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PD-L1/PD-1 Inhibitor
Immune Therapy + Bevacizumab for Advanced Liver Cancer
Phase 2
Waitlist Available
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years and older (Japan-20 years and older)
Immunotherapy-naïve
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of different combinations of drugs for treating advanced liver cancer.
Who is the study for?
This trial is for adults with advanced liver cancer who have either not responded to, cannot tolerate, or chose not to use sorafenib or similar drugs. It's also open to those who haven't had any systemic therapy for their cancer. People can't join if they've had certain complications like ascites needing intervention, hepatic encephalopathy, major blood vessel thrombosis in the liver, active autoimmune diseases, recent immunosuppressive meds use, or gastrointestinal bleeding within the last year.Check my eligibility
What is being tested?
The study is testing different treatments: Durvalumab alone; Tremelimumab alone; and combinations of Durvalumab with Tremelimumab or Bevacizumab. The goal is to see how safe these treatments are and how well they work against advanced liver cancer by monitoring tumor response and changes in the body's immune system.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect organs like lungs or intestines (pneumonitis or colitis), infusion reactions during treatment administration, fatigue from treatment burden on the body, potential bleeding issues due to drug effects on blood vessels and clotting mechanisms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old (20 if in Japan).
Select...
I have never received immunotherapy.
Select...
My liver cancer diagnosis was confirmed through a biopsy or other methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)
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 With Abnormal Vital Signs Reported as TEAEs
Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters
Number of Participants With Dose Limiting Toxicities (DLTs)
+2 moreSecondary outcome measures
Disease Control Rate (DCR) Based on Investigator Assessments and BICR
Duration of Response (DoR) Based on Investigator Assessments and BICR
Overall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)
+4 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
9Treatment groups
Experimental Treatment
Group I: Parts 2 and 3: Tremelimumab 750 mgExperimental Treatment1 Intervention
Participants will receive tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Group II: Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgExperimental Treatment2 Interventions
Participants will receive tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first. Participant recruitment to this arm was closed following protocol amendment 5.
Group III: Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgExperimental Treatment2 Interventions
Participants will receive tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurs first.
Group IV: Parts 2 and 3: Durvalumab 1500 mgExperimental Treatment1 Intervention
Participants will receive durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Group V: Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgExperimental Treatment2 Interventions
Participants will receive durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first
Group VI: Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgExperimental Treatment2 Interventions
Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) will receive tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Group VII: China Cohort: Tremelimumab 10 mg/kgExperimental Treatment1 Intervention
Participants will receive tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Group VIII: China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgExperimental Treatment2 Interventions
Participants will receive tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Group IX: China Cohort: Durvalumab 20 mg/kgExperimental Treatment1 Intervention
Participants will receive durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Bevacizumab
2013
Completed Phase 4
~5280
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
MedImmune LLCLead Sponsor
347 Previous Clinical Trials
793,476 Total Patients Enrolled
MedImmune, LLC MedImmune, LLCStudy DirectorMedImmune LLC
3 Previous Clinical Trials
2,472 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've needed a procedure to remove excess belly fluid in the last 6 months.I am not currently on any cancer treatments like chemotherapy or immunotherapy.I haven't taken immunosuppressive drugs in the last 14 days, with some exceptions.I have liver cancer and cannot tolerate or have refused standard treatments.I have not had brain function issues due to liver disease in the last year.I haven't had any serious stomach or esophagus bleeding in the last year.I am at least 18 years old (20 if in Japan).I have or had an autoimmune or inflammatory disease.I have never received immunotherapy.I have been treated with immunotherapy before.My liver cancer diagnosis was confirmed through a biopsy or other methods.I am either male or female.
Research Study Groups:
This trial has the following groups:- Group 1: Parts 2 and 3: Tremelimumab 750 mg
- Group 2: China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
- Group 3: Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mg
- Group 4: China Cohort: Tremelimumab 10 mg/kg
- Group 5: Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mg
- Group 6: Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kg
- Group 7: China Cohort: Durvalumab 20 mg/kg
- Group 8: Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kg
- Group 9: Parts 2 and 3: Durvalumab 1500 mg
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.
In what circumstances is the combined use of Durvalumab and tremelimumab typically indicated?
"An immunotherapy regimen, durvalumab + tremelimumab is mainly used to treat recurrent platinum drug resistant primary peritoneal cancer. It can additionally be utilized for the management of previously untreated diseases and recurrence of non-squamous non-small cell lung cancers."
Answered by AI
In how many locations can individuals access this trial?
"This trial is presently accepting participants at 15 different sites, including New york, Stony Brook and Durham. To reduce the amount of travel necessary for your participation, it's best to choose a location close by."
Answered by AI
What other investigations have explored the potential of Durvalumab plus tremelimumab?
"Currently, there are 684 studies underway investigating the Durvalumab + Tremelimumab combination treatment. 138 of these active research projects are in Phase 3. With 29307 trial locations across New york City alone, many patients have access to this experimental therapy."
Answered by AI
Are there any eligibility criteria to partake in this trial?
"Eligibility for this trial requires potential participants to have carcinoma and be between 18-99 years old. The desired number of enrollees is 433 people."
Answered by AI
Is recruitment for participants still underway?
"Unfortunately, this trial is no longer actively recruiting. It was initially posted on October 19th 2015 and last modified on October 10th 2022. For folks searching for other studies, there are presently 2608 trials accepting cancer patients and 684 clinical trials with Durvalumab + tremelimumab still open to participants."
Answered by AI
Does this experiment accommodate individuals in the 55+ age bracket?
"This clinical trial has a strict age range of 18-99 years old. For minors, there are 115 studies available and for those over the pensionable age, 3253 trials may be suitable."
Answered by AI
How many participants are included in this research endeavor?
"As of the last edit on October 10th 2022, this trial has temporarily ceased to accept participants. If you are still looking for clinical trials involving carcinoma and Durvalumab + tremelimumab there are currently 2608 studies recruiting former and 684 actively seeking latter respectively."
Answered by AI
To what extent are Durvalumab and tremelimumab deleterious to patients?
"The safety of Durvalumab + tremelimumab is rated an intermediate score of 2 because there are some records indicating that it is safe, while no studies have proven its efficacy."
Answered by AI
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