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Monoclonal Antibodies
Durvalumab + SNDX-6352 for Bile Duct Cancer
Phase 2
Waitlist Available
Led By Lei Zheng, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All disease must be localized to the liver (locally advanced)
Must be a candidate for conventional transarterial chemoembolization or yttrium-90 radioembolization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat people with intrahepatic cholangiocarcinoma.
Who is the study for?
This trial is for adults over 18 with intrahepatic cholangiocarcinoma who are not surgical candidates, have measurable disease confirmed by imaging, and a life expectancy of at least 12 weeks. Participants must be able to perform daily activities with little assistance (ECOG status 0 or 1), have adequate organ function, and use birth control. Excluded are those with autoimmune diseases, uncontrolled illnesses, certain infections like HIV/TB/hepatitis B/C, recent immunosuppressants or vaccines usage, pregnancy/breastfeeding women, prior durvalumab/SNDX-6532 treatment.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining durvalumab (an immunotherapy drug) with SNDX-6352 (a CSF-1R inhibitor) in patients after they've had chemotherapy or radio-embolization treatments for bile duct cancer localized to the liver.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to durvalumab affecting organs like the intestines or thyroid gland; infection risks; fatigue; allergic reactions specific to either drug's components; as well as any general side effects from chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is only in my liver and has not spread.
Select...
I am eligible for specific liver cancer treatments involving artery injections.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
I am not pregnant and will follow the study's birth control requirements.
Select...
My cancer is confirmed as bile duct cancer inside the liver.
Select...
I am not considered a candidate for surgery.
Select...
My cancer can be seen and measured on scans.
Select...
My body weight is over 30 kg.
Select...
I am using a reliable method of birth control during the study.
Select...
My kidney function, measured by creatinine clearance, is above 40 mL/min.
Select...
My liver functions well despite my illness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Experiencing Study Drug-related Toxicities
Objective Response Rate (ORR) Per mRECIST (Modified RECIST)
Secondary outcome measures
Duration of Response (DOR)
Overall Survival (OS)
Progression-free Survival (PFS) Per mRECIST
Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Durvalumab and SNDX-6352Experimental Treatment2 Interventions
Participants will receive Durvalumab and SNDX-6352.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
SNDX-6352
2017
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,895 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,262 Previous Clinical Trials
288,595,237 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
50 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Syndax PharmaceuticalsIndustry Sponsor
48 Previous Clinical Trials
2,769 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab and SNDX-6352
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it risky to take Durvalumab?
"While Phase 2 trials are not as extensive as Phase 3, there is still some data to support the safety of Durvalumab."
Answered by AI
How many people can participate in this research project?
"As of now, this clinical trial is not looking for any more participants. The original posting date was 8/24/2021 and the most recent update was on 11/10/2022. For anyone interested, there are currently 213 clinical trials actively recruiting participants with cholangiocarcinoma and 341 studies for Durvalumab that still need patients."
Answered by AI
Are patients still being accepted into this research program?
"This particular trial is not taking in any more patients at the moment. The study was created on August 24th, 2021 and last updated on November 10th, 20202. For individuals still searching for other trials, there are 213 studies related to cholangiocarcinoma and 341 trials involving Durvalumab that are currently recruiting patients."
Answered by AI
Are there any other drugs like Durvalumab that have been studied before?
"Currently, 341 different clinical trials are ongoing that involve Durvalumab with 52 of them in Phase 3. While a few research centres for these studies are based out of Cordoba, Texas, there are 13121 locations running trials for Durvalumab globally."
Answered by AI
Why is Durvalumab prescribed to patients?
"Durvalumab can be used to treat patients with unresectable stage iii non-small cell lung cancer, metastatic ureter urothelial carcinoma and those who have not received any prior treatment."
Answered by AI
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