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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
DOSa Trial Summary
This trial is testing how well two immunotherapy drugs work in treating patients with advanced sarcoma.
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.Check my eligibility
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.See study design
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.
DOSa Trial 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.
Select...
I am at least 18 years old (for cohort 1 and 2) or at least 12 years old (for cohort 3).
Select...
I have been diagnosed with angiosarcoma.
Select...
I weigh at least 35 kilograms.
Select...
My condition is dedifferentiated liposarcoma.
Select...
My sarcoma is confirmed and is either low-grade with spread or getting worse.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
DOSa Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival (Cohort 3)
Response rate (Cohorts 1 and 2)
Secondary outcome measures
Incidence of adverse events (immune-related grade 3 and/or 4 toxicity)per treatment cohort
Overall survival
PFS
+2 moreOther outcome measures
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)
DOSa 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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,968 Previous Clinical Trials
1,786,797 Total Patients Enrolled
14 Trials studying Osteosarcoma
432 Patients Enrolled for Osteosarcoma
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,566 Total Patients Enrolled
103 Trials studying Osteosarcoma
16,543 Patients Enrolled for Osteosarcoma
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.
Osteosarcoma Patient Testimony for trial: Trial Name: NCT04668300 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior experiments have utilized Oleclumab as a potential treatment?
"Presently, there are 333 ongoing experiments examining the efficacy of Oleclumab with 52 trials in Phase 3. While a majority of these studies are based in Cordoba, Texas, approximately 12952 locations have clinical trial programs for Oleclumab."
Answered by AI
What ailments is Oleclumab typically employed to address?
"Oleclumab is typically used to treat inoperable stage three non-small cell lung cancer, but it can be prescribed for other maladies such as untreated metastatic ureter urothelial carcinoma and advanced directives."
Answered by AI
Could you provide details about whether this research study is recruiting participants?
"According to the information sourced from clinicaltrials.gov, this trial is currently accepting participants and was initially published on November 26th 2020 before being updated as of November 1st 2022."
Answered by AI
What are the chief aims of this analysis?
"The primary focus of this four month trial is to assess Event-free Survival (Cohort 3). Other objectives include recording the Incidence of adverse events, evaluating Response rate, and gauging Overall survival. Data will be captured via 95% confidence intervals for toxicity rates, Immune-related Response Criteria for response assessment and Kaplan Meier Method in regard to overall survivability. The proportional hazards assumption will then be tested through graphical and analytical regression diagnostics."
Answered by AI
How many participants have enrolled in this research experiment?
"Affirmative. According to clinicaltrials.gov, this study became available for recruitment on November 26th 2020 and is still active today - its most recent update was made on November 1st 2022. The trial seeks 75 participants from a single site."
Answered by AI
What risks are associated with Oleclumab consumption?
"The safety of Oleclumab was rated a 2, since it is currently in its Phase 2 trial and data has only been collected to gauge its safety but not efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
Why did patients apply to this trial?
Poor prognosis with hepatic liver angiosarcoma and my Oncologist is leaving my provider in April. Hope to help find better treatment with improved possible outcomes.
PatientReceived 2+ prior treatments
Willing to help find better treatment options for people with Angiosarcoma. I have tried two standard chemotherapy treatments here in Colorado and do not have any further treatment options that have a record of helping combat.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long would I need to be in Houston for this trial??
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- M D Anderson Cancer Center: < 24 hours
Average response time
- < 1 Day
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