NCT05380713

......SMARTEST Trial......

Surgery for Mesothelioma After Radiation Therapy Using Exquisite Systemic Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The SMARTEST trial is a phase II non-blinded randomized trial designed to evaluate the benefit of low dose cyclophosphamide in sequential combination with sub-ablative radiation (Arm A) versus sub-ablative radiation alone (Arm B) before surgery as well as the safety and efficacy of consolidation tremelimumab-durvalumab for eligible patients after surgery in both arms.

Detailed description

This study has two parts. In the first part of the study the investigators are exploring the benefit of using low dose Cyclophosphamide in combination with low dose radiation before surgery and in the second part of the study the investigators are exploring safety and efficacy of using a combination of immunotherapy drugs, tremelimumab-durvalumab, after surgery.

Conditions

• Mesothelioma, Malignant

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide will be applied in the neoadjuvant setting
DRUG	Tremelimumab	tremelimumab-durvalumab in adjuvant setting
DRUG	Durvalumab	tremelimumab-durvalumab in adjuvant setting

Timeline

• Start date: 2022-05-03
• Primary completion: 2025-08-11
• Completion: 2025-12-20
• First posted: 2022-05-19
• Last updated: 2025-12-29

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study