NCT03955978

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

Active, enrolled Phase 1 Last updated 6 January 2026

What this trial tests

Phase 1 trial testing TSR-042 in Endometrial Cancer in 10 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 October 2019

Primary endpoint
22 March 2024

1 February 2029

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	15 October 2019
Primary completion	22 March 2024
Estimated completion	1 February 2029
Sites	1 location across United States

Drugs / interventions tested

• TSR-042 — full drug profile →
• Brachytherapy — full drug profile →
• Endometrial biopsy
• Blood draw for immune response

Conditions studied

• Endometrial Cancer — all drugs for Endometrial Cancer →
• Cancer of the Endometrium — all drugs for Cancer of the Endometrium →

Sponsor

Washington University School of Medicine

Who can join

18 and older, female only, with Endometrial Cancer or Cancer of the Endometrium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiation-induced tumor immune microenvironments and potential targets for combination therapy.
   Guo S, Yao Y, Tang Y, Xin Z, et al · · 2023 · cited 136× · PMID 37208386 · DOI 10.1038/s41392-023-01462-z
2. Immunotherapy in endometrial cancer: rationale, practice and perspectives.
   Cao W, Ma X, Fischer JV, Sun C, et al · · 2021 · cited 79× · PMID 34134781 · DOI 10.1186/s40364-021-00301-z
3. Determinants of Sensitivity to Radiotherapy in Endometrial Cancer.
   Sorolla MA, Parisi E, Sorolla A. · · 2020 · cited 22× · PMID 32679719 · DOI 10.3390/cancers12071906
4. Dostarlimab an Inhibitor of PD-1/PD-L1: A New Paradigm for the Treatment of Cancer.
   Alkholifi FK, Alsaffar RM. · · 2022 · cited 17× · PMID 36363529 · DOI 10.3390/medicina58111572
5. Combination radiation and immunotherapy in gynecologic malignancies-a comprehensive review.
   Ladbury C, Germino E, Novak J, Liu J, et al · · 2021 · cited 6× · PMID 35116574 · DOI 10.21037/tcr-20-3019
6. Drug discovery in advanced and recurrent endometrial cancer: Recent advances.
   Francoeur AA, Ayoub N, Greenberg D, Tewari KS. · · 2025 · cited 4× · PMID 40612873 · DOI 10.32604/or.2025.061120
7. Accuracy of surveillance serum squamous cell carcinoma antigen for cervical cancer recurrence after definitive chemoradiation.
   Shi V, Grover S, Huang Y, Thaker PH, et al · · 2024 · cited 4× · PMID 38684343 · DOI 10.1136/ijgc-2024-005303
8. A working group report from the 2024 National Cancer Institute / Gynecologic Cancer Steering Committee endometrial cancer clinical trials planning meeting: refining the approach to endometrial cancer in the immunotherapy era.
   Cosgrove CM, Zamarin D, Conejo-Garcia JR, Hacker KE, et al · · 2025 · cited 3× · PMID 40211092 · DOI 10.1093/jnci/djaf089