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Immune Checkpoint Blockade
Combination Therapy for Gastrointestinal Cancer (MEKiAUTO Trial)
Phase 1 & 2
Waitlist Available
Led By Gulam Manji, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histological or pathological confirmation of malignancy with a KRAS-activating mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
MEKiAUTO Trial Summary
This trial is for patients with an advanced cancer that has a KRAS gene mutation. The trial is testing if a combination of atezolizumab, cobimetinib, and hydroxychloroquine is safe and effective at decreasing the size of the tumor and prolonging life.
Who is the study for?
This trial is for adults with advanced gastrointestinal cancers that have a KRAS mutation and have tried other treatments without success. They should be in good physical condition (ECOG 0 or 1), not pregnant, willing to use birth control, and able to follow the study plan. People can't join if they've had certain recent treatments, surgeries, infections like hepatitis or HIV, heart problems, severe allergies to similar drugs, or are on conflicting medications.Check my eligibility
What is being tested?
The trial tests a combination of Cobimetinib (MEK inhibitor), Atezolizumab (immune checkpoint blocker), and Hydroxychloroquine (autophagy inhibitor) on patients with specific gene mutations in their tumors. The goal is to see if this drug combo is safe and effective at shrinking tumors and extending life.See study design
What are the potential side effects?
Possible side effects include liver issues from Hydroxychloroquine; high blood pressure, bleeding or skin rash from Cobimetinib; immune-related reactions like inflammation of organs from Atezolizumab; as well as general symptoms such as fatigue or digestive discomfort.
MEKiAUTO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer has a KRAS mutation.
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My cancer has worsened despite treatment, excluding pancreatic and colorectal types.
Select...
My white blood cell count is healthy without needing medication.
Select...
My condition cannot be cured with current treatments.
Select...
My colorectal cancer has worsened despite treatment with specific chemotherapy drugs.
Select...
I am on blood thinners.
Select...
My tumor is MSI-H/dMMR or NTRK-fusion positive and I've had treatment for it.
Select...
My cancer can be measured and is accessible for a biopsy.
Select...
My cancer has a KRAS mutation.
Select...
I am 18 years old or older.
MEKiAUTO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Estimated maximum tolerated dose (MTD)
Secondary outcome measures
Phase 1: Incidence of Treatment-Emergent Adverse Events with drug combination (Safety and Tolerability)
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)
MEKiAUTO Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2: Cohort 3Experimental Treatment3 Interventions
Histology Agnostic Adenocarcinoma (N = 23-56) subjects will receive study treatment based on the MTD determined from Phase 1
Group II: Phase 2: Cohort 2Experimental Treatment3 Interventions
Advanced Colorectal Adenocarcinoma (N = 20-34) subjects will receive study treatment based on the MTD determined from Phase 1
Group III: Phase 2: Cohort 1Experimental Treatment3 Interventions
Advanced Pancreatic Adenocarcinoma (N = 23-67) subjects will receive study treatment based on the MTD determined from Phase 1
Group IV: Phase 1: MTDExperimental Treatment3 Interventions
Subjects will be treated with combination therapy at the designated dose levels:
Dose 1 - Hydroxychloroquine 600mg twice per day, Cobimetinib 40mg, no Atezolizumab Dose 2 - Hydroxychloroquine 600mg twice per day, Cobimetinib 40mg, Atezolizumab 840mg Dose 3 - Hydroxychloroquine 600mg twice per day, Cobimetinib 60mg, Atezolizumab 840mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
FDA approved
Hydroxychloroquine
FDA approved
Atezolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,432 Previous Clinical Trials
2,460,798 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,724 Total Patients Enrolled
Gulam Manji, MD3.33 ReviewsPrincipal Investigator - Columbia University
Columbia University
4Patient Review
Dr Manji is very successful in his role as an oncologist but can be neglectful of other duties. I recommend him as long as you stay on top of him.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have not had severe bleeding in the last 28 days.I have experienced side effects from previous cancer treatments.I have a serious heart condition.My disease is advanced and cannot be cured with available treatments.I have received treatments specific to my type of cancer.My heart's pumping ability is below normal or less than 50%.My pancreatic cancer worsened or didn't tolerate previous treatments with 5-FU/Capecitabine or gemcitabine.I am allergic to 4-aminoquinoline compounds or ingredients in the study drug.My cancer has worsened despite treatment, excluding pancreatic and colorectal types.I have a significant liver condition.I have brain metastases that are causing symptoms.I have active tuberculosis.My cancer has a KRAS mutation.I have received treatments before.I have a G6PD deficiency.You have received experimental treatment in the past.I have had cancer before.My white blood cell count is healthy without needing medication.I do not have uncontrolled skin, muscle, nerve disorders or a rare blood disorder.You have a medical history of connective tissue disorders.You are pregnant or breastfeeding.You are currently taking any experimental drugs.I have a history of specific lung conditions not caused by known factors.My condition cannot be cured with current treatments.I am not taking other cancer-fighting drugs.My colorectal cancer has worsened despite treatment with specific chemotherapy drugs.My blood and organs are functioning well.I am on blood thinners.My tumor is MSI-H/dMMR or NTRK-fusion positive and I've had treatment for it.My cancer can be measured and is accessible for a biopsy.I have recently taken antibiotics.I have high calcium levels that aren't managed or need medication to control.I have had a stem cell or organ transplant before.I have had a major surgery or significant injury recently.I take antacid medication more than once a day.I have had a retinal disease.I am currently suffering from a severe infection.I have been diagnosed with severe depression.I have had radiation therapy before.I cannot swallow pills or have a condition that affects how my body absorbs medication.My cancer has a KRAS mutation.I have an active Hepatitis B infection.I have received treatment for my condition before.I am not taking strong drugs that affect liver enzyme activity.Men who are capable of fathering a child must agree to use birth control during the trial.You understand the study and agree to participate by signing a consent form.I have recently been on medication to suppress my immune system.I am currently taking certain medications.I do not have uncontrolled fluid buildup in my chest, heart, or abdomen.I am 18 years old or older.You have recently received a vaccine.You have a current or past autoimmune disease or a weakened immune system.There are other medical conditions that make you ineligible for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2: Cohort 1
- Group 2: Phase 2: Cohort 2
- Group 3: Phase 2: Cohort 3
- Group 4: Phase 1: MTD
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
What therapeutic purposes are Cobimetinib commonly used for?
"Cobimetinib may be an efficacious treatment for lupus erythematosus, discoid, pharmacotherapy and small cell lung cancer (SCLC)."
Answered by AI
How many participants are being recruited for this medical experiment?
"Absolutely. The portal clinicaltrials.gov attests that this research is still recruiting patients. This investigation, initially posted on February 12th 2020, was last modified on November 7th 2022 and requires the participation of 175 volunteers from two different centres."
Answered by AI
Are there any slots remaining for participants in this study?
"Affirmative, the information accessible on clinicaltrials.gov establishes that this clinical trial is currently accepting applicants. It was uploaded to the website in February of 2020 and recently amended in November 2022; it seeks 175 participants across two sites."
Answered by AI
What precedent has been set for Cobimetinib in prior clinical trials?
"As of now, the research surrounding Cobimetinib includes 437 trials. 78 studies are in their last phase while 19,474 locations around the world conduct clinical tests for this medication with a concentration in Harvey, Illinois."
Answered by AI
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