Open-to-Accrual Therapeutic Trials

Phase I

Protocol ID Official Title PI Name Lead CRC Disease Site Phase
I137-102    NCT02931110 A Phase 1 Dose-Escalation and Cohort-Expansion Study of Intravenous CBL0137 in Subjects with Previously Treated Hematological Cancers C. Sportès Sandra Wall Lymphomas (B-Cell, Diffuse Large B-Cell,  Mantle Cell, Follicular, Hodgkin; Lymphosarcoma) I
NLG-2105 NCT02502708 A Phase 1 Trial of Indoximod in Combination with Temozolomide-Based Therapy for Children with Progressive Primary Brain Tumors T. Johnson Robin Dobbins Primary Brain Tumors I
TESARO 4010-01-001   NCT02715284 Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors S. Ghamande Kelly Jenkins Advanced solid tumors I

Phase I/II

Phase 1-2 Study of MEDI4736 Alone or In Combination With ADXS11-001 In Recurrent/Persistent or Metastatic Cervical or HPV+ Metastatic Head & Neck Cance S. Ghamande Renee Townsend Phase 1: Cervical Cancer,  HPV+ Head & Neck Cancer
Phase 2: Cervical Cancer
CC-16047   NCT02834052 A phase I/II trial of pembrolizumab (MK-3475) and poly-ICLC in patients with metastatic mismatch repair-proficient (MRP) colon cancer A. Nayak Kelly Jenkins Phase 1: All solid tumors, following at least one therapy Phase 2: Mismatch Repair Proficient “MRP” (includes microsatellite stable [MSS] and MSI-low) colon cancer that has progressed following at least two lines of therapy I/II
A phase Ib /II trial of pembrolizumab and idelalisib in patients with non-small cell lung cancer (NSCLC) who have failed immune checkpoint inhibitor Z. Hao Kelly Jenkins Non-Small Cell Lung Cancer (NSCLC) I/II
GSK 201973  NCT02964507 A Phase I/II Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination with Fulvestrant in Subjects with ER+ Breast Cancer H. Boppidi Sandra Wall ER+ Breast Cancer I/II
INCB-39110-206     NCT02760485 An Open Label Phase 1/2 Study of INCB039110 in Combination with Ibrutinib in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma   L. Bryan Sandra Wall Diffuse Large B-Cell Lymphoma I/II 
INO-VT-464-CL-006     NCT02580448 A Phase 1/2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of VT-464 in Patients with Advanced Breast Cancer H. Boppidi Sandra Wall Advanced Breast Cancer I/II
M14-361  NCT02289690 A Phase 1 Dose Escalation and Phase 2 Randomized Double-Blind Study of Veliparib in Combination With Carboplatin and Etoposide as a Therapy of Treatment-Naïve Extensive Stage Disease Small Cell Lung Cancer Z. Hao Kelly Jenkins Small Cell Lung Cancer I/II
NLG-2104     NCT02077881 A Phase 1/2 Study of Indoximod in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Adenocarcinoma of the Pancreas A. Nayak Lisa Marshall Pancreatic Cancer I/II
NLG-2106 NCT02835729 A Phase 1b/Randomized Phase 2a Trial of Indoximod in Combination with Idarubicin and Cytarabine in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) J. Pantin Sandra Wall Acute Myeloid Leukemia (AML) I/II

NRG-GY007   NCT02713386

A Phase I/II Study of Ruxolitinib with Front-Line Neoadjuvant and Post-Surgical Therapy in Patients with Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Protocol Type: Treatment S. Ghamande Melissa James Ovarian, Fallopian Tube, or Peritoneal Cancer I/II

VT3996-201  NCT03397706

A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies Protocol Type: Treatment L. Bryan Sandra Wall  Epstein-Barr Virus Associated Lymphoid Malignancies Ib/II

Closed for New Patient Enrollment, Open for Current Patients

EMR 100070-001 A Phase 1, Open-Lable, Multiple-Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0010718C in Subjects with Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indicators (PI: Khleif)
GO29753 (formerly NLG-9191) A Phase 1 Study of GDC-0919 for Adult Patients with Recurrent Advanced Solid Tumors (PI: Khleif)
MEDI4736-1108 A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors (PI: Khleif)
NLG-2102 A Phase 1/2 Study of the Combination of 1-Methyl-D-Tryptophan (Indoximod) and Temozolomide for Adults Patients with Temozolomide-Refractory Primary Malignant Brain Tumors (PI: Hao)
NLG-2103 A Phase 1/2 Study of the Concomitant Administration of Indoximod plus Ipilimumab for Adult Patients with Advanced or Metastatic Melanoma (PI: Parikh)