Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlliance for Clinical Trials in Oncology
About this trial
This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.
Eligibility criteria
Qualifiers
Sarcomatoid or sarcomatoid-dominant (> 50%) biphasic, pleural mesothelioma
Stage: I-IIIA disease per Union for International Cancer Control (UICC) TNM Classification of Malignant Tumours 8th edition
Measurable disease or non-measurable disease as defined
No prior treatment which would be considered treatment for the primary neoplasm or impact the primary endpoint
Disqualifiers
No patients deemed to be unresectable or poor surgical candidates
No patients with chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes
No patients with a history of symptomatic interstitial lung disease
Trial design
Treatments tested in this trial
- Nivolumab
- Ipilimumab
- Surgical Procedure
- Computed Tomography
- Magnetic Resonance Imaging
- Positron Emission Tomography
Treatment groups
26 Participants
are divided into 1 treatment groupSponsors and collaborators
Alliance for Clinical Trials in Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov