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

Sponsor
University Health Network, Toronto
Study ID
NCT05380713
Phase
PHASE2
Status
Completed

Conditions

  • Mesothelioma, Malignant

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Cyclophosphamide will be applied in the neoadjuvant setting
  • Tremelimumab — DRUG
    tremelimumab-durvalumab in adjuvant setting
  • Durvalumab — DRUG
    tremelimumab-durvalumab in adjuvant setting

Study Details

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.

Key Dates

Start date
May 3, 2022
Status verified
Dec 2025
Primary completion
Aug 11, 2025
Completion
Dec 20, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation+Drug (Arm A)
    sub-ablative radiation plus low dose cyclophosphamide followed by surgery and adjuvant immunotherapy
  • Experimental: Radiation alone (Arm B)
    sub-ablative radiation alone followed by surgery and adjuvant immunotherapy

Primary Outcome Measure

CD8 TILs density / gross tumor volume (GTV) [ Time Frame: Up to five years ]

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