What side effects are associated with this type of intervention?

Common treatments for osteosarcoma include surgery, chemotherapy, and radiation therapy. When focusing on immunotherapy with monoclonal antibodies, such as Oleclumab and Durvalumab, the known side effects can include fatigue, skin reactions at the injection site, flu-like symptoms, and gastrointestinal issues like nausea and diarrhea. More serious side effects may involve immune-related adverse events, such as inflammation of organs (e.g., pneumonitis, colitis, hepatitis), endocrinopathies, and infusion reactions. These treatments aim to enhance the immune system's response against cancer cells but can also lead to the immune system attacking normal tissues.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for the treatment of osteosarcoma using immunotherapy with monoclonal antibodies like oleclumab and durvalumab. Osteosarcoma treatment primarily involves surgery, chemotherapy, and radiation therapy. However, research and clinical trials are ongoing to explore the efficacy of immunotherapy in osteosarcoma, aiming to enhance the immune system's response against cancer cells.

What other types of research exist?

Promising novel alternatives to Oleclumab and Durvalumab for osteosarcoma patients include Pembrolizumab and Nivolumab, which are checkpoint inhibitors targeting PD-1. Additionally, CAR-T cell therapies and bispecific T-cell engagers (BiTEs) are emerging as innovative treatments. Clinical trials investigating these therapies have shown encouraging results in enhancing the immune response against various cancers, including osteosarcoma.

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Checkpoint Inhibitor

Oleclumab + Durvalumab for Advanced Sarcoma (DOSa Trial)

Phase 2

Recruiting

Led By Neeta Somaiah

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Must have received and have progressed, are refractory or intolerant to standard therapy appropriate for the specific sarcoma subtype, if there is a standard therapy for the subtype

Age: 18 years of age or older (cohort 1 and cohort 2); 12 years of age or older (cohort 3)

Must not have

Subjects with a history of venous thrombosis within the past 3 months

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two immunotherapy drugs, oleclumab and durvalumab, in patients with difficult-to-treat sarcoma. These drugs help the immune system to find and destroy cancer cells and may stop the cancer from growing and spreading.

Who is the study for?

Adults and children over 12 with recurrent, refractory, or metastatic sarcoma who have tried standard treatments without success. They must be in good health otherwise, not pregnant or breastfeeding, willing to use contraception, and able to provide consent. Excluded are those with certain medical conditions, recent major surgery or immunotherapy treatment.

What is being tested?

The trial is testing oleclumab and durvalumab—two monoclonal antibodies—to see if they can help the immune system fight sarcoma that's hard to treat because it came back or spread. It's a phase II study which means it’s checking how well these drugs work and their safety.

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation of organs (like colitis), skin rashes, hormonal gland problems (like thyroid issues), fatigue, infusion reactions during drug administration, and potential 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 sarcoma hasn't responded to or I can't tolerate the usual treatment.

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I am at least 18 years old (for cohort 1 and 2) or at least 12 years old (for cohort 3).

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I have been diagnosed with angiosarcoma.

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I weigh at least 35 kilograms.

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My condition is dedifferentiated liposarcoma.

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My sarcoma is confirmed and is either low-grade with spread or getting worse.

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I am fully active or restricted in physically strenuous activity but can do 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 a blood clot in the last 3 months.

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I do not have any uncontrolled illnesses.

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I haven't had any live vaccines in the last 30 days.

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I have a history of certain lung and heart conditions.

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I have previously received specific immunotherapies.

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My cancer has spread to my brain or spinal cord and hasn't been treated.

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I am currently using other cancer treatments.

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

Study Objectives

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

Primary study objectives

Event-free survival (Cohort 3)

Response rate (Cohorts 1 and 2)

Secondary study objectives

Incidence of adverse events (immune-related grade 3 and/or 4 toxicity)per treatment cohort

Overall survival

PFS

+2 more

Other study objectives

Biomarker (CD73, PD-1/PD-L1) expression analysis (pre & post treatment tissue samples)

Identification/quantification of immunologic changes (CD4+, CD8+, Teff, Treg cells and NK cells) in peripheral blood

Tumor infiltrating lymphocytes (pre and post treatment tissue samples)

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: Treatment (oleclumab, durvalumab)Experimental Treatment2 Interventions

Patients receive oleclumab IV over 1 hour every 2 weeks for 5 doses, then every 4 weeks thereafter. Patients also receive durvalumab IV over 1 hour every 4 weeks. Cycle repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

FDA approved

Oleclumab

Not yet FDA approved

0 / 14Eligibility 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

Immunotherapy with monoclonal antibodies, such as Oleclumab and Durvalumab, works by enhancing the body's immune response against cancer cells. These antibodies target specific proteins on the surface of cancer cells or immune cells, thereby blocking inhibitory signals that prevent the immune system from attacking the tumor. For Osteosarcoma patients, this approach is significant because it offers a targeted method to boost the immune system's ability to recognize and destroy cancer cells, potentially leading to better control of the disease and improved survival outcomes.