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Kinase Inhibitor
Cobimetinib for Langerhans Cell Histiocytosis (NACHO-COBI Trial)
Phase 2
Recruiting
Research Sponsored by Carl Allen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age at study entry: Participant must be at least 6 months of age and less than 21 years of age at the time of enrollment for Group 1, at least 6 months of age at the time of enrollment for Group 2, and at least 6 months of age and less than 21 years of age at the time of enrollment for Group 3. Participant must be 21 years of age or older at the time of enrollment for Group 4.
Participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet which may be taken by mouth or other enteral route such as nasogastric or gastric tube.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
NACHO-COBI Trial Summary
This trial is testing a drug called cobimetinib to see if it can help kids and adults with Langerhans cell histiocytosis (LCH) who have relapsed or who haven't responded to other treatments.
Who is the study for?
This trial is for children and adults with Langerhans cell histiocytosis (LCH) or other histiocytic disorders that are resistant to treatment. Participants must have proper blood, kidney, liver, and heart function, not be pregnant or breastfeeding, agree to use contraception if applicable, and be able to take oral medication. Specific age groups are targeted for different parts of the study.Check my eligibility
What is being tested?
The drug cobimetinib is being tested on patients with various histiocytic disorders including LCH. Cobimetinib works by blocking a protein involved in abnormal cell growth signals. The study will include four distinct patient groups based on their specific conditions.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of drugs like cobimetinib may include diarrhea, acneiform rash (skin eruptions similar to acne), increased liver enzymes indicating liver inflammation, muscle pain or spasms, fatigue, nausea and vomiting.
NACHO-COBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take medicine by mouth or through a feeding tube.
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My blood counts meet the required levels without recent medical help.
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My kidney function is good based on tests.
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My liver functions within the normal range for my age.
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I can do most daily activities by myself.
NACHO-COBI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rates using modified RECiST criteria
Secondary outcome measures
Nature and Severity of Adverse Events
Progression Free Survival
Other outcome measures
Response assessment (Modified RECIST) of histiocytic lesions with specific mutations
Side 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)
NACHO-COBI Trial Design
4Treatment groups
Experimental Treatment
Group I: Patients ≥ 21 years with LCH/histiocytic disorders (Grp4)Experimental Treatment1 Intervention
Adults (≥21 years) with LCH or other histiocytic disorder with recurrent active lesions (may also have LCH-ND).
Group II: Patients of any age with LCH-ND (Grp2)Experimental Treatment1 Intervention
Patients of any age (≥ 6 months) with progressive LCH Neurodegenerative Disease (LCH-ND) without other sites of active LCH.
Group III: Patients <21 years with other histiocytic disorders (Grp3)Experimental Treatment1 Intervention
Newly diagnosed or relapsed/refractory children (≥ 6 months) and young adults (<21 years) with other histiocytic disorders including juvenile xanthogranuloma, Erdheim-Chester disease, histiocytic sarcoma and Rosai-Dorfman disease.
Group IV: Patients < 21 years with recurrent LCH (Grp1)Experimental Treatment1 Intervention
Children (≥ 6 months) and young adults (<21 years) with recurrent active LCH lesions (may also have LCH-ND).
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?
Carl AllenLead Sponsor
North American Consortium for HistiocytosisOTHER
4 Previous Clinical Trials
1,687 Total Patients Enrolled
Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,002,162 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no other active cancer or a history of another cancer.My heart's pumping ability is confirmed to be good by a recent heart scan.I have a history of serious heart problems.I haven't taken drugs that affect liver enzyme levels in the last 14 days.I experience uncontrollable nausea and vomiting, have issues absorbing food, or have an external biliary shunt.If there is any other health issue that could make it unsafe for you to take the new medicine, you won't be able to join the study.I haven't used blood thinners in the week before joining the study.I can take medicine by mouth or through a feeding tube.I finished my last cancer treatment over 28 days ago and have recovered from side effects.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I have been diagnosed with HIV.I have not had radiation therapy in the last 28 days.I've taken low-dose steroids but stopped 14 days before joining the study.I am on blood thinners or have a bleeding disorder not caused by histiocytic disease.I have had a solid organ transplant.I have LCH or a related disease, with treatment failure or recent worsening.My blood counts meet the required levels without recent medical help.I haven't taken any long-acting blood cell growth boosters in the last 14 days or short-acting ones in the last 7 days.I am not pregnant or breastfeeding.I am not pregnant and agree to use birth control or I will use two forms of contraception if my partner could become pregnant.My kidney function is good based on tests.I have not had a stem cell transplant in the last 3 months.I have not had a serious brain bleed or any brain bleed in the last 28 days.My liver functions within the normal range for my age.I can do most daily activities by myself.I have had an infection in the last 28 days that is not fully resolved.I have had major bowel surgery affecting my nutrient absorption.I have had pneumonitis before.I do not have serious eye conditions or risks for retinal vein blockage.I haven't had hormone, immunotherapy, or other cancer treatments in the last 28 days or 5 half-lives.
Research Study Groups:
This trial has the following groups:- Group 1: Patients <21 years with other histiocytic disorders (Grp3)
- Group 2: Patients ≥ 21 years with LCH/histiocytic disorders (Grp4)
- Group 3: Patients < 21 years with recurrent LCH (Grp1)
- Group 4: Patients of any age with LCH-ND (Grp2)
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.
Have regulatory authorities accepted Cobimetinib for public consumption?
"There is limited evidence of Cobimetinib's safety, so it was designated a score of 2."
Answered by AI
In what geographical areas is this research experiment taking place?
"Patients can enrol for this trial at 4 different locations, such as Children's Hospital of Orange County in California and Texas Children's Hospital. Additionally, NACHO Consortium is hosting patients from Memphis and there are a further four sites across the country."
Answered by AI
Is this a pioneering attempt at research?
"Cobimetinib has been under clinical trial since 2013, when a Bristol-Myers Squibb sponsored study involving 1163 participants was conducted. Following the initial research project, cobimetinib received approval for phases 1 & 2 drug trials and is currently being studied in 48 countries across 354 cities with 55 active studies."
Answered by AI
Are individuals currently able to register for this trial?
"According to the clinicaltrials.gov database, this investigation is still actively seeking participants with an initial post date of April 19th 2021 and most recent update on November 8th 2022."
Answered by AI
What earlier investigations have been conducted concerning Cobimetinib?
"Cobimetinib was initially studied in 2013 at Local Institution - 0046, and 30 clinical trials have been completed thus far. Currently, 55 recruitment efforts are underway across the globe, with a notable concentration of studies occurring around Orange, California."
Answered by AI
What is the enrolment limit for participants in this trial?
"Correct. The records published on clinicaltrials.gov verify that enrollment for this medical investigation, which was initially listed on April 19th 2021, is actively underway. Approximately 90 participants must be enlisted from 4 distinctive research centres."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
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