EXPANDED ACCESS PROGRAM WITH NIVOLUMAB FOR SUBJECTS WITH HISTOLOGICALLY CONFIRMED STAGE III (UNRESECTABLE) OR STAGE IV MELANOMA PROGRESSING POST PRIOR SYSTEMIC TREATMENT CONTAINING AN ANT-CTLA-4 MONOCLONAL ANTIBODY.

Not Applicable

• Conditions: -C439 Malignant melanoma of skin, unspecified; Malignant melanoma of skin, unspecified; C439

• Registration Number: PER-012-15
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Key inclusion criteria (See Section 3.3.1 for the full list of criteria):
a) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
b) Histologically confirmed malignant melanoma, including mucosal melanoma
c) Previously treated unresectable stage III or stage IV melanoma, as per American Joint Committee on
Cancer staging system regardless of BRAF mutation status
d) Progressed on or after treatment with an anti-CTLA-4-containing therapy. Prior treatment with other
therapies is permitted (eg, chemotherapy)
i) Subjects with BRAF mutation positive advanced melanoma must also have progressed on or after
treatment with BRAF inhibitor monotherapy or in combination with a MEK inhibitor

Exclusion Criteria

Key exclusion criteria (See Section 3.3.2 for the full list of criteria)
a) Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
b) Subjects with ocular melanoma
c) Life expectancy < 6 weeks
d) Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment or conditions not expected to recur in the absences of an external trigger are permitted to enroll.
e) Subjects with a known history of the following anti-CTLA-4 therapy related adverse reactions based on the CTCAE v criteria:
i) Grade 4 anti-CTLA-4 therapy related adverse reaction except resolved nausea, fatigue, infusion
reactions or endocrinopathies where clinical symptoms were able to be controlled with appropriate hormone replacement therapy
ii) Grade 3 anti-CTLA-4 therapy related adverse reactions must have resolved or been controlled within 12 weeks
iii) Any ≥Grade 2 eye pain or reduction of visual acuity that did not respond to topical therapy and did not improve to ≤ Grade 1 severity within 2 weeks of starting topical therapy or required systemic treatment
iv) Any ≥Grade 3 sensory neurologic toxicity
v) Any Grade 4 laboratory abnormalities, except AST, ALT or T. bilirubin:
(1) AST or ALT > 10 x ULN
(2) T. bilirubin > 5 x ULN
vi) Subjects who required infliximab or other immune suppressants including mycophenolic acid for management of drug related toxicities
vii) History of Grade ≥3 neurologic toxicity
viii) History of Grade ≥3 allergy to study drug components.
f) Any treatment in a nivolumab trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified