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Checkpoint Inhibitor
Durvalumab + Tremelimumab for Liver Cancer ((NEOTOMA) Trial)
Phase 2
Recruiting
Led By Jennifer Knox, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Childs Pugh score of 5 or 6
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
(NEOTOMA) Trial Summary
This trial is testing a new cancer treatment that consists of two drugs, Durvalumab and Tremelimumab. The treatment is given before surgery to remove the tumor and then given again after surgery. The trial is testing if this treatment is safe and if it changes the tumor microenvironment. 28 patients are expected to enroll at three sites.
Who is the study for?
This trial is for adults over 18 with early to intermediate stage resectable liver cancer (HCC). They must be in good health, have a specific liver function score (Childs Pugh 5 or 6), and agree to use effective contraception. Excluded are those with certain types of HCC, previous HCC therapies except one curative surgery/ablation, active infections like TB or HIV, recent major surgeries, heart issues, other cancers or autoimmune diseases.Check my eligibility
What is being tested?
The study tests the safety and effects of Durvalumab combined with Tremelimumab before surgery in patients with resectable liver cancer. Participants will receive these drugs pre-surgery followed by up to 13 cycles of Durvalumab post-surgery. The goal is to see if this treatment can improve outcomes by affecting the tumor environment.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that could affect various organs, infusion reactions similar to allergic responses during drug administration, fatigue, digestive problems and an increased risk of infections due to immune system suppression.
(NEOTOMA) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function is slightly impaired.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am on antiviral therapy for my hepatitis B to control the virus.
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I am post-menopausal or not pregnant if pre-menopausal.
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My liver cancer is in an early or intermediate stage and can be surgically removed.
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I am older than 18 years.
(NEOTOMA) Trial 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 greater than grade 3 adverse events (AEs) or immune related adverse events that leads to treatment cessation
Secondary outcome measures
Number of patients who experience a surgical delay due to treatment related adverse events (TRAEs)
Overall response rate (ORR)
Pathological response rate
+1 moreOther outcome measures
Changes in immune markers in tissue collected
Durvalumab and Tremelimumab and blood biomarkers expression
Overall survival
+3 moreSide effects data
From 2019 Phase 2 trial • 33 Patients • NCT0300740738%
Fatigue
21%
Diarrhea
17%
Pruritus
17%
Maculopapular rash
17%
Anorexia
17%
Nausea
17%
Fever
14%
Rash maculo-papular
14%
Constipation
10%
Itching
10%
Anemia
10%
Abdominal pain
7%
Cough
7%
Dry Skin
7%
Dehydration
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab
(NEOTOMA) Trial Design
1Treatment groups
Experimental Treatment
Group I: Tremelimumab in combination with Durvalumab preoperatively, followed by adjuvant DurvalumabExperimental Treatment1 Intervention
Patients will receive 1 dose Tremelimumab (300 mg) with Durvalumab (1500mg) at cycle 1 (4W) and 1 further cycle of Durvalumab (1500mg) pre surgical resection. Post-surgical resection patients will begin adjuvant Durvalumab (1500mg Q4W) to complete 13 cycles of treatment (or 11 post operatively) in total.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,473 Previous Clinical Trials
484,977 Total Patients Enrolled
3 Trials studying Liver Cancer
51 Patients Enrolled for Liver Cancer
University of MilanOTHER
251 Previous Clinical Trials
299,521 Total Patients Enrolled
1 Trials studying Liver Cancer
448 Patients Enrolled for Liver Cancer
Clinica Universidad de Navarra, Universidad de NavarraOTHER
135 Previous Clinical Trials
69,347 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had significant fluid buildup in my abdomen within the last 6 months.My cancer has spread to distant parts of my body.I have both hepatitis B and either hepatitis C or D.My liver cancer is of a specific rare type.My organs and bone marrow are functioning well.I have not had major surgery in the last 28 days.I have had an organ transplant or am waiting for a liver transplant.I am not pregnant, breastfeeding, and if capable of having children, I agree to use effective birth control.I have or had an autoimmune or inflammatory disorder.My liver function is slightly impaired.I am fully active or restricted in physically strenuous activity but can do light work.I am on antiviral therapy for my hepatitis B to control the virus.I do not have an active tuberculosis or HIV infection.My hepatitis C is being managed according to my hospital's guidelines.I had liver surgery or ablation for HCC over two years ago, with no other treatments.I have not had hepatic encephalopathy in the last year.I have heart failure symptoms or uncontrolled heart rhythm problems.I am post-menopausal or not pregnant if pre-menopausal.I have had cancer before, but it was a specific type that's allowed.I am currently receiving treatment for cancer.My liver cancer is in an early or intermediate stage and can be surgically removed.I haven't taken immunosuppressive drugs in the last 14 days.I have not received a live vaccine in the last 30 days.I have had kidney problems like nephrotic or nephritic syndrome.I am willing and able to follow the study's requirements.I do not have any unmanaged ongoing illnesses.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: Tremelimumab in combination with Durvalumab preoperatively, followed by adjuvant Durvalumab
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.
Does the FDA approve of using Tremelimumab and Durvalumab together before surgery, followed by more Durvalumab afterwards?
"Our analysts rate the safety of Tremelimumab in combination with Durvalumab to be a 2. While there is evidence that this intervention is safe, Phase 2 trials have not yet demonstrated efficacy."
Answered by AI
Are patients still being accepted into this trial program?
"The clinical trial in question, which was first publicly announced on January 1st 2023, is not looking for patients at the moment. However, there are 2694 other trials that are still recruiting individuals."
Answered by AI
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