Phase II Study of Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy. Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response.
• Subjects aged ≥ 18 years.
• Histologically confirmed Stage IIIB-D or Stage IV recurrent metastatic melanoma that is resectable or borderline resectable as determined by a Surgical Oncologist.
• Recurrent disease at eligibility must have been confirmed with biopsy while receiving or within 3 months of completion of adjuvant anti-PD1 therapy.
• ECOG Performance Status ≤ 1.
• Adequate organ function as defined as:
‣ Hematologic:
• Absolute neutrophil count (ANC) ≥ 1500/mm3
∙ Platelet count ≥ 100,000/mm3
∙ Hemoglobin ≥ 10 g/dL
⁃ Hepatic:
• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
∙ AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
⁃ Renal:
• Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula:
• For subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
‣ Subjects \< 50 years of age:
• Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
∙ Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
⁃ Subjects ≥ 50 years of age:
• Amenorrheic for ≥ 12 months following cessation of all exogenous hormonal treatments; or
∙ Had radiation-induced menopause with last menses \>1 year ago; or
∙ Had chemotherapy-induced menopause with last menses \>1 year ago
• Subjects of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.3.1.
• Subject has adequate archival tissue or agrees to undergo a fresh tissue biopsy if sufficient archival tissue is unavailable.
• Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy per the treating investigator.
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.