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

NCT01984242.

Study characteristics
Methods Study name: IMmotion150
Study design: a two‐arm, RCT, phase II (three‐arm trial)
Blinding: none, open‐label
Study dates: 8 January 2014 to 16 March 2015 (date of enrolment)
Date of data cut‐off: 17 October 2016 (clinical cutoff date)
Location: 9 countries (Czech Republic, France, Germany, Italy, Poland, Romania, Spain, UK, USA), types of centres: cancer centres, medical centres, hospitals, research institutions (45 study locations)
Cross‐over study or cross over permitted: not per design, but participants enrolled in atezolizumab (except EU participants) or sunitinib group could crossover to receive atezolizumab and bevacizumab combination therapy in case of disease progression
Participants Inclusion criteria:

  • all sexes

  • 18 years and older

  • unresectable advanced or metastatic renal cell carcinoma with component of clear cell histology and/or component of sarcomatoid histology that has not been previously treated with any systemic agents, including treatment in the adjuvant setting

  • measurable disease, as defined by RECIST v1.1

  • KPS (>/=) 70


Exclusion criteria:
Disease‐Specific Exclusions:

  • radiotherapy for renal cell carcinoma within 14 days prior to Cycle 1, Day 1 with the exception of single‐fraction radiotherapy given for the indication of pain control

  • known active malignancies or metastasis of the brain or spinal cord or leptomeningeal disease, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments

  • malignancies other than renal cell carcinoma within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death, treated with expected curative outcome


Sample size: N=305
Age, median (years, range): experimental arm I: 62 (32‐88), experimental arm II: 61 (27‐81), control arm: 61 (25‐85)
Sex (m/f): experimental arm I: 74/27, experimental arm II: 77/26, control arm: 79/22
Prognostic factors:

  • MSKCC risk category, n(%)

    • Favourable (0)

      • experimental arm I: 30 (30), experimental arm II: 26 (25), control arm: 21 (21)

    • Intermediate (1 or 2)

      • experimental arm I: 62 (61), experimental arm II: 69 (67), control arm: 70 (69)

    • Poor (≥3)

      • experimental arm I: 9 (9), experimental arm II: 8 (8), control arm: 10 (10)

  • Prior nephrectomy

    • Yes

      • experimental arm I: 88 (87), experimental arm II: 88 (87), control arm: 89 (86)
Interventions Experimental arm I (n = 101): atezolizumab (1200 mg, intravenous, every three weeks) + Bevacizumab (15 mg/kg, intravenous, every three weeks)
Experimental arm II (n = 103): atezolizumab (1200 mg, intravenous, every three weeks)
Control arm (n = 101): sunitinib (50 mg, oral, once/day) ‐ treatment was 4 weeks on treatment, 2 weeks off treatment (1 cycle ‐ 6 weeks)
Outcomes Primary outcome(s)

  • PFS per RECIST v1.1 via IRC assessment in ITT population

    • Time frame: from randomisation until disease progression or death due to any cause (until data cut‐off date 17 October 2016, up to approximately 2.75 years)


Secondary outcome(s)

  • OS in ITT population

    • Time frame: randomisation until death due to any cause (until data cut‐off date 17 October 2016, up to approximately 2.75 years)

  • AEs, SAEs

    • Time frame: baseline up to approximately 60 months

  • Number of participants who discontinued treatment due to an AE


Relevant to this review but not reported: TFST, QoL
Other outcomes (not relevant to this review): OS and PFS in different subgroups, pharmacokinetics of study drugs, laboratory parameters, disease progression, DoR,OR (CR, PR), number of deaths, DP
Notes Funding sources: Quote; Prometheus Laboratories. M.B.A., Roche/Genentech, Novartis, Pfizer, Eisai, and Exelixis, F. Hoffmann‐La Roche, AG (...)
Declaration of Interest: "D.F.M. reports a consulting/advisory role for Bristol‐Myers Squibb, Merck, Roche/ Genentech, Pfizer, Exelixis, Novartis, Eisai, X4 Pharmaceuticals, and Array BioPharma (...). J.A.R., J.H., T.H., C. Suárez, and R.D. have nothing to disclose."
Clinical study report available: no
Study protocol available: no
Statistical analysis plan available: no