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Endometrial Cancer clinical trials

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NCT ID: NCT06463028 Not yet recruiting - Endometrial Cancer Clinical Trials

Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer

Start date: September 30, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, randomized study to evaluate the efficacy and safety of sapanisertib and serabelisib (PIKTOR) with paclitaxel and the efficacy and safety of serabelisib with paclitaxel versus paclitaxel alone in participants with advanced or recurrent endometrial cancer.

NCT ID: NCT06457997 Not yet recruiting - Lung Cancer Clinical Trials

A Study of PHN-010 in Patients With Advanced Solid Tumors

Start date: July 2024
Phase: Phase 1
Study type: Interventional

This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-010, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.

NCT ID: NCT06440018 Not yet recruiting - Breast Cancer Clinical Trials

INSPIRE: A Multi-Cancer Early Detection Study

INSPIRE
Start date: June 20, 2024
Phase:
Study type: Observational

This research constitutes a multi-centric, case-control designed investigation aimed at developing and implementing a blinded validation of a machine learning-powered, multi-cancer early detection model. This is to be achieved through the prospective collection of blood specimens from newly diagnosed cancer patients and individuals devoid of a confirmed cancer diagnosis

NCT ID: NCT06409052 Not yet recruiting - Endometrial Cancer Clinical Trials

Endometrial Cancer, Risk Factors and Prevention Strategies: Perspectives of Patients and At-Risk Women

Start date: August 30, 2024
Phase:
Study type: Observational

To learn more about women's attitudes toward and knowledge about endometrial cancer and options that might decrease the risk of developing

NCT ID: NCT06385548 Not yet recruiting - Endometrial Cancer Clinical Trials

Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer

LiDer
Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Endometrial cancer is a prevalent gynecological malignancy, with a significant number of cases diagnosed at an advanced stage or recurring following initial treatment. Platinum-based chemotherapy represents a standard treatment option for these patients; however, disease progression often occurs, highlighting the need for novel therapeutic approaches. Lurbinectedin, a synthetic analog of marine alkaloid-derived compounds, and dostarlimab, a monoclonal antibody targeting PD-1, have demonstrated promising antitumor activity in various malignancies. This phase I-II clinical trial seeks to evaluate the safety, tolerability, and efficacy of combining lurbinectedin and dostarlimab in patients with advanced or recurrent endometrial cancer who have experienced disease progression following platinum-based chemotherapy. Primary Objectives: To determine the maximum tolerated dose (MTD) and recommended dose for further investigation of lurbinectedin and dostarlimab in combination therapy for advanced or recurrent endometrial cancer. To assess the antitumor activity of lurbinectedin and dostarlimab combination therapy, measured by objective response rate (ORR), in patients with advanced or recurrent endometrial cancer. Secondary Objectives: To evaluate the safety and tolerability of lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer. To characterize the pharmacokinetic profile of lurbinectedin and dostarlimab when administered in combination therapy. To explore pharmacogenomic biomarkers predictive of response and/or resistance to lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer. To assess progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and overall survival (OS) in patients receiving lurbinectedin and dostarlimab combination therapy for advanced or recurrent endometrial cancer. To investigate the impact of lurbinectedin and dostarlimab combination therapy on quality of life and symptom control in patients with advanced or recurrent endometrial cancer.

NCT ID: NCT06366347 Not yet recruiting - Endometrial Cancer Clinical Trials

ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab

Start date: September 2024
Phase: Phase 2
Study type: Interventional

A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together followed by pembrolizumab maintenance for two years. This treatment regimen has shown benefit in terms of delaying cancer progression in prior clinical trials, but the benefit of the pembrolizumab maintenance treatment and whether all participants need it is unclear. This research is being done on the maintenance portion of treatment to compare the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone following chemotherapy and pembrolizumab. The names of the study drugs involved in this study are: - Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor) - Letrozole (a type of aromatase inhibitor) - Pembrolizumab (a type of monoclonal antibody)

NCT ID: NCT06360653 Not yet recruiting - Endometrial Cancer Clinical Trials

a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer

SISTER-RAY
Start date: June 2024
Phase: N/A
Study type: Interventional

The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer

NCT ID: NCT06340568 Not yet recruiting - Endometrial Cancer Clinical Trials

A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer

Start date: August 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to assess the efficacy of BNT323/DB-1303 compared with investigator's choice of chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the endometrial cancer population.

NCT ID: NCT06297811 Not yet recruiting - Breast Cancer Clinical Trials

Myeloprotection With Trilaciclib in Pan-cancer Population

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this open-label randomized controlled study is to assess the myeloprotective effect of trilaciclib in pan-cancer population. The main questions it aims to answer are: - effect and safety of trilaciclib on myeloprotection in cancer patients receiving paclitaxel plus carboplatin chemotherapy - does trilaciclib 's myeloprotective efficacy in patients receiving the same chemotherapy regimen correlate with tumor type Participants will be randomized 2:1 to the treatment arm of trilaciclib in combination with a paclitaxel and carboplatin-based regimen and the control arm of a paclitaxel and carboplatin-based regimen for at least 6 cycles or until disease progression or intolerable toxicity. Patients in both groups could extend the chemotherapy cycle at the investigator 's discretion depending on the tumor type and in combination with anti-angiogenic/PD-X/anti-HER2 therapy.

NCT ID: NCT06284343 Not yet recruiting - Ovarian Cancer Clinical Trials

Development and Validation of a Risk Prediction Model for Venous Thromboembolism in Gynecological Cancer Patients Undergoing Systemic Antineoplastic Treatment: The Gynecological Cancer Associated Thrombosis (GynCAT) Study

GynCAT
Start date: April 1, 2024
Phase:
Study type: Observational

Cancer patients are burdened by an increased risk of venous thromboembolism (VTE), which has a significant impact on morbidity and mortality. Existing Risk Prediction Models (RPMs), including the widely accepted Khorana Risk Score (KRS), have some limitations when used in certain tumor site populations, such as gynecological cancers. Notably, gynecological patients exhibit a variable risk of VTE based on their specific tumor sites, with ovarian cancer representing the highest risk. Moreover, currently available RPMs lack validation in a broad gynecological population and may fail to effectively stratify VTE risk. GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment. During the screening phase, symptomatic VTE will be excluded, and KRS will be assessed. Pharmacological thromboprophylaxis will be considered and prescribed at clinical judgement, for patients with a KRS score of 3 or higher. Clinical, hematological, biochemical, coagulation, and genetic variables will be collected. Follow-up will last for the entire duration of the antineoplastic treatment line, and VTE events, bleeding events, and mortality will be recorded. The primary objective is the development and validation of an RPM for VTE in gynecologic cancer patients undergoing systemic antineoplastic treatment. Secondary objectives are evaluation of the predictive value of the identified model, comparing it with existing general oncology RPMs; assessment of its performance in predicting mortality; evaluation of VTE incidence in patients with KRSā‰„3 receiving thromboprophylaxis; identification of risk factors for bleeding in this patient population. The sample size calculation is based on an estimated VTE incidence of 5% over a mean follow-up of 12 months. Hence, a sample size of at least 1,200 patients in the derivation cohort is considered sufficient for the determination of a risk prediction model incorporating up to six predictor variables. A split-sample method will be used, with two-thirds of the study participants randomly assigned to the model derivation cohort (n=1,200) and one-third (n=600) to an independent validation cohort. The total number of patients recruited in the study will thus be of 1,800. A competing risk survival analysis with Fine & Gray model will be used to study the association between prognostic variables and VTE occurrence, considering death as a competitive risk. The RPM will be identified through a bootstrap approach to reduce the risk of overfitting. Discrimination power of the RPM will be assessed using time-dependent Receiving Operating Characteristic curve, and model calibration will be evaluated graphically and with the calculation of relative calibration slopes. In conclusion, this prospective cohort study aims to overcome the limitations of current RPMs in gynecologic cancer patients, improving the accuracy of VTE risk stratification in this population.