Nivolumab and ipilimumab +/- UV1 vaccination as second line treatment in patients with malignant mesothelioma (the NIPU-study)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502604-67-00

Enrollment

Registered

2023-02-17

Start date

2019-12-20

Completion date

Unknown

Last updated

2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pleural mesothelioma (MPM)

Brief summary

Progression-free survival (PFS) per Modified Response Evaluation Criteria in Solid Tumours (RECIST) as determined by blinded independent central review (BICR).

Detailed description

Overall survival (OS), objective response rate (ORR), disease control rate (DCR), time to response (TTR) and duration of response (DOR)., European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) and it's Lung Cancer Module (LC13) scores., Adverse events (AEs)., Study drug discontinuations due to AEs.

Interventions

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGLeukine

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) per Modified Response Evaluation Criteria in Solid Tumours (RECIST) as determined by blinded independent central review (BICR).	—

Secondary

Measure	Time frame
Overall survival (OS), objective response rate (ORR), disease control rate (DCR), time to response (TTR) and duration of response (DOR)., European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) and it's Lung Cancer Module (LC13) scores., Adverse events (AEs)., Study drug discontinuations due to AEs.	—

Countries

Denmark, Norway, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026