Why endometrial cancer trial monitoring is increasingly important
Endometrial cancer is the most common gynecologic malignancy in the United States, and incidence is rising. The treatment landscape has undergone a fundamental shift with the approval of pembrolizumab for dMMR/MSI-H tumors and the HER2-targeted regimen trastuzumab deruxtecan (T-DXd) in HER2-positive serous endometrial cancer.
With the live active and recruiting counts on this page, key areas to monitor include:
- HER2-targeted ADC and bispecific trials in serous and clear cell histologies
- dMMR/MSI-H immunotherapy combinations and maintenance strategies
- POLE-ultramutated subtype trials, a molecularly distinct group with excellent prognosis
- FGFR2 inhibitor trials in FGFR2-amplified endometrial cancer
- CDK4/6 inhibitors in hormone receptor-positive endometrial cancer
- Novel ADCs targeting FOLR1, MSLN, and endometrial-specific antigens
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Start Free: No Credit CardA primary completion date pushed out, enrollment cut, or a primary endpoint changed in the last 90 days. Active trials only.
| Trial | Warning signs | Status |
|---|---|---|
| A Study of Sofe-M in Participants With Selected Advanced Solid Tumors NCT06400472 | Primary completion moved at least 2 years 3 months later Primary endpoint(s) modified | Recruiting |
52 more on the Trials at Risk page. See which trials →
Phase 2 and Phase 3 trials with a primary completion date in the next 180 days, as ClinicalTrials.gov estimates it today. Active trials only.
| Trial | Scheduled | Phase |
|---|---|---|
| Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With… NCT04634877 | Nov 20, 2026 · Estimated | Phase 3 |
45 more on the Completions page. See the calendar →
What we monitor for endometrial cancer
Configure a search profile for endometrial cancer with the following options:
- Condition keywords: "endometrial cancer", "uterine cancer", "endometrial carcinoma", "uterine serous carcinoma", "endometrioid adenocarcinoma"
- Phase filter: Phase 1 for early pipeline visibility, Phase 2/3 for registration-enabling trials
- Sponsor filter: Industry-sponsored only, or all including academic and NCI-funded trials
- Status filter: Recruiting only, or all active studies
Phase 3 endometrial cancer trials (2025–2026)
The 2026 endometrial Phase 3 pipeline is primarily ADC- and immunotherapy-driven. Key programs actively recruiting or completing enrollment:
| Drug / Program | Sponsor | Mechanism / Target | Population |
|---|---|---|---|
| Trastuzumab deruxtecan (T-DXd) | AstraZeneca / Daiichi | HER2-directed ADC (topo-I payload) | HER2-positive serous endometrial (approved + expansion) |
| Datopotamab deruxtecan (Dato-DXd) | AstraZeneca / Daiichi | TROP2-directed ADC (topo-I payload) | Advanced/recurrent endometrial (TROPION-EndoMet) |
| Pembrolizumab + lenvatinib | MSD / Eisai | PD-1 + VEGFR TKI combination | pMMR/MSS advanced endometrial (KEYNOTE-775, approved; label expansions ongoing) |
| Dostarlimab + carboplatin/paclitaxel | GSK | PD-1 + chemotherapy | Advanced primary endometrial (RUBY trial: dMMR/pMMR) |
| Sacituzumab tirumotecan (MK-2870) | MSD | TROP2-directed ADC | Endometrial cancer Phase 3 expansion programs (2025–2026) |
| Upifitamab rilsodotin (UpRi) | Sutro Biopharma / Pieris | FOLR1-directed ADC (auristatin payload) | FOLR1-positive advanced/recurrent endometrial cancer |
The endometrial cancer treatment landscape
HER2-targeted therapies reshaping serous histology
Trastuzumab deruxtecan (T-DXd) approval in HER2-positive advanced endometrial cancer opened a new targeted therapy opportunity in a subtype historically lacking effective options. The trial space is now active with follow-on studies examining T-DXd combinations, novel HER2 bispecifics, and next-generation HER2 ADCs. Monitoring these registrations is essential for companies positioning assets in the gynecologic oncology space.
dMMR immunotherapy: combinations and maintenance
Pembrolizumab's approval in dMMR endometrial cancer established the checkpoint inhibitor standard. The current generation of trials is testing dual checkpoint combinations (PD-1 + CTLA-4, PD-1 + LAG-3), maintenance strategies after first-line therapy, and biomarker refinement to identify who benefits most from immunotherapy. These trials represent the next competitive frontier in MSI-H endometrial cancer.
Molecular subtype-driven precision oncology
The TCGA classification, POLE-ultramutated, MSI-H/dMMR, copy-number high (serous-like), and copy-number low, is driving subtype-specific trial design. POLE-mutant endometrial cancer has extraordinary rates of response to immunotherapy, and dedicated trials are now quantifying this benefit. Companies with molecular diagnostic platforms are following these trials closely.
ADCs targeting gynecologic antigens
FOLR1 (folate receptor alpha) is highly expressed in endometrial cancer, making it an attractive ADC target. Multiple FOLR1 ADC programs are in clinical development alongside agents targeting mesothelin, MSLN, and other gynecologic cancer antigens. Several trials opened in 2025–2026 and are actively recruiting.
Who uses endometrial cancer trial monitoring
Gynecologic oncology pharma and biotech teams
Companies developing assets in gynecologic cancers track endometrial trial activity to understand the competitive landscape, identify partnership opportunities, and monitor competitor pipeline progress in relevant molecular subtypes.
Academic gynecologic oncologists
Physician-researchers monitor new trial registrations to inform their own study designs, identify NCCN or clinical trial network studies relevant to their patient populations, and stay current with emerging treatment paradigms.
Oncology nurses and patient advocates
Patients diagnosed with advanced endometrial cancer frequently seek clinical trial options. Healthcare providers and advocates tracking available trials can connect patients with relevant studies at institutions near them.
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613 active trials, 357 recruiting.
Industry sponsors run 193 of these trials. The rest are run by universities, hospitals, government bodies and other non-commercial sponsors. The table below lists the 5 largest of 132.
| Top industry sponsor | Active trials |
|---|---|
| AstraZeneca | 13 |
| GlaxoSmithKline (GSK) | 10 |
| Eli Lilly and Company | 8 |
| Merck (MSD) | 6 |
| Daiichi Sankyo | 3 |
| Trial | Status | Latest tracked change | Seen |
|---|---|---|---|
| Single cEll pRofiling PErsistaNce To ImmuNothErapy NCT06680739 | Active, Not Recruiting | Final enrollment: 35 participants (planned 60) | 2026-11-14 |
| Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced… NCT06218914 | Active, Not Recruiting | Trial sites reduced: 18 → 12 locations | 2026-11-14 |
| A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors NCT06270706 | Recruiting | Trial sites expanded: 22 → 27 locations | 2026-11-13 |
| A Study of LY4175408 in Participants With Advanced Cancer NCT07046923 | Active, Not Recruiting | Trial sites reduced: 27 → 24 locations | 2026-11-13 |
| Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer NCT04683653 | Recruiting | Study completion pushed from Dec 20, 2026 to Dec 20, 2027 | 2026-11-13 |
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