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

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=== Trials: How to participate ===
'''Contact information:''' [https://www.ipolisboa.min-saude.pt/centroinvestigacao/unidade-de-investigacao-clinica/ Click here to access].


'''NCTID''': NCT04410445 
 '''Title''': Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence 
 '''Study Summary''': The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence. 
 '''Sponsor''': Nektar Therapeutics 
 '''Intervention''': Bempegaldesleukin 
 '''Start Date''': 2020-07-27 
 '''Last Updated''': 2023-04-21 
 '''Number of Patients''': 765 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Melanoma 
'''NCTID''': NCT00312845 
 '''Title''': Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma 
 '''Study Summary''': The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below. 
 '''Sponsor''': Millennium Pharmaceuticals, Inc. 
 '''Intervention''': Bortezomib + Rituximab 
 '''Start Date''': 2006-03 
 '''Last Updated''': 2012-06-25 
 '''Number of Patients''': 676 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Non-Hodgkin’s Lymphoma 
'''NCTID''': NCT02692339 
 '''Title''': Safety Study of Lenalidomide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple Myeloma 
 '''Study Summary''': Multicentre, prospective, observational, open-label, single arm, post-marketing study intended to record Lenalidomide/Dexamethasone treatment data from patients with relapsed/refractory Multiple Myeloma (rrMM) treated under the settings defined by the standard clinical practice and approved Summary of Product Characteristics (SmPC). 
 '''Sponsor''': Celgene 
 '''Intervention''': Lenalidomide 
 '''Start Date''': 2016-02-25 
 '''Last Updated''': 2022-06-30 
 '''Number of Patients''': 22 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Multiple Myeloma 
'''NCTID''': NCT00849667 
 '''Title''': Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse 
 '''Study Summary''': This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer. 
 '''Sponsor''': Morphotek 
 '''Intervention''': Farletuzumab 
 '''Start Date''': 2009-04-16 
 '''Last Updated''': 2022-12-30 
 '''Number of Patients''': 1100 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Ovarian Cancer 
'''NCTID''': NCT02513394 
 '''Title''': PALbociclib CoLlaborative Adjuvant Study 
 '''Study Summary''': This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC).  The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned. 
 '''Sponsor''': Alliance Foundation Trials, LLC. 
 '''Intervention''': Palbociclib 
 '''Start Date''': 2015-08 
 '''Last Updated''': 2023-06-15 
 '''Number of Patients''': 5796 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT01808573 
 '''Title''': A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting 
 '''Study Summary''': This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. 
 '''Sponsor''': Puma Biotechnology, Inc. 
 '''Intervention''': neratinib 
 '''Start Date''': 2013-03-29 
 '''Last Updated''': 2021-06-11 
 '''Number of Patients''': 621 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': HER2+ Metastatic Breast Cancer (MBC) 
'''NCTID''': NCT01763164 
 '''Title''': Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma 
 '''Study Summary''': Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival 
 '''Sponsor''': Pfizer 
 '''Intervention''': MEK162 
 '''Start Date''': 2013-07-12 
 '''Last Updated''': 2021-03-22 
 '''Number of Patients''': 402 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Metastatic or Unresectable Cutaneous Melanoma 
'''NCTID''': NCT01909453 
 '''Title''': Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma 
 '''Study Summary''': This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.  Part 1:  Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:  # LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or # vemurafenib 960 mg BID (denoted as vemurafenib arm)  Part 2:  Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:  # LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) 
 '''Sponsor''': Pfizer 
 '''Intervention''': LGX818 
 '''Start Date''': 2013-12-13 
 '''Last Updated''': 2023-09-07 
 '''Number of Patients''': 921 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Melanoma 
'''NCTID''': NCT04961996 
 '''Title''': A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) 
 '''Study Summary''': This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.  In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Giredestrant 
 '''Start Date''': 2021-08-27 
 '''Last Updated''': 2023-11-18 
 '''Number of Patients''': 4200 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Early Breast Cancer 
'''NCTID''': NCT04793919 
 '''Title''': Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia 
 '''Study Summary''': The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age. 
 '''Sponsor''': Associazione Italiana Ematologia Oncologia Pediatrica 
 '''Intervention''': Mylotarg 
 '''Start Date''': 2019-10-09 
 '''Last Updated''': 2022-08-10 
 '''Number of Patients''': 89 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Acute Promyelocytic Leukemia 
'''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''': NCT04622319 
 '''Title''': A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) 
 '''Study Summary''': Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy. 
 '''Sponsor''': Daiichi Sankyo, Inc. 
 '''Intervention''': DS-8201a 
 '''Start Date''': 2020-12-04 
 '''Last Updated''': 2023-11-07 
 '''Number of Patients''': 1600 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': HER2-Positive Primary Breast Cancer 
'''NCTID''': NCT03773302 
 '''Title''': Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations 
 '''Study Summary''': Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin. 
 '''Sponsor''': QED Therapeutics, Inc. 
 '''Intervention''': BGJ398 
 '''Start Date''': 2019-12-27 
 '''Last Updated''': 2023-04-03 
 '''Number of Patients''': 48 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Advanced Cholangiocarcinoma 
'''NCTID''': NCT04307576 
 '''Title''': A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia 
 '''Study Summary''': ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design. 
 '''Sponsor''': Mats Heyman 
 '''Intervention''': Omitted Doxorubicin 
 '''Start Date''': 2020-07-13 
 '''Last Updated''': 2023-11-21 
 '''Number of Patients''': 6430 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Leukemia, Acute Lymphoblastic 
'''NCTID''': NCT05270044 
 '''Title''': Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. 
 '''Study Summary''': The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance). 
 '''Sponsor''': Pierre Fabre Medicament 
 '''Intervention''': Encorafenib and Binimetinib 
 '''Start Date''': 2022-05-02 
 '''Last Updated''': 2023-11-22 
 '''Number of Patients''': 815 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Melanoma
<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>