What side effects are associated with this type of intervention?

Common treatments for liver cancer, particularly immunotherapies like Pembrolizumab (a PD-1 inhibitor), are associated with immune-related adverse effects. These include fatigue, rash, pruritus, diarrhea, and nausea. Severe side effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Other treatments like sorafenib, a targeted therapy, can cause hand-foot skin reactions, diarrhea, hypertension, and hepatotoxicity.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for the treatment of liver cancer, specifically for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Another PD-1 inhibitor, Nivolumab, has also received FDA approval for the treatment of HCC in patients who have been previously treated with sorafenib. These approvals highlight the role of immunotherapy in liver cancer treatment, similar to the investigational combination of Nanrilkefusp alfa and Pembrolizumab being studied.

What other types of research exist?

Promising alternatives for liver cancer treatment in 2024 include: 1) Nivolumab, an immune checkpoint inhibitor that has shown efficacy in HCC patients, especially those previously treated with sorafenib. 2) Lenvatinib, a multikinase inhibitor, which has been used in combination with anti-PD-1 antibodies to improve overall survival in HCC patients. 3) Atezolizumab combined with Bevacizumab, which has demonstrated clinical activity in HCC by targeting both VEGF and PD-L1 pathways.

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Checkpoint Inhibitor

SOT101 + Pembrolizumab for Advanced Cancers

Phase 2

Waitlist Available

Research Sponsored by SOTIO Biotech AG

Eligibility Criteria Checklist

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

Must have

Participants must have adequate organ function including hematological, renal, and hepatic function

Participants must have measurable disease per RECIST 1.1. mCRPC participants with no measurable disease and only widespread bone disease must have a CTC count of >5 cells per 7.5 mL of blood

Must not have

History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease

Clinically significant cardiac abnormalities, uncontrolled hypertension, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called nanrilkefusp alfa together with an existing cancer treatment called pembrolizumab. Pembrolizumab is already approved for various cancer treatments and is often used with other therapies to improve survival rates. The goal is to see if combining these drugs can more effectively shrink tumors by boosting the immune system's ability to fight cancer.

Who is the study for?

This trial is for adults with certain advanced solid tumors, including lung, colorectal, liver, prostate and ovarian cancers. They must have a tumor that can be biopsied (except some prostate cancer cases), measurable disease or specific blood markers, good performance status (ECOG 0-1), stable side effects from past treatments except hair loss and mild neuropathy, proper organ function and no active hepatitis infections. Participants cannot join if they've had severe reactions to immune therapies before or recent major surgeries.

What is being tested?

The study tests the effectiveness of SOT101 combined with Pembrolizumab in treating selected tumors. It aims to see how well this combination works against different types of advanced cancers by measuring changes in tumor size and other indicators of response.

What are the potential side effects?

Potential side effects may include immune-related issues such as inflammation in various organs like the lungs or intestines; infusion reactions during treatment administration; fatigue; skin reactions; hormonal gland problems leading to hormone imbalances; and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My blood, kidney, and liver functions are all within normal ranges.

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My cancer can be measured by scans or I have a high number of cancer cells in my blood.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have had lung inflammation that needed steroids or have it now.

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I don't have major heart issues, uncontrolled high blood pressure, or a stem cell transplant in the last 5 years.

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I have been treated with drugs that target IL-2 or IL-15.

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I have not received a live vaccine in the last 30 days.

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I have not had major surgery or radiotherapy recently.

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I stopped a specific cancer treatment due to severe side effects.

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I do not have HIV, immunodeficiency, or active brain metastases.

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I have been treated for an autoimmune disease in the last 2 years.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Nanrilkefusp Alfa and PembrolizumabExperimental Treatment2 Interventions

Participants will be treated with 12 μg/kg of nanrilkefusp alfa on Day 1, Day 2, Day 8, and Day 9 of each 3-week cycle in combination with 200 mg pembrolizumab on Day 1 of each 3-week cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 12Eligibility 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

Common treatments for liver cancer include immune checkpoint inhibitors like Pembrolizumab, which is a PD-1 inhibitor that reactivates T-cells to recognize and attack cancer cells by blocking the PD-1 pathway. Other treatments include tyrosine kinase inhibitors such as Sorafenib and Lenvatinib, which inhibit multiple pathways involved in tumor growth and angiogenesis, and monoclonal antibodies like Bevacizumab that target VEGF to inhibit tumor blood supply. These targeted mechanisms are important for liver cancer patients as they disrupt cancer progression and enhance the immune response, potentially leading to improved outcomes.

Role of cellular, molecular and tumor microenvironment in hepatocellular carcinoma: Possible targets and future directions in the regorafenib era.