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MEK Inhibitor
Cobimetinib for Chronic Myelomonocytic Leukemia (CONCERTO Trial)
Phase 2
Recruiting
Led By Ami Patel, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1st dose of study medication to decision to end treatment or up to 12 months of treatment, whichever came first
Awards & highlights
CONCERTO Trial Summary
This trial is testing a drug to see if it's effective in treating a type of blood cancer. The drug is taken daily for 3 weeks, then there is a 1 week break before the next 3 week cycle. Patients stay on the drug until they meet certain criteria to stop.
Who is the study for?
Adults aged 18+ with Chronic Myelomonocytic Leukemia (CMML) and specific RAS pathway mutations, who have either not been treated or did not respond to hypomethylating agents. They must be able to perform daily activities (ECOG ≤3), have good kidney and liver function, heart function ≥50%, and no central nervous system leukemia. Women of childbearing potential must test negative for pregnancy and use effective contraception.Check my eligibility
What is being tested?
The trial is testing the drug Cobimetinib in patients with CMML that has certain genetic changes. Participants will take Cobimetinib daily for three weeks followed by a one-week break, repeating this cycle until they meet criteria for stopping treatment. The study aims to see how well the drug works in these patients.See study design
What are the potential side effects?
Cobimetinib may cause side effects such as abnormal blood tests reflecting liver or muscle problems, high blood pressure, skin rash, eye problems like retinal detachment or vein occlusion, heart issues including congestive heart failure or arrhythmias, increased risk of infections due to immune suppression.
CONCERTO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 1st dose of study medication to decision to end treatment or up to 12 months of treatment, whichever came first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1st dose of study medication to decision to end treatment or up to 12 months of treatment, whichever came first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate defined as the proportion of patients achieving complete remission, complete cytogenetic remission, partial remission, marrow response, and clinical benefit according to the 2015 MDS/MPN-IWG criteria
Secondary outcome measures
Frequency of adverse events characterized by seriousness, severity (CTCAEv5.0), duration and relationship to study therapy.
Overall Survival (OS)
Progression-free survival (PFS)
+1 moreSide effects data
From 2024 Phase 2 trial • 86 Patients • NCT0320145874%
Disease Progression
47%
Fatigue
35%
Aspartate aminotransferase (AST) increased
33%
Abdominal pain
33%
Diarrhea
30%
Hypertension
30%
Lymphocyte count decreased
30%
Anemia
28%
Hyponatremia
28%
Alkaline phosphatase increased
28%
Nausea
26%
Hypoalbuminemia
26%
Hypokalemia
23%
Alanine aminotransferase (ALT) increased
23%
Vomiting
21%
Fever
21%
Platelet count decreased
21%
Anorexia
21%
Cough
19%
Pain
16%
Blood bilirubin increased
16%
Constipation
16%
White blood cell decreased
14%
Dyspnea
14%
Creatinine increased
12%
Hypomagnesemia
12%
Bloating
12%
Chills
12%
Dehyrdation
12%
Weight loss
9%
Hypothyroidism
9%
Rash
9%
Dizziness
9%
Edema
9%
Headache
9%
Infusion-related reaction
9%
Hypotension
9%
Ascites
7%
Back pain
7%
Hypophosphotemia
7%
Allergic reaction
7%
Neutrophil count decreased
7%
Dyspepsia
7%
Thrush
7%
Hypercalcemia
7%
Hyperglycemia
5%
Hypocalcemia
5%
Myalgia
5%
Gastric obstruction
5%
Insomnia
5%
Malaise
5%
Proteinuria
5%
Allergic rhinitis
5%
Dysgeusia
5%
Dysphagia
5%
Flatulence
5%
Generalized muscle weakness
5%
Non-cardiac chest pain
5%
Oral pain
5%
Peripheral neuropathy
5%
Pleural effusion
5%
Pruritus
5%
Sinus tachycardia
5%
Colitis
5%
Death NOS
5%
Abdominal distension
5%
Anxiety
5%
Arthralgia
5%
Hyperhidrosis
2%
Biliary tract infection
2%
Gastroesophageal reflux disease (GERD)
2%
Presyncope
2%
Myocarditis
2%
Biliary duct obstruction
2%
Hyperkalemia
2%
Syncope
2%
Cardiac troponin increased
2%
Duodenal obstruction
2%
Lipase increased
2%
Pleuritic pain
2%
