Ipilimumab (Yervoy)

IMMUNOTHERAPY

This immunotherapy helps the body’s immune system recognize and destroy melanoma cells. It blocks CTLA-4, a protein on T cells that normally helps keep them in check. Ipilimumab is given intravenously. One dose is given every three weeks for four treatments. Ipilimumab can lengthen life in people with advanced disease with melanoma that can’t be removed by surgery or that has spread to other parts of the body (stage IIIC – IV). Often, ipilimumab is prescribed in combination with nivolumab, which has resulted in longer progression-free survival and a higher objective response rate than ipilimumab alone.

Side Effects

The most common side effects from this drug include fatigue, diarrhea, skin rash, and itching. Serious side effects seem to happen more often with this drug than with the PD-1 inhibitors. Like the PD-1 inhibitors, this drug can cause the immune system to attack other parts of the body, which can lead to serious problems in the intestines, liver, hormone-making glands, nerves, skin, eyes, or other organs. In some people these side effects have been fatal.

It’s very important to report any new side effects during or after treatment to your health care team promptly.

Refrence: https://www.cancer.org/cancer/melanoma-skin-cancer/treating/immunotherapy.html

Watch Now – Video on the side effects of Immunotherapies

Provincial Funding Summary

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Ipilimumab (Yervoy) for Advanced Melanoma
This information is current as of August 4, 2016

Note: Funding criteria as listed on the decision date. Please refer to the provincial drug programs for the most recent funding criteria and program eligibility.

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Funded, July 1, 2015

Unresectable stage IIIC or stage IV melanoma:
– ECOG 0 or 1
– Adequate hepatic and renal function
– Life expectancy of at least 4 months
– Access to a treatment centre with expertise to manage immune-mediated adverse reactions of ipilimumab
– A BCCA “Compassionate Access Program” request with appropriate clinical information for each patient must be approved prior to treatment

Funded, Mar 30, 2015
Ipilimumab for the first line treatment of advanced (unresectable or metastatic) melanoma dosed at 3 mg/kg every 3 weeks for 4 doses. Only patients with a documented response maintained for 6
months are eligible for retreatment.

Funded, May 1, 2015

First line treatment of adult patients with stage IIIC or IV melanoma, regardless of BRAF mutation status, who have an ECOG performance status of 0 or 1, and are not currently receiving immunosuppressive therapy.

Funded, Mar 5, 2015

Inclusion criteria:
– Primary unresectable stage IIIC or IV melanoma
– ECOG performances status of 0 or 1
Exclusion criteria:
– Current immunosuppressive therapy
– Unstable CNS metastases
– Pregnant or lactating females
Approved dosing schedule: 3 mg/kg intravenously every 3 weeks for 4 doses

Funded, Apr 1, 2015
For the first line treatment of patients who are at least 18 years old with advanced melanoma (i.e. primary cutaneous unresectable state IIIC or IV melanoma or metastatic melanoma), regardless of BRAF mutation status, who have an ECOG PS score less than or equal to 1, and are not currently receiving immunosuppressive therapy. – If a patient has brain metastasis, then he or she must be asymptomatic or stable. Dosage Regimen: – 3mg/kg every three weeks for four doses. Exclusion Criteria: – Requests for dose escalation up to 10 mg/kg will not be considered – Maintenance or reinduction requests in the 1st line setting will not be considered – Patients who have used ipilimumab for advanced/ metastatic melanoma in the 1st line setting are not eligible for funding in the 2nd line setting

Funded, Apr 1, 2015

As a single agent for the treatment of primary cutaneous unresectable stage IIIC or IV melanoma in patients (regardless of BRAF mutation status) as first line therapy or who have received at least one prior systemic treatment (excluding ipilimumab) for advanced melanoma , have an ECOG performance status (PS) ≤ 1 and are not currently receiving imunosuppressive therapy. If brain
metastases are present, patients should be asymptomatic or stable.

Funded, Jul 15, 2015

Initial treatment: As a single agent for the first line treatment of primary cutaneous unresectable stage IIIC or IV melanoma in patients (regardless of BRAF mutation status) or who have received at least one prior systemic treatment (excluding ipilimumab) for advanced melanoma, have an ECOG performance status (PS) ≤ 1 and are not currently receiving imunosuppressive therapy. If brain metastases are present, patients should be asymptomatic or stable. 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

For the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic therapy for advanced disease

Funded,

First line treatment of adult patients with stage IIIC or IV melanoma, regardless of BRAF mutation status, who have an ECOG performance status of 0 or 1, and are not currently receiving immunosuppressive therapy.
– If brain metastases are present, patients should be asymptomatic or stable
– Ipilimumab induction is funded for four (4) doses at 3 mg/kg administered every 3 weeks
– Induction therapy is discontinued if 4 doses cannot be administered within 16 weeks

Note: re-induction with a further 4 doses may be considered in patients who remain ECOG 0 or 1 and who experienced clinical benefit (e.g., partial/complete response or stable disease) for a
minimum of 3 months following first induction or who achieved a partial or complete response to first induction.

Funded, July 10, 2019
Listed for all lines of therapy in Quebec for patients with no or treated and stable brain metastases and ECOG performance status of 0-1

Please note: This information is not meant to act as a treatment decision aid, but rather to provide general information about which metastatic melanoma or skin cancer treatments are covered by provincial health care plans in Canada. It is current to the date indicated and may not be currently accurate due to the changing landscape of coverage in Canada. If you have private insurance coverage, you may have access to therapies not covered by the provincial plans in your province. All information obtained about specific treatments should be further discussed with your physician.

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