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Monoclonal Antibodies
Combination Therapy for Melanoma
Phase 2
Recruiting
Led By Matthew S. Block, M.D., Ph.D.
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 belowSelect...
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 fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 moreTrial 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
2017
Completed Phase 3
~5860
Cobimetinib
2017
Completed Phase 3
~3090
Tiragolumab
2020
Completed Phase 2
~460
Vemurafenib
2015
Completed Phase 3
~3540
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,722 Previous Clinical Trials
40,964,352 Total Patients Enrolled
4 Trials studying Cutaneous Melanoma
198 Patients Enrolled for Cutaneous Melanoma
Mayo ClinicLead Sponsor
3,246 Previous Clinical Trials
3,783,354 Total Patients Enrolled
SU2C (StandUp 2 Cancer)UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled illnesses or active infections.I have received cancer treatments or been part of a study before registering.I am 18 years old or older.I haven't had cancer, except for melanoma, in the last 3 years.I have had melanoma spread beyond the lymph nodes or to my brain.I have a history of specific eye retina problems.I am not on any systemic immunosuppressive medications or required diets that are not allowed.My melanoma has spread to more than one lymph node area.My melanoma is confirmed to be at stage III.I am willing to stop any cancer treatments before joining the study.I have had a previous transplant of stem cells or an organ.I do not have major heart issues, stroke, severe bleeding, uncontrolled diabetes, or serious mental health/social problems.I will be taking medication that can affect my heart's rhythm.My condition can be treated with surgery.I am not on any experimental drugs for my cancer.My melanoma has been tested for the BRAFV600 mutation.I need treatment for my active psoriasis.I have had treatment for melanoma before, with some exceptions.I have had major surgery recently or expect to need one soon.I have a significant liver condition.My melanoma is suspected to have spread beyond the lymph nodes.I am willing to provide tissue samples for BRAF testing and research.I am fully active or can carry out light work.I have a history of nutrient absorption problems or significant metabolic issues.I have had radiation therapy for melanoma.I have a history of certain lung and autoimmune diseases.I have signs of an infection or have recently used antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (atezolizumab, tiragolumab)
- Group 2: Arm A - CLOSED (vemurafenib, cobimetinib, atezolizumab)
- Group 3: Arm B - CLOSED (cobimetinib, atezolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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