 9; 2 | — |
Summary
Eligibility Criteria
Inclusion:
Cohort 1: Subjects must have histologically confirmed previously untreated squamous cell carcinoma of the head and neck which is amenable to surgical resection as part of standard of care.
Cohort 2: Subjects must have histologically confirmed recurrent squamous cell carcinoma of head and neck, which is amenable for salvage surgery. Sites of recurrence may either be locoregional or distant if resection can be done ideally in one surgical field.
- The primary site should be a head and neck squamous cell carcinoma (including, but not limited to oral cavity, oropharynx, hypopharynx, or larynx, paranasal sinuses, nasal cavity). Squamous cell carcinoma of unknown primary, diagnosed in lymph nodes in neck, can be included but should be tested for p16 and confirmed specific assay.
- Subjects with oropharyngeal primary tumors must have confirmation of human papillomavirus (HPV) tumor status per clinical standards, although not necessary at enrollment.
- Subjects must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist and a radiation oncologist.
- Subjects must have at least one lesion that can be biopsied at baseline.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Age >18 years.
- Life expectancy of greater than 6 months.
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥ 1,500/ microliter (mcL)
- absolute neutrophil count ≥ 1,000/mcL
- platelets ≥ 100,000/mcL
- total bilirubin ≤ 1.5 X institutional upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses < 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Patients Epstein-Barr virus + (EBV+) with nasopharynx carcinoma
- Patient with HIV are excluded given the unknown risk of interaction with HAART and the unknown benefit of immunotherapy in this population.
- Participants who have received a live / attenuated vaccine within 30 days of first treatment.
Data sourced from ClinicalTrials.gov (NCT03878979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.