Edema limbs
2%
Encephalopathy
2%
Hypoxia
2%
Ileal obstruction
2%
Myocardial infarction
2%
Sepsis
2%
Ureteral obstruction
2%
Urinary retention
2%
Dry mouth
2%
Dry skin
2%
Sinus bradycardia
2%
Sore throat
2%
Bacteremia
2%
Fungemia
2%
Infusion related reaction
2%
Meningitis
2%
Peritoneal infection
2%
Viral infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Atezolizumab)
Arm B (Atezolizumab, Cobimetinib)
CONCERTO Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment: all patientsExperimental Treatment1 Intervention
Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
2017
Completed Phase 3
~2660
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,114 Total Patients Enrolled
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,660 Total Patients Enrolled
Ami Patel, MDPrincipal InvestigatorHuntsman Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have CMML with specific gene mutations and haven't responded to HMA treatment.My FLT3-ITD ratio is 0.05 or higher from a recent test.I am 18 years old or older.I have a history of lung scarring or fibrosis.I have recovered from previous treatment side effects, or they are minor/stable.I have had serious eye conditions or am at high risk for them.I have not had major surgery in the last 4 weeks.I don't have stomach or bowel problems affecting my medication absorption.My organs are functioning well.I am not on any strong medications that affect liver enzymes or taking St. John's Wort.I have HIV with a detectable viral load.I do not have an active infection like TB, hepatitis B, or C.I haven't had any cancer except certain skin cancers or treated early-stage cancers with no current signs of disease in the last 2 years.My liver function tests are within normal limits, except for conditions like Gilbert's syndrome.I am using or willing to use effective birth control during and for 3 months after the study.I am capable of only limited self-care, confined to a bed or chair more than 50% of waking hours.I am not taking any medications that are not allowed in the study.My leukemia has spread to my brain or spinal cord.I am not pregnant or I am post-menopausal.I've had specific genetic tests done within the last 21 days.I have a heart condition or my ECG shows a specific irregular heartbeat.My kidney function, measured by creatinine levels or clearance, is within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: all patients
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical experiment unprecedented in its scope and methodology?
"Since 2013, Cobimetinib has been the subject of 55 distinct medical studies spanning 48 countries and 354 cities. The inaugural study for this drug was sponsored by Bristol-Myers Squibb in 2013 and featured 1163 participants; after its success Cobimetinib received phase 1 & 2 approval from regulators."
Answered by AI
Are there any open enrollment slots available for the clinical trial at present?
"Affirmative. According to information on clinicaltrials.gov, the trial is actively recruiting for patients and was first posted on December 1st 2021 with a most recent update happening June 9th 2022. 29 individuals need to be enrolled from one site."
Answered by AI
Are there any preceding studies that have explored Cobimetinib?
"Currently, there are 55 active clinical trials researching Cobimetinib; 3 of these have reached Phase 3. While the main concentration lies in Portland, Oregon, 1473 other locations are running similar studies for this drug."
Answered by AI
Has Cobimetinib acquired the sanction of the Food and Drug Administration?
"Given the Phase 2 nature of this clinical trial, our group at Power has placed a score of two on Cobimetinib's safety profile as there are some data points to support its security but no evidence for efficacy."
Answered by AI
How many participants are currently being accepted into this research project?
"Correct. Clinicaltrials.gov confirms that this medical research, which had its initial announcement on 12th of January 2021, is recruiting volunteers at present. 29 participants need to be gathered from a single site."
Answered by AI
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