← Back to Search

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

Must not have

Disease that is considered surgically unresectable, including, but not limited to significant vascular, neural, or bone involvement, and in cases where a complete surgical resection cannot be safely performed

Prior or concurrent immunotherapy, including treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody; tumor vaccines; interferon, or interleukins

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I am not able to have children due to menopause or surgery.

Select...

I am medically cleared for surgery and can care for myself.

Select...

I have untreated DDLPS or UPS cancer in my abdomen or limbs.

Select...

My kidney function is normal or only slightly impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition cannot be treated with surgery due to its complexity or risk.

Select...

I have received immunotherapy or treatments like anti-PD-1.

Select...

I am currently taking blood thinners at treatment doses.

Select...

I have another active cancer besides the one being treated.

Select...

I have had radiation therapy for sarcoma in the same area before.

Select...

I have not had abdominal surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Pathologic response

Secondary study objectives

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

2015

Completed Phase 3

~3070

Nivolumab

2015

Completed Phase 3

~4010