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

NCT00420888.

Study characteristics
Methods Study name: ‐
Study design: randomised, parallel‐group trial, phase II/ III
Blinding: none, open‐label
Study dates: May 2007 ‐ October 2010 (date of randomisation)
Date of data cut‐off: not reported
Location: 5 countries (Bulgaria, Romania, Russian Federation, Ukraine, UK), types of centres: hospitals, urology clinics, cancer centres, research centres (51 study locations)
Cross‐over study or cross over permitted: not per design; not reported whether cross over was permitted at some point (e.g. upon progression)
Participants Inclusion criteria:

  • participants with confirmed metastatic or inoperable locally advanced RCC eligible for standard therapy with IFN

  • histologically or cytologically confirmed clear cell or papillary type RCC

  • KPS ≥ 70

  • favourable or moderate risk group MSKCC

  • life expectancy > 3 months

  • acceptable levels of specific haematology and serum chemistry parameters


Sample size: N = 513
Age, mean in years (standard deviation (SD)): experimental arm: 58 (25‐79), control arm: 57 (19‐83)
Sex (m/f): experimental arm: 183/77), control arm: 183/70
prognostic factors:

  • ECOG PS, n (%)

    • 0

      • experimental arm: 164 (65); control arm: 159 (61)

    • 1

      • experimental arm: 89 (35); control arm: 100 (39)

  • MSKCC risk subgroup, n (%)

    • Favourable

      • experimental arm: 152 (60); control arm: 152 (59)

    • Intermediate

      • experimental arm: 101 (40); control arm: 108 (42)

  • Prior nephrectomy n(%

    • Yes

      • experimental arm: 206 (81.4), control arm: 209 (80.4%)
Interventions Experimental arm (n=253): naptumomab (15 mg/kg, intravenous, once/day) + IFN‐alfa (9 MIU, subcutaneous injection, thrice/week)
Control arm (n = 260): IFN‐alfa (9 MIU, subcutaneous injection, thrice/week)
Outcomes Primary outcome(s)

  • OS (time frame: every 12 weeks, including after a maximum of 18 months of study treatment)


Secondary outcome(s)

  • PFS (time frame: every 12 weeks for the 18‐month treatment period and also every 12 weeks after the treatment period)

  • AE (time frame: every visit through week 73)


Relevant to this review but not reported: quality of life (QoL), serious adverse events (SAEs), time to first subsequent therapy (TFST), number of participants who discontinued treatment due to an AE
Other outcomes (not relevant to this review): response rate (RR); immunological response to treatment in participants receiving naptumomab; pharmacokinetics
Notes Funding sources: GlaxoSmithKline, Novartis, Pfizer and Bayer
Declarations of interests: "R.E. Hawkins reports receiving commercial research grants from Glaxo‐SmithKline, Novartis, and Pfizer; speakers bureau honoraria from Bristol‐ Meyers Squibb, GlaxoSmithKline, Novartis, and Pfizer; and is a consultant/ advisory board member for Pfizer. G. Hedlund, G. Forsberg, and O. Nordle have ownership interest (including patents) in Active Biotech. T. Eisen is an employee of AstraZeneca; reports receiving commercial research grants from Bayer, GlaxoSmithKline, and Pfizer and other research grants from AstraZeneca; has ownership interest (including patents) in AstraZeneca; and is a consultant/ advisory board member for Aveo, Bayer, Bristol‐Meyers Squibb, GlaxoSmithKline, Immatics, Novartis, and Pfizer. No potential conflicts of interest were disclosed by the other authors."
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no