A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients With Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers: A ComboMATCH Treatment Trial
This phase II ComboMATCH treatment trial compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of olaparib to selumetinib could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to selumetinib alone.
NCT05554328 — Recurrent Ovarian Carcinoma
Status: Recruiting
http://inclinicaltrials.com/recurrent-ovarian-carcinoma/NCT05554328/
A Phase IB and Randomized Phase II Trial of Megestrol Acetate With or Without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer
This phase Ib/II trial tests the safety, side effects, best dose, and effectiveness of the combination of ipatasertib with megestrol acetate to megestrol acetate alone in patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Megestrol acetate lowers the amount of estrogen and also blocks the use of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. The combination of ipatasertib and megestrol acetate may be more effective in treating endometrial cancer than megestrol acetate alone.
NCT05538897 — Stage IV Uterine Corpus Cancer AJCC v8
Status: Recruiting
http://inclinicaltrials.com/stage-iv-uterine-corpus-cancer-ajcc-v8/NCT05538897/
A Prospective Multicentre Phase III Randomised Open Clinical Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions
The purpose of this study is to compare the efficacy and toxicity of early stage endometrial cancer based on molecular classification and conventional risk stratification adjuvant therapy decision-making, and to provide high-quality evidence-based medical evidence for individualized adjuvant therapy selection under the guidance of fine stratification system of endometrial cancer.
NCT05524389 — Endometrial Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05524389/
Detection of Tumor DNA Through Cervical Smear and Liquid Biopsy in Endometrial Cancer Patients and Evaluation of Prognostic and Predictive Values of Tumor DNA Assay
Circulating tumor DNA (ctDNA) may help detect and prognosis-stratify patients with endometrial cancer. Both cervical swab-based genomic DNA (gDNA) and whole blood-based ctDNA can be utilized for this goal. Our objective is to utilize cervical swab and whole blood samples to analyze tumor-derived ctDNA from patients with endometrial cancer. These samples will be collected prospectively, and prior to staging operation. Samples from patients without cancer, who undergo hysterectomy for benign gynecological cause, will be utilized as controls. Variants called by next generation sequencing were classified into four-tiers based on ASCO/AMP system. These initially captured samples will be used to compare performance in terms of detection rate and to stratify patients based on the mutational profile. Additionally, in patients with advanced disease, we plan to collect whole blood samples every 3 months to assess any changes in mutational landscape. Clinical data including age, cormorbidities, treatment methods, date of diagnosis and recurrence, response evaluation for chemotherapy or radiotherapy, survival data will be used to contextualize our findings.
NCT05504161 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05504161/
18-fluorofuranylnorprogesterone (FFNP) Positron Emission Tomography-Magnetic Resonance Imaging (PET/MRI) as a Potential Biomarker of Response to Progesterone Therapy in Complex Atypical Hyperplasia (CAH) and Grade 1 Endometrial Cancer (EC)
Purpose: The purpose of this study is to evaluate FFNP PET/MRI's utility for predicting response to Levonorgestrel-releasing Intrauterine Device (LR-IUD) hormonal therapy for Complex Atypical hyperplasia (CAH) and Endometrial Cancer (EC). Participants: Eight women with histologically confirmed CAH or Grade 1 EC who have planned treatment with LR-IUD will be recruited.. Procedures (methods): The is a prospective, single arm, pilot study of 8 participants who will receive one FFNP PET/MRI scan. Medical records will be followed for 6 months.
NCT05483023 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05483023/
Evaluating the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for First-line Treatment of Patient With Advanced Endometrial Cancer or Sarcoma of Uterus: a Multi-center, Open-label, Randomized Controlled, Phase II Clinical Trial.
This study plans to enroll 69 subjects of endometrial cancer and 5-10 subjects of sarcoma of uterus. The experimental set is divided into lead-in trial and formal trial. The lead-in trial includes 9 subjects to observe the safety of the combination and determine the dosage of anlotinib dihydrochloride capsules before the formal phase. The formal trial includes 60 subjects of endometrial cancer and 5-10 subjects of sarcoma of uterus. The purpose is to evaluate efficacy and safety of TQB2450 injection combined with chemotherapy ± anlotinib hydrochloride capsules for first-line treatment and maintenance treatment of patient with advanced endometrial cancer or sarcoma of uterus, and explore biomarkers related to efficacy, mechanism of action, safety and/or pathological mechanisms, the surgical conversion rate. ORR is the primary endpoint.
NCT05481645 — Advanced Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/advanced-endometrial-cancer/NCT05481645/
A Performance Evaluation Study of Arquer Diagnostics Ltd's MCM5 ELISA (ADXGYNAE) Test to Aid in the Diagnosis of Endometrial Cancer
The objective of this multi-centre, prospective study, is to evaluate the performance of a urine MCM5 ELISA test (ADXGYNAE) in the detection of endometrial cancer in patients with postmenopausal bleeding. Patients attending a gynaecology clinic for investigation of postmenopausal bleeding will be recruited and asked to provide a urine sample to be tested. The results of the MCM5 test will be recorded and compared to the patient's routine investigations to determine the clinical utility of the test as an aid in the diagnosis of endometrial cancer.
NCT05287048 — Endometrial Cancer
Status: Recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT05287048/
Effect of a Uterine Manipulator on the Incidence of Lymphovascular Propagation (LVSI) in Treatment of Endometrial Cancer
We retrospectively analyzed data and compared the impact of intrauterine manipulators on incidence of LVSI in endometrial cancer patients treated at our department.
NCT05261165 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT05261165/
A Single-arm, Multicenter Phase II Clinical Trial to Evaluate TQB2858 Injection Combined With Anlotinib Hydrochloride Capsule in the Treatment of Recurrent or Metastatic Advanced Endometrial Cancer
A clinical trial to evaluate TQB2858 injection combined with Anlotinib Hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial carcinoma
NCT05121363 — Endometrial Carcinoma
Status: Not yet recruiting
http://inclinicaltrials.com/endometrial-carcinoma/NCT05121363/
A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer
This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol). Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors: - Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer) - ECOG score at baseline (0 vs 1) - Geographic region (Asia vs ROW)
NCT05077215 — Advanced Endometrial Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/advanced-endometrial-cancer/NCT05077215/