Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Durvalumab + Tremelimumab + Radiation for Liver Cancer
Phase 2
Recruiting
Led By Theodore S. Hong, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status ≤ 1
Immunotherapy-naïve
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 years)
Awards & highlights
Study Summary
This trial is studying a combination of drugs as a possible treatment for liver or bile duct cancer. The interventions being studied are durvalumab, tremelimumab, and radiation therapy.
Who is the study for?
Adults with advanced liver or biliary tract cancer, who haven't had certain treatments and are not pregnant. They must have good organ function, no prior immunotherapy, and be able to follow the study plan. Those with hepatitis B or C need controlled infection levels.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs (Durvalumab and Tremelimumab) along with radiation therapy as a potential treatment for Hepatocellular Carcinoma or Biliary Tract Cancer.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that can affect organs, fatigue, skin rash, digestive issues like diarrhea, liver inflammation, hormone gland problems such as thyroid disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I have never received immunotherapy.
Select...
I have hepatitis C confirmed by a specific blood test.
Select...
My body weight is at least 30 kg.
Select...
My cancer is confirmed to be liver or bile duct cancer.
Select...
I am 18 years old or older.
Select...
I have a cancer lesion that hasn't been treated with radiation and can receive specific radiotherapy, and another measurable lesion outside of this treatment area.
Select...
My cancer did not respond or I cannot tolerate previous treatments like sorafenib for liver cancer.
Select...
I know my hepatitis status and if positive for HBV, I am on antiviral medication.
Select...
I have hepatitis B under control with treatment, and my viral load is low.
Select...
My blood and organ functions are within the required ranges.
Select...
My cancer cannot be removed by surgery and may have spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, start of cycle 3, start of cycle 5, and then the start of every subsequent 4-week cycle for the remainder of treatment (approximately 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best Overall Response rate
Secondary outcome measures
Disease Control Rate
Duration of Response
Number of Participants With Treatment Related Adverse Events
+3 moreSide 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: Tremelimumab + Durvalumab + RadiationExperimental Treatment3 Interventions
Durvalumab via IV infusion every 28 days for up to 4 doses/cycles
Tremelimumab via IV infusion every 28 days for up to 4 doses/cycles, and then continue durvalumab monotherapy every 4 weeks starting on Week 16 for up to 8 months.
Radiation therapy will only be given during cycle 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
Not yet FDA approved
Durvalumab
FDA approved
Radiation
2003
Completed Phase 3
~1020
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,411 Total Patients Enrolled
6 Trials studying Liver Cancer
562 Patients Enrolled for Liver Cancer
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,789 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer
Theodore S. Hong, MDPrincipal InvestigatorMassachusetts General Hospital
10 Previous Clinical Trials
705 Total Patients Enrolled
1 Trials studying Liver Cancer
83 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active and can carry on all my pre-disease activities without restriction.I have never received immunotherapy.I have moderate to severe nerve pain or damage, and need to discuss this with the study doctor.I have not had major surgery in the last 28 days.I have hepatitis C confirmed by a specific blood test.I have had a solid organ transplant.I have had an autoimmune disease in the last 2 years.I have or had Crohn's disease or ulcerative colitis.My liver cancer is a specific type (fibrolamellar, sarcomatoid, or mixed with bile duct cancer).The area needing radiation has been treated before.I have previously received immunotherapy treatments such as anti-CTLA4, anti-PD-1, or anti-PD-L1.I have not received any live vaccines in the last 30 days.I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.I have seizures that are not controlled by medication.My body weight is at least 30 kg.My blood and organ functions are within the required ranges.I am a woman who cannot become pregnant or I have tested negative for pregnancy.I have not had any other cancer in the last 2 years.I do not have any severe illnesses that could interfere with the study.I haven't taken immunosuppressive drugs in the last 28 days.I don't have major side effects from cancer treatment, except for hair loss or skin changes.I have side effects from past treatments that won't worsen with durvalumab or tremelimumab.I have cancer that has spread to my brain or spinal cord.My cancer is confirmed to be liver or bile duct cancer.I am 18 years old or older.I have a cancer lesion that hasn't been treated with radiation and can receive specific radiotherapy, and another measurable lesion outside of this treatment area.My cancer did not respond or I cannot tolerate previous treatments like sorafenib for liver cancer.I have discussed sorafenib with my doctor and decided not to take it.I know my hepatitis status and if positive for HBV, I am on antiviral medication.I have hepatitis B under control with treatment, and my viral load is low.My liver function is good or slightly impaired without severe symptoms.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.I have had lung inflammation treated with steroids, or I have a lung condition.My cancer cannot be removed by surgery and may have spread.
Research Study Groups:
This trial has the following groups:- Group 1: Tremelimumab + Durvalumab + Radiation
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 study novel in design or similar to other research?
"Durvalumab is being trialed in 345 different ongoing studies taking place in 58 countries and 1325 cities. The first trial began in 2007 and, sponsored by AstraZeneca, it involved 37 patients who completed Phase 2 of the drug approval process. Since then, 191 more trials have been conducted."
Answered by AI
What are some of the most common maladies that durvalumab has been shown to be effective against?
"The most common treatment for unresectable stage III non-small cell lung cancer is durvalumab. Durvalumab is also effective in treating other conditions such as metastatic ureter urothelial carcinoma and advance directives."
Answered by AI
What does the scientific community know about Durvalumab from previous research?
"As of right now, there are a total of 345 active clinical trials that are studying Durvalumab. Out of those, 51 are in Phase 3. The majority of these studies taking place Cordoba, Texas; however, there are 13051 different locations where research is being conducted."
Answered by AI
Does Durvalumab present serious health risks for patients?
"While Phase 2 trials provide some data to support a medication's safety, there is none yet affirming its efficacy. Therefore, our team has given Durvalumab a score of 2."
Answered by AI
What is the projected total of participants for this clinical trial?
"Yes, the information on clinicaltrials.gov indicates that this trial is actively recruiting patients. The trial was originally posted on 5/14/2018 and was last updated on 9/7/2022. The study is looking for 70 patients between 2 sites."
Answered by AI
Are researchers still recruiting participants for this trial?
"Yes, this is an ongoing trial that was first posted on May 14th, 2018. The study's organizers are looking for 70 individuals spread out across 2 locations."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger