Editing Trials (Istituto Nazionale Tumori -IRCCS Fondazione G.Pascale)

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'''NCTID''': NCT03771456 
 '''Title''': Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery 
 '''Study Summary''': Prospective observational multicenter study on the influence of adherence to enhanced recovery pathways on early outcomes (anastomotic leakage, morbidity, mortality, readmission, reoperation rates and length of postoperative stay) after elective colorectal surgery in Italy. 
 '''Sponsor''': Ospedale C &amp; G Mazzoni 
 '''Intervention''': Colorectal resections 
 '''Start Date''': 2019-01-07 
 '''Last Updated''': 2018-12-11 
 '''Number of Patients''': 1748 
 '''Recruitment Status''': UNKNOWN 
 '''Condition''': Colorectal Neoplasms 
'''NCTID''': NCT04460807 
 '''Title''': Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer 
 '''Study Summary''': In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment.  The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS). 
 '''Sponsor''': Ente Ospedaliero Ospedali Galliera 
 '''Intervention''': Exemestane 
 '''Start Date''': 2020-02-13 
 '''Last Updated''': 2020-07-08 
 '''Number of Patients''': 468 
 '''Recruitment Status''': UNKNOWN 
 '''Condition''': Ovarian Cancer 
'''NCTID''': NCT04383119 
 '''Title''': Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma 
 '''Study Summary''': Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator.  In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option.  In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype. 
 '''Sponsor''': Italian Sarcoma Group 
 '''Intervention''': Trabectedin 
 '''Start Date''': 2021-10-29 
 '''Last Updated''': 2023-09-13 
 '''Number of Patients''': 100 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Leiomyosarcoma of Ovary 
'''NCTID''': NCT02155647 
 '''Title''': Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) 
 '''Study Summary''': This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC). 
 '''Sponsor''': EMD Serono Research &amp; Development Institute, Inc. 
 '''Intervention''': Avelumab 
 '''Start Date''': 2014-07-03 
 '''Last Updated''': 2023-06-05 
 '''Number of Patients''': 204 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Carcinoma, Merkel Cell 
'''NCTID''': NCT05818865 
 '''Title''': “Principle Test” for Isolation and Characterization of Circulating Cancer Cells (CTC)-CXCR4+. 
 '''Study Summary''': This is multicentric, interventional, non farmacological and prospective study. 
 '''Sponsor''': National Cancer Institute, Naples 
 '''Intervention''': CLG 
 '''Start Date''': 2021-01-18 
 '''Last Updated''': 2023-10-30 
 '''Number of Patients''': 47 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Neoplasm Malignant 
'''NCTID''': NCT04464226 
 '''Title''': Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer 
 '''Study Summary''': The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor’s visits as often as they did in the previous study. 
 '''Sponsor''': Bayer 
 '''Intervention''': Darolutamide (Nubeqa, BAY1841788) 
 '''Start Date''': 2020-10-20 
 '''Last Updated''': 2023-11-18 
 '''Number of Patients''': 678 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Cancer 
'''NCTID''': NCT03224208 
 '''Title''': Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients 
 '''Study Summary''': In the BRIM-3 trial, which was conducted in patients with previously untreated advanced melanoma harboring the BRAF V600E mutation, vemurafenib, a potent inhibitor of mutated BRAF, was associated with prolonged overall survival (OS) and progression-free survival (PFS) compared to dacarbazine. In the same setting, combined use of vemurafenib and cobimetinib, a selective inhibitor of MEK, yielded a significant improvement in PFS and response rate, compared to vemurafenib monotherapy, along with an advantage in OS, which did not cross the pre-specified significance bounderies (COBRIM trial). In treatment-naïve patients with mutated BRAF, both anti PD-1-based immunotherapy and BRAF-targeted agents are feasible therapeutic options, with the former and latter agents being associated with more durable and earlier responses, respectively.  As suggested by National Comprehensive Cancer Network (NCCN) guidelines, the use of combined BRAF and MEK inhibitors in patients with progressive disease after immunotherapy, is also feasible, but it is not supported by category 1 evidence, in view of the lack of studies conducted in this setting.  The main objective of this phase II trial is to evaluate the efficacy and safety of the combined use of vemurafenib plus cobimetinib in advanced melanoma patients who have received first-line systemic immunotherapy for inoperable locally advanced / metastatic disease. 
