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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

Must not have

Uncontrolled intercurrent illness including, but not limited to: Ongoing or active infections, Cardiac conditions, such as: symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, Active peptic ulcer disease or gastritis, History of inflammatory bowel disease, ulcerative colitis or Crohn's Disease, Active bleeding diatheses, Any subject known to have evidence of acute or chronic hepatitis B or hepatitis C, Any subject known to have evidence of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS), Uncontrolled seizures, Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's Correction, Known history of current or recent clinical diagnosis of tuberculosis (within three months prior to enrollment), Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), Any signs or symptoms of bowel obstruction within 28 days prior to study entry, History of leptomeningeal carcinomatosis, Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab or tremelimumab, or active infection, History of psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent, Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, Previously enrolled in the present study, Participation in another clinical study with an investigational product during the last 6 months, Previously enrolled in the present study, Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site), Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.

Retroperitoneal soft tissue sarcoma

Timeline

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is larger than 5 cm, deep, recurrent, metastatic, or not fully removed before.

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I am fully active or can carry out light work.

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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.

Exclusion Criteria

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

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I have a soft tissue sarcoma in the area behind my abdomen.

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My cancer has spread beyond my lungs but not just to lymph nodes.

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My cancer is a type of sarcoma that started in the bone or soft tissue.

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I do not need immediate treatment for brain metastases.

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I have previously been treated with specific immune therapies.

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I have had pneumonitis or lung disease affecting the tissue and space around the air sacs of my lungs.

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I have had an organ or bone marrow transplant from another person.

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I haven't had cancer treatment in the last 28 days, or 6 weeks for specific drugs.

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I have been diagnosed with a gastrointestinal stromal tumor.

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My cancer is a type of low-grade soft tissue sarcoma.

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My primary cancer cannot be removed with surgery.

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I have experienced significant side effects from previous immunotherapy.

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My cancer is a type of pediatric soft tissue sarcoma.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.