drugset / Trial / NCT04300244
Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma
Phase 2
Active not recruiting
118 enrolled
Åslaug Helland
Bristol-Myers Squibb · collabOslo University Hospital · collabUltimovacs ASA · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of the study is to induce a meaningful progression-free survival benefit in patients with Malign Pleural Mesothelioma (MPM) after progression on first line standard platinum doublet chemotherapy, by treating with nivolumab and ipilimumab with or without UV1 vaccine.
Timeline
- Start
- 2020-05-04
- Primary completion
- 2025-03-15
- Completion
- 2027-03-15
Publications
- Thunold S, Hernes E, Gyland Mikalsen LT, Farooqi S, Ojlert AK, Francis RJ, Nowak AK, Szejniuk WM, Nielsen SS, Cedres S, Perdigo MS, Sorensen JB, Meltzer C, Helland A, Malinen E, Haakensen VD. Dual-time-point [18F]FDG-PET/CT as a prognostic biomarker in patients with pleural mesothelioma undergoing immunotherapy. EJNMMI Res. 2026 Jun 20. doi: 10.1186/s13550-026-01469-x. Online ahead of print.
- Thunold S, Hernes E, Farooqi S, Ojlert AK, Francis RJ, Nowak AK, Szejniuk WM, Nielsen SS, Cedres S, Perdigo MS, Sorensen JB, Meltzer C, Mikalsen LTG, Helland A, Malinen E, Haakensen VD. Outcome prediction based on [18F]FDG PET/CT in patients with pleural mesothelioma treated with ipilimumab and nivolumab +/- UV1 telomerase vaccine. Eur J Nucl Med Mol Imaging. 2025 Jan;52(2):693-707. doi: 10.1007/s00259-024-06853-0. Epub 2024 Aug 12.
- Haakensen VD, Nowak AK, Ellingsen EB, Farooqi SJ, Bjaanaes MM, Horndalsveen H, Mcculloch T, Grundberg O, Cedres SM, Helland A. NIPU: a randomised, open-label, phase II study evaluating nivolumab and ipilimumab combined with UV1 vaccination as second line treatment in patients with malignant mesothelioma. J Transl Med. 2021 May 31;19(1):232. doi: 10.1186/s12967-021-02905-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | — |
| Subject | UV1 | Peptide | — | Other |
| Background | sargramostim | Protein / enzyme biologic | — | — |