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Monoclonal Antibodies

Combination Therapy for Melanoma

Phase 2
Recruiting
Led By Matthew S Block
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
High-risk stage III melanoma as defined by recurrent nodal metastasis, clinically detectable nodal metastasis, or metastatic involvement of more than one nodal basin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a combination of immunotherapies and targeted therapies to treat high-risk stage III melanoma. Vemurafenib and cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab and tiragolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Who is the study for?
This trial is for adults over 18 with high-risk stage III melanoma that can be surgically removed. Participants must have a specific BRAFV600 mutation, agree to provide tissue samples, and not use other cancer treatments during the study. They should not have certain health conditions like active psoriasis or uncontrolled diabetes, nor should they be pregnant or unwilling to use contraception.Check my eligibility
What is being tested?
The trial tests how well vemurafenib and cobimetinib (which block enzymes for cell growth) work with atezolizumab and tiragolumab (monoclonal antibodies boosting immune response against cancer). It aims to see if this combination is more effective in treating patients than current methods.See study design
What are the potential side effects?
Possible side effects include allergic reactions, inflammation of organs due to immune response, liver issues from enzyme blockers, fatigue, skin rash, joint pain from targeted therapies and immunotherapies. Each patient may experience different side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My melanoma has spread to more than one lymph node area.
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My melanoma is confirmed to be at stage III.
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I am willing to stop any cancer treatments before joining the study.
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My condition can be treated with surgery.
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My melanoma has been tested for the BRAFV600 mutation.
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I am willing to provide tissue samples for BRAF testing and research.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median recurrence-free (RFS) rate (adjuvant phase)
Melanoma
Pathologic complete response rate in patients with stage III BRAFwt (wild type) melanoma (neoadjuvant phase)
Secondary outcome measures
Cognitive Therapy
Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) (neoadjuvant phase)
Other outcome measures
Changes in T cell receptor clonality
Changes in the concentration of circulating tumor deoxyribonucleic acid (DNA) during neoadjuvant treatment
Molecular features of melanomas and the tumor immune microenvironment evaluated with multiplexed immunohistochemistry (mIHC) and ribonucleic acid sequencing (RNASeq)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (atezolizumab, tiragolumab)Experimental Treatment2 Interventions
Patients with BRAF wild-type or BRAF mutant melanoma receive atezolizumab IV over 30-60 minutes and tiragolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm B - CLOSED (cobimetinib, atezolizumab)Experimental Treatment2 Interventions
Patients receive cobimetinib as in Arm A and atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Group III: Arm A - CLOSED (vemurafenib, cobimetinib, atezolizumab)Experimental Treatment3 Interventions
Patients receive vemurafenib PO BID on days 1-28 and cobimetinib PO QD on days 1-21. Patients also receive atezolizumab intravenously (IV) over 30-60 minutes on days 1 and 15 of cycles 2 and 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients undergo surgery then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~6040
Cobimetinib
2015
Completed Phase 3
~2630
Tiragolumab
2020
Completed Phase 2
~350
Vemurafenib
2015
Completed Phase 3
~3100

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,481 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,365 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
SU2C (StandUp 2 Cancer)UNKNOWN

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03554083 — Phase 2
Cutaneous Melanoma Research Study Groups: Arm B - CLOSED (cobimetinib, atezolizumab), Arm C (atezolizumab, tiragolumab), Arm A - CLOSED (vemurafenib, cobimetinib, atezolizumab)
Cutaneous Melanoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03554083 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03554083 — Phase 2

Frequently Asked Questions

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

What pathologies has Cobimetinib been proven to be efficacious for?

"Cobimetinib is frequently used to manage small cell lung cancer, and has been found effective against other forms of cancers such as metastatic melanoma, non-small cell lung carcinoma, and unresectable melanoma."

Answered by AI

Are there any precarious risks associated with taking Cobimetinib?

"Our internal ratings at Power gave cobimetinib a score of 2, as sufficient data has been collected to confirm its safety but there is still no evidence of efficacy."

Answered by AI

What is the maximum possible enrollment for this research endeavor?

"Affirmative. Clinicaltrials.gov indicates that the medical experiment, which was originally posted on June 22nd 2018, is currently enrolling participants. Approximately 30 subjects must be recruited between 2 clinical locations."

Answered by AI

Can you provide any information on prior experiments involving Cobimetinib?

"In 2008, cobimetinib was first tested at SCRI Tennessee Oncology Chattanooga. As of this date there have been 144 successful trials and 391 ongoing studies conducted primarily in Rochester, Minnesota."

Answered by AI

Are any opportunities available for participants in this investigation?

"Affirmative. According to clinicaltrials.gov, this scientific trial is currently enrolling 30 patients from two separate sites; the first posting was on June 22nd 2018 and its most recent update happened October 21st 2022."

Answered by AI

Is this endeavor the inaugural attempt of its type?

"Research into cobimetinib began in 2008 and was initiated by Hoffmann-La Roche. The first research study, which involved 720 patients, lead to the drug's Phase 2 approval. Currently there are 391 active trials for cobimetinib taking place across 74 countries and 1735 cities worldwide."

Answered by AI
~1 spots leftby Jun 2024