Editing Trials (Instituto Português de Oncologia de Coimbra Francisco Gentil)

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=== Trials: How to participate ===
'''Contact information:''' [https://www.ipocoimbra.min-saude.pt/category/investigacaoeformacao/investigacao/ Click here to access].


'''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 &amp; 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
<span style="display:none">hasCancerType::C00-D48: All neoplasms</span>
<span style="display:none">hasCancerType::C00-C97: All cancer types</span>
<span style="display:none">hasCancerType::C00-C14: Mouth/throat cancers</span>
<span style="display:none">hasCancerType::C15-C26: Digestive system cancers</span>
<span style="display:none">hasCancerType::C30-C39: Lung/chest cancers</span>
<span style="display:none">hasCancerType::C40-C41: Bone cancers</span>
<span style="display:none">hasCancerType::C43-C44: Skin cancers/melanoma</span>
<span style="display:none">hasCancerType::C45-C49: Soft tissue cancer</span>
<span style="display:none">hasCancerType::C50: Breast cancer</span>
<span style="display:none">hasCancerType::C51-C58: Female genitalia cancers</span>
<span style="display:none">hasCancerType::C60-C63: Male genitalia cancer</span>
<span style="display:none">hasCancerType::C64-C68: Urinary system cancers</span>
<span style="display:none">hasCancerType::C69-C72: Eye and brain cancer</span>
<span style="display:none">hasCancerType::C73-C75: Thyroid and other gland cancers</span>
<span style="display:none">hasCancerType::C76-C80: Cancers of unknown or unspecified areas</span>
<span style="display:none">hasCancerType::C81-C96: Cancers of the blood and immune system</span>
<span style="display:none">hasCancerType::C97-C97: Cancers in multiple locations from the start</span>
<span style="display:none">hasCancerType::D00-D09: Early-stage cancers not yet spread</span>
<span style="display:none">hasCancerType::D10-D36: Benign tumour</span>
<span style="display:none">hasCancerType::D37-D48: Growths of uncertain nature</span>
<span style="display:none">hasCancerType::unknown</span>
<span style="display:none">isTrial</span>