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Kinase Inhibitor

MCS110 + BRAF/MEK Inhibitors for Melanoma

Phase 1 & 2
Waitlist Available
Led By Elizabeth I Buchbinder, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Archival tumor tissue available
Normal organ and marrow function as defined by specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a combination of two targeted therapies, MCS110 and Dabrafenib, as a possible treatment for advanced melanoma patients with a BRAF V600E or BRAF V600K genetic mutation.

Who is the study for?
This trial is for adults over 18 with advanced melanoma that has a specific BRAF mutation and hasn't responded to standard treatments. They must have measurable disease, be in relatively good health, not pregnant or breastfeeding, and willing to use contraception. People can't join if they have certain illnesses, recent other cancer treatments, untreated brain metastases, or need drugs that interact poorly with the study medications.Check my eligibility
What is being tested?
The study tests a combination of MCS110 with two targeted therapies—Dabrafenib and Trametinib—as potential treatment for melanoma with specific genetic mutations. It's designed to see how well these drugs work together after previous therapies failed.See study design
What are the potential side effects?
Possible side effects include but are not limited to fatigue, skin reactions, heart issues like changes in heartbeat rhythm (QTc prolongation), liver problems (as indicated by blood tests), vision changes due to retinal pathology risks associated with the tested drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have samples of my tumor stored.
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My organ and bone marrow functions are normal.
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My cancer progressed despite previous BRAF and MEK inhibitor treatments.
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I am 18 years old or older.
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All my side effects from previous cancer treatments are mild.
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My melanoma cannot be surgically removed, has spread, and does not respond to standard treatments.
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My cancer can be measured or seen on tests.
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I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Dose Limiting Toxicity
Secondary outcome measures
Complete Response rate
Overall Response Rate
Overall Survival
+3 more

Side effects data

From 2018 Phase 2 trial • 36 Patients • NCT01643850
40%
Headache
20%
Blood creatine phosphokinase increased
20%
Face oedema
20%
Influenza
20%
Sinusitis
20%
Gamma-glutamyltransferase increased
20%
Lipase increased
20%
Benign joint neoplasm
20%
Hypoaesthesia
20%
Hypotension
20%
Aspartate aminotransferase increased
20%
Arthritis
20%
Amylase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo/10mg/kg (PART B)
MCS110 10 mg/kg (PART A)
Placebo (PART A)
MCS110 10mg/kg (PART B)
MCS110 3mg/kg (PART C)
MCS110 5mg/kg (PART C)
MCS110 10mg/kg (PART C)

Trial Design

2Treatment groups
Experimental Treatment
Group I: MCS110+ Trametinib + DabrafenibExperimental Treatment3 Interventions
For Phase 1 MCS110 will be administered intravenously every 3 weeks. Dabrafenib is given orally every 12 hours. Trametinib is given orally daily
Group II: MCS110 + Trametinib + Dabrafenib Phase 2Experimental Treatment3 Interventions
MCS110 will be administered intravenously every 3 weeks. The Dosage will be determine by the DLT of Phase 1 Dabrafenib is given orally every 12 hours. Trametinib is given orally daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1600
MCS110
2012
Completed Phase 2
~230
Dabrafenib
2011
Completed Phase 3
~4120

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,607 Previous Clinical Trials
2,709,748 Total Patients Enrolled
18 Trials studying Melanoma
2,034 Patients Enrolled for Melanoma
Dana-Farber Cancer InstituteLead Sponsor
1,071 Previous Clinical Trials
340,321 Total Patients Enrolled
31 Trials studying Melanoma
2,815 Patients Enrolled for Melanoma
Elizabeth I Buchbinder, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
1 Trials studying Melanoma

Media Library

Dabrafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03455764 — Phase 1 & 2
Melanoma Research Study Groups: MCS110+ Trametinib + Dabrafenib, MCS110 + Trametinib + Dabrafenib Phase 2
Melanoma Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT03455764 — Phase 1 & 2
Dabrafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03455764 — Phase 1 & 2

Frequently Asked Questions

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

Can you provide an overview of the preceding investigations involving MCS110?

"Currently, 96 research projects concerning MCS110 are underway with 6 of them in the third phase. Although most tests on this substance take place in Milano (MI), there are 5817 different locations providing trials for MCS110."

Answered by AI

How many participants are enrolled in the current clinical trial?

"Unfortunately, this clinical trial is not looking to enrol patients at the moment. First posted on June 22nd 2018 and last updated December 8th 2021, it has since ceased recruitment; however there are 754 active trials related to melanoma and 96 for MCS110 that are still open to participants."

Answered by AI

Are there any opportunities to partake in this research experiment?

"Per the information hosted on clinicaltrials.gov, it appears that this study has exhausted its recruitment and is not currently searching for candidates. The trial was first posted in June 2018 with a most recent update appearing in December 2021. Despite this conclusion, there are still 850 other trials which remain open to participants at present."

Answered by AI
~3 spots leftby Sep 2024