ctDNA for Melanoma Stage II

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
City of Hope, Duarte, CAMelanoma Stage IIctDNA - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Melanoma Stage II

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Atezolizumab
1
SYNB1891
1
RO7296682

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Through completion of follow-up (estimated to be 48 months)

Week 8
ctDNA clearance rate
Month 15
Number of treatment-related grade 3 or greater adverse events
Month 12
Proportion of ctDNA-positive participants having a ctDNA-negative test at two consecutive measures
Month 12
Number of treatment discontinuations due to treatment-related adverse events
Month 48
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)
Overall survival (OS)
Relapse-free survival (RFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Atezolizumab
1
SYNB1891
1
RO7296682

Side Effects for

Atezolizumab
27%Fatigue
25%Decreased appetite
24%Cough
19%Asthenia
19%Dyspnoea
18%Constipation
18%Nausea
18%Pyrexia
16%Diarrhoea
13%Arthralgia
12%Anaemia
12%Vomiting
11%Musculoskeletal pain
11%Rash
11%Back pain
10%Headache
9%Oedema peripheral
9%Insomnia
9%Weight decreased
9%Chest pain
9%Pruritus
9%Pain in extremity
8%Dizziness
7%Aspartate aminotransferase increased
7%Myalgia
7%Haemoptysis
7%Upper respiratory tract infection
6%Influenza like illness
6%Alanine aminotransferase increased
6%Nasopharyngitis
6%Bronchitis
6%Productive cough
5%Depression
5%Dry skin
5%Musculoskeletal chest pain
4%Abdominal pain
4%Urinary tract infection
4%Paraesthesia
4%Neuropathy peripheral
3%Pneumonia
3%Stomatitis
3%Dysgeusia
2%Neutropenia
2%Pleural effusion
2%Malaise
1%Respiratory tract infection
1%Sepsis
1%Pulmonary embolism
1%Peripheral sensory neuropathy
1%Pneumonitis
1%Lacrimation increased
1%Alopecia
1%Mucosal inflammation
1%Bone pain
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02008227) in the Atezolizumab ARM group. Side effects include: Fatigue with 27%, Decreased appetite with 25%, Cough with 24%, Asthenia with 19%, Dyspnoea with 19%.

Trial Design

2 Treatment Groups

Arm 2: Atezolizumab
1 of 2
Arm 1: Atezolizumab + Tiragolumab
1 of 2

Active Control

Experimental Treatment

244 Total Participants · 2 Treatment Groups

Primary Treatment: ctDNA · No Placebo Group · Phase 2

Arm 1: Atezolizumab + TiragolumabExperimental Group · 4 Interventions: Signatera Assay, ctDNA, Atezolizumab, Tiragolumab · Intervention Types: Device, Procedure, Drug, Drug
Arm 2: AtezolizumabActiveComparator Group · 3 Interventions: Signatera Assay, ctDNA, Atezolizumab · Intervention Types: Device, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Tiragolumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through completion of follow-up (estimated to be 48 months)

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,821 Previous Clinical Trials
2,280,764 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,499 Previous Clinical Trials
564,824 Total Patients Enrolled
George Ansstas, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
18 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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