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BRAF Inhibitor
Triple Drug Therapy for Melanoma (COMBI-i Trial)
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Double-blind, randomized, placebo-controlled part: Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
Safety run-in: ECOG performance status ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first documented response to date of first documented progression or death, up to 3.3 years (part 1), 3 years (part 2) and 2.8 years (part 3)
Awards & highlights
COMBI-i Trial Summary
This trial is testing a combination of 3 drugs to treat metastatic melanoma.
Who is the study for?
This trial is for adults with advanced melanoma that can't be removed by surgery or has spread, and must have a specific mutation (BRAF V600). They should not have had previous systemic cancer treatments for advanced melanoma, no recent radiation therapy, no active brain metastases, and no history of autoimmune diseases requiring treatment.Check my eligibility
What is being tested?
The study tests the combination of Spartalizumab (an anti-PD-1 antibody), Dabrafenib (a BRAF inhibitor), and Trametinib (a MEK inhibitor) in patients. It aims to assess safety and effectiveness compared to placebo alongside standard treatments for this type of skin cancer.See study design
What are the potential side effects?
Potential side effects may include immune system reactions affecting organs, liver enzyme changes indicating liver stress, fatigue due to treatment burden on the body's resources, as well as other drug-specific reactions.
COMBI-i Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma cannot be removed by surgery and has a BRAF V600 mutation.
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I am fully active or can carry out light work.
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My melanoma cannot be surgically removed and has a BRAF V600 mutation.
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My melanoma cannot be surgically removed and has a BRAF V600 mutation.
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I can take care of myself but might not be able to do heavy physical work.
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I can take care of myself and am up and about more than half of my waking hours.
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I have at least two skin or lymph node lesions suitable for biopsy.
COMBI-i Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first documented response to date of first documented progression or death, up to 3.3 years (part 1), 3 years (part 2) and 2.8 years (part 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first documented response to date of first documented progression or death, up to 3.3 years (part 1), 3 years (part 2) and 2.8 years (part 3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1
+1 moreSecondary outcome measures
Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1
Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1
Number of Participants With Dose Interruptions
+17 moreCOMBI-i Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinibExperimental Treatment3 Interventions
In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Group II: Part 2: Biomarker cohortExperimental Treatment3 Interventions
In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
Group III: Part 1: Safety run-in CohortExperimental Treatment3 Interventions
In Part 1, participants are treated at different dose levels to determine the recommended Phase 3 regimen of spartalizumab in combination with dabrafenib and trametinib. The starting dose of spartalizumab is 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
Group IV: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinibPlacebo Group3 Interventions
In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spartalizumab
2020
Completed Phase 2
~280
Trametinib
2014
Completed Phase 2
~1550
Dabrafenib
2011
Completed Phase 3
~4120
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,863 Previous Clinical Trials
4,198,766 Total Patients Enrolled
51 Trials studying Melanoma
30,335 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have uveal or mucosal melanoma.I have an active autoimmune disease or a history of one that needed treatment.My melanoma cannot be removed by surgery and has a BRAF V600 mutation.I am fully active or can carry out light work.Your disease can be measured using a specific standard called RECIST 1.1.I finished my initial melanoma treatment less than 6 months ago.I have an active autoimmune disease or a history of one that needed treatment.I have had treatment for melanoma that couldn't be removed by surgery.I finished treatment for melanoma less than 6 months ago.I received radiation therapy less than 4 weeks ago.I have active brain metastases from melanoma.I can take care of myself but might not be able to do heavy physical work.I can take care of myself and am up and about more than half of my waking hours.I have had cancer spread to my brain.I have had treatment for melanoma that could not be removed by surgery.My melanoma cannot be surgically removed and has a BRAF V600 mutation.My melanoma cannot be surgically removed and has a BRAF V600 mutation.I received radiation therapy less than 4 weeks ago.I have at least two skin or lymph node lesions suitable for biopsy.Your liver enzymes (AST and ALT) are not too high.My cancer can be measured using standard health scans.I have uveal or mucosal melanoma.You need to have a measurable disease based on specific guidelines for assessing tumors.
Research Study Groups:
This trial has the following groups:- Group 1: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib
- Group 2: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib
- Group 3: Part 1: Safety run-in Cohort
- Group 4: Part 2: Biomarker cohort
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients that have not yet been enrolled in this research project?
"The study in question is not currently looking for new patients, as the last update on clinicaltrials.gov was on October 21st, 2022. However, there are 903 other trials that might be a fit for you."
Answered by AI
What are some of the risks associated with Spartalizumab (PDR001)?
"Spartalizumab (PDR001) is a Phase 3 clinical trial medication, meaning that it has passed multiple rounds of testing with positive results. Consequently, our team rates its safety as a 3."
Answered by AI
In how many different places is this trial being run today?
"So far, this trial has recruited patients from 17 different locations including California Cancer Associates for Research and Excellence SC-2 in San Diego, University of Pittsburgh Medical Center SC in Pittsburgh, and Utah Cancer Specialists SC-2 in Encinitas."
Answered by AI
To your knowledge, does a similar study exist?
"Spartalizumab (PDR001) was first studied in 2011 by Novartis Pharmaceuticals. After the first 185-person trial, it received approval for Phase 1 clinical trials. Spartalizumab (PDR001) is currently being investigated in 122 active trials across 1166 cities and 41 countries."
Answered by AI
What is the efficacy of Spartalizumab (PDR001) in other medical studies?
"Currently, there are 122 ongoing clinical trials for Spartalizumab (PDR001), with 6 of them being in the third phase. Most of these trials are based in New york City, but there are a total of 6118 locations conducting clinical trials for Spartalizumab (PDR001)."
Answered by AI
What is the goal that researchers are hoping to achieve with this clinical trial?
"The goal of this trial, over a 2 year period, is to assess Progression-Free Survival (PFS), as measured by RECIST 1.1. Additionally, the study will track changes in patients' EORTC QLQ-C30 scores, interruptions or reductions in medication dosage, and number of patients who experience dose interruptsions or reductions."
Answered by AI
How many people are taking part in this experiment?
"This study is not recruiting at the moment. The clinical trial was initially posted on 2/17/2017 and was last updated on 10/21/2022. If you are exploring for other studies, there are currently 781 clinical trials actively looking for patients with melanoma and 122 trials for Spartalizumab (PDR001) actively looking for participants."
Answered by AI
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