This document provides a summary of immune checkpoint inhibitors used in melanoma care, including ipilimumab, nivolumab, and pembrolizumab. It lists the FDA-approved indications for each as first-line or adjuvant therapy for unresectable or metastatic melanoma. The dosing schedules are also provided. Additionally, it outlines how to manage immune-mediated adverse reactions to checkpoint inhibitors, noting the most common types and treatment approach based on severity grade.
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Tracing the Arc of Immunotherapy in Melanoma: Insights on the Current Role and Cutting-Edge Uses of Checkpoint Inhibitors for Patient Care
1. This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Immune Checkpoint Inhibitors in Melanoma Care:
Therapeutic Profile and Clinical Roles
PRACTICE AID
Access the activity,“Tracing the Arc of Immunotherapy in Melanoma: Insights on the Current Role and Cutting-Edge
Uses of Checkpoint Inhibitors for Patient Care,”at www.peerview.com/KUZ40.
Ipilimumab2
(anti–CTLA-4)
Unresectable or
metastatic melanoma
in adults and
pediatric patients
(≥12 y)
Nivolumab3
(anti–PD-1)
BRAF V600 wild-type
or mutation-positive,
unresectable,
or metastatic
melanoma
Pembrolizumab4
(anti–PD-1)
Unresectable or
metastatic melanoma
3 mg/kg IV over
90 min Q3W
for 4 doses
Nivolumab + ipilimumab approved for patients with
unresectable or metastatic melanoma, nivolumab 1 mg/kg,
followed by ipilimumab on the same day, every 3 weeks for
4 doses, then nivolumab 240 mg every 2 weeks or
480 mg every 4 weeks3
240 mg Q2W or
480 mg Q4W
IV infusion
over 30 min
200 mg
over 30 min Q3W
Indications/Current Status
Immune
Checkpoint
Inhibitors in
Melanoma:
Advanced
Disease1
Dosing
MHC TCR
PD-L1
PD-L1
CTLA-4
PD-1
PD-L2
B7.1
B7.1
T cell
Immune cell
Tumor cell
2. Immune Checkpoint Inhibitors in Melanoma Care:
Therapeutic Profile and Clinical Roles
CTLA-4: cytotoxic T-lymphocyte–associated antigen-4; PD-1: programmed death 1; Q2W: every 2 wk; Q3W: every 3 wk; Q4W: every 4 wk; Q12W: every 12 wk.
1. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Melanoma. v2.2018. https://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Accessed May 14, 2018. 2. Yervoy (nivolumab) Prescribing Information. https://packageinserts.bms.
com/pi/pi_yervoy.pdf. Accessed May 14, 2018. 3. Opdivo (nivolumab) Prescribing Information. https://packageinserts.bms.com/pi/pi_opdivo.pdf. Accessed May 14, 2018. 4. Keytruda (pembrolizumab) Prescribing Information. http://www.merck.com/product/usa/pi_circulars/k/keytruda/
keytruda_pi.pdf. Accessed May 14, 2018. 5. Eggermont AMM et al. N Engl J Med. 2018;378:1789-1801.
PRACTICE AID
Access the activity,“Tracing the Arc of Immunotherapy in Melanoma: Insights on the Current Role and Cutting-Edge
Uses of Checkpoint Inhibitors for Patient Care,”at www.peerview.com/KUZ40.
Ipilimumab2
(anti–CTLA-4)
Cutaneous melanoma
with pathologic involvement
of regional lymph nodes of
>1 mm after complete
resection, including total
lymphadenectomy
Nivolumab3
(anti–PD-1)
Pembrolizumab5
(anti–PD-1)
Indications/Current Status
Immune
Checkpoint
Inhibitors
in Melanoma:
Adjuvant
Therapy1
Dosing
Phase 3 data in patients with
completely resected stage III
disease; 43% reduction in risk
of recurrence or death
(HR = 0.57; P < .001)
Melanoma with lymph
node involvement or
metastatic disease after
complete resection
10 mg/kg IV over 90 min Q3W
for 4 doses, then 10 mg/kg
Q12W ≤3 y or documented
disease recurrence or
unacceptable toxicity
240 mg over 30 min Q2W
or 480 mg over 30 min Q4W
200 mg over 30 min Q3W
(used in phase 3 trial)
3. Immune Checkpoint Inhibitors in Melanoma Care:
ManagementofImmune-MediatedAdverseReactions1
ICPi: immune-checkpoint inhibitor; IMAR: immune-mediated adverse reaction.
1. Brahmer JR et al. J Oncol Pract. 2018;14:247-249.
PRACTICE AID
Access the activity,“Tracing the Arc of Immunotherapy in Melanoma: Insights on the Current Role and Cutting-Edge
Uses of Checkpoint Inhibitors for Patient Care,”at www.peerview.com/KUZ40.
This Practice Aid has been provided as a quick reference to help learners apply the information to their daily practice and care of patients.
Educate patients and caregivers on immunotherapies,
their MOA, and any potential IMARs prior to and
throughout treatment
Hepatic
(autoimmune hepatitis ALT/AST increases)
Endocrine
(hypophysitis, thyroiditis, type 1 diabetes)
Respiratory
(pneumonitis)
Renal
(nephritis, renal failure)
Neuromuscular
(peripheral sensory neuropathy; rarely)
Gastrointestinal
(colitis/diarrhea)
Skin
(maculopapular rash, pruritus)
Continue ICPi therapy
with close monitoring in
most cases
Instruct patients to report any new symptoms,
as they could be IMARs and may require
immediate management
Talking Points
Overview of IMARs
General Guidelines:
Management by Grade
1
Hold ICPis and consider resuming
when symptoms/laboratory values
grade ≤1; low-dose corticosteroids
may be administered
2
Hold ICPis and initiate
high-dose corticosteroids;
consider infliximab if symptoms
do not improve with 48-72 h
of corticosteroid treatment
3
Permanently discontinue
ICPis in most cases
4