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Immunotherapy + Radiation for Soft Tissue Sarcoma (NEXIS Trial)
Phase 1 & 2
Waitlist Available
Led By Vincent Y. Ng, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor at least 5 cm in greatest dimension and deep to fascia, or locally recurrent, or metastatic, or have had prior inadequate resections
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of surgery
Awards & highlights
NEXIS Trial Summary
This trial is testing whether two types of immunotherapy, given together with radiation, can help the immune system recognize and fight a type of cancer called soft tissue sarcoma.
Who is the study for?
This trial is for adults with certain high-risk soft tissue sarcomas that haven't spread widely. Participants must be in good health, able to follow the study plan, and have tumors of a specific size or characteristic. Women must not be able to become pregnant or agree to use contraception. People can't join if they've had certain previous treatments, autoimmune diseases, organ transplants, infections like HIV/Hepatitis B/C, uncontrolled illnesses (like heart disease), or are on immunosuppressants.Check my eligibility
What is being tested?
The trial tests combining two immunotherapy drugs (Durvalumab and Tremelimumab) with radiation before surgery in patients with soft tissue sarcoma. The goal is to see if this combination helps the immune system fight cancer cells better than current standard treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving the drugs through a vein, fatigue, digestive issues like upset stomachs or diarrhea, skin problems like rash or itching and potential increased risk of infections.
NEXIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is larger than 5 cm, deep, recurrent, metastatic, or not fully removed before.
Select...
I am fully active or can carry out light work.
Select...
My sarcoma is confirmed to be of a serious type.
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My tumor is located on my trunk or limbs, not near my back organs.
NEXIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days after receipt of final dose of durvalumab monotherapy or 180 days after receipt of final dose of combination durvalumab/tremelimumab, whichever is longer
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days after receipt of final dose of durvalumab monotherapy or 180 days after receipt of final dose of combination durvalumab/tremelimumab, whichever is longer
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Histopathologic Response
Toxicity: Number of subjects experiencing high-grade toxicity
Secondary outcome measures
Disease-Specific Survival Rate
Overall Survival Rate
Radiologic Response To Treatment
+1 moreSide effects data
From 2012 Phase 2 & 3 trial • 4 Patients • NCT0009049375%
DVT
75%
Staphyloccocal infections
25%
Shingles
100%
80%
60%
40%
20%
0%
Study treatment Arm
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
NEXIS Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Neoadjuvant Radiation plus Durvalumab and Tremelimumab Wide Surgical Resection Adjuvant Durvalumab
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Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,272 Previous Clinical Trials
288,612,653 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,634 Total Patients Enrolled
University of ArizonaOTHER
515 Previous Clinical Trials
148,692 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a soft tissue sarcoma in the area behind my abdomen.I don't have severe side effects from past cancer treatments.My tumor is larger than 5 cm, deep, recurrent, metastatic, or not fully removed before.I am fully active or can carry out light work.My cancer has spread beyond my lungs but not just to lymph nodes.My cancer is a type of sarcoma that started in the bone or soft tissue.I do not need immediate treatment for brain metastases.I have previously been treated with specific immune therapies.I have had pneumonitis or lung disease affecting the tissue and space around the air sacs of my lungs.I have had an organ or bone marrow transplant from another person.I haven't had cancer treatment in the last 28 days, or 6 weeks for specific drugs.I haven't taken strong immune system suppressing drugs in the last 28 days, except for low-dose steroids or inhalers.I am willing and able to follow the study's requirements.My sarcoma is confirmed to be of a serious type.My tumor is located on my trunk or limbs, not near my back organs.My doctor thinks my tumor can be partially removed by surgery.I am a woman who cannot become pregnant or I have tested negative for pregnancy before joining the study.My organs and bone marrow are functioning well.I agree to use two forms of birth control during and after my treatment.I have been diagnosed with a gastrointestinal stromal tumor.My cancer is a type of low-grade soft tissue sarcoma.I haven't had autoimmune diseases except for vitiligo, Grave's, or mild psoriasis in the last 2 years.My primary cancer cannot be removed with surgery.I have experienced significant side effects from previous immunotherapy.My cancer is a type of pediatric soft tissue sarcoma.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
Are there any opportunities for patients to enroll in this research endeavor?
"This experiment is not presently accepting participants; data on clinicaltrials.gov indicates that the initial posting was June 21st 2017 and last updated December 7th, 2022. Despite this study's closure, there are still 445 other trials recruiting individuals in need of medical interventions."
Answered by AI
What is the desired outcome of this research endeavor?
"Within a 90-day period following the final dose of Durvalumab monotherapy or 180 days after receiving their last dosage of combination Durvalumab/Tremelimumab, whichever is longer, this clinical trial's primary objective will be to measure Histopathologic Response. They will also assess Relapse-Free Survival Rate (the percentage of patients that have not experienced documented relapse), Radiologic Response To Treatment (best overall response to Neoadjuvant Radiation and Immunotherapy with irRC scores used as criteria) and Overall Survival Rate (percentage of surviving participants)."
Answered by AI
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