Immunotherapy for Liver Cancer Before Transplant

Recruiting at 2 trial locations

Overseen By Christine Vollmer, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Davendra Sohal

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: Autoimmune disease, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Immunotherapy can safely downstage patients and achieve durable systemic disease control to improve clinical outcomes in HCC patients undergoing liver transplant.

Research Team

Davendra P. Sohal

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for adults over 18 with hepatocellular carcinoma (HCC) who haven't had prior HCC therapy, are listed for a liver transplant, and meet specific health criteria including a Child-Pugh Score of 5-7. They must have tumors within certain size limits, no extrahepatic disease or severe autoimmune disorders, and be able to follow the study protocol.

Inclusion Criteria

My organs and bone marrow are working well.

I have at least one measurable cancer lesion that has not been treated with radiation.

My body weight is over 30 kg.

Exclusion Criteria

Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements

I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.

I have or had an autoimmune or inflammatory condition, with some exceptions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive durvalumab and tremelimumab for up to 4 months

16 weeks

Washout

A minimum 28-day washout period before locoregional therapy

4 weeks

Locoregional Therapy

Participants undergo locoregional therapy per institutional standards

Pre-Transplant Washout

A minimum 72-day washout period from the end of immunotherapy before liver transplant

10 weeks

Liver Transplant

Participants undergo liver transplant

Follow-up

Participants are monitored for safety and effectiveness after transplant

30 days

Long-term Follow-up

Survival follow-up will continue for 5 years after the end of treatment

5 years

Treatment Details

Interventions

• Durvalumab
• Liver Transplant
• Tremelimumab

Trial Overview The trial tests Durvalumab and Tremelimumab in patients with HCC awaiting liver transplants. It aims to see if immunotherapy can safely reduce tumor size and control the disease long-term to improve outcomes post-transplant.

Participant Groups

Group I: Durvalumab + Tremelimumab + Liver Transplant Experimental Treatment 3 Interventions

Patients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Imfinzi for:

• Locally advanced, unresectable non-small cell lung cancer (NSCLC)

Approved in United States as Imfinzi for:

• Extensive-stage small cell lung cancer (ES-SCLC)
• Limited-stage small cell lung cancer (LS-SCLC)
• Locally advanced or metastatic urothelial carcinoma

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

Davendra Sohal

Lead Sponsor

Trials

1

Recruited

30+