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Studies Open for recruitment at Johns Hopkins Singapore last updated: 24-Mar-16 Liver Cancer Main Criteria Study title Any HCC National Registry of Hepatocellular Carcinona 2nd line Protocol XL184-309: A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib Specification Principal Investigator Study information website SC, contact Prof. Alex Chang Not applicable Xiaoying, 96446688 CHILD-PUGH A, after sorafenib failed, must has histological or Dr. Akhil Chopra cytological diagnosis of HCC http://www.clinicaltrials.gov/ct2/show /NCT01908426?term=Cabozantinib+% Ruth, 96421767 28XL184%29&rank=7 https://clinicaltrials.gov/ct2/show/NCT 02576509?term=A+Randomized%2C+ Multicenter+Phase+III+Study+of+Nivolumab Xiaoying, 96446688 +versus+Sorafenib+as+FirstLine+Treatment+in+Patients+with+Ad vanced+Hepatocellular+Carcinoma&ra nk=1 https://clinicaltrials.gov/ct2/show/NCT 02519348?term=A+Study+of+Safety%2 C+Tolerability%2C+and+Clinical+Activit y+of+MEDI4736+and+Tremelimumab+ Elaine, 90887254 Administered+as+Monotherapy+and+i n+Combination+to+Subjects+with&ran k=1 1st line A Randomized, Multi-center Phase III Study of Nivolumab versus Sorafenib as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma CHILD-PUGH A, has histological/cytological diagnosis of HCC, ECOG 0-1 Dr. Akhil Chopra 2nd Line and above [projected SIV in April] A Study of Safety, Tolerability, and Clinical Activity of MEDI4736 and Tremelimumab Administered as Monotherapy and in Combination to Subjects with Unresectable Hepatocellular Carcinoma confirmed diagnosis of unresectable HCC; must have progressed, refused or intolerant to Sorafenib Dr. Akhil Chopra Main Criteria Study title Specification Up to 3rd line A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer Her 2 negative, BRCA mutated, Failed Maximum 2 lines of chemotherapy 3rd line or more A Study of Neratinib plus Capecitabine versus Lapatinib plus Her 2 positive. Must have Capecitabine in patients with HER2+ metastatic breast failed 2 lines of HER 2 directed Dr. Lavina Bharwani cancer who have received two or more prior HER2-directed regimens. regimens in the metastatic setting http://www.clinicaltrials.gov/ct2/show /NCT01808573?term=lapatinib+plus&r Elaine, 90887254 ank=5 1st line A multicenter, randomized, double‑blind Phase 3 study of Palbociclib (Oral CDK 4/6 inhibitor) plus letrozole versus placebo plus letrozole for the treatment of previously untreated east Asian postmenopausal women with ER (+), HER2 (‑) advanced breast cancer [A5481027] https://clinicaltrials.gov/ct2/show/NCT Samantha, 83882481 02297438?term=Palbociclib&rank=29 Breast Cancer SC, contact Dr. Chia Yee Hong postmenopausal, ER (+), Her 2 Dr. Chia Yee Hong (-) https://clinicaltrials.gov/ct2/show/NCT Xiaoying, 96446688 02163694?term=Veliparib&rank=20 2nd and 3rd line [SIV 6 Apr 2016] A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Treatment of Physician’s Choice Monotherapy for Metastatic Triple Negative Breast Cancer (mTNBC) Disease progression; previous tx with one or two systemic treatment; biopsy for PD-L1 positive status, ECOG 0-1 Dr Lavina Bharwani https://clinicaltrials.gov/ct2/show/NCT 02555657?term=pembrolizumab+phys Samantha, 83882481 ician%27s+choice&rank=2 Lung cancer 3rd line or more 1st line 2nd or 3rd line A Phase III, Open label, Randomised, Multi-centre, International Study of MEDI4736, given as monotherapy or in combination with Tremelimumab determined by PD-L1 expression versus Standard of Care in Patients with Locally EGFR and ALK negative, failed Dr Akhil Chopra Advanced or Metastatic Non-Small Cell Lung Cancer (Stage at least 2 lines of treatment IIIB-IV) Who Have Received at Least Two Prior Systemic including platinum Treatment Regimens Including One Platinum-based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC) https://clinicaltrials.gov/ct2/show/NCT 