List of Clinical Studies

Study Name
EA1181 (CompassHER2-pCR) – A de-escalation study assessing the effect of decreasing chemotherapy in patients with HER2 positive breast cancer, with no evidence of cancer remaining after pre-operative chemotherapy and HER2-targeted therapy. For more information about this study and to inquire about eligibility, please contact the Oncology research program at 201-530-7934.
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Principal Investigator
Yadyra Rivera, MD

Study Name
A191901 GETSET Study – An Additional Support Program Via Text Messaging and Telephone-Based Counselling for Breast Cancer Patients Receiving Hormonal Therapy. For more information about this study and to inquire about eligibility, please contact the Oncology research program at 201-530-7934.
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Principal Investigator
Yadyra Rivera, MD

Study Name
S1501 – Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III. For more information about this study and to inquire about eligibility, please contact the Oncology research program at 201-530-7934.
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Principal Investigator
Yadyra Rivera, MD

Study Name
NRG-BR007 – A De-Escalation of Breast Radiation Trial for Hormone Sensitive, Her2 Negative, Oncotype Recurrence Score less than or equal 18 Breast cancer. For more information about this study and to inquire about eligibility, please contact the Oncology research program at 201-530-7934.
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Principal Investigator
Raimonda Goldman, MD

Study Name
A011801 – A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib”. For more information about this study and to inquire about eligibility, please contact the Oncology Research Program at 201-530-7934.
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Principal Investigator
Yadyra Rivera, MD

Study Name
A221805 – A Study of Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in patients with Stage II-III Colorectal Cancer. For more information about this study and to inquire about eligibility, please contact the Oncology research program at 201-530-7934.
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Principal Investigator
Jason Lee, MD

Study Name
A021806 – A Phase III Trial of Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer. For more information about this study and to inquire about eligibility, please contact the Oncology Research Program at 201-530-7934.
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Principal Investigator
Steve Kwon, MD

Study Name
The JANUS RECTAL Cancer Trial – A Randomized Phase II Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer. For more information about this study and to inquire about eligibility, please contact the Oncology research program at 201-530-7934.
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Principal Investigator
Jason Lee, MD

Study Name
MK7902-001 – A Multicenter, Open-label, Randomized Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Pembrolizumab versus Treatment of Physician’s Choice in Participants with Advanced Endometrial Cancer. Hypothesis is that combination therapy leads to improved progression-free survival.
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Principal Investigator
Sharyn Lewin, MD

Study Name
MK3475-775 – A Phase 3 Randomized, Open-label, Study of Pembrolizumab (MK-3475) Plus Levantinib versus Chemotherapy for First-Line Treatment of Advanced or Recurrent Endometrial Carcinoma. Hypothesis is that the combination for pembrolizumab plus Levantinib is superior to chemotherapy with respect to progression-free survival.
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Principal Investigator
Sharyn Lewin, MD

Study Name
GOG-3039 – A Phase II Study of Abemaciclib in Combination With Letrozole in Advanced, Recurrent or Metastatic Endometroid Endometrial Cancer.
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Principal Investigator
Sharyn Lewin, MD

Study Name
AZ DUO-E – A Randomized, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer
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Principal Investigator
Maria Schiavone, MD

Study Name
FIRST – A Randomized, double-Blind, Phase 3 Comparison of Platinum-Based Therapy with TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-line treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer. Hypothesis is that TSR-042 and Niraparib produces a deeper response and prolonged progression-free survival.
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Principal Investigator
Sharyn Lewin, MD

Study Name
MK7339-001 – A randomized phase 3, double-blind study of chemotherapy with or without Pembrolizumab followed by maintenance with Olaparib or placebo for the first-line treatment of BRCA non-mutated advanced epithelial ovarian cancer.
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Principal Investigator
Maria Schiavone, MD

Study Name
QPT-ORE-005 – A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma
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Principal Investigator
Sharyn Lewin, MD

Study Name
LAE002INT2001 – An Open-Label Randomized Active-Controlled Phase II Clinical Study to Assess the Efficacy and Safety of Afuresertib Plus Paclitaxel Versus Paclitaxel in Patients with Platinum-Resistant Ovarian Cance
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Principal Investigator
Maria Schiavone, MD

Study Name
IMGN853-0416 – A randomized, open-label, phase 3 study of Mirvetuximab Soravtansine vs. investigator's choice of chemotherapy in advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression (MIRASOL)
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Principal Investigator
Sharyn Lewin, MD

Study Name
IMGN853-0417 – A phase 3, single arm study of Mirvetuximab Soravtansine in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha expression (SORAYA)
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Principal Investigator
Sharyn Lewin, MD

Study Name
AVB500-OC-004 – A phase 3, randomized, double-blind, adaptive, placebo/Paclitaxel-controlled study of AVB-S6-500 in combination with Paclitaxel in patients with platinum-resistant recurrent ovarian cancer (ARAVIVE)
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Principal Investigator
Sharyn Lewin, MD

Study Name
IMGN853-0419 – A Phase 2, Single Arm Study of Mirvetuximab Sorvtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression (PICCOLO).
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Principal Investigator
Sharyn Lewin, MD

Study Name
IMGN853-0420 – A Multicenter, Open-label, Phase 2 Study of Carboplatin plus Mirvetuximab Soravtansine followed by Mirvetuximab Soravtansine continuation in Folate Receptor-Alpha Positive, Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Following One Prior Line of Platinum-Based Chemotherapy. For more information about this study and to inquire about eligibility, please contact the Oncology Research Program at 201-530-7934.
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Principal Investigator
Sharyn Lewin, MD

Study Name
S1802 – A Study of Standard Systemic Therapy with or Without Definitive Treatment in Treating Patients with Metastatic Prostate Cancer. For more information about this study and to inquire about eligibility, please contact the Oncology research program at 201-530-7934.
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Principal Investigator
Jason Lee, MD