Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection

Conditions

• Stage II Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Atezolizumab is provided by Genentech.
• Tiragolumab — DRUG
  Tiragolumab is provided by Genentech.
• Signatera Assay — DEVICE
  * To detect residual disease or to determine cancer recurrence with ctDNA * Step 2 screening (4-12 weeks after date of surgery), cycle 3 day 1, cycle 6 day 1, cycle 9 day 1, cycle 12 day 1, and end of treatment (optional)

Study Details

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.

Key Dates

Start date

Nov 8, 2022

Status verified

Feb 2024

Primary completion

Nov 27, 2023

Completion

Nov 27, 2023

Study Design

Enrollment

7 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Atezolizumab + Tiragolumab
  * Atezolizumab is given as an IV infusion every 4 weeks at a dose of 1680 mg over 60 minutes (+/- 15 minutes). * Tiragolumab is given as an IV infusion every 4 weeks at a dose of 840 mg over 60 minutes (+/- 15 minutes). * Treatment can continue for up to 13 cycles.
• Active Comparator: Arm 2: Atezolizumab
  * Atezolizumab is given as an IV infusion every 4 weeks at a dose of 1680 mg over 60 minutes (+/- 15 minutes). * Treatment can continue for up to 13 cycles.

Primary Outcome Measure

ctDNA Clearance Rate [ Time Frame: Cycle 3 Day 1 (estimated to be 8 weeks) ]

Locations (1)

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