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.

BRISTOL MYERS SQUIBB COMPANY,0 sites0 target enrollmentSeptember 24, 2015

Conditions-C439 Malignant melanoma of skin, unspecified Malignant melanoma of skin, unspecified C439

Overview

Phase: N/A
Intervention: Not specified
Conditions: -C439 Malignant melanoma of skin, unspecified
Sponsor: BRISTOL MYERS SQUIBB COMPANY,
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 24, 2015

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

BRISTOL MYERS SQUIBB COMPANY,

Eligibility Criteria

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