nivolumab (Opdivo) + ipilimumab (Yervoy)
Nivolumab (Opdivo) + ipilimumab (Yervoy)
nivolumab (Opdivo) + ipilimumab (Yervoy)
Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Nivolumab (Opdivo) + ipilimumab (Yervoy) are immune checkpoint inhibitors that target separate, distinct and complementary checkpoint pathways (PD-1 and CTLA-4).1 which increases your body’s immune response. The drugs activate immune cells—unleashing them, in effect—so that they can invade tumors and attack melanoma cells.
Ipilimumab blocks a checkpoint molecule called CTLA-4. CTLA-4 regulates the growth and activity of T cells, a type of white blood cell that attacks other cells in the body that look foreign, including some cancer cells. By blocking CTLA-4, ipilimumab activates your immune system against melanoma by allowing T cells to multiply and increase your body’s immune response.
Nivolumab blocks a different checkpoint molecule called PD-1, which helps protect tumor cells from being attacked by your immune system. Nivolumab removes the PD-1 “shield” to allow your immune system to find and attack melanoma cells.
Side Effects
It’s very important to report any new side effects during or after treatment to your health care team promptly.
Watch Now – Video on the side effects of Immunotherapies
Provincial Funding Summary
for Advanced Melanoma
This information is current as of August 1, 2019
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.
Click Here to visit CADTH pan-Canadian Oncology Drug Review
Funded, Apr 1, 2019
Unresectable stage III or stage IV melanoma
• ECOG 0 – 1
• Adequate hepatic and renal function
• No prior systemic therapy for advanced disease with the exception of BRAF and/or MEK inhibitors for BRAF mutant metastatic melanoma
• Patients on or completed anti-PD-1 monotherapy for advanced disease without progression, particularly if at high risk for disease progression
• Patients who relapse after a response > 2 years with ipilimumab started prior to 1 April 2019 for advanced disease
• Access to a treatment centre with expertise to manage immune-mediated adverse reactions of immunotherapy checkpoint inhibitors
• A BC Cancer “Compassionate Access
Program” request with appropriate clinical information for each patient must be approved prior to treatment
• Note: No replacement of nivolumab with pembrolizumab in the maintenance phase
Funded Jul 16, 2019
Nivolumab in combination with Ipilimumab for the treatment of patients with unresectable or metastatic melanoma, regardless of BRAF status, with good performance status and with stable brain metastases, if present. Treatment should continue until unacceptable toxicity or disease progression. Treatments will be limited to tertiary centres only.
Funded Apr 15, 2019
Combination use of Nivolumab plus Ipilimumab followed by Nivolumab maintenance for patients with unresectable or metastatic melanoma regardless of BRAF status who are treatment naïve, or may have received treatment with BRAF-targeted therapy, with ECOG performance status of 0-1 and with stable brain metastases, if present. Treatment should continue until unacceptable toxicity or disease progression.
Funded Apr 15, 2019
For patients with unresectable or metastatic melanoma regardless of BRAF status who are treatment-naive, with ECOG performance status 0 to 1 and with stable brain metastases, if present. Treatment should continue until acceptable toxicity. Note: Patients currently on 1st line treatment for BRAF positive unresectable or metastatic melanoma with BRAF (+/-) MEK inhibitor can have access to Nivolumab and Ipilimumab upon progression of the BRAF (+/-) MEK inhibitor.
Funded Apr 4, 2019
Combination nivolumab plus ipilimumab is used for the treatment of unresectable or metastatic melanoma regardless of BRAF status, who are treatment naïve or may have received prior treatment with BRAF-targeted therapy, with ECOG performance status of 0 or 1 and with stable brain metastases (if present).
• Treatment with combination nivolumab plus ipilimumab (followed by nivolumab maintenance) should be continued until unacceptable toxicity or confirmed disease progression.
• Patients with BRAF mutation may be initiated on BRAF targeted therapy or immunotherapy. Upon disease progression, the patient may be switched to the other treatment modality as a subsequent line of therapy.
• For patients who stop nivolumab maintenance without disease progression, continuation of maintenance nivolumab will be funded provided that no other treatment is given in between.
Funded Jul 1, 2019
As combination use of nivolumab plus ipilimumab for the treatment of patients with unresectable or metastatic melanoma regardless of BRAF status who are treatment naïve, or may have received prior treatment with BRAF-targeted therapy, with an ECOG performance status of 0-1 and with stable brain metastases, if present. Treatment should continue until unacceptable toxicity or
disease progression.
Funded Jun 28, 2019
For the treatment of patients with unresectable or metastatic melanoma, regardless of BRAF status, who are treatment naïve or have received prior treatment with BRAF-targeted therapy. Patients must have an ECOG performance status of 0 or 1 and, if present, stable brain metastases. Treatment should be discontinued upon disease progression or unacceptable toxicity.
Funded Jul 16, 2019
Combination of Ipilimumab and Nivolumab, followed by Nivolumab maintenance for patients with unresectable or metastatic melanoma regardless of BRAF status. Patients must be treatment-naïve, however BRAF mutation positive patients may have received prior first-line treatment with BRAF-targeted (+/- MEK inhibitor) therapy. Patients must have ECOG performance status 0-2
Melanoma – Advanced (unresectable or metastatic) – view full funding from PEI Oncology
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
o If brain metastases are present, patients should be asymptomatic or stable
o Ipilimumab induction is funded for four (4) doses at 3 mg/kg administered every 3 weeks
o Induction therapy is discontinued if 4 doses cannot be administered within 16 weeks
Treatment of patients who have received at least one prior systemic therapy for advanced
melanoma (unresectable stage III or metastatic) with good performance status (ECOG 0 or 1).
As combination use of ipilimumab plus nivolumab for the treatment of patients with unresectable or
metastatic melanoma regardless of BRAF status who are treatment naïve, or may have received
prior treatment with BRAF-targeted therapy, with an ECOG performance status of 0-1 and with
stable brain metastases, if present. Treatment should continue until unacceptable toxicity or disease
progression.
Notes:
o Patients receiving anti-PD-1 monotherapy initiated without the combination of Ipilimumab
who experience disease progression are eligible for Ipilimumab monotherapy as a
subsequent line of therapy, but are not eligible to continue anti-PD-1 therapy with the
addition of Ipilimumab
o See nivolumab listing for additional funding details
Renal Cell Carcinoma – Metastatic (mRCC)
Combination use of ipilimumab plus nivolumab in patients with intermediate or poor-risk advanced
renal-cell carcinoma based on the International Metastatic Renal Cell Carcinoma Database
Consortium (IMDC) criteria.
Notes:
See nivolumab listing for additional funding details
Melanoma Newsletter
Get the latest melanoma news straight to your inbox. Sign up for the Melanoma Patient Exchange Newsletter.
Melanoma Support
The Melanoma Network of Canada has a number of free services for patients, caregivers and healthcare professionals.