What side effects are associated with this type of intervention?

Common treatments for liver cancer, particularly immune checkpoint inhibitors such as TSR-022 (cobolimab) and TSR-042 (dostarlimab), can have several side effects. These may include fatigue, diarrhea, nausea, and immune-related adverse events such as hypothyroidism and hepatic toxicities. Regular clinical monitoring is essential to manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of liver cancer. Pembrolizumab, a PD-1 inhibitor, has shown antitumor activity in advanced hepatocellular carcinoma (HCC) and was evaluated in the KEYNOTE-240 trial. Although it did not show statistically significant superiority over placebo, it demonstrated safety and some efficacy. Other immune checkpoint inhibitors, such as nivolumab (another PD-1 inhibitor), have also been explored in clinical trials for HCC. These treatments aim to enhance the immune system's ability to attack cancer cells, similar to the investigational drugs TSR-022 (cobolimab) and TSR-042 (dostarlimab).

What other types of research exist?

Promising novel alternatives for liver cancer treatment in 2024 include PD-1 inhibitors such as toripalimab, camrelizumab, and sintilimab, which have shown efficacy and safety in HBV-associated HCC patients. Additionally, combination therapies like Tremelimumab plus Durvalumab and Sorafenib combined with Radio-frequency Ablation are also emerging as effective options.

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Monoclonal Antibodies

Anti-TIM-3 + Anti-PD-1 Antibodies for Liver Cancer

Phase 2

Waitlist Available

Led By Jared D Acoba, MD

Research Sponsored by University of Hawaii

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed hepatocellular cancer

Cirrhosis grade of Child-Pugh class A or B7

Must not have

History of organ transplantation including allogeneic bone marrow transplantation

Prior therapy with any medication targeting PD-1, PD-L1, or TIM-3

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of treatment until the date of death, assessed up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two drugs, cobolimab and dostarlimab, to help the immune system fight advanced or spreading liver cancer. The drugs work by blocking proteins that allow cancer cells to hide from the immune system, making it easier for the body to attack them.

Who is the study for?

Adults with advanced liver cancer who haven't had systemic therapy can join this trial. They need good kidney function, controlled hepatitis if present, and at least one measurable tumor. They must not have severe lung conditions or be on recent immunosuppressants, live vaccines, or have other active cancers (with some exceptions). Pregnant women are excluded.

What is being tested?

The trial is testing the combination of two immune system-boosting drugs: TSR-022 (cobolimab) and TSR-042 (dostarlimab), to see if they help the body fight liver cancer better together than existing treatments.

What are the potential side effects?

Possible side effects include immune-related reactions that could affect various organs, infusion-related symptoms like fever or chills, fatigue, potential blood abnormalities, and increased risk of infections due to immune system changes.

Eligibility Criteria

Inclusion Criteria

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

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My liver cancer diagnosis was confirmed through lab tests.

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My liver disease is mild to moderate.

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My liver cancer is at an intermediate or advanced stage.

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I have HBV and am on antiviral therapy with a viral load under 100 IU/mL.

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I have a tumor that can be measured by standard criteria.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My liver tests are within the required ranges.

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I have not had any drug treatments for liver cancer.

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My kidneys work well enough, with a creatinine clearance rate of at least 40 mL/min.

Exclusion Criteria

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

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I have had an organ or bone marrow transplant.

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I have been treated with drugs targeting PD-1, PD-L1, or TIM-3.

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I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.

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I do not have any serious, uncontrolled health conditions.

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I haven't had recent severe heart issues like new or worsening chest pain or a heart attack in the last 6 months.

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I do not have an active infection requiring IV antibiotics.

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I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.

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I have a history of specific lung conditions like asthma or pulmonary fibrosis.

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I have not received a live vaccine in the week before starting the treatment.

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I do not have active or untreated brain or spinal cord cancer spread.

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I have been diagnosed with HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of treatment until the date of death, assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of treatment until the date of death, assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of treatment until the date of death, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate

Secondary study objectives

AFP response

Duration of Response

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0

+4 more

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: TSR-022 (Cobolimab) and TSR-042 (Dostarlimab)Experimental Treatment1 Intervention

Patients receive TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) via IV day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immune checkpoint inhibitors, such as TSR-022 (cobolimab) and TSR-042 (dostarlimab), work by targeting specific proteins that regulate the immune system's ability to attack cancer cells. Cobolimab binds to TIM-3, while dostarlimab targets PD-1. By inhibiting these checkpoints, these drugs prevent cancer cells from evading immune detection, thereby enhancing the body's immune response against the tumor. This is particularly important for liver cancer patients as it offers a novel therapeutic approach that can potentially improve outcomes in cases where traditional treatments like chemotherapy and targeted therapies may be less effective.