 '''Sponsor''': Fondazione Melanoma Onlus 
 '''Intervention''': Vemurafenib 
 '''Start Date''': 2018-05-17 
 '''Last Updated''': 2021-04-26 
 '''Number of Patients''': 9 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Melanoma 
'''NCTID''': NCT02238509 
 '''Title''': Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies 
 '''Study Summary''': Recent clinical studies have shown that the combination of lapatinib and trastuzumab has superior antitumor activity compared to either single drug in both neoadjuvant and metastatic setting and is well tolerated. According to this evidence, the combination of lapatinib and trastuzumab today offers a valid chemotherapy-free option, primarily for patients with pre-treated HER2-positive MBC 
 '''Sponsor''': Consorzio Oncotech 
 '''Intervention''': Lapatinib 
 '''Start Date''': 2014-11 
 '''Last Updated''': 2016-06-15 
 '''Number of Patients''': 154 
 '''Recruitment Status''': UNKNOWN 
 '''Condition''': Metastatic Breast Cancer 
'''NCTID''': NCT05794906 
 '''Title''': A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies 
 '''Study Summary''': Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer.  BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat.  In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments.  The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months.  To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells.  To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy.  During the study, the study team will:  * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems  About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. 
 '''Sponsor''': Bayer 
 '''Intervention''': Darolutamide (BAY1841788, Nubeqa) 
 '''Start Date''': 2023-04-03 
 '''Last Updated''': 2023-11-28 
 '''Number of Patients''': 750 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Biochemically Recurrent Prostate Cancer 
'''NCTID''': NCT01412307 
 '''Title''': A Phase 1/2 Study of Lenalidomide in Combination With Bendamustine in Relapsed and Primary Refractory Hodgkin Lymphoma 
 '''Study Summary''': Management of patients with recurring Hodgkin lymphoma (HL) after stem cell transplantation failure represents a typical unmet medical need prompting active development and validation of new agents and treatment strategies. The LEBEN protocol combines two agents, lenalidomide and bendamustine, framing different targets on both tumor and microenvironmental cells of HL. These agents, while showing a low risk of overlapping extrahematologic toxicities, may hit the proliferation machinery of H-RS cells and/or their progenitors, synergistically inhibit tumor-related angiogenesis and interfere on cytokine-mediate circuitries operating in the microenvironment to support tumor cell survival.  A weekly schedule of bendamustine, at 60 mg/m2, is combined with the continuous administration of increasing dose of lenalidomide (10, 15, 20 e 25 mg dose levels in a 28-day cycle). Such schedule of Bendamustine is aimed at enhancing the antiangiogenic and immunomodulatory activity of continuous Lenalidomide, as studies have shown that low and protracted doses of alkylators induce a decrease in microvascular density of tumor tissues and inhibit mobilization and viability of circulating endothelial progenitors.  The Bayesian phase 1/2 dose finding method of Thall and Cook was employed. This method chooses doses based-on both response and toxicity, and accounts for the trade-off between these two outcomes. 
 '''Sponsor''': Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale 
 '''Intervention''': Lenalidomide 
 '''Start Date''': 2011-07 
 '''Last Updated''': 2015-08-11 
 '''Number of Patients''': 36 
 '''Recruitment Status''': UNKNOWN 
 '''Condition''': Recurrent Adult Hodgkin Lymphoma 
'''NCTID''': NCT02043730 
 '''Title''': Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer. 
 '''Study Summary''': Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management.  Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients. 
