IPILIMUMAB INJ,SOLN

Clinical Criteria Summary

Active autoimmune disease (excluding diabetes and history of thyroid disease)
Active or untreated brain metastases
Primary ocular or mucosal melanoma
Concomitant treatment with immunosuppressants including systemic corticosteroids (prednisone equivalent > 5mg/day)
Child-Pugh Class B or C liver dysfunction
Known pregnancy
Lactating

Monotherapy or in combination with nivolumab for treatment of unresectable or metastatic melanoma
Adjuvant treatment of cutaneous melanoma with pathologic involvement of regional lymph nodes (> 1mm) after complete resection
In combination with nivolumab as first-line treatment of intermediate or poor risk advanced renal cell carcinoma
In combination with nivolumab in unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
In combination with nivolumab as first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) or in those previously treated with sorafenib
In combination with nivolumab as first-line treatment of metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations and PD-L1 expression > 1%
In combination with nivolumab and 2 cycles of a platinum-doublet as first-line treatment of metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations
In combination with nivolumab as first-line treatment of unresectable malignant pleural mesothelioma
In combination with nivolumab as first-line treatment of unresectable advanced or metastatic esophageal squamous cell carcinoma

Pregnancy & Fertility Management
For females who can become pregnant: Pregnancy must be excluded prior to receiving ipilimumab.
For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 3 months after stopping treatment.
Oncology Care & Performance Status
Care for the oncologic condition provided by VA or VA community care oncology provider
Goals of care and role of Palliative Care consult have been discussed and documented
Eastern Cooperative Oncology Group (ECOG) performance status 0-1

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