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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

Must not have

Evidence of distant metastasis co-existing malignant disease or macrovascular invasion on baseline imaging

Active co-infection with both HBV and HCV, or co-infected with HBV and hepatitis D virus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant parts of my body.

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I have both hepatitis B and either hepatitis C or D.

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My liver cancer is of a specific rare type.

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I have not had major surgery in the last 28 days.

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I have had an organ transplant or am waiting for a liver transplant.

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I am not pregnant, breastfeeding, and if capable of having children, I agree to use effective birth control.

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I have or had an autoimmune or inflammatory disorder.

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I do not have an active tuberculosis or HIV infection.

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I had liver surgery or ablation for HCC over two years ago, with no other treatments.

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I have heart failure symptoms or uncontrolled heart rhythm problems.

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I have had cancer before, but it was a specific type that's allowed.

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I am currently receiving treatment for cancer.

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I have had kidney problems like nephrotic or nephritic syndrome.

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I do not have any unmanaged ongoing illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of greater than grade 3 adverse events (AEs) or immune related adverse events that leads to treatment cessation

Secondary study objectives

Overall response rate (ORR)

Pathological response rate

Rates of R0 resection

Other study objectives

Changes in immune markers in tissue collected

Durvalumab and Tremelimumab and blood biomarkers expression

Overall survival

+3 more

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407

38%

Fatigue

21%

Diarrhea

17%

Nausea

17%

Fever

17%

Anorexia

17%

Maculopapular rash

17%

Pruritus

14%

Constipation

14%

Rash maculo-papular

10%

Anemia

10%

Abdominal pain

10%

Itching

Hypothyroidism

Non-cardiac chest pain

Weight loss

Cough

Dry Skin

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab and Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 20Eligibility criteria met