Unresectable stage Ill or stage IV me lanoma ; ECOG 0 -1; adequate he patic and renal function ; at least one prior systemic therapy; life expectancy of  at least 4 months; access to a treatment cent re with expertise to manage immune -media ted adverse reactions of ipilimumab.

A BCCA “Compassionate Access Program” request with appropriate clinical information for each patient must be approved prior to treatment.

Completion of the SCA Treatment Evaluation Program (STEP) request form for each patient is required for treatment approval. Treatment of patients who have received at least one prior systemic therapy for advanced melanoma (unresectable stage Ill or metastatic) wit h a good performance status (ECOG 0 or 1). lpilimumab induction is funded for four (4) doses at 3 mg/ kg administered every 3 weeks. Induction tharapy is discontinued if 4 doses cannot be administered within 16 weeks. If re-induction with a further 4 doses is being considered in patients who remain ECOG 0 or 1 and who have had stable disease for a minimum of 3 months following first induction or who achieved a partial or complete response to first induction, re-application and approval through STEP must be made .

Not approved for the following indication:  First line treatment of advanced melanoma (unresectable stage Ill or metastatic)

For t he treatmen t of patients: With unresectable or metastatic (Stage IIIC or IV) melanoma AND With an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less AND With anticipated life expectancy of more than 3 months AND Who have received at least one line of systemic therapy for advanced melanoma OR With intolerance to a previous line of systemic therapy for advanced melanoma.

the patient has had stable disease for at least three months or has previously experienced a complete or partial response to ipilimumab. The patient  has an ECOG s 1.Induction/ Re- induction Dose: lpilimuma b 3mg/ kg every 3 weeks for 4 doses

Notes: a) To be eligible for re-induction , a clinic note must be submitted to CCO documenting t ha t a t the time of disease progression, the patient has had stable disease for at least 3 months or the patient has previously experienced a complete or partial response to ipilimuma b, and the patient has an ECOG s 1 . b) lpilimumab is not funded if used in the first line treatment of unresectable Stage 3 or 4 melanoma, or if the patient has an ECOG 2.

Initial Treatment : As a single agent for the treatment of unresectable Stage Ill or IV melanoma in patients who have received at least one prior systemic treatment for advanced melanoma and ECOG performance status (PS) s 1.

Retreatment : At the time of disease progression, re-induction may be considered if patients have had stable disease for at least three months or have previously experienced a complete or partial response to ipilimumab and ECOG PS s 1.

Initial treatment : As a single agent for the

treatment of unresectable stage Ill or IV melanoma in patients who have received at least one prior systemic therapy for advanced melanoma an d have good performance status (ECOG s. 1 );

Re -induction:  At the time of disease progression, the patient has had stable disease for at least three months or has previously experienced a complete or partial response to ipilimumab. The patient  has an ECOG s. 1.

Dosing Regimen: 3mg / kg every three weeks for four doses

Re -Induction: At the time of disesase progression, re-induction may be considered if patients have had stable disease for at least three months duration or have previously experienced a complete or partial response to ipilimumab and an ECOG o f s.1 .

Dosing Regimen: 3mg / kg every three weeks for four doses
Exclusion Criteria:

• ECOG 2
• First-line unresectable or metastatic stage Ill or IV melanoma.