Editing Trials (Radboudumc Centre for Oncology)

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'''NCTID''': NCT01322490 
 '''Title''': A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer 
 '''Study Summary''': The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer. 
 '''Sponsor''': Bavarian Nordic 
 '''Intervention''': PROSTVAC-V 
 '''Start Date''': 2011-11-28 
 '''Last Updated''': 2019-09-04 
 '''Number of Patients''': 1297 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Prostate Cancer Metastatic 
'''NCTID''': NCT05173987 
 '''Title''': Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) 
 '''Study Summary''': The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.  The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': pembrolizumab 
 '''Start Date''': 2022-02-03 
 '''Last Updated''': 2023-11-09 
 '''Number of Patients''': 280 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Endometrial Neoplasms 
'''NCTID''': NCT05116189 
 '''Title''': Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65) 
 '''Study Summary''': The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score <math display="block">CPS</math> ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2021-12-13 
 '''Last Updated''': 2023-08-08 
 '''Number of Patients''': 616 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Ovarian Cancer 
'''NCTID''': NCT04647526 
 '''Title''': Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment 
 '''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of <math display="block">Lu-177</math>-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT). 
 '''Sponsor''': POINT Biopharma 
 '''Intervention''': [Lu-177]-PNT2002 
 '''Start Date''': 2021-02-25 
 '''Last Updated''': 2023-11-02 
 '''Number of Patients''': 415 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Metastatic Castration-Resistant Prostate Cancer 
'''NCTID''': NCT04031677 
 '''Title''': Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma 
 '''Study Summary''': This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.  After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm. 
 '''Sponsor''': European Organisation for Research and Treatment of Cancer - EORTC 
 '''Intervention''': Surgery 
 '''Start Date''': 2021-01-20 
 '''Last Updated''': 2023-10-27 
 '''Number of Patients''': 250 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Retroperitoneal Sarcoma 
'''NCTID''': NCT04895358 
 '''Title''': Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) 
 '''Study Summary''': The safety and efficacy of pembrolizumab plus the investigator’s choice of chemotherapy will be assessed compared to placebo plus the investigator’s choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.  The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': pembrolizumab 
 '''Start Date''': 2021-06-18 
 '''Last Updated''': 2023-11-27 
 '''Number of Patients''': 800 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Breast Neoplasms 
'''NCTID''': NCT05239728 
 '''Title''': A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) 
 '''Study Summary''': The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.  The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Belzutifan 
 '''Start Date''': 2022-03-15 
 '''Last Updated''': 2023-11-28 
 '''Number of Patients''': 1800 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Carcinoma, Renal Cell 
'''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''': NCT03511664 
 '''Title''': Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer 
 '''Study Summary''': The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone. 
 '''Sponsor''': Endocyte 
 '''Intervention''': 177Lu-PSMA-617 
 '''Start Date''': 2018-05-29 
 '''Last Updated''': 2023-10-12 
 '''Number of Patients''': 831 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Prostate Cancer 
'''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 
'''NCTID''': NCT04303780 
 '''Title''': Study to Compare AMG 510 “Proposed INN Sotorasib” With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). 
 '''Study Summary''': A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation 
 '''Sponsor''': Amgen 
 '''Intervention''': AMG 510 
 '''Start Date''': 2020-06-04 
 '''Last Updated''': 2023-10-23 
 '''Number of Patients''': 345 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': KRAS p, G12c Mutated /Advanced Metastatic NSCLC