Trials / Completed
CompletedNCT02497508
Nivolumab in Patients With Recurrent Malignant Mesothelioma
A Single Arm Phase II Study of Nivolumab in Patients With Recurrent Malignant Pleural Mesothelioma: Interim Biopsy Analysis to Determine Efficacy. Acronym: NivoMes Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, single arm, phase II trial in previously treated patients with MPM who are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic biopsies. Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection. The administration of nivolumab as monotherapy will improve DCR form 20% to 40% at 12 weeks when compared to DCR of patients treated with best supportive care based on historical controls.
Detailed description
Patients will undergo pre- and post-treatment thoracoscopies/biopsies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nivolumab |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2017-07-01
- Completion
- 2017-07-01
- First posted
- 2015-07-14
- Last updated
- 2017-09-14
Source: ClinicalTrials.gov record NCT02497508. Inclusion in this directory is not an endorsement.