02352948?term=MEDI4736+%28ARCTI Elaine, 90887254 C%29&rank=1 A Phase 2, multicenter, randomized, double-blind study of ficlatuzumab plus erlotinib versus placebo plus erlotinib in subjects who have previously untreated metastatic, EGFRmutated non-small cell lung cancer (NCSLC) and BDX004 Poor Label Prof. Alex Chang https://clinicaltrials.gov/ct2/show/NCT Elaine, 90887254 02318368?term=ficlatuzumab&rank=4 Dr Akhil Chopra https://clinicaltrials.gov/ct2/show/NCT 02191891?term=BI+836845+EGFR&ra Ruth, 96421767 nk=1 EGFR positive, BDX004 Poor label (blood draw) A phase 1b open-label clinical trial of once daily oral treatment of afatinib plus weekly intraveneous infusion of BI 836845 in patients with EGFR mutant non-small cell lung Fail TKI, T790M negative. cancer with progression following prior EGFR tyrosine kinase inhibitors. 1st line [SIV 30 Mar 2016] An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs. Erlotinib or Gefitinib in Firstline Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations (SOLAR Study) EGFR+, ECOG 0-2, Histologically confirmed Stage IIIB/IV adenocarcinoma NSCLC Dr Akhil Chopra Subjects with mixed histology are eligible if adenocarcinoma is the predominant histology https://clinicaltrials.gov/ct2/show/NCT 02588261?term=An+Openlabel%2C+Randomized+Phase+3+Effic Belinda, 81025447 acy+Study+of+ASP8273+vs.+Erlotinib+ or+Gefitinib&rank=1 1st line [projected SIV in April] Protocol: A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum based doublet as a first line treatment of recurrent or Stage IV PD L1+ non small cell lung cancer EGFR and ALK (-), PD-L1 positive, ECOG 0-1, measurable Dr Akhil Chopra lesion https://clinicaltrials.gov/ct2/show/NCT Siti Maryam, 96192498 02576574?term=avelumab&rank=10 MEDI4736 in combination with tremelimumab, MEDI4736 monotherapy, and tremelimumab monotherapy will be safe and demonstrate clinical activity in subjects with metastatic or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma. Her 2 negative, Refractory to platimnum or Fluoropyrimidine based chemotherapy https://clinicaltrials.gov/ct2/show/NCT 02340975?term=MEDI4736+monother Belinda, 81025447 apy%2C+and+tremelimumab&rank=1 Gastric Cancer 2nd and 3rd line Dr. Alex Chang Lymphoma 3rd line A Single-Arm, Open-Label Phase 2 Study of Nivolumab (BMSFollicular Lymphoma 936558) in Subjects with Relapsed or Refractory Follicular Lymphoma (FL) [CA209-140] Dr. Akhil Chopra https://clinicaltrials.gov/ct2/show/NCT 02038946?term=Lymphoma+%28FL%2 Belinda, 81025447 9+Nivolumab&rank=1 [re-opened, 2 slots available] Multicenter Phase II Study of Nivolumab in Previously Treated Patients with Recurrent and Metastatic Nasopharyngeal Carcinoma non-keratinizing nasopharyngeal carcinoma Dr. Akhil Chopra https://clinicaltrials.gov/ct2/show/NCT 02339558?term=Nivolumab+Nasophar Samantha, 83882481 yngeal&rank=1 A Multicentre, Randomized, Open-Label, Phase III Clinical Trial Of Gemcitabine And Carboplatin Followed By EpsteinBarr Virus-Specific Autologous Cytotoxic T Lymphocytes Versus Gemcitabine And Carboplatin As First Line Treatment For Advanced Nasopharyngeal Carcinoma Patients Metastatic or locally recurrent EBV positive, non-keratinizing Dr. Akhil Chopra and/or undifferentiated NPC with measurable disease https://clinicaltrials.gov/show/NCT025 Xiaoying, 96446688 78641 Castration-Resistant, failed at least 12 weeks of Docetaxel and abiraterone. https://clinicaltrials.gov/ct2/show/NCT 02204072?term=BI+836845+Enzaluta mide&rank=1 Siti Maryam, 96192498 NPC 2nd and above 1st line NPC Prostate Cancer 3rd line A Phase Ib/II, Multicentre, Open Label, Randomised Study of BI 836845 in Combination With Enzalutamide, versus Enzalutamide alone, in Metastatic Castration-Resistant Prostate Cancer (CRPC) Following Disease Progression on Dr. Akhil Chopra