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    August 2017   Inside This Issue:

     
 

The following cancer clinical trials are currently open at The Ohio State University. If you would like more information or are interested in referring a patient to one of these trials, click on the PI's name to generate a contact email, reply to this message or call The James Line at 1-800-293-5066. To search all cancer clinical trials available at Ohio State, visit cancer.osu.edu.

  Featured Trials »
  Recently Opened Trials »
  Immune Therapy Trials »
  Featured Trial From Nationwide Children's Hospital »
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  Featured TrialS
 
 

Sarcoma

Phase II Study of Anti-PD-L1 Antibody (Atezolizumab) in Alveolar Soft Part Sarcoma
(OSU-17043) James Chen, MD

Phase Ib (Open-Label) / Phase II (Randomized,Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma
(OSU-15300) David Liebner, MD


    Recently Opened
 
  Breast

Phase III, Open-Label, Randomized, Multicenter Study of NKTR-102 vs. Treatment of Physician’s Choice (TPC) In Patients With Metastatic Breast Cancer who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane and Capecitabine
(OSU-17033) Nicole Williams, MD

Genitourinary

Randomized, Double-Blind, Placebo-Controlled Phase III Study of ODM-201 vs. Placebo in Addition to Standard Androgen-Deprivation Therapy and Ocetaxel in Patients With Metastatic Hormone-Sensitive Prostate Cancer
(OSU-17107) J. Paul Monk, MD

Hematologic Malignancies and BMT

Phase I Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas
(OSU-17076) Kami Maddocks, MD 

Thoracic

Maintenance Systematic Therapy vs. Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial
(NRG-LU002) Jose Bazan, MD

Phase III, Randomized, Open-Label Study of Lorlatinib (PF-06463922) Monotherapy vs. Crizotinib Monotherapy in the First-Line Treatment of Patients With Advanced Alk-Positive Non-Small Cell Lung Cancer
(OSU-17048) Erin Bertino, MD

Thyroid/Neuroendocrine

Phase I Study of Oral LOXO-292 in Adult Patients With Advanced Solid Tumors, Including RET-Fusion Non-Small Cell Lung Cancer, Medullary Thyroid Cancer and Other Tumors With Increased RET Activity
(OSU-17109) Manisha Shah, MD
 
  Immune Therapy Trials
 

 

 

 

Breast

 Phase II, Multiple-Arm, Open-Label, Randomized Study of PARP Inhibition (Veliparib; ABT-888) and Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) Either Alone or in Combination in Homologous DNA Repair (HDR)-Deficient Triple-Negative Breast Cancer (TNBC)
(OSU-17011) Anne Noonan, MBBCh

Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With > 1 cm Residual Invasive Cancer or Positive Lymph Nodes (>pN1mic) After Neoadjuvant Chemotherapy
(SWOG-S1418) Sagar Sardesai, MBBS

Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884) and to Estimate the Maximum Tolerated Dose in Subjects With Advanced or Refractory Cancer
(OSU-15281) Robert Wesolowski, MD

Randomized, Phase II Study of Neoadjuvant Chemotherapy, Carboplatin and Paclitaxel, With or Without Atezolizumab in Triple-Negative Breast Cancer (TNBC)
(OSU-17164) Robert Wesolowski, MD

CNS Malignancy

Phase II, Multicenter, Open-Label Study of a Conditionally Replicative Adenovirus (DNX-2401) With Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma
(OSU-16034) Vinay Puduvalli, MBBS

 Randomized, Phase II, Single-Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma  
(OSU-16043) Raju Raval, MD, DPhil

Randomized, Phase III, Open-Label Study of Nivolumab vs. Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma
(OSU-15304) Raju Raval, MD, DPhil

Phase I Study of Ipilimumab, Nivolumab and the Combination in Patients With Newly Diagnosed Glioblastoma
(NRG-BN002) Raju Raval, MD, DPhil

Gastrointestinal

Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)
(OSU-15298) Kristen Ciombor, MD

Phase I, Multicenter, Open-label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumor Activity of MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
(OSU-15169) Kristen Ciombor, MD

 Phase I, Open-Label, 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 Indications
(OSU-13257) John Hays, MD, PhD

Multi-Institutional, Phase II Study of Nivolumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal
(OSU-15115) John Hays, MD, PhD

Genitourinary

 Phase I, Multiple-Dose, Dose-Escalation Trial of Pt2385 Tablets, a HIF-2alpha Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
(OSU-16236) Paul Monk, MD

 Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti−Pd-L1 Antibody) vs. Observation as Adjuvant Therapy in Patients With Pd-L1−Selected, High-Risk Muscle-Invasive Bladder Cancer After Cystectomy
(OSU-16078) Amir Mortazavi, MD

Phase I Study of (Cabozantinib) Plus Nivolumab (CaboNivo) Alone or in Combination With Ipilimumab (CaboNivoIpi) in Patients With Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumors
(OSU-15150) Amir Mortazavi, MD

Randomized, Double-Blinded, Phase II Study of Maintenance Pembrolizumab vs. Placebo After First-line Chemotherapy in Patients With Metastatic Urothelial Cancer
(OSU-16133) Amir Mortazavi, MD

 Phase III, Multinational, Randomized, Open-Label, Parallel-Arm Study of Avelumab (Msb0010718c) in Combination With Axitinib (Inlyta®) vs. Sunitinib (Sutent®) Monotherapy in the First-Line Treatment of Patients With Advanced Renal Cell Carcinoma  
(OSU-15292) Thomas Olencki, DO

 Phase II, Fast Real-Time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)  
(OSU-17004) Thomas Olencki, DO

Phase II Study of MK-3475 in Patients With Advanced Merkel Cell Carcinoma (MCC)
(OSU-14248) Thomas Olencki, DO

 Phase Ib/II, Open-Label Study of the Safety and Pharmacology of Atezolizumab Administered With or Without Bacille Calmette-Guerin in Patients With High-Risk Non-Muscleinvasive Bladder Cancer
(OSU-16174) Kamal Pohar, MD

Gynecologic

Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and Ctep-Supplied Atezolizumab (Ind #134427) vs. Pegylated Liposomal Doxorubicin/Bevacizumab and Ctep-Supplied Atezolizumab vs. Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum-Resistant Ovarian Cancer
(NRG-GY009) David O'Malley, MD

Phase I/II Study of Chemo-Immunotherapy With Toll-Like Receptor 8 Agonist Motolimod (VTX-2337) and Anti-PD-L1 Antibody MEDI4736 in Subjects With Recurrent, Platinum-Resistant Ovarian Cancer for Whom Pegylated Liposomal Doxorubicin