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

NCT05380713 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Mesothelioma, Malignant

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide will be applied in the neoadjuvant setting

DRUG

Tremelimumab

tremelimumab-durvalumab in adjuvant setting

DRUG

Durvalumab

tremelimumab-durvalumab in adjuvant setting

Sponsors & Collaborators

  • Ontario Institute for Cancer Research

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2025-08-11
Completion
2025-12-20
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05380713 on ClinicalTrials.gov