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NCT07527325
Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma
Conditions: Melanoma (Skin)
Sex: All
Healthy volunteers: No
Phase: PHASE2
Enrollment: 35
Sponsor: University of California, Irvine
Location: Chao Family Comprehensive Cancer Center University of California, Irvine Orange California
Summary
This is a phase II, open label clinical trial determining efficacy of Fianlimab in combination with Cemiplimab in subjects with Melanoma. These are subjects who will have surgery to remove their cancer.
Eligibility Criteria
Inclusion Criteria:
* ≥18 years at the time of signing informed consent form (ICF) and able to independently complete informed consent. A certified translator must be used in the completion of informed consent for non-English speaking individuals.
* Patients must have surgically resectable, macroscopic Stage IIIB-D cutaneous melanoma or oligometastatic resectable stage IV (M1a, M1b, and M1c) melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria. Patients are eligible at the time of the initial diagnosis or recurrence after previous surgery. Patients should have \> 1 RECIST measurable lesion.
* Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at initial screening.
* Life expectancy of at least 12 weeks.
* Adequate bone marrow, liver, and renal function:
* Hemoglobin \>8.0 g/dL
* Platelets \>75/mm3
* ANC \>1.5/mm3
* Creatinine Clearance \> 30mL/min
* AST and ALT less than 3 times the Upper Limit of Normal. participants with Gilbert's syndrome are excluded if total bilirubin \> 3.0 × ULN; or direct bilirubin \> 1.5 × ULN
* Total Bilirubin \< 3.1.
* Albumin ≥ 3.0 g/dL
* Absolute neutrophil count ≥ 1.5 × 109/L
* Absolute lymphocyte count ≥ 0.5 × 109/L
* Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment.
* Females of childbearing potential and males must be willing and able to use a highly effective method of contraception to avoid pregnancy for the duration of the study and for at least 6 months after the last dose of study treatment. Acceptable means of contraception are listed in the fianlimab institutional brochure.
* Male participants must be willing to abstain from donating sperm from the time of enrollment until 6 months after administration of study interventions.
Exclusion Criteria:
* Participants with visceral, bone, or brain metastases.
* Participants with a local recurrence in scar or surgical bed of the primary melanoma as the sole site of disease.
* Participants with N1a or N2a only disease.
* Participants with a diagnosis of acral, ocular or mucosal melanoma.
* Participants with a history of a malignant disease that can interfere with interpretation of study results.
* Participants with previous treatment with investigational or standard immunotherapy for melanoma or other malignancy.
* Patients with a history of myocarditis.
* Patients with a TnT or troponin I (TnI) \> 2x institutional ULN at baseline. Patients with Troponin T (TnT) or troponin levels between \> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.
* Participants with known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Known hypersensitivity to the active substances or to any of the excipients.
* Participants with a known history of chronic viral infections as indicated below.
* Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible.
* Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable during Screening.
* HIV infection with CD4 count \
Source: ClinicalTrials.gov (NCT07527325). StuddyBuddy aggregates publicly available trial information.