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PD-L1 Inhibitor

TSR-042 + Radiation for Endometrial Cancer

Phase 1

Waitlist Available

Led By Stephanie Markovina, M.D, Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.

Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance 60mL/min using the Cockcroft-Gault equation

Must not have

Known brain or leptomeningeal metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for endometrial cancer that could help the body's immune system fight the cancer.

Who is the study for?

This trial is for adults with inoperable endometrial cancer who can undergo radiation therapy. They must have adequate organ function, not be pregnant or breastfeeding, and agree to use contraception if of childbearing potential. Excluded are those with prior endometrial cancer treatments, metastatic disease outside the uterus, certain recent malignancies, previous anti-PD-1/PD-L1 drugs usage, known brain metastases, uncontrolled medical conditions or infections.

What is being tested?

The trial tests TSR-042 (an immunotherapy drug) alongside standard radiation treatment for patients with inoperable endometrial cancer. It aims to assess whether adding TSR-042 can boost the immune system's response against tumor cells and improve outcomes compared to radiation alone.

What are the potential side effects?

TSR-042 may cause side effects similar to other immunotherapies which include but are not limited to fatigue, skin reactions at injection sites, flu-like symptoms such as fever and chills, nausea or diarrhea. More serious side effects might involve the immune system attacking normal organs/tissues.

Eligibility Criteria

Inclusion Criteria

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

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I agree not to donate blood during and for 3 months after the study.

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My kidney function, measured by creatinine levels, is within the normal range.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My kidney function, measured by creatinine levels, is within the normal range.

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My cancer is a type of endometrial carcinoma graded 1-3.

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I have been newly diagnosed with early-stage endometrial cancer.

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I am over 45 and have not had a period for more than a year.

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I can understand and am willing to sign a consent form.

Exclusion Criteria

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

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I do not have brain or spinal cord cancer spread.

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I do not have any serious health issues that are not under control.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.

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I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.

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I have never had interstitial lung disease.

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My cancer has spread beyond my cervix or uterus, confirmed by a scan.

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I have received or am receiving chemotherapy for endometrial cancer.

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I have a known history of HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: TSR-042 and BrachytherapyExperimental Treatment4 Interventions

* Patients will receive four doses of TSR-042. The first dose is given 21 days prior to the first planned brachytherapy fraction. The second dose is given 21 (+3) days later, corresponding to the time of brachytherapy fraction #1. The third dose is given 21 (+3) days after dose 2, corresponding to the time of brachytherapy fraction #4. The fourth dose is given 21 (+3) days after dose corresponding to 1 weeks after brachytherapy fraction #6. * Brachytherapy will consist of 6 weekly fractions of 6 Gy per fraction (total 36Gy)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brachytherapy

2007

Completed Phase 3

~2140

Endometrial biopsy

2013

Completed Phase 3

~960