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Checkpoint Inhibitor
Immunotherapy + Radiation for Sarcoma Before Surgery
Phase 2
Waitlist Available
Led By Christina L Roland
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
Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic men do not require contraception
Patients must be medically fit to undergo surgery as determined by the treating medical and surgical oncology team and have Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of immunotherapy drugs and radiation given before surgery to see if it's more effective than just surgery in treating a type of soft tissue sarcoma.
Who is the study for?
This trial is for adults with specific sarcomas (undifferentiated pleomorphic or dedifferentiated liposarcoma) that can be surgically removed. Participants must be fit for surgery, not have had prior treatments like chemotherapy or immunotherapy for their sarcoma, and agree to provide tumor samples. Women of childbearing age must use effective contraception, and men too if their partners are of childbearing potential.Check my eligibility
What is being tested?
The study tests the effectiveness of nivolumab alone or combined with ipilimumab plus radiation therapy before surgery in treating certain sarcomas. Nivolumab and ipilimumab are antibodies that may help the immune system fight cancer; radiation uses high-energy x-rays to kill tumor cells.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, fatigue, skin issues, hormonal gland problems like thyroid dysfunction, digestive disturbances such as diarrhea or colitis, liver inflammation, and possible infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not able to have children due to menopause or surgery.
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I am medically cleared for surgery and can care for myself.
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I have untreated DDLPS or UPS cancer in my abdomen or limbs.
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My kidney function is normal or only slightly impaired.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic response
Secondary outcome measures
Assessment of immunologic changes in the tumor microenvironment and blood
Change in Immune Infiltrate in Response to Neoadjuvant Nivolumab Monotherapy and Neoadjuvant Nivolumab and Ipilimumab Combination Therapy
Health status assessment
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Arm D (nivolumab, ipilimumab, RT)Experimental Treatment3 Interventions
Patients receive nivolumab as in Arm C, ipilimumab as in Arm B, and RT as in Arm C in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery within 2 weeks after day 71.
Group II: Arm C (nivolumab, RT)Experimental Treatment2 Interventions
Patients receive nivolumab IV over 1 hour on days 1, 15, 29, and 43. Patients also undergo RT QD for 5 days during days 15-47 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery within 2 weeks after day 71.
Group III: Arm B (nivolumab, ipilimumab)Experimental Treatment2 Interventions
Patients receive nivolumab as in Arm A. Patients also receive ipilimumab IV over 90 minutes on day 1 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery within 2 weeks after day 43.
Group IV: Arm A (nivolumab)Experimental Treatment1 Intervention
Patients receive nivolumab IV over 1 hour on days 1, 15, and 29 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery within 2 weeks after day 43.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Radiation Therapy
2017
Completed Phase 3
~7250
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,770 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,635 Total Patients Enrolled
Christina L RolandPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
227 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition cannot be treated with surgery due to its complexity or risk.I've had chemotherapy or targeted therapy for my current sarcoma but have recovered from any side effects.You are expected to live for at least 6 more months.I will be checked by the anesthesia team before my surgery.I am not able to have children due to menopause or surgery.I have an autoimmune disease but it's under control or not expected to worsen.You have a positive test for hepatitis B or C virus, which means you have an ongoing infection.Your absolute neutrophil count is higher than 1,000 per microliter of blood.Your hemoglobin level is higher than 9 grams per deciliter.Your bilirubin level is less than or equal to 1.5 times the upper limit of normal.I have received immunotherapy or treatments like anti-PD-1.I am medically cleared for surgery and can care for myself.I have not received immunotherapy but may have had chemotherapy for sarcoma.I have not received vaccines for infectious diseases in the last 4 weeks.I am currently taking blood thinners at treatment doses.I have untreated DDLPS or UPS cancer in my abdomen or limbs.My cancer is considered removable by surgery, as agreed by a team of cancer specialists.I am willing to have multiple biopsies of my tumor.I am a woman who cannot become pregnant due to surgery or being postmenopausal.I agree to use effective birth control during and after the study.I haven't had any cancer except for sarcoma or certain skin, bladder, prostate, cervix, or breast cancers in the last 2 years.I haven't taken high-dose steroids or immune-weakening drugs in the last 2 weeks.I must use effective birth control for 7 months after my last dose.My cancer is a type of sarcoma that might have different names but is aggressive.Your AST levels should not be more than 1.5 times the upper limit of normal.I am willing and able to follow the study's required procedures.My kidney function is normal or only slightly impaired.I have another active cancer besides the one being treated.I have had radiation therapy for sarcoma in the same area before.You had a very bad reaction to a type of medication called monoclonal antibody in the past.Women of childbearing potential must have a negative pregnancy test within 24 hours before starting the study drug.Your white blood cell count is higher than 3000 per microliter.You are being held against your will for psychiatric or physical treatment.Your alanine transaminase (ALT) level is not more than 1.5 times the normal upper limit.I have not had abdominal surgery in the last 4 weeks.I can sign and follow the study's consent form.You need to have had a CT or MRI scan in the past 4 weeks that shows the disease being studied.Your platelet count is higher than 100,000 per cubic millimeter.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (nivolumab)
- Group 2: Arm C (nivolumab, RT)
- Group 3: Arm B (nivolumab, ipilimumab)
- Group 4: Arm D (nivolumab, ipilimumab, RT)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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