✦ Cancer Clinical Trials

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Endometrial Cancer

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Jul 13 – Jul 20, 2026

Surgical window of opportunity clinical trial of abemaciclib and letrozole for endometrioid adenocarcinoma of the endometrium.
GYNECOL ONCOL · Q1 JOURNAL - RANK #11/140
Investigators conducted a single-arm prospective multicenter surgical window of opportunity clinical trial to assess abemaciclib and letrozole for endometrioid adenocarcinoma of the endometrium. Patients planned for hysterectomy received abemaciclib 150 mg twice daily plus letrozole 2.5 mg once daily for 14 days. Mean Ki-67 was reduced from 34% to 19% (SD 23%, p < 0.001) in 25 evaluable patients, with no serious adverse events. These results suggest that short-term neoadjuvant abemaciclib and letrozole can reduce tumor proliferation in endometrioid endometrial cancer.
10.1016/j.ygyno.2026.07.001

Jul 06 – Jul 13, 2026

Quality of life and patient-reported outcomes after non-surgical management of early-stage endometrial cancer and endometrial hyperplasia with atypia: a long-term follow-up of the feMMe phase II randomized clinical trial.
INT J GYNECOL CANCER · Q1 JOURNAL - RANK #8/140
This prospective, open-label, randomized phase II trial evaluated long-term quality of life, self-efficacy, social support, and patient-reported experiences following fertility-sparing, non-surgical management of early-stage endometrial adenocarcinoma and endometrial hyperplasia with atypia. Participants were randomized to one of three arms: levonorgestrel intra-uterine device alone, levonorgestrel intra-uterine device plus weight loss, or levonorgestrel intra-uterine device plus metformin, and followed for a median of 63 months. Among 44 patients, overall quality of life was high (mean FACT-General total score = 80.5 ± 16.4), with higher self-efficacy for physical activity among those achieving complete response at trial completion (p = .002). The authors concluded that long-term patient-reported outcomes were favorable, supporting non-surgical, fertility-preserving approaches and highlighting the importance of survivorship-focused outcomes in shared treatment decision-making.
10.1016/j.ijgc.2026.104806

Jun 29 – Jul 06, 2026

Poly(adenosine diphosphate-ribose) polymerase inhibitor maintenance therapy with niraparib in patients with primary advanced or recurrent endometrial cancer receiving dostarlimab plus chemotherapy.
INT J GYNECOL CANCER · Q1 JOURNAL - RANK #8/140
The phase-3 ENGOT-EN6-NSGO/GOG-3031/RUBY Part 2 trial randomized 291 patients with primary advanced or recurrent endometrial cancer 2:1 to receive dostarlimab + carboplatin-paclitaxel followed by niraparib + dostarlimab maintenance versus placebo-based chemotherapy and maintenance. This prospective, controlled clinical trial evaluated progression-free survival (PFS; primary endpoint) in the overall and mismatch-repair-proficient/microsatellite-stable (MMRp/MSS) populations, with overall survival (OS) and safety as secondary outcomes, over 22–36.2 months’ follow-up. Niraparib + dostarlimab reduced risk of progression or death by 40 % in the overall cohort (HR 0.60, 95 % CI 0.43–0.82; p<0.001) and 37 % in MMRp/MSS patients (HR 0.63, 95 % CI 0.44–0.91; p=0.006), but did not improve OS (HR 1.2, 95 % CI 0.81–1.78). Higher grade ≥3 treatment-related adverse events (70.7 % vs 37.5 %) and discontinuations (38.7 % vs 11.5 %) occurred with niraparib, leading authors to conclude that while PFS benefits are meaningful, dostarlimab + chemotherapy remains the only regimen with proven OS advantage.
10.1016/j.ijgc.2026.104774

Jun 22 – Jun 29, 2026

Cediranib with weekly paclitaxel or olaparib versus weekly paclitaxel for advanced or recurrent endometrial cancer (COPELIA): a multicentre, open-label, randomised, phase 2 trial in the UK.
ECLINICALMEDICINE · Q1 JOURNAL - RANK #11/332
This UK multicentre, open-label, randomised phase 2 trial (COPELIA) compared cediranib + weekly paclitaxel (arm 2) or cediranib + olaparib (arm 3) with weekly paclitaxel alone (arm 1) in 124 patients with advanced or recurrent endometrial cancer previously treated with platinum-based chemotherapy. Patients received up to six 28-day cycles of paclitaxel; responders in arm 2 continued cediranib maintenance. At 3 months, progression-free survival (PFS) was higher with cediranib + paclitaxel than control (73.2 % vs 48.8 %; adjusted OR 3.2, one-sided 80 % CI lower limit 2.1; p = 0.01) and RECIST response rates were 56.4 % versus 28.2 % (adjusted OR 5.7, 95 % CI 1.8–17.6; p < 0.001); no improvements were seen for cediranib + olaparib. Median overall survival was 18.1 months in arm 2 versus 12.8 months in control (p = 0.42). The combination improved short-term PFS and response but conferred no durable PFS or OS benefit, and increased hypertension, neutropenia and diarrhoea, suggesting further biomarker-guided evaluation is required.
10.1016/j.eclinm.2026.104012

Gonadotropin-releasing hormone agonist plus aromatase inhibitor versus oral progestins for fertility-sparing treatment in early endometrial carcinoma and atypical hyperplasia: interim analysis of a prospective controlled trial.
INT J GYNECOL CANCER · Q1 JOURNAL - RANK #8/140
This prospective, open-label, randomized non-inferiority clinical trial compared a gonadotropin-releasing hormone agonist plus letrozole (Arm A) versus oral progestins (Arm B) for fertility-sparing treatment in early endometrial carcinoma or atypical endometrial hyperplasia. In a pre-specified interim analysis (data cutoff March 17, 2025), 131 patients completing 24 weeks (Arm A n=67; Arm B n=64) were analyzed; 24-week complete response was higher with Arm A (98.5% vs 68.8%; OR 30.00, 95% CI 3.88–231.71, p<.001) and time to response shorter (127.48 vs 185.30 days; mean difference 57.8 days, 95% CI 32.97–82.66, p<.001). Pregnancy (53.1% vs 35.7%, p=.14) and recurrence (6.1% vs 12.3%, p=.19) did not differ significantly, while weight gain was less with Arm A (21.9% vs 43.9%, p=.012) but menopausal symptoms were higher. The regimen met non-inferiority and showed superior complete response, supporting continued investigation pending final results.
10.1016/j.ijgc.2026.104718

Jun 15 – Jun 22, 2026

No prognostic role for FIGO grading in mismatch repair deficient endometrial carcinoma.
EUR J CANCER · Q1 JOURNAL - RANK #45/326
This pooled analysis evaluated the prognostic role of FIGO grading in mismatch repair deficient (MMRd) endometrial carcinoma using data from three randomized trials (PORTEC-1, -2, -3) and five clinical cohorts, totaling 730 MMRd cases. The study was prospective in design, as it derived from interventional trials and clinical cohorts with central pathology review. Key findings showed no difference in five-year recurrence (18.0% vs. 18.8%, p=0.67) or cancer-specific death (12.3% vs. 14.2%, p=0.44) between low- and high-grade MMRd tumors. The authors conclude FIGO grading has no independent prognostic value and may be omitted from risk stratification.
10.1016/j.ejca.2026.116885

Jun 08 – Jun 15, 2026

Circulating immune cell profiling in advanced cervical and endometrial cancer patients treated with PD-1 blockade, radiotherapy, and immune modulation in the PRIMMO trial.
FRONT IMMUNOL · Q1 JOURNAL - RANK #32/183
This exploratory translational study of the PRIMMO clinical trial (NCT03192059) prospectively analyzed blood-based immune profiles from 19 advanced cervical cancer (CC) and 24 endometrial cancer (EC) patients treated with an ICB-based regimen combining PD-1 blockade, radiotherapy, and immune modulation. Peripheral blood was collected at baseline, on-treatment (week 7), and post-treatment (week 26 or earlier) and assessed via multicolor flow cytometry and ELISA. Key findings include that CTLA-4+PD-1+CD4+ T cells and CD161+CD56+CD16+ NK cells at baseline were associated with survival, while responders showed stable immune profiles and non-responders exhibited sustained decreases in pDCs, increases in activation markers (CD69, CD137, HLA-DR) on T cells and NK cells, expansion of MDSCs and Tregs, elevated kynurenine/tryptophan ratio, and increased sPD-1 levels. The authors conclude that non-response is characterized by systemic immune imbalance rather than inactivity, supporting longitudinal immune monitoring in future trials.
10.3389/fimmu.2026.1794131

May 25 – Jun 01, 2026

Four-year survival outcomes with dostarlimab plus chemotherapy in mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer in the RUBY trial.
GYNECOL ONCOL · Q1 JOURNAL - RANK #11/140
This is a prospective, randomized, double-blind, placebo-controlled Phase 3 clinical trial (RUBY, NCT03981796) evaluating dostarlimab plus carboplatin-paclitaxel (CP) versus placebo plus CP in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer. With a median follow-up of 55.6 months, the study reports descriptive analyses of overall survival (OS) and progression-free survival (PFS), plus post-hoc conditional survival and mixture cure model (MCM) analyses to estimate curative potential. Key findings include a 66% reduction in risk of death, median PFS and OS not reached, and a 54% (95% CI 35%-72%) cure rate estimated by MCM at 4 years with dostarlimab plus CP. The authors conclude that dostarlimab plus CP demonstrates sustained remission and long-term survival benefit, suggesting potential for curative intent in this patient population.
10.1016/j.ygyno.2026.05.008

Molecular classification and association with survival outcomes in high-intermediate and high-risk early-stage endometrial cancers: Ancillary analysis of GOG-0249.
GYNECOL ONCOL · Q1 JOURNAL - RANK #11/140
The study aimed to determine whether mismatch repair (MMR) and p53 expression predict recurrence-free survival (RFS) and overall survival (OS) in early-stage endometrial cancer (EC) patients treated with vaginal cuff brachytherapy plus chemotherapy (VCB/C) versus pelvic radiation therapy (RT). In the GOG-0249 trial, 601 patients with high-intermediate risk (HIR) early-stage EC were randomized to VCB/C or pelvic RT, with molecular subgroups analyzed by immunohistochemistry. Five-year RFS and OS were worse in patients with p53abn cancers (58.7% RFS, HR=4.0; 70.7% OS, HR=9.4) and dMMR cancers (74.4% RFS, HR=1.8; 84.3% OS, HR=3.0) compared to p53wt (83.4% RFS, 95.3% OS). Molecular classification was prognostic for survival, but treatment outcomes did not differ by molecular subgroup, highlighting the need for novel therapies for high-risk patients.
10.1016/j.ygyno.2026.05.013