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Compensation: Varies

Number of Visits: Unknown

Duration: Until confirmed progressive disease or other discontinuation criteria

Immune Therapy + Bevacizumab for Advanced Liver Cancer

Not currently recruiting at 47 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: MedImmune LLC

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Hepatic encephalopathy, Gastrointestinal bleeding, others

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

Prior Safety DataThis treatment has passed at least one previous human trial

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of certain medicines against advanced liver cancer. Researchers are testing combinations of immune therapy drugs, durvalumab and tremelimumab, with bevacizumab (also known as Avastin, an anti-angiogenesis drug) to assess their impact on tumors. The goal is to understand the safety and efficacy of these treatments in combating cancer. Individuals with advanced liver cancer who have not previously received immune therapy and have encountered issues with other treatments might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot be on any chemotherapy, immunotherapy, or certain immunosuppressive medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies found the combination of tremelimumab and durvalumab safe for patients with advanced liver cancer. Most participants tolerated these treatments well, though some experienced common side effects like tiredness and loss of appetite. Serious side effects occurred less frequently.

Research has also shown that durvalumab combined with bevacizumab is generally safe. Most patients did not experience severe reactions. These findings suggest that the treatment is manageable for most people.

Both treatment options in the trial have shown promising safety results in past studies, indicating they are generally safe for people in similar situations.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of immune therapy with Bevacizumab for advanced liver cancer because it offers a novel approach to treatment. Unlike current standard treatments, which typically involve chemotherapy or targeted therapy drugs like Sorafenib, this trial combines immune checkpoint inhibitors, Durvalumab and Tremelimumab, with Bevacizumab, an anti-angiogenic agent. This combination is designed to enhance the body's immune response against cancer cells while simultaneously inhibiting the blood vessels that supply the tumor, potentially leading to more effective and durable responses. This dual action could provide a more comprehensive attack on liver cancer compared to existing therapies, offering hope for improved outcomes.

What evidence suggests that this trial's treatments could be effective for advanced liver cancer?

Research has shown that using durvalumab and tremelimumab together yields promising results for treating advanced liver cancer. One study found that about 20% of patients lived for five years, a notable outcome for this condition. On average, patients lived 16.4 months with this treatment, compared to 13.8 months with sorafenib. In this trial, some participants will receive the combination of durvalumab and tremelimumab.

Another group in this trial will test the combination of durvalumab and bevacizumab. Studies have shown that this combination successfully slowed the progression of liver cancer. Patients tolerated it well, and earlier trials showed encouraging results. These findings suggest that both combinations could be effective options for treating advanced liver cancer.² ⁴ ⁵ ⁶ ⁷

Who Is on the Research Team?

MedImmune, LLC MedImmune, LLC

Principal Investigator

MedImmune LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have liver cancer and cannot tolerate or have refused standard treatments.

I am at least 18 years old (20 if in Japan).

I have never received immunotherapy.

See 2 more

Exclusion 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.

See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various dosing regimens of durvalumab, tremelimumab, and bevacizumab based on the study part and cohort

Until confirmed progressive disease or other discontinuation criteria

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months after the first dose of study drug given to the last participant

Survival Follow-up

All participants will be followed for survival until the end of study visit

Until the last participant discontinues the study treatment

What Are the Treatments Tested in This Trial?

Interventions

Bevacizumab
Durvalumab
Tremelimumab

Trial Overview 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.

How Is the Trial Designed?

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.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

MedImmune LLC

Lead Sponsor

Trials

348

Recruited

788,000+

Founded

1988

Headquarters

Gaithersburg, USA

Known For

Biologics research

Citations

1.thelancet.comthelancet.com/journals/lancet/article/PIIS0140-6736(24)02551-0/abstract

Durvalumab with or without bevacizumab with transarterial ...With additional follow-up of the EMERALD-1 study, future analyses, including the final overall survival data and patient-reported outcomes, will ...

2.astrazeneca-us.comastrazeneca-us.com/media/press-releases/2023/imfinzi-durvalumab-plus-bevacizumab-met-primary-endpoint-for-progression-free-survival-in-liver-cancer-eligible-for-embolization-in-emerald-1-phase-iii-trial-11092023.html

IMFINZI® (durvalumab) plus bevacizumab met primary ...IMFINZI (durvalumab) plus bevacizumab met primary endpoint for progression-free survival in liver cancer eligible for embolization in EMERALD-1 Phase III trial.

3.astrazeneca.comastrazeneca.com/media-centre/press-releases/2023/imfinzi-combination-improves-pfs-in-liver-cancer.html

Imfinzi plus bevacizumab met primary endpoint for ...First global Phase III trial to show improved clinical outcome for systemic therapy in combination with transarterial chemoembolisation ...

4.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC10571707/

Outcomes of Patients with Advanced Hepatocellular ...Recent trial data have established atezolizumab plus bevacizumab as well as tremelimumab plus durvalumab as preferred first-line treatment ...

5.ascopubs.orgascopubs.org/doi/10.1200/JCO.2022.40.4_suppl.436

Safety and efficacy of durvalumab plus bevacizumab in ...Durvalumab plus bevacizumab was well tolerated and showed promising clinical activity in patients with uHCC.

6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39798579/

Durvalumab with or without bevacizumab with ... - PubMedWe aimed to assess whether adding durvalumab, with or without bevacizumab, might improve progression-free survival.

7.astrazeneca.comastrazeneca.com/media-centre/press-releases/2024/imfinzi-with-tace-and-bevacizumab-in-patients-with-hepatocellular-carcinoma-eligible-for-embolisation.html

Imfinzi plus transarterial chemoembolisation (TACE) and ...Treatment with Imfinzi plus TACE and bevacizumab reduced the risk of disease progression or death by 23% compared to TACE alone.

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