Nivolumab monotherapy (mesothelioma 2L, CONFIRM)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-NIVOLUMAB |
|---|
| ID | REG-NIVO-MONO-MESOTHELIOMA-2L |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-05-07 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-CONFIRM-FENNELL-2021 |
Notes
CONFIRM trial (Fennell 2021, Lancet Oncol): nivolumab 240 mg IV q2w vs placebo in relapsed MPM after ≥1 prior platinum-based regimen. Phase 3, double-blind RCT, n=332. OS: median 9.2 mo vs 6.6 mo (HR 0.72, 95% CI 0.55–0.94; p=0.018). PFS: HR 0.61 (95% CI 0.46–0.81; p=0.0003). ORR: 11% vs 2%. Benefit observed across epithelioid and non-epithelioid histological subtypes and regardless of PD-L1 expression (unselected population). Dose: CONFIRM used 240 mg flat dose q2w (not weight-based 3 mg/kg) — consistent with post-2018 flat-dose nivolumab standardisation. Up to 12 months (24 cycles). Monitoring: CBC, CMP, LFTs, TSH q2-4 weeks; CT chest/abdomen q8-12 weeks using modified RECIST for MPM (bidimensional pleural measurement — NOT standard RECIST 1.1). Hepatitis B/C serology required before first dose.
Used By
Indication
IND-MESOTHELIOMA-2L-NIVO- IND-MESOTHELIOMA-2L-NIVO