What side effects are associated with this type of intervention?

Common side effects of PD-1 inhibitors, such as Zimberelimab, include fatigue, hypothyroidism, decreased appetite, and rash. Severe adverse events can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Adenosine A2a receptor antagonists like Etrumadenant may cause nausea, vomiting, and fatigue. These treatments aim to modulate the immune system to target cancer cells, but they can also lead to immune-related adverse events affecting various organs.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of various types of sarcoma. Pembrolizumab, a PD-1 inhibitor, has shown efficacy in certain sarcomas with high levels of microsatellite instability (MSI-H). However, the use of immune checkpoint inhibitors in sarcoma remains largely investigational, with ongoing studies exploring their potential benefits. There are no specific FDA approvals for the combination of an Adenosine A2a Receptor Antagonist and a PD-1 Inhibitor in sarcoma treatment as of now.

What other types of research exist?

Promising alternatives for sarcoma patients in 2024 may include: 1) Pembrolizumab (PD-1 inhibitor) in combination with Lenvatinib (VEGFR inhibitor), which has shown efficacy in various advanced solid tumors including endometrial cancer. 2) Atezolizumab (PD-L1 inhibitor) combined with Cabozantinib (VEGFR, MET, and AXL inhibitor), which has demonstrated activity in advanced renal cell carcinoma. 3) Nivolumab (PD-1 inhibitor) plus Ipilimumab (CTLA-4 inhibitor), which has been effective in multiple advanced cancers including renal cell carcinoma and melanoma.

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Etrumadenant + Zimberelimab for Sarcoma

Phase 2

Recruiting

Led By Evan Rosenbaum, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, etrumadenant and zimberelimab, to treat patients with advanced dedifferentiated liposarcoma (DDLS). These patients have cancer that has come back, spread, or cannot be removed by surgery. Etrumadenant stops cancer cells from growing, while zimberelimab helps the immune system fight the cancer.

Who is the study for?

Adults with advanced dedifferentiated liposarcoma that's inoperable, recurrent, or has spread to other parts of the body can join this trial. They should have tried other treatments without success and be in good health otherwise, with no severe allergies to certain antibodies or active infections like hepatitis or tuberculosis.

What is being tested?

The study is testing a combination of two drugs: Etrumadenant and Zimberelimab. It aims to see if they work together as an effective treatment for this type of sarcoma. Participants will receive both medications and their effects on the cancer will be monitored.

What are the potential side effects?

Possible side effects include immune system reactions that might cause inflammation in various organs, allergic responses to the drug infusion, fatigue, potential liver function changes, blood-related issues such as low counts which could increase infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Response Rate

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: Participants With Dedifferentiated Liposarcoma/DDLPSExperimental Treatment2 Interventions

Participants will have a diagnosis of recurrent or metastatic Dedifferentiated Liposarcoma/DDLPS

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2019

Completed Phase 2

~300

Etrumadenant

2019

Completed Phase 2

~380

Do I qualify?Apply below to find out

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 sarcoma include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as CDK4/6 inhibitors, specifically target molecular abnormalities in cancer cells, offering a more precise approach with potentially fewer side effects. Immunotherapy, including PD-1 inhibitors like Zimberelimab, enhances the body's immune response against cancer cells by blocking proteins that inhibit immune activity. Etrumadenant, an adenosine A2a receptor antagonist, works by blocking adenosine pathways that suppress immune responses in the tumor microenvironment. These mechanisms are crucial for sarcoma patients as they offer more tailored and potentially effective treatment options, especially for advanced or treatment-resistant cases.

Integrative Management of Pancreatic Cancer (PDAC): Emerging Complementary Agents and Modalities.Olaratumab: a platelet-derived growth factor receptor-α-blocking antibody for the treatment of soft tissue sarcoma.Olaratumab for the treatment of soft-tissue sarcoma.