Newly Activated Clinical Trials

October and September

Program	UMCC#	IRB#	PI	Title	Active

Cutaneous Oncology	UMCC 2018.025	HUM00141849	Lao, Christopher	A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma	10/5/2018

Leukemia / Lymphoma / Myeloma	UMCC 2017.141	HUM00137981	Devata, Sumana	Phase I/II Study of Ixazomib and Romidepsin in Relapsed/ Refractory Peripheral T-cell Lymphoma (PTCL)	10/10/2018

Leukemia / Lymphoma / Myeloma	UMCC 2018.018	HUM00147548	Campagnaro, Erica	A Phase 1/2 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects with Relapsed or Refractory Multiple Myeloma	10/152018

Leukemia / Lymphoma / Myeloma	SWOG S1702	HUM00144661	Campagnaro, Erica	A PHASE II STUDY OF ISATUXIMAB (SAR650984) (NSC-795145) FOR PATIENTS WITH PREVIOUSLY TREATED AL AMYLOIDOSIS	10/16/2018

Thoracic Oncology	UMCC 2018.066	HUM00146769	Gadgeel, Shirish	A PHASE 2, MULTICENTER, OPEN-LABEL, 2-COHORT STUDY OF TRASTUZUMAB DERUXTECAN (DS-8201A), AN ANTI-HER2 ANTIBODY DRUG CONJUGATE (ADC), FOR HER2-OVER-EXPRESSING OR -MUTATED, UNRESECTABLE AND/OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)	10/23/2018

Head & Neck	UMCC 2018.070	HUM00110146	Lipps, David	Evaluation of cervical, thoracic, and scapular dysfunction in head and neck cancer patients	10/24/2018

Head & Neck	UMCC 2018.073	HUM00147130	Worden, Francis	A phase I/II study of MLN0128 in metastatic anaplastic thyroid cancer	10/26/2018

Gastrointestinal Oncology	UMCC 2018.049	HUM00144559	Crysler, Oxana	A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab vs Placebo for Participants with Hepatocellular Carcinoma (HCC) who Are at High-risk of Recurrence after Curative Hepatic Resection or Ablation	10/26/2018

September

Program	UMCC#	IRB#	PI	Title	Active

Leukemia / Lymphoma / Myeloma	UMCC 2018.057	HUM00145074	Ye, Jing Christine	A Phase I Dose-Escalation Study Of The Selective PKC-beta Inhibitor MS-553 In Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	9/7/2018

Gastrointestinal Oncology	UMCC 2018.065	HUM00146481	Zalupsky, Mark	A Phase 1b/2 Study to Evaluate the Safety,Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma	9/11/2018

Leukemia / Lymphoma / Myeloma	UMCC 2017.122	HUM00136973	Ye, Jing Christine	A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects with High-risk Smoldering Multiple Myeloma	9/13/2018

Thoracic Oncology	UMCC 2018.037	HUM00143209	Gadgeel, Shirish	Phase 1b/2 Safety, Pharmacokinetic, and Efficacy Study of G1T38 in Combination with Osimertinib in Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)	6/15/2018