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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 belowSelect...
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:Select...
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
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 moreOther 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
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.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,571 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,963 Total Patients Enrolled
Neeta SomaiahPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have at least one spot that can be measured to see how the treatment is working.I have been diagnosed with osteosarcoma.I have had a blood clot in the last 3 months.You have had a diagnosed autoimmune disease in the past 2 years, unless there are special circumstances.My sarcoma hasn't responded to or I can't tolerate the usual treatment.I am at least 18 years old (for cohort 1 and 2) or at least 12 years old (for cohort 3).I have been diagnosed with angiosarcoma.I do not have any uncontrolled illnesses.My sarcoma is confirmed and either low-grade with spread or progressing.I agree to provide tumor samples for study before starting treatment.I haven't had any cancer besides my current one in the last 2 years, except for non-spreading types that were removed by surgery.I have had a heart-related event in the past 3 months.I can have a biopsy on a tumor that is at least 2 cm big or on another risky area.I have a history of certain medical conditions or infections.I haven't taken immunosuppressive drugs in the last 14 days, with some exceptions.I haven't taken any cancer treatment in the last 21 days.I haven't had any live vaccines in the last 30 days.My previously treated cancer area has grown since my last radiation treatment.I have a history of certain lung and heart conditions.My blood, kidney, liver, and clotting tests are normal.You are expected to live for at least 6 more months.I weigh at least 35 kilograms.You need to have at least one noticeable and measurable abnormality for the study.I have previously received specific immunotherapies.I am using reliable birth control methods if capable of having children.I have not had major surgery recently.I have no lasting side effects from previous cancer treatments.I agree to give my previous tumor samples for research.My condition is dedifferentiated liposarcoma.My cancer has spread to my brain or spinal cord and hasn't been treated.I am currently using other cancer treatments.My sarcoma is confirmed and is either low-grade with spread or getting worse.My previously treated cancer area has grown despite radiation.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (oleclumab, durvalumab)
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.
Angiosarcoma Patient Testimony for trial: Trial Name: NCT04668300 — Phase 2
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