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Clinical Trial Summary

This study's hypothesis is that patients with stage II melanoma who test positive for circulating tumor DNA are at a higher risk for recurrence and therefore adjuvant treatment is justified. In this study, the blood of consenting and eligible patients will be tested for ctDNA and those patients who test positive will be randomized on a 1:1 basis to either treatment with atezolizumab and tiragolumab or atezolizumab alone during Stage 1 of the study. If at least 3 patients in the atezolizumab + tiragolumab arm are shown to be ctDNA negative at C3D1, stage 2 of the study will begin enrollment. Stage 2 consists of 25 patients all enrolled to the atezolizumab + tiragolumab arm (no randomization and no atezolizumab monotherapy arm).Patients who test negative for ctDNA will be observed off protocol.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05060003
Study type Interventional
Source Washington University School of Medicine
Contact George Ansstas, M.D.
Phone 314-362-5677
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date December 31, 2021
Completion date December 31, 2027

See also
  Status Clinical Trial Phase
Completed NCT00462280 - Lovastatin in Treating Patients At High Risk of Melanoma Phase 2