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Endometrial CancerPhase 1NCT03955978

TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer

A Phase 1 study testing TSR-042, Brachytherapy and Endometrial biopsy in people with Endometrial Cancer and Cancer of the Endometrium, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Patients with inoperable endometrial cancer have limited treatment options. PD-L1 expression is common in endometrial cancers and RT induces tumor and systemic changes that induce the immune system. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer, Cancer of the Endometrium
What is being tested?
TSR-042, Brachytherapy and Endometrial biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
15 Oct 2019to 1 Feb 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed biopsy proven The International Federation of Gynecology and Obstetrics (FIGO) clinical stage I or II endometrial carcinoma.
  • Histology of FIGO grade 1-3 endometrioid endometrial carcinoma.
  • Medically inoperable per treating gynecologic oncologist.
  • Candidate for definitive radiation therapy as determined by treating radiation oncologist.
  • At least 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
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  • Participant must have adequate organ function, defined as follows:
  • Absolute neutrophil count ≥ 1,500/µL
  • Platelets ≥ 100,000/µL
  • Hemoglobin ≥ 9 g/dL; transfusion is allowed to meet this criterion
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance 60mL/min using the Cockcroft-Gault equation
  • Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
  • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
  • International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  • Participant receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Female participant has a negative serum pregnancy test the day of and prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):
  • ≥45 years of age and has not had menses for >1 year
  • Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation.
  • Post-bilateral oophorectomy, or post-tubal ligation. Documented oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 4.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents.
  • Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
  • Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Who cannot join

  • Any prior treatment for endometrial cancer or currently receiving chemotherapy for endometrial cancer.
  • Evidence of metastatic disease outside of the cervix or uterus as determined on CT or MRI.
  • A history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.
  • Previous treatment with an anti-PD-1, anti-PD-L1, or any PD-L2 drug.
  • 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.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to TSR-042 or other agents used in the study.
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  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry.
  • Participant must not be simultaneously enrolled in any interventional clinical trial
  • Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
  • Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
  • Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
  • 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.
  • Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
  • Participant has a diagnosis of immunodeficiency or has receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.
  • Participant has a known history of human immunodeficiency virus (type 1 or 2 antibodies).
  • Participant has known active hepatitis B (eg, hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (eg, hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
  • Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunomodulatory drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Participant must not have a history of interstitial lung disease.
  • Participant has received a live vaccine within 14 days of initiating protocol therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I Study of PD-1 Inhibition With TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer

Patients with inoperable endometrial cancer have limited treatment options. PD-L1 expression is common in endometrial cancers and RT induces tumor and systemic changes that induce the immune system. The purpose of this trial is to evaluate anti-PD-1/PD-L1 axis therapy in conjunction of standard of care RT for patients with inoperable endometrial cancer in order to establish the safety and efficacy of inducing an anti-tumor immune response.

Being tested
TSR-042, Brachytherapy, Endometrial biopsy, Blood draw for immune response
Keywords
Immune checkpoint inhibition, Radiation-induced immune response, CyTOF
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TSR-042Drug

    -TSR-042 is administered intravenously via a 30-minute (-5-minute/+15-minute infusion window allowed) infusion

  • BrachytherapyRadiation

    -This trial will include image-guided brachytherapy with three-dimensional (3-D) treatment planning and in cases where pelvic radiation is deemed appropriate by the treating radiation oncologist, external beam radiation therapy (EBRT) using intensity modulated radiation therapy (IMRT) technique.

  • Endometrial biopsyProcedure or surgery

    -Prior to the start of treatment with TSR-042. If this biopsy yields insufficient tumor tissue, an archival sample may be requested, with Fraction 1 of brachytherapy, with Fraction 4 of brachytherapy

  • Blood draw for immune responseProcedure or surgery

    -Prior to the start of any treatment, at the time of brachytherapy fractions 1 and 4 (corresponding to endometrial biopsy), prior to fourth dose of TSR-042, 6 weeks after the completion of all protocol related therapy

Study groups in NCT03955978
Study groupRoleWhat they receive
TSR-042 and BrachytherapyExperimental* 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)
Receives: Drug: TSR-042; Radiation: Brachytherapy; Procedure: Endometrial biopsy; Procedure: Blood draw for immune response

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of the regimen as measured by the grade of toxicities experienced as assessed by CTCAE v5.0

    Measured: Through 30 days after completion of treatment (estimated to be 10 weeks)

Secondary outcomes (1)

  1. Progression-free survival (PFS)

    PFS is defined as the time from last TSR-042 administration to disease progression or death. Response and progression will be evaluated in this study in a qualitative fashion by symptoms (such as bleeding, abdominal or pelvic pain, changes of bowel or bladder habits lasting more than two weeks), clinical exam and/or evidence of disease on imaging by RECIST 1.1 as not all patients will have measurable disease at baseline on imaging. Persistent/recurrent clinical disease will be confirmed by biopsy whenever possible.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study start15 Oct 2019
  3. Primary completion22 Mar 2024
  4. Study completion1 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955978
Sponsor's protocol ID
201907060
Status last verified
Jan 2026
First submitted
13 May 2019
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Acharya S, Esthappan J, Badiyan S, DeWees TA, Tanderup K, Schwarz JK, Grigsby PW. Medically inoperable endometrial cancer in patients with a high body mass index (BMI): Patterns of failure after 3-D image-based high dose rate (HDR) brachytherapy. Radiother Oncol. 2016 Jan;118(1):167-72. doi: 10.1016/j.radonc.2015.12.019. Epub 2015 Dec 29.

    PubMed 26743834

  • Sharabi AB, Lim M, DeWeese TL, Drake CG. Radiation and checkpoint blockade immunotherapy: radiosensitisation and potential mechanisms of synergy. Lancet Oncol. 2015 Oct;16(13):e498-509. doi: 10.1016/S1470-2045(15)00007-8.

    PubMed 26433823

  • Spiotto M, Fu YX, Weichselbaum RR. The intersection of radiotherapy and immunotherapy: mechanisms and clinical implications. Sci Immunol. 2016 Sep;1(3):EAAG1266. doi: 10.1126/sciimmunol.aag1266. Epub 2016 Sep 30.

    PubMed 28018989

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TSR-042, Brachytherapy and Endometrial biopsy in people with Endometrial Cancer and Cancer of the Endometrium, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of the regimen as measured by the grade of toxicities experienced as assessed by CTCAE v5.0 (time frame: Through 30 days after completion of treatment (estimated to be 10 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955978, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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