CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 26 target
Drug / intervention
Nivolumab +5 morebiological
Likely dose
Not stated in record
Key inclusion· 13
  • Sarcomatoid or sarcomatoid-dominant (>50%) biphasic pleural mesothelioma
  • Stage I-IIIA disease per UICC TNM 8th edition
  • Age ≥18 years
  • ECOG performance status ≤2 or Karnofsky ≥60%
Key exclusion· 7
  • Patients deemed unresectable or poor surgical candidates
  • Chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, contralateral intrathoracic lymph node metastases, or supraclavicular node involvement
  • History of symptomatic interstitial lung disease
  • Prior treatment for primary neoplasm or treatment that would impact primary endpoint

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05647265
NCT05647265Phase 2RecruitingHigh Momentum

Official Title Neoadjuvant Immunotherapy in Sarcomatoid Mesothelioma

Alliance for Clinical Trials in Oncology·interventional·Posted Dec 12, 2022·Updated Jun 2, 2026

In Brief

A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 4 other interventions for Pleural Biphasic Mesothelioma and Pleural Sarcomatoid Mesothelioma. Currently recruiting, targeting 26 participants across 132 sites.

Signals

Enrolling ahead of pace

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2Recruiting
20232024202520262027
First PostedDec 12, 2022
Enrollment StartNov 27, 2024
Primary CompletionDec 15, 2026
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 3.6 years agoPrimary completion in 5 months

Arms & Interventions

Treatment (nivolumab, ipilimumab, surgery)experimental

Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.

Biological: NivolumabBiological: IpilimumabProcedure: Surgical ProcedureProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Interventions

Nivolumabbiological

Given IV

Ipilimumabbiological

Given IV

Surgical Procedureprocedure

Undergo surgery

Computed Tomographyprocedure

undergo CT

Magnetic Resonance Imagingprocedure

Undergo MRI

Positron Emission Tomographyprocedure

Undergo PET