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. 2020 May 12;2020(5):CD013238. doi: 10.1002/14651858.CD013238.pub2

Weller 2017.

Study characteristics
Methods Phase III randomised, double‐blind
Participants First‐line glioblastoma patient: randomisation (1:1) ‐ 195 rindopepimut and temozolomide, 210 standard of care (temozolomide)
Interventions Rindopepimut + temozolomide vs temozolomide
Outcomes
  • OS: HR 0.89, P = 0.22 (17.4 vs 17.4 months ITT analysis)

  • PFS: HR 1.01 (8.0 vs 7.4 months)

  • QoL: no difference

  • Toxicity:

    • Injection site reactions, transient grade 1 to 2 erythema, pruritus, rash

    • Thrombocytopenia, fatigue, brain oedema, seizure, headache

Notes Terminated early at second preplanned interim analysis – futility boundary crossed.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random assignment to treatment groups with a prespecified randomisation sequence with a block size of 4.
Allocation concealment (selection bias) Low risk Double‐blinded study – unblinded pharmacists obtained randomly assigned treatment assignments and managed study treatment via interactive response technology
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blinded study
Placebo vaccine ‐ preloaded with immunostimulant
Blinding of outcome assessment (detection bias)
All outcomes Low risk Local assessors (blinded), central assessors (also blinded for PFS and ORR assessments)
Incomplete outcome data (attrition bias)
All outcomes Low risk None
Selective reporting (reporting bias) Unclear risk None
Other bias Low risk