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. 2023 May 4;2023(5):CD013798. doi: 10.1002/14651858.CD013798.pub2

NCT02684006.

Study characteristics
Methods Study name: JAVELIN
Study design: a two‐arm, RCT, phase III
Blinding: none, open‐label
Study dates: March 29, 2016 ‐ December 19, 2017 (date of randomisation)
Date of data cut‐off: June 20, 2018 (for safety); exact dates for OS and PFS not reported, but data for PFS was reported and extracted from the second interim analysis for OS, and OS data were reported/extracted from the third interim analysis (longest follow‐up available for both outcomes)
Location: 21 countries (Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Republic of Korea, Mexico, the Netherlands, New Zealand, Romania, Russian Federation, Spain, Sweden, UK, USA), types of centres: hospitals, university hospitals, medical centres, centres/institutes (280 study locations)
Cross‐over study or cross over permitted: no
Participants Inclusion criteria:

  • all sexes

  • 18 years and older

  • histologically or cytologically confirmed advanced or metastatic RCC with clear cell component

  • at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated

  • ECOG performance status 0 or 1


Exclusion criteria:

  • prior systemic therapy directed at advanced or metastatic RCC

  • prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment

  • prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors

  • newly diagnosed or active brain metastasis


Sample size: N = 886
Age, median (years, range): experimental arm: 62 (29‐83),control arm: 61 (27‐88)
Sex (m/f): experimental arm: 316/126 (71.5/28.5), control arm: 344/100 (77.5/22.5)
Prognostic factors:

  • MSKCC prognostic risk group, n(%)

    • Favourable

      • experimental arm: 96 (21.7), control arm: 100 (22.5)

    • Intermediate

      • experimental arm: 283 (64.0), control arm: 293 (66.0)

    • Poor

      • experimental arm: 51 (11.5), control arm: 45 (10.1)

    • Not reported

      • experimental arm: 12 (2.7), control arm: 6 (1.4)

  • IMDC prognostic risk group, n(%)

    • Favourable

      • experimental arm: 94 (21.3), control arm: 96 (21.6)

    • Intermediate

      • experimental arm: 271 (61.3), control arm: 276 (62.2)

    • Poor

      • experimental arm: 72 (16.3), control arm: 71 (16.0)

    • Not reported

      • experimental arm: 5 (1.1), control arm: 1 (0.2)

  • Previous nephrectomy, n(%)

    • Yes

      • experimental arm: 352 (79.6), control arm: 355 (80.0)
Interventions Experimental arm (n = 442): avelumab (10 mg/kg, intravenous, every 2 weeks) + axitinib ( mg, oral, twice/day)
Control arm (n = 444): sunitinib (50 mg, oral, once/day) ‐ treatment was 4 weeks on, 2 weeks off (1 cycle = 6 weeks)
Outcomes Primary outcome(s)
‐
Secondary outcome(s)

  • OS

    • Time frame: every 3 months up to 8 years

  • PFS by investigator assessment

    • Time frame: every 6 weeks up to 18 months from patient enrolment in the study, then every 12 weeks up to 40 months from randomisation

  • PFS

    • Time frame: from randomisation up to 40 months

  • Treatment discontinuation/failure due to toxicity

    • Time frame: from Cycle 1 Day 1, every 6 weeks up to the end of treatment


Relevant to this review but not reported: QoL
Other outcomes (not relevant to this review): OS and PFS in different subgroups, TTF, VAS, DR, TTR, DC, OR, biomarker status, laboratory parameters (ADA), pharmacokinetics
Notes Funding sources: Pfizer and Merck
Declaration of Interest: Disclosure forms provided by the authors are available at NEJM.org.
Clinical study report available: no
Study protocol available: yes
Statistical analysis plan available: yes