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Checkpoint Inhibitor

Tiragolumab + Atezolizumab for Stage II Melanoma

Phase 2
Waitlist Available
Led By George Ansstas, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal bone marrow and organ function as defined below: Absolute neutrophil count ≥ 1,500/mcL, Lymphocyte count ≥ 500/mcL, Platelets ≥ 100,000/mcL, Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this criterion), Total bilirubin ≤ 1.5 x IULN or direct bilirubin ≤ IULN for participants with total bilirubin levels > 1.5 x IULN; patients with known Gilbert disease must have total bilirubin ≤ 3 x IULN, AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN, Alkaline phosphatase ≤ 2.5 x IULN, Creatinine clearance ≥ 45 mL/min by Cockcroft-Gault, Serum albumin ≥ 2.5 g/dL, INR or PT ≤ 1.5 x IULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants, aPTT ≤ 1.5 x IULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants, ECOG performance status ≤ 1, The effects of atezolizumab and tiragolumab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation, for 90 days after the final dose of tiragolumab, and for 5 months after the final dose of atezolizumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 90 days after completion of the study
Participants must not have been previously treated for melanoma beyond complete surgical resection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 48 months)
Awards & highlights

Study Summary

This trial is testing whether a certain type of cancer treatment is more effective when given to patients who also test positive for a specific biomarker. Blood will be taken from patients to test for the biomarker, and those who test positive will be randomly assigned to receive either one type of treatment or a combination of two treatments. The goal is to see if the combination treatment is more effective at reducing the biomarker in patients' blood.

Who is the study for?
This trial is for adults over 18 with stage II cutaneous melanoma that's been surgically removed within the last 16 weeks. They must have normal organ and bone marrow function, not have had previous melanoma treatments beyond surgery, and test positive for ctDNA. Participants need to use effective contraception and cannot join if they're pregnant, breastfeeding, or have a history of certain diseases like autoimmune disorders or severe allergies to similar drugs.Check my eligibility
What is being tested?
The study tests whether adding Tiragolumab to Atezolizumab improves outcomes in patients whose blood tests show circulating tumor DNA after melanoma surgery. Initially, participants are randomly assigned to receive either both drugs or only Atezolizumab. If successful in Stage 1, all patients in Stage 2 will receive both medications without randomization.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation of organs; infusion reactions which may cause chills or fever; fatigue; skin issues; hormonal changes affecting thyroid function; liver problems indicated by abnormal blood tests; and possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have only had surgery for my melanoma, with no other treatments.
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I am 18 years old or older.
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My blood test for cancer DNA was positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 48 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 48 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ctDNA Clearance Rate
Secondary outcome measures
Assess the Impact of ctDNA Kinetics on Distant Metastasis-free Survival
Assess the Impact of ctDNA Kinetics on Relapse-free Survival
Distant Metastasis-free Survival (DMFS)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Atezolizumab + TiragolumabExperimental Treatment3 Interventions
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.
Group II: Arm 2: AtezolizumabActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Tiragolumab
2020
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,702 Total Patients Enrolled
11 Trials studying Melanoma
326 Patients Enrolled for Melanoma
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,682 Total Patients Enrolled
34 Trials studying Melanoma
1,680 Patients Enrolled for Melanoma
George Ansstas, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
18 Total Patients Enrolled
2 Trials studying Melanoma
18 Patients Enrolled for Melanoma

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05060003 — Phase 2
Melanoma Research Study Groups: Arm 1: Atezolizumab + Tiragolumab, Arm 2: Atezolizumab
Melanoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05060003 — Phase 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05060003 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a novel clinical trial?

"ctDNA has had a long history, with the first study being completed over a decade ago in 2008. The drug went through Phase 2 approval after the initial study and there are now 357 active trials taking place all over the world."

Answered by AI

Could you please list other research projects that have utilized ctDNA?

"In 2008, ctDNA was first studied at Illinois Cancer Care. As of now, there have been a total of 79 completed clinical trials with 357 more currently underway. A large number of these studies are based in Duarte, Missouri."

Answered by AI

How many people fit the requirements for this research?

"Yes, this is an active trial recruiting patients. The listing on clinicaltrials.gov reveals that the study was posted on November 8th, 2020 and last updated two days later. They are looking for 244 people to participate at 6 sites."

Answered by AI

Does this research project have a broad reach in terms of the number of hospitals participating?

"At the moment, there are 6 sites where this trial is taking place. They are in Duarte, Saint Louis and New Haven as well as three other locations. If you want to take part in this trial, it would be best to choose a location near you so that travelling isn't too much of an inconvenience."

Answered by AI

What is the official stance of the FDA on ctDNA?

"Currently, there is not enough data to confirm ctDNA's efficacy. However, because there are Phase 2 clinical trial results supporting its safety, our team has given it a rating of 2."

Answered by AI

Are there any available positions for patients in this trial?

"The information available on clinicaltrials.gov supports that this trial is looking for volunteers at this time. This specific trial was first posted on November 8th, 2020 and updated two days ago. In total, 244 people are needed for the study taking place at 6 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection
2022. "Tiragolumab Plus Atezolizumab Versus Atezolizumab in the Treatment of Stage II Melanoma Patients Who Are ctDNA-positive Following Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05060003.
~3 spots leftby Apr 2025
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