Treatment regimen

Immunotherapy regimens in kidney cancer: pembrolizumab-axitinib, nivolumab-ipilimumab and adjuvant pembrolizumab

First line in advanced clear cell kidney cancer and adjuvant treatment after nephrectomy

Updated: 28 October 20261 min read6 references

Summary for doctors

  • First line in advanced disease: immunotherapy combined with a TKI, or two immunotherapies [1, 2].
  • Nivolumab-ipilimumab in intermediate and poor risk (IMDC) [2].
  • Adjuvant: one year of pembrolizumab at high risk of recurrence [3].

Dose and schedule

Treatment regimens and doses: index3 regimens

Pembrolizumab + axitinib

Advanced clear cell kidney cancer, first lineEach drug’s schedule in the table

Advanced clear cell kidney cancer, first line

DrugDoseRouteSchedule
Pembrolizumab200 mgIVEvery 3 weeks
Axitinib5 mg twice a day (increase to 7 and 10 if tolerated)OralDaily
Cycle schedule
Pembrolizumab every 3 weeks; axitinib daily and continuously
Duration
Until progression; pembrolizumab up to 35 cycles

As in KEYNOTE-426 [1].

Dose source: [4, 5].

Evidence: KEYNOTE-426 (2019)

Nivolumab + ipilimumab

Intermediate- and poor-risk advanced kidney cancer

Intermediate-‎ and poor-risk advanced kidney cancer

DrugDoseRouteSchedule
Phase 1: 4 cycles
Nivolumab3 mg/kgIVDay 1
Ipilimumab1 mg/kgIVDay 1
Phase 2
Nivolumab240 mg every 2 weeks or 480 mg every 4 weeksIVDay 1
Cycle length
Combination every 21 days; then nivolumab alone
Duration
Until progression

As in CheckMate 214 [2].

Dose source: [6].

Evidence: CheckMate 214 (2018)

Adjuvant pembrolizumab

After nephrectomy at intermediate-high or high risk of recurrenceCycle length: Every 3 weeks

After nephrectomy at intermediate-high or high risk of recurrence

DrugDoseRouteSchedule
Pembrolizumab200 mg (or 400 every 6 weeks)IVEvery 3 weeks
Cycle length
Every 3 weeks
Duration
Up to 17 doses (about one year)

As in KEYNOTE-564 [3].

Dose source: [5].

Evidence: KEYNOTE-564 (2021)

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Premedication and supportive care

  • Axitinib: control blood pressure before and during treatment; diarrhoea and hand-foot syndrome.
  • Teach the symptoms of immune-related toxicity; distinguish axitinib-induced liver enzyme rises from immune hepatitis (stop axitinib first).

Monitoring and dose adjustment

  • TSH, glucose, liver enzymes and creatinine at baseline and before each cycle; immune-related toxicity as in the immunotherapy toxicity lesson.
  • Blood pressure and urine protein with axitinib.

Main evidence

Show detailsHide

KEYNOTE-426: 12-month survival 89.9% vs 78.3% with sunitinib [1]. CheckMate 214: in intermediate and poor risk, 18-month survival 75% vs 60% [2]. KEYNOTE-564: 2-year disease-free survival 77.3% vs 68.1% [3].

Related cancer types

References

6 references
Show all references, 3 with a study cardClose the reference list

Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.

  1. 1
    Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell CarcinomaRini BI, Plimack ER, Stus V, et al · N Engl J Med · 2019;380:1116-1127
    Study cardDOIPubMed Back to text: 1 2 3
  2. 2
    Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell CarcinomaMotzer RJ, Tannir NM, McDermott DF, et al · N Engl J Med · 2018;378:1277-1290
    Study cardDOIPubMed Back to text: 1 2 3 4
  3. 3
    Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell CarcinomaChoueiri TK, Tomczak P, Park SH, et al · N Engl J Med · 2021;385:683-694
    Study cardDOIPubMed Back to text: 1 2 3
  4. 4
    INLYTA (AXITINIB) — Prescribing InformationU.S. Pharmaceuticals · FDA label · 2026
  5. 5
    KEYTRUDA (PEMBROLIZUMAB) — Prescribing InformationMerck Sharp & Dohme LLC · FDA label · 2026
    Source Back to text: 1 2
  6. 6
    OPDIVO (NIVOLUMAB) — Prescribing InformationE.R. Squibb & Sons, L.L.C · FDA label · 2026

This page is based on reputable scientific sources and was last updated on 28 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.