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

NCT01274273.

Study characteristics
Methods Study name: DARENCA
Study design: a two‐arm, RCT, phase II
Blinding: none, open‐label
Study dates: 26 October 2009 ‐ 21 November 2014 (date of randomisation)
Date of data cut‐off: 31 May 2017 (final analysis)
Location: 1 country (Denmark), type of centre: university hospitals (2 study locations)
Cross‐over study or cross over permitted: no
Participants Inclusion criteria:

  • age ≥ 18 years

  • all sexes

  • histologic or cytologic biopsy proven locally advanced or metastatic renal cell carcinoma, considered non‐candidates for curative surgery nephrectomy is not mandatory

  • MSKCC favourable‐ and intermediate prognostic group

  • measurable or non‐measurable disease (as per RECIST 1.1 criteria)

  • KPS of 70% or higher


Exclusion criteria:

  • prior systemic treatment for metastatic RCC disease

  • major surgical procedure, open surgical biopsy, or significant traumatic injury within 28 days prior to randomisation

  • evidence of current central nervous system (CNS) metastases or spinal cord compression. Patient must undergo an MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to randomisation

  • history or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications

  • known hypersensitivity to interleukin‐2, Interferon, alfa or bevacizumab


Sample size: N = 118
Age, Mean (years, range): experimental arm: 58 (28‐70), control arm: 55 (37‐69)
Sex (m/f): experimental arm: 46/13, control arm:: 47/12
Prognostic factors:

  • KPS, n(%)

    • 100

      • experimental arm: 31 (53), control arm: 37 (63)

    • 90

      • experimental arm: 19 (32), control arm: 16 (27)

    • 80

      • experimental arm: 6 (10), control arm: 4 (7)

    • 70

      • experimental arm: 3 (5), control arm: 2 (3)

  • IMDC risk, n(%)

    • Favourable

      • experimental arm: 14 (24), control arm: 12 (20)

    • Intermediate

      • experimental arm: 32 (54), control arm: 36 (61)

    • Poor

      • experimental arm: 13 (22), control arm: 11 (19)

  • MSKCC risk, n(%)

    • Favourable

      • experimental arm: 30 (51), control arm: 31 (52)

    • Intermediate

      • experimental arm: 29 (49), control arm: 28 (48)

  • Nephrectomy, n(%)

    • Yes

      • experimental arm: 50 (85), control arm: 51 (86)
Interventions Experimental arm (n = 59): interleukin‐2 (2.4 MIU/m2, subcutaneous, twice/day, 5 days per week) + interferon (3 MIU, subcutaneous, once/day, 5 days/week) + bevacizumab (10 mg/kg, intravenous, every 2 weeks)
Control arm (n = 59): interleukin‐2 (2.4 MIU/m2, subcutaneous, twice/day, 5 days per week) + interferon (3 MIU, subcutaneous, once/day, 5 days/week)
All cytokines were administered over 4‐week cycles for up to a maximum of 9 cycles (i.e., 9 months):
Outcomes Primary outcome(s)

  • PFS

  • exact time frame of assessment not reported


Secondary outcome(s)

  • OS

    • exact time frame of assessment not reported

  • Toxicity (AEs)

    • exact time frame of assessment not reported

  • Number of participants who discontinued treatment due to an AE


Relevant to this review but not reported: TFST, SAEs
Other outcomes (not relevant to this review): NED, biomarkers in imaging and biopsies, surgical resection, TTF, TTP, DoR, ORR (CR/PR), tolerability, TTF
Notes Funding sources: Quote: "This study was supported financially by Roche and Novartis and BEV was provided by Roche."
Declarations of Interests: "No potential conflict of interest was reported by the authors. Roche provided BEV. Roche and Novartis did not have access to data."
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no