 '''Sponsor''': Gruppo Italiano per lo studio dei Carcinomi dell’Apparato Digerente 
 '''Intervention''': Nab-paclitaxel and Gemcitabine 
 '''Start Date''': 2014-01 
 '''Last Updated''': 2019-10-09 
 '''Number of Patients''': 124 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Pancreatic Cancer Stage II 
'''NCTID''': NCT01959633 
 '''Title''': Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation 
 '''Study Summary''': The hypothesis of this study is to evaluate the safety and the efficacy of Vemurafenib/PEG-interferon combination and the IFNAR1 upregulation lead by this treatment. 
 '''Sponsor''': Fondazione Melanoma Onlus 
 '''Intervention''': Vemurafenib 
 '''Start Date''': 2014-04-03 
 '''Last Updated''': 2022-02-24 
 '''Number of Patients''': 11 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Melanoma 
'''NCTID''': NCT02175446 
 '''Title''': Safety and Efficacy Study of Eribulin in Combination With Bevacizumab for Second-line Treatment HER2- MBC Patients 
 '''Study Summary''': In the second-line treatment setting for MBC, many agents, including antitubulin drugs (Taxanes, Vinorelbine) and antimetabolites (Capecitabine, Gemcitabine), have demonstrated activity, but no agent is clearly superior. Although some combinations of cytotoxic agents provide a small progression-free survival advantage, none has demonstrated an OS advantage, and toxicity is generally greater than for single agents. At present, there is no standard for this treatment setting. New treatments that could delay disease progression without systemic toxicity would represent a significant advancement. 
 '''Sponsor''': Consorzio Oncotech 
 '''Intervention''': Bevacizumab and eribulin 
 '''Start Date''': 2014-09 
 '''Last Updated''': 2016-06-15 
 '''Number of Patients''': 61 
 '''Recruitment Status''': UNKNOWN 
 '''Condition''': Metastatic Breast Cancer 
'''NCTID''': NCT04393753 
 '''Title''': Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 
 '''Study Summary''': This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody 
 '''Sponsor''': 4SC AG 
 '''Intervention''': domatinostat in combination with avelumab 
 '''Start Date''': 2020-09-01 
 '''Last Updated''': 2023-07-13 
 '''Number of Patients''': 19 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Merkel Cell Carcinoma 
'''NCTID''': NCT04595032 
 '''Title''': MAnagement of METastatic Disease In Campania (MAMETIC) 
 '''Study Summary''': The MAMETIC Trial represents the first regional epidemiological study that aims to evaluate patients living in Campania with metastatic cancer, with the intent to detect different prevalence of tumors in the metastatic phase and evaluate the local response to the patient’s request for assistance.  Condition or disease: Metastatic disease Intervention/treatment: Radiation Treatment 
 '''Sponsor''': National Cancer Institute, Naples 
 '''Intervention''': 3DCRT, IMRT, VMAT, SBRT 
 '''Start Date''': 2020-09-11 
 '''Last Updated''': 2023-03-23 
 '''Number of Patients''': 12500 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Metastatic Disease 
'''NCTID''': NCT02533765 
 '''Title''': Olaparib as Salvage Treatment for Cisplatin-resistant Germ Cell Tumor 
 '''Study Summary''': This is open-label, single-arm, two-stage phase II trial of olaparib in patients with relapsed/refractory metastatic germ cell cancer. The primary objective is to evaluate the preliminary activity of Olaparib in GCT tumors. The secondary objective is to evaluate the safety of Olaparib in patients with cisplatin-refractory GCT. 
 '''Sponsor''': Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori 
 '''Intervention''': Olaparib 
 '''Start Date''': 2015-09-11 
 '''Last Updated''': 2021-02-26 
 '''Number of Patients''': 18 
 '''Recruitment Status''': UNKNOWN 
 '''Condition''': Neoplasms, Germ Cell and Embryonal 
'''NCTID''': NCT02918084 
 '''Title''': CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer 
 '''Study Summary''': Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet. 
 '''Sponsor''': IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy 
 '''Intervention''': Anastrozole or Letrozole or Exemestane 
 '''Start Date''': 2013-06 
 '''Last Updated''': 2022-05-24 
 '''Number of Patients''': 1000 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT05099172 
 '''Title''': First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) 
 '''Study Summary''': Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body.  Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer.  Several EGFR and/or HER2 mutations exist in the cancer cells. Two mutations observed in NSCLC are called EGFR- or HER2exon20ins and EGFR C797X. The study treatment, BAY2927088, works by blocking the mutated EGFR protein and also its ex20ins version which are present in NSCLC. It is also believed to work against HER2 and HER2ex20ins mutations. Researchers think this may help stop the further spread of NSCLC cancer.  This is the first time that researchers will study BAY2927088 in humans. In this study, the researchers want to learn more about using BAY2927088 in participants who have NSCLC with EGFR and/or HER2 mutations including EGFRex20ins and/or HER2ex20ins mutations.  The main aims of this study are to find for BAY2927088  * how safe BAY2927088 is * how it affects the body (also referred to as tolerability) * how BAY2927088 moves into, through and out of the body * the maximum amount of BAY2927088 that the participants can take without too many side effects.  The researchers will also study the action of BAY2927088 against the cancer. The study will have three parts: Dose Escalation, Backfill, and Dose Expansion. Each participant of the first, so called dose escalation part, will be assigned to one of specific sequential dose groups for BAY2927088. The amount of BAY2927088 that is given increases stepwise from one group to the next.  The second may be initiated at any dose that has already been tested during the first part and found to be safe and to have either reached a predicted efficacious exposure range or to have induced an objective response. The first part and second part will run concurrently.  The participants of the third, so called dose expansion part, will receive the most appropriate dose of BAY2927088 found in the first and second parts. The third part may be initiated in parallel with the first and second part based on emerging data.  During the study, the participants will take the study treatment in 3 week periods called “cycles”. They will in general take BAY2927088 once daily until their cancer gets worse, until they have medical problems, until they leave the study or until the study is terminated. Participants will have around 5 visits in each cycle.  During the study, the study team will:  * take blood and urine samples * take regular CT or MRI scans to check if the participants’ cancer has gotten better or worse * check the participants’ overall health and heart health * ask the participants questions about how they are feeling and what adverse events they are having.  An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. 
 '''Sponsor''': Bayer 
 '''Intervention''': BAY2927088_formulation A 
 '''Start Date''': 2021-10-25 
 '''Last Updated''': 2023-11-28 
 '''Number of Patients''': 340 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Advanced Non-small Cell Lung Cancer 
'''NCTID''': NCT04999202 
 '''Title''': A Study to Learn How Safe the Study Drug BAY 2416964 (AhR Inhibitor) in Combination With the Treatment Pembrolizumab is, How This Combination Affects the Body, the Maximum Amount That Can be Given, How it Moves Into, Through and Out of the Body and Its Action Against Advanced Solid Cancers in Adults 
 '''Study Summary''': Researchers are looking for a better way to treat advanced solid cancers including head and neck cancer, lung cancer and bladder cancer.  In some people with cancer a protein called Aryl Hydrocarbon Receptor (AhR) can prevent immune cells from fighting tumor cells. The study drug, BAY 2416964, is a small molecule which blocks the AhR allowing the body to use its immune response against the cancer cells. Researchers think that BAY 2416964 given together with a cancer treatment called pembrolizumab may help shrink tumors in people with cancer.  The main aims of this study are to find for BAY 2416964 in combination with pembrolizumab,  * how safe this drug combination is * how it affects the body (also referred to as tolerability) * the highest amount of BAY 2416964 that can be given in combination with pembrolizumab without too many side effects.  The researchers will also study the action of BAY 2416964 in combination with pembrolizumab against the cancer.  The participants in this study will get BAY 2416964 and pembrolizumab. BAY 2416964 will be given by mouth. Pembrolizumab will be given as an intravenous (IV) infusion. An IV infusion is given through a needle into a vein.  This study will have two parts. The first part will help find the most appropriate dose that can be given in the second part.  Each participant of the first, so called dose escalation part, will be assigned to one specific dose group for BAY 2416964. The amount of BAY 2416964 that is given changes step-wise from one group to the next. The dose of pembrolizumab will always be the same.  The participants of the second, so called dose expansion part, will receive the most appropriate dose of BAY 2416964 found in the first part.  During the study, the participants will receive the treatment in 3-week periods called cycles. In each cycle, the participants will in general get pembrolizumab once and BAY 2416964 in a daily schedule. These 3-week cycles will be repeated throughout the trial. The participants can take the study treatment until their cancer gets worse, until they have medical problems, or until they leave the trial. Participants will have around 4 visits in each cycle. Some of the visits can also be done via phone.  During the study, the study doctors and their team will:  * take blood and urine samples * check if the participants’ cancer has changed in size using computed tomography scans or magnetic resonance imaging scans of the participants’ tumors * check the participants’ overall health * ask the participants questions about how they are feeling and what adverse events they are having.  An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. 
 '''Sponsor''': Bayer 
 '''Intervention''': BAY2416964 
 '''Start Date''': 2021-08-30 
 '''Last Updated''': 2023-11-14 
 '''Number of Patients''': 164 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Advanced Solid Tumors 
'''NCTID''': NCT03945084 
 '''Title''': Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy 
 '''Study Summary''': This is a 2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II study conducted in patients affected by unresectable, locally advanced or metastatic urothelial cancer receiving niraparib plus best supportive care versus best supportive care as maintenance therapy after a first-line platinum-based chemotherapy.  The primary objective of the trial is to evaluate the efficacy of niraparib plus Best Supportive Care (BSC) vs. BSC alone, as maintenance treatment, in terms of prolongation of progression-free survival (PFS), in patients with locally advanced or metastatic urothelial cancer that obtained disease control (objective response or stable disease) with first-line platinum-based chemotherapy. 
 '''Sponsor''': University of Turin, Italy 
 '''Intervention''': Niraparib 
 '''Start Date''': 2019-08-27 
 '''Last Updated''': 2022-05-23 
 '''Number of Patients''': 58 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Urothelial Carcinoma 
'''NCTID''': NCT01849874 
 '''Title''': A Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer 
 '''Study Summary''': The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician’s choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study. 
 '''Sponsor''': Pfizer 
 '''Intervention''': MEK162, MEK inhibitor; oral 
 '''Start Date''': 2013-06-27 
 '''Last Updated''': 2023-10-30 
 '''Number of Patients''': 341 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Low-grade Serous Ovarian Cancer 
'''NCTID''': NCT04072198 
 '''Title''': Nivolumab Plus FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced Colorectal Cancer RASm/BRAFm Patients 
 '''Study Summary''': This is a multicentric single arm, open label trial. In this study patients candidated to a first line of chemotherapy for metastatic colorectal cancer will be treated with 8 cycles of folfoxiri plus bevacizumab plus nivolumab followed by a maintenance with bevacizumab plus nivolumab.  Patients who do not progress during chemotherapy phase will receive bevacizumab plus nivolumab as maintenance therapy.  Patients will be treated until disease progression, unacceptable toxicity or patient/physician decision. 
 '''Sponsor''': Gruppo Oncologico Italiano di Ricerca Clinica 
 '''Intervention''': Nivolumab 
 '''Start Date''': 2019-09-26 
 '''Last Updated''': 2020-07-31 
 '''Number of Patients''': 70 
 '''Recruitment Status''': UNKNOWN 
 '''Condition''': Colorectal Cancer 
'''NCTID''': NCT04338399 
 '''Title''': The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC 
 '''Study Summary''': The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy. 
 '''Sponsor''': Adlai Nortye Biopharma Co., Ltd. 
 '''Intervention''': Buparlisib &amp; Paclitaxel 
 '''Start Date''': 2020-12-12 
 '''Last Updated''': 2023-11-02 
 '''Number of Patients''': 483 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Head and Neck Cancer