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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
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
2020
Completed Phase 2
~230
Etrumadenant
2018
Completed Phase 2
~300
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.
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.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,971 Previous Clinical Trials
597,483 Total Patients Enrolled
156 Trials studying Lymphoma
8,882 Patients Enrolled for Lymphoma
Evan Rosenbaum, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
325 Total Patients Enrolled
Sandra D'Angelo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
192 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active cancer spread to my brain or spinal cord.I am currently being treated for another cancer that is not related.I have been treated with PD-1 or PD-L1 inhibitors before.I have HIV with specific CD4+ T-cell counts or opportunistic infections.My condition is an advanced liposarcoma that cannot be surgically removed.I have had an active tuberculosis infection in the past.I have been treated with drugs targeting the adenosine pathway.I have an active hepatitis B or C infection.I am fully active or able to carry out light work.My blood tests for organ function are within normal ranges.I cannot take pills due to my stomach or intestinal problems.My current medications do not interact with etrumadenant.I have had previous treatments for my condition.I am 18 years old or older.I haven't had recent cancer treatments or major surgery.I do not have any uncontrolled illnesses or heart failure symptoms in the last 6 months.My cancer came back after surgery to remove the initial tumor.I have not needed treatment for an autoimmune disease in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Participants With Dedifferentiated Liposarcoma/DDLPS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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