Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinom… (NCT05929664) | Clinical Trial Compass
RecruitingPhase 2
Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
United States70 participantsStarted 2023-07-05
Plain-language summary
A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Patients will undergo at least 2 and up to 6 infusions of immunotherapy prior to surgical resection. If patients have progression on neoadjuvant treatment, they may switch to standard of care surgical resection or hedgehog inhibitors prior to surgery. The primary endpoints are objective response rate and disease control rate. Safety and surgical benefit rate (de-escalation of surgery) with preservation of key anatomic structures are secondary endpoints. Correlative endpoints include analysis of pre and post treatment primary tumor and blood samples compared for histology, tumor genetics and immune cell composition.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
✓. Pathologically confirmed, locally-advanced BCC of the head and neck of any stage which is not resectable without major morbidity or unresectable, defined as requiring greater than 30% auriculectomy, rhinectomy, upper or lower lip resection, orbital exenteration (due to lid or orbital involvement), facial nerve sacrifice, or any Brigham and Women's stage 2b or 3 disease of head and neck (see Table 5).
✓. Male or female, aged ≥18 years of age
✓. Performance status 0-1.
✓. Must have a life expectancy of at least 6 months as judged by the treating physician.
✓. Adequate organ function:
✓. Absolute neutrophil count 1500/μl or more;
✓. Platelets 100,000/μl or more,
Exclusion criteria
✕. Prior radiation therapy within the past 6 months for this target cancer documented by surgeon at Visit 1, Day 0 initial assessment. (Prior surgical resection to area/tumor is acceptable.)
What they're measuring
1
Objective response rate (ORR)
Timeframe: Up to 6 months post surgery (up to Day 309 +/- 3 days)
2
Disease control rate (DCR)
Timeframe: Up to 6 months post surgery (up to Day 309 +/- 3 days)
✕. Any history of allergy to the study drug components.
✕. Any concurrent malignancies: exceptions include- basal cell carcinoma of the skin at another site, chronic lymphocytic leukemia, melanoma in situ, squamous cell carcinoma of the skin of a secondary location, superficial bladder cancer or in situ cervical cancer that has undergone potentially curative therapy. Patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 2 years post-diagnosis.
✕. Any unresolved toxicity NCI CTCAE v 5.0 Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with anti-PD1 therapy may be included only after consultation with the Study Physician.
✕. Any Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 28 days of study drug administration., or a prior history of allogenic organ transplantation.
✕. Any diagnosis of a significant connective tissue disorder as determined by the treating surgeon or medical team.
✕. Patients must not be receiving any other investigational agents.
✕. Receipt of a live attenuated vaccine within 30 days prior to the first dose of drug on trial.