BC Cancer Protocol Summary for the Adjuvant Treatment of Resected
Renal Cell Carcinoma using Pembrolizumab
Protocol Code GUAJPEM
Tumour Group Genitourinary
Contact Physician Dr. Krista Noonan
ELIGIBILITY:
Patients must have:
Renal cell carcinoma (RCC) with a clear cell component, with or without sarcomatoid
features,
Previous radical or partial nephrectomy with negative surgical margins,
No prior systemic therapy for RCC,
Previous resection of metastatic lesions (if applicable), and
Intermediate-high risk for recurrence (pT2, Grade 4 or sarcomatoid, N0, M0 or pT3,
any grade, N0, M0), or
High risk for recurrence (pT4, any grade, N0, M0, or pT any stage, any grade, N+,
M0), or
M1 No Evidence of Disease (NED): Primary kidney tumour and solid, isolated,
and/or soft tissue metastases which are completed resected. Must have negative
surgical margins for resected metastases. Metastases must be resected 4 weeks
or greater from start of treatment.
Initiation of pembrolizumab within 12 weeks of surgery (nephrectomy or
metastasectomy). Metastasectomy must be within 12 months from nephrectomy.
Patients should have:
ECOG 0 to 2,
Adequate baseline hematological, hepatic and renal function, and
Access to a treatment centre with expertise in managing immunotherapy mediated
toxicities of pembrolizumab.
Notes:
Patients may have subsequent checkpoint inhibitors-based therapy for advanced
disease if last adjuvant pembrolizumab dose was completed 6 months ago or longer
CAP approval is not required to switch between 3-weekly and 6-weekly dosing of
pembrolizumab.
BC Cancer Protocol Summary GUAJPEM Page 1 of 3
Activated: 1 June 2023 Revised:
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/terms-of-use
EXCLUSIONS:
Patients must not have concurrent treatment. This protocol is for monotherapy only.
CAUTIONS:
Concurrent autoimmune disease
Patients with long term immunosuppressive therapy or systemic corticosteroids
(requiring more than 10 mg predniSONE/day or equivalent)
TESTS:
Baseline: CBC and differential, platelets, creatinine, alkaline phosphatase, ALT, total
bilirubin, LDH, sodium, potassium, TSH, morning serum cortisol, appropriate
imaging (at least a baseline CXR if no baseline chest CT)
Before each treatment: CBC and differential, platelets, creatinine, alkaline
phosphatase, ALT, total bilirubin, LDH, sodium, potassium, TSH
If clinically indicated: chest x-ray, morning serum cortisol, lipase, serum or urine
HCG (required for woman of child bearing potential if pregnancy suspected), Free
T3 and Free T4, serum ACTH levels, testosterone, estradiol, FSH, LH, glucose,
ECG, C-reactive protein (CRP), creatine kinase (CK), troponin
Weekly telephone nursing assessment for signs and symptoms of side effects while
on treatment (Optional).
PREMEDICATIONS:
Antiemetics are not usually required.
Antiemetic protocol for low emetogenicity (see SCNAUSEA).
If prior infusion reactions to pembrolizumab: diphenhydrAMINE 50 mg PO,
acetaminophen 325 to 975 mg PO, and hydrocortisone 25 mg IV 30 minutes prior to
treatment
TREATMENT:
Drug Dose BC Cancer Administration Guideline
2 mg/kg IV in 50 mL NS over 30 minutes
pembrolizumab
(maximum 200 mg) using a 0.2 micron in-line filter
Repeat every 3 weeks for 18 cycles* maximum (approximately 1 year), unless
disease progression or unacceptable toxicity.
*Includes cycles received as GUAJPEM6.
BC Cancer Protocol Summary GUAJPEM Page 2 of 3
Activated: 1 June 2023 Revised:
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/terms-of-use
DOSE MODIFICATIONS:
No specific dose modifications. Toxicity managed by treatment delay and other
measures (see SCIMMUNE protocol for management of immune-mediated
adverse reactions to checkpoint inhibitors immunotherapy,
http://www.bccancer.bc.ca/chemotherapy-protocols-
site/Documents/Supportive%20Care/SCIMMUNE_Protocol.pdf)
PRECAUTIONS:
Serious immune-mediated reactions: these can be severe to fatal and usually
occur during the treatment course. They may include enterocolitis, intestinal
perforation or hemorrhage, hepatitis, dermatitis, neuropathy, endocrinopathy, as well
as toxicities in other organ systems. Early diagnosis and appropriate management
are essential to minimize life-threatening complications (see SCIMMUNE protocol
for management of immune-mediated adverse reactions to checkpoint
inhibitors immunotherapy, http://www.bccancer.bc.ca/chemotherapy-protocols-
site/Documents/Supportive%20Care/SCIMMUNE_Protocol.pdf)
Infusion-related reactions: isolated cases of severe reaction have been reported.
In case of a severe reaction, pembrolizumab infusion should be discontinued and
appropriate medical therapy administered. Patients with mild or moderate infusion
reaction may receive pembrolizumab with close monitoring. Premedications with
acetaminophen and anti-histamine may be considered if there is a history of
reaction.
Call Dr. Krista Noonan or tumour group delegate at 604-930-2098 or 1-800-523-
2885 with any problems or questions regarding this treatment program.
References:
1. KN 564: Choueiri TK, Tomczak P, Park SH, et al. Adjuvant pembrolizumab after nephrectomy in renal-cell
carcinoma. N Engl J Med 2021;385(8):683-694.
2. Powles T, Tomczak P, Park SH, et al. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for
clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-
blind, placebo-controlled, phase 3 trial. Lancet Oncol 2022;23(9):1133-1144.
3. Pembrolizumab (Keytruda) CADTH Reimbursement Recommendation. Canadian Journal of Health Technologies
2022;2(10):1-18.
4. CADTH Reimbursement Recommendation. Provisional funding algorithm. Renal cell carcinoma. January 2023.
BC Cancer Protocol Summary GUAJPEM Page 3 of 3
Activated: 1 June 2023 Revised:
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/terms-of-use
