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UVA Department of Medicine: FY 2015 Annual Report

Clinical Trials

Division of Hematology & Oncology
CLINICAL TRIALS

Hematology-Oncology clinical trials open to accrual in FY 2015.

For a complete listing of active clinical trials, go to: http://cancer.uvahealth.com/research/ActiveProtocolReportNovember2015.pdf.

PI: Christiana M. Brenin, MD

  • A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Men and Postmenopausal Women with Hormone Receptor-Positive Advanced Breast Cancer.

PI: Thao P. Dang, MD

  • Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer.

PI: Patrick Dillon, MD

  • A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC).
  • A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus A Taxane Following Anthracylines versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines As Adjuvant Therapy in Patients With Operable HER2- Positive Primary Breast Cancer.
  • Breast 41: A pilot study of the immunogenicity of a 9-peptide breast cancer vaccine plus poly-ICLC in stage IB-IV breast cancer (investigator initiated protocol).
  • Phase II Trial of Combination Immunotherapy with nelipepimut-S + GM-CSF (NeuVax¿) and Trastuzumab in high-risk HER2+ Breast Cancer Patients.
  • A Phase 2 Study of Docetaxel in Combination with 1-methyl-D- tryptophan indoximod) in Metastatic Breast Cancer.
  • A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less.
  • Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating The Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk Hormone Receptor-Positive and Her2/Neu Negative Breast Cancer.

PI: Michael Douvas, MD

  • A randomized, double-blind, placebo-controlled, phase 3 study of brentuximab vedotin and CHP (A+CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas.

PI: Robert Dreicer, MD

  • Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer.
  • A Phase 1/2, Open-Label, Uncontrolled, Multiple-Dose Escalation, Cohort Expansion and Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASN001 in Subjects With Metastatic Progressive Castrate Resistant Prostate Cancer.
  • A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle- Invasive Bladder Cancer.
  • A Phase III, Open-Label, Multicenter, Randomized Study Of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation As Adjuvant Therapy In Patients With PD-L1-Selected, High-Risk Muscle-Invasive Bladder Cancer After Cystectomy.

PI: Elizabeth M. Gaughan, MD

  • A Phase II, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic.
  • A Phase III, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects who are at High Risk for Recurrence.
  • A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.

PI: Ryan Gentler, MD

  • A Phase I/II Study of MK-3475 (SCH900475) in Combination with Chemotherapy or Immunotherapy in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma (investigator initiated protocol).
  • Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer.

PI: William W. Grosh, MD

  • A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients with Advanced Pancreatic Neuroendocrine Tumors.
  • A Randomized, Double-Blinded, Placebo-Controlled Phase II Study of Adjuvant Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the Liver.

PI: Richard Hall, MD

  • Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC).
  • A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein.

PI: Tamila Kindwall-Keller, MD

  • A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications.
  • Defibrotide for Patients with Hepatic Veno-Occlusive Disease(VOD): A Treatment IND Study(Under CFR 312.34).
  • A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients.
  • A Pilot Study of CDX-301 (rhuFlt3L) with or without Plerixafor for the Mobilization and Transplantation of Allogeneic Blood Cell Grafts in HLA- Matched Donor/Recipient Sibling Pairs.

PI: Craig Portell, MD

  • A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>=65 Years of Age) With Chronic Lymphocytic Leukemia (CLL).
  • Multi-institution Phase I/Ib study of ibrutinib with ABT-199 in relapsed/refractory mantle cell lymphoma (investigator initiated protocol).
  • A Phase II, Open-Label Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine Plus Rituximab (BR) in Comparison with BR Alone or GDC-0199 Plus Rituximab (R) in Patients with Relapsed and Refractory Follicular Non-Hodgkin’s Lymphoma.
  • A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination with Rituximab in Subjects with Relapsed/Refractory B- Cell Malignancies.
  • A Phase 3 Study of IPI-145 versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
  • A Study of IPI-145 and Ofatumumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07.
  • Phase II Randomized Trial Comparing GA101 (Obinutuzumab) and Rituximab in Patients with Previously Untreated Low Tumor Burden Indolent Non-Hodgkin’s Lymphoma.

PI: Osama Rahma, MD

  • A Phase 3, Multicenter, Open-Label, Randomized Study of nab®-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone As Adjuvant Therapy In Subjects With Surgically Resected Pancreatic Adenocarcinoma.
  • A Phase 2B, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX Pancreas Vaccine (with Cyclophosphamide) and CRS-207 Compared to Chemotherapy or to CRS-207 Alone in Adults with Previously-treated Metastatic Pancreatic Adenocarcinoma.
  • A Phase III Study of Chemotherapy With or Without Algenpantucel- (HyperAcute® – Pancreas) Immunotherapy in Subjects with Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer.
  • A Randomized Multicenter Phase Ib/II study to assess the safety and the immunological effect of chemoradiation therapy (CRT) in combination with MK-3475 (anti-PD1) to CRT alone in patients with resectable or borderline resectable pancreatic cancer (investigator initiated protocol).

Michael Williams, PI

  • Intergroup Randomized Phase II Four Arm Study In Patients >= 60 With Previously Untreated Mantle Cell Lymphoma.
  • Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma.

 

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