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Checkpoint Inhibitor
Atezolizumab +/− Cobimetinib for Bile Duct and Gallbladder Cancer
Phase 2
Waitlist Available
Led By Nilofer S Azad
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral CT scan, MRI, or calipers by clinical exam; assessment must be completed within 4 weeks of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat bile duct and gallbladder cancer.
Who is the study for?
Adults with metastatic or unresectable bile duct or gallbladder cancer, who have had at least one but no more than two prior systemic therapies. Participants must have a life expectancy over 2 months, good organ function, and an ECOG performance status of 0-1 (able to carry out light activity). They should not be pregnant or breastfeeding and must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Atezolizumab alone versus combined with Cobimetinib in treating advanced bile duct and gallbladder cancers. It examines if these treatments can help the immune system fight cancer and prevent tumor growth by blocking certain proteins.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs, liver problems, fatigue, skin issues like rash or itching, hormonal changes affecting thyroid function, digestive disturbances such as diarrhea or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a tumor that can be measured and it's been checked in the last 4 weeks.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I have a tumor that can be measured and it's been checked in the last 4 weeks.
Select...
I have cholangiocarcinoma or gallbladder cancer that can't be removed by surgery, and I've had 1-2 treatments for it.
Select...
My kidney function, measured by creatinine clearance, is within the required range.
Select...
My cancer is in the bile ducts or gallbladder, not near the pancreas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Change in CD8+ Density Within the Tumor
Number of Participants With Adverse Events
Objective Response Rate
+1 moreOther outcome measures
Number of Participants With PD-L1 Expression
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)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (atezolizumab, cobimetinib)Experimental Treatment6 Interventions
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and collection of blood samples throughout the trial and undergo tumor biopsy on study.
Group II: Arm A (atezolizumab)Experimental Treatment5 Interventions
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and collection of blood samples throughout the trial and undergo tumor biopsy on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Cobimetinib
2017
Completed Phase 3
~2660
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,067 Total Patients Enrolled
101 Trials studying Cholangiocarcinoma
9,684 Patients Enrolled for Cholangiocarcinoma
Nilofer S AzadPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
2 Previous Clinical Trials
111 Total Patients Enrolled
1 Trials studying Cholangiocarcinoma
64 Patients Enrolled for Cholangiocarcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I haven't taken strong immune system medications in the last 6 weeks, except for minor exceptions.My blood clotting tests are within normal limits, or I'm on a stable dose of blood thinners.I agree to use effective contraception or abstain from sex to avoid pregnancy during and 5 months after the study.I have a tumor that can be measured and it's been checked in the last 4 weeks.I am fully active and can carry on all pre-disease activities without restriction.You are expected to live for at least two more months.I have an autoimmune disease but it's either stable or controlled.My skin condition affects less than 10% of my body and is well-controlled with mild treatments.I have never had lung conditions like pulmonary fibrosis or pneumonitis, except for fibrosis from radiation.I haven't had any severe infections or been hospitalized for infection complications in the last 4 weeks.I have not had signs of infection in the last 2 weeks.I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.You cannot or do not want to swallow pills.I have a condition that affects how my body absorbs food.I have a tumor that can be measured and it's been checked in the last 4 weeks.I have not had treatments with anti-PD-1 or anti-PD-L1, or any organ transplants.I have stable brain metastases, haven't had recent brain radiation, and am not on steroids.I do not have any other cancer that needs treatment within 2 years, except for certain low-risk types.I do not have a history of serious eye diseases like serous retinopathy or retinal vein occlusion.I am not taking strong CYP3A4 inhibitors or inducers like St. John's wort or grapefruit juice.I do not have significant liver disease, or if I had hepatitis B or C, it is now resolved or undetectable.I have not taken antibiotics in the last 2 weeks, except for prevention.I have been treated with a MEK or ERK inhibitor before.My heart's pumping ability is below the normal range.I am not pregnant or breastfeeding.I have had serious fluid buildup in my abdomen needing drainage.I have cholangiocarcinoma or gallbladder cancer that can't be removed by surgery, and I've had 1-2 treatments for it.I haven't had a live vaccine in the last 4 weeks and won't need one during the study.My heart's electrical system has a known issue or my QTc is over 450 msec.I do not have any serious illnesses that could interfere with the study.My kidney function, measured by creatinine clearance, is within the required range.My cancer is in the bile ducts or gallbladder, not near the pancreas.You can not have taken any experimental drugs within the last 4 weeks or 5 drug half-lives (whichever is longer) before starting the trial.I am HIV positive, on stable HAART, with no opportunistic infection prevention needed, a CD4 count over 250, and undetectable viral load.I haven't had chemotherapy or radiotherapy in the last 3 weeks and have recovered from side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (atezolizumab, cobimetinib)
- Group 2: Arm A (atezolizumab)
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.
Cholangiocarcinoma Patient Testimony for trial: Trial Name: NCT03201458 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What research has been done to explore the efficacy of Cobimetinib?
"Cobimetinib was first investigated at SCRI Tennessee Oncology Chattanooga in 2008. Consequently, 791 trials are listed as completed and 374 clinical studies remain open for enrollment with many of these located in Cleveland, Ohio."
Answered by AI
What deleterious effects have been observed with Cobimetinib use?
"Taking into consideration that Cobimetinib is in Phase 2 clinical trials, thus there being no data to support efficacy yet but some evidence of safety, our team at Power assigned it a score of 2."
Answered by AI
What is the current recruitment size for this trial?
"At this time, applicants are not being sought for this trial. Originally posted on December 22nd 2017 and last amended on November 25th 2022; prospective participants can consider the 201 trials currently recruiting individuals with cholangiocarcinoma or opt to join one of 374 medical studies focused on Cobimetinib."
Answered by AI
Is this endeavor a pioneer of its kind?
"Data demonstrates that 374 ongoing trials of Cobimetinib exist in 74 nations and 1651 cities, with the first one being sponsored by Hoffmann-La Roche, commencing in 2008. This Phase 2 Drug Approval Stage encompassed 720 participants and was ultimately completed, contributing to a total of 791 finished studies concerning this medication."
Answered by AI
Is this clinical research actively enrolling participants?
"At present, this clinical trial has ceased participant recruitment. It was initially posted on December 22nd 2017 and last revised November 25th 2022. If you are searching for additional studies concerning cholangiocarcinoma there are currently 201 in the process of enrolling patients; similarly Cobimetinib related trials have 374 open recruitments."
Answered by AI
In what venues can interested participants access this project?
"Massachusetts General Hospital Cancer Center in Cleveland, Case Western Reserve University in Detroit and Wayne State University/Karmanos Cancer Institutein Waterbury are three of the 41 locations currently offering this trial."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Oregon
How old are they?
18 - 65
What site did they apply to?
University of California Davis Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I was on chemotherapy and did the full treatment cycle, was put on immunotherapy for ever 6 weeks with zometa for lytic lesions. My most recent PET scan came back and the results show that the cancer has progressed and I want to try this clinical trial to see if it can help as my oncologist wants to put me back on cis/gen.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
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