60 Participants NeededMy employer runs this trial

Nivolumab + Ipilimumab for Liver Cancer

CM
Overseen ByCarrie Manwaring, BS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Texas Southwestern Medical Center
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 tests a combination of two immunotherapy drugs, nivolumab and ipilimumab, to determine their safety and effectiveness in treating liver cancer, specifically hepatocellular carcinoma. These drugs aim to enhance the immune system's ability to fight cancer cells. Individuals with liver cancer that cannot be treated with surgery or other local therapies, and who have not previously received certain immunotherapy treatments, might be suitable candidates for this trial. Participants should be able to manage their daily lives without significant assistance. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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

Research has shown that the combination of nivolumab and ipilimumab is generally safe for patients. Most people experience some side effects, but they are usually manageable. For instance, one study found that 88% of patients experienced side effects, but only 23% had more serious ones. No very severe side effects were reported.

Importantly, recent studies have not identified any new safety concerns. This indicates that the side effects align with what doctors expect from these drugs. The FDA has also approved this combination for other types of liver cancer, suggesting confidence in its safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using nivolumab and ipilimumab together for liver cancer because they harness the power of the immune system to fight cancer more effectively. Nivolumab is a PD-1 inhibitor and ipilimumab is a CTLA-4 inhibitor; both work by blocking proteins that prevent immune cells from attacking cancer cells. This dual approach is different from traditional treatments like targeted therapy or chemotherapy, which directly attack cancer cells but often come with significant side effects. By potentially offering a more targeted and less toxic option, this combination could improve outcomes for liver cancer patients.

What evidence suggests that nivolumab plus ipilimumab might be an effective treatment for liver cancer?

Research has shown that using nivolumab and ipilimumab together can effectively treat liver cancer, specifically hepatocellular carcinoma (HCC). In one study, about 38% of patients survived three years after receiving this treatment. This combination also reduced tumor size in many patients. Another study found that the average survival time was 23.7 months, longer than with some other treatments. Participants in this trial will receive the combination of nivolumab and ipilimumab, which could be a promising option for liver cancer treatment.13467

Who Is on the Research Team?

DH

David Hsieh, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with liver cancer (hepatocellular carcinoma). Participants should be in generally stable health and able to receive immunotherapy. People with certain other serious illnesses or conditions may not be eligible.

Inclusion Criteria

I had local treatment, but my tumor grew by 25% or was not treated.
I have not received immunotherapy for advanced liver cancer.
I am a woman who can still become pregnant.
See 9 more

Exclusion Criteria

I have an autoimmune disease that needs ongoing medication.
Known severe hypersensitivity reactions to monoclonal antibodies (≥Grade 3)
I have HIV with a detectable viral load and am not on HIV treatment.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nivolumab plus ipilimumab with adaptive dosing strategy based on interim imaging assessments

Up to 24 months
Every 3 weeks for cycles 1-4, then every 4 weeks

Interim Assessment

Short-interval restaging exam to assess disease response and adjust treatment accordingly

Ongoing during treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ipilimumab
  • Nivolumab

Trial Overview

The study is testing a combination of two immunotherapy drugs, nivolumab and ipilimumab, given at specific doses to see if they are safe and effective for treating liver cancer.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Nivolumab plus ipilimumabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Nivolumab plus ipilimumab combination therapy in patients ...

In arm A, investigator-assessed ORR increased from 32% at 30.7 months to 34% at 60 months. BICR-assessed outcomes remained consistent at all three follow-ups, ...

Update on Nivolumab Plus Ipilimumab Combination Therapy ...

Overall survival was 23.7 months, which was also very high. At 36 months, 38% of patients receiving nivolumab plus ipilimumab combination therapy were alive

Nivolumab/Ipilimumab in HCC Offers Clinical Gains but ...

Nivolumab–ipilimumab extends survival in unresectable HCC, but US cost-effectiveness falls short; dosing changes or price cuts may shift value.

Nivolumab plus ipilimumab for potentially resectable ...

Immune checkpoint inhibitor-based combination therapy has demonstrated high objective response rates in patients with hepatocellular carcinoma (HCC) and may ...

Efficacy of Nivolumab plus Ipilimumab in Advanced ...

The high-risk group exhibited a significantly lower objective response rate (ORR) (12.8% vs. 34.3%) and shorter median progression-free ...

Nivolumab Plus Ipilimumab Improves OS and Response in ...

For overall survival (OS), the combination of nivolumab plus ipilimumab showed a significant improvement in median OS compared with lenvatinib ( ...

FDA approves nivolumab with ipilimumab for unresectable ...

The primary efficacy outcome measure was overall survival (OS) in all randomized patients. Median OS was 23.7 months 8, 29.4) in the nivolumab ...