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Systemic Anti-Cancer Therapy Regimen Library

Home > GU URO Advanced - cISplatin, gemcitabine and nivolumab

GU URO Advanced - cISplatin, gemcitabine and nivolumab

Treatment Overview

This regimen is intended for patients with a GFR of 60 mL/minute or greater. 


Usually up to 6 cycles of cISplatin, gemcitabine and nivolumab Q3W.

Continue nivolumab Q4W monotherapy for up to two years, or until disease progression or unacceptable toxicity.       

Cycles 1 to 6 - 21 days - cISplatin, gemcitabine and nivolumab Q3W

Cycle length:
21

Cycles 7 to 27 - 28 days - nivolumab Q4W continuation

Cycle length:
28

Cycle details

Cycles 1 to 6 - 21 days - cISplatin, gemcitabine and nivolumab Q3W

Medication Dose Route Days Max Duration
nivolumab * 360 mg flat dosing intravenous 1 30 minutes
olanzapine * 5 mg oral administration 1 to 4
aprepitant 125 mg oral administration 1
aprepitant 80 mg oral administration 2, 3
dexamethasone * 12 mg oral administration 1
dexamethasone * 8 mg oral administration 2, 3, 4
ondansetron 8 mg oral administration 1, 8
gemcitabine * 1000 mg/m² intravenous 1, 8 30 minutes
magnesium sulfate heptahydrate 10 mmol intravenous 1 60 minutes
cISplatin * 70 mg/m² intravenous 1 60 minutes
sodium chloride 0.9 % intravenous 1 60 minutes
ondansetron 8 mg oral administration 1
cyclIZINE 50 mg Three times daily oral administration 1

Cycles 7 to 27 - 28 days - nivolumab Q4W continuation

Medication Dose Route Days Max Duration
nivolumab * 480 mg flat dosing intravenous 1 30 minutes

Full details

Cycles 1 to 6 - 21 days - cISplatin, gemcitabine and nivolumab Q3W

Day: 1

Medication Dose Route Max duration Details
nivolumab * 360 mg flat dosing intravenous 30 minutes
Instructions:

Administer via a sterile, non-pyrogenic, low protein binding 0.2 to 1.2 micron in-line filter.
olanzapine * 5 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
  • Some centres may choose to omit pre-chemotherapy dose or advise patient to take the night before chemotherapy if patient has to drive to appointment.
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 12 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
gemcitabine * 1000 mg/m² intravenous 30 minutes
magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin * 70 mg/m² intravenous 60 minutes
Instructions:
  • In 500 - 1000 mL of sodium chloride 0.9%, depending on stability.
  • Ensure patient has passed urine as per institutional policy.
  • Hypersensitivity risk increases with number of cycles of cISplatin.
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:

After cISplatin infusion.

  • If cISplatin is infused in 1000 mL, centres may choose to omit this bag of fluid.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
cyclIZINE 50 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

  • Warning: may cause drowsiness.
  • Consider starting dose at 25 mg and increasing as tolerated/required.
  • The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
  • Note that domperidone is not recommended in combination with olanzapine and ondansetron due to potential risk of QT prolongation.

Day: 2

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.

Day: 3

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.

Day: 4

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

  • Dose and duration may be individualised at clinician’s discretion.

Day: 8

Medication Dose Route Max duration Details
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

  • Alternative is dexamethasone 4 mg. 
gemcitabine * 1000 mg/m² intravenous 30 minutes

Cycles 7 to 27 - 28 days - nivolumab Q4W continuation

Day: 1

Medication Dose Route Max duration Details
nivolumab * 480 mg flat dosing intravenous 30 minutes
Instructions:
Administer via a sterile, non-pyrogenic, low protein binding 0.2 to 1.2 micron in-line filter.

Supportive Care Factors

Factor Value
Emetogenicity: Variable
Hydration: Variable
Hypersensitivity / Infusion related reaction risk: Low - routine premedication not recommended

Emetogenicity:

  • Cycles 1 to 6: HIGH day 1, LOW day 8;
  • nivolumab alone: MINIMAL.

Hydration: Routine hydration recommended with cISplatin (cycles 1 to 6). 


References

van der Heijden MS, Sonpavde G, Powles T, et al; CheckMate 901 Trial Investigators. Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma. N Engl J Med. 2023 Nov 9;389(19):1778-1789., PMID: 37870949

Bristol-Myers Squibb (NZ) Limited. Opdivo (nivolumab) New Zealnd Datasheet 25 July 2024. https://www.medsafe.govt.nz/profs/datasheet/o/opdivoinf.pdf (Accessed 12 November 2024).

Boulanger J, Boursiquot JN, Cournoyer G, et al. Management of hypersensitivity to platinum- and taxane-based chemotherapy: cepo review and clinical recommendations. Curr Oncol. 2014;21(4):e630-e641. , PMID: 25089112

Castells, M.C., Matulonis, U.A., and Horton, TM. Infusion reactions to systemic chemotherapy. Savarese DMF and Feldweg AM, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/infusion-reactions-to-systemic-chemotherapy (Accessed 26 March 2021).

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.