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PD-L1 Inhibitor
TSR-042 + Radiation for Endometrial Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of the regimen as measured by the grade of toxicities experienced as assessed by CTCAE v5.0
Secondary outcome measures
Progression-free survival (PFS)
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
Endometrial biopsy
2013
Completed Phase 3
~960
Brachytherapy
2007
Completed Phase 3
~2100
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,855 Total Patients Enrolled
6 Trials studying Endometrial Cancer
462 Patients Enrolled for Endometrial Cancer
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,538 Total Patients Enrolled
3 Trials studying Endometrial Cancer
127 Patients Enrolled for Endometrial Cancer
Stephanie Markovina, M.D, Ph.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to donate blood during and for 3 months after the study.My organs are functioning well.My kidney function, measured by creatinine levels, is within the normal range.I do not have brain or spinal cord cancer spread.I have an autoimmune disease treated with strong medication in the last 2 years.I have been on a stable dose of corticosteroids for at least 4 weeks.I agree not to donate blood during and for 3 months after the study.I do not have any serious health issues that are not under control.I haven't had significant radiation therapy affecting my bone marrow in the last 2 weeks.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.My doctor says surgery isn't an option for my condition.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I had a severe reaction to previous immunotherapy, except for minor lab changes.I have had my ovaries or fallopian tubes surgically removed or I'm using two reliable birth control methods.I use abstinence as my preferred method of birth control.I am not pregnant, cannot become pregnant, or will avoid pregnancy during and up to 180 days after the study.I have not received a live vaccine in the last 14 days.My kidney function, measured by creatinine levels, is within the normal range.My oncologist has approved me for targeted radiation therapy.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.My hemoglobin level is at least 9 g/dL, transfusions included.I have never had interstitial lung disease.My cancer is a type of endometrial carcinoma graded 1-3.I have been newly diagnosed with early-stage endometrial cancer.I have had cancer other than skin cancer in the last 3 years.I am over 45 and have not had a period for more than a year.I am not pregnant and agree to avoid pregnancy during the study.My cancer has spread beyond my cervix or uterus, confirmed by a scan.I have been on a stable dose of corticosteroids for at least 4 weeks.My hemoglobin level is at least 9 g/dL, transfusions included.I can understand and am willing to sign a consent form.I have received or am receiving chemotherapy for endometrial cancer.I have a known history of HIV.
Research Study Groups:
This trial has the following groups:- Group 1: TSR-042 and Brachytherapy
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.
Has the Endometrial biopsy procedure been certified by the FDA?
"There is limited data on the safety and efficacy of endometrial biopsy, so it earned a score of 1 to reflect this."
Answered by AI
Are there any openings for new participants in this research experiment?
"This trial, which was initially posted on October 15th 2019, is actively seeking participants according to clinicaltrials.gov's records and the most recent update was made 24th of October 2022."
Answered by AI
What is the current tally of participants in this trial?
"Affirmative. The clinical trial is presently seeking patients and can be found on the website, clinicaltrials.gov; it was initially posted in October 2019 and last updated earlier this month. 12 individuals will need to be recruited from 1 particular medical centre for the study's completion."
Answered by AI
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