Trials (Instituto Português de Oncologia de Coimbra Francisco Gentil)

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NCTID: NCT04459715

Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) 
Study Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). 
Sponsor: EMD Serono Research & Development Institute, Inc. 
Intervention: Xevinapant (Debio 1143) 
Start Date: 2020-08-07 
Last Updated: 2023-10-24 
Number of Patients: 730 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Squamous Cell Carcinoma of the Head and Neck 

NCTID: NCT04534205

Title: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 
Study Summary: An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1.  This trial has two parts.  Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.  Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1.  For Part B, an optional pre-screening phase is available for all patients where patients’ tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial. 
Sponsor: BioNTech SE 
Intervention: BNT113 
Start Date: 2021-01-07 
Last Updated: 2023-11-15 
Number of Patients: 285 
Recruitment Status: RECRUITING 
Condition: Unresectable Head and Neck Squamous Cell Carcinoma 

NCTID: NCT03395197

Title: Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC 
Study Summary: This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. 
Sponsor: Pfizer 
Intervention: Talazoparib with enzalutamide 
Start Date: 2017-12-18 
Last Updated: 2023-08-02 
Number of Patients: 1125 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: mCRPC 

NCTID: NCT01125566

Title: LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment 
Study Summary: To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment 
Sponsor: Boehringer Ingelheim 
Intervention: BIBW 2992 
Start Date: 2010-06-22 
Last Updated: 2019-07-18 
Number of Patients: 508 
Recruitment Status: COMPLETED 
Condition: Breast Neoplasms 

NCTID: NCT02603432

Title: A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) 
Study Summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy. 
Sponsor: Pfizer 
Intervention: Avelumab 
Start Date: 2016-04-25 
Last Updated: 2023-06-06 
Number of Patients: 700 
Recruitment Status: COMPLETED 
Condition: Urothelial Cancer 

NCTID: NCT05089734

Title: Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) 
Study Summary: The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC). 
Sponsor: Gilead Sciences 
Intervention: Sacituzumab Govitecan-hziy (SG) 
Start Date: 2021-11-17 
Last Updated: 2023-06-29 
Number of Patients: 580 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-Small Cell Lung Cancer

hasCancerType::C00-D48: All neoplasms hasCancerType::C00-C97: All cancer types hasCancerType::C00-C14: Mouth/throat cancers hasCancerType::C15-C26: Digestive system cancers hasCancerType::C30-C39: Lung/chest cancers hasCancerType::C40-C41: Bone cancers hasCancerType::C43-C44: Skin cancers/melanoma hasCancerType::C45-C49: Soft tissue cancer hasCancerType::C50: Breast cancer hasCancerType::C51-C58: Female genitalia cancers hasCancerType::C60-C63: Male genitalia cancer hasCancerType::C64-C68: Urinary system cancers hasCancerType::C69-C72: Eye and brain cancer hasCancerType::C73-C75: Thyroid and other gland cancers hasCancerType::C76-C80: Cancers of unknown or unspecified areas hasCancerType::C81-C96: Cancers of the blood and immune system hasCancerType::C97-C97: Cancers in multiple locations from the start hasCancerType::D00-D09: Early-stage cancers not yet spread hasCancerType::D10-D36: Benign tumour hasCancerType::D37-D48: Growths of uncertain nature hasCancerType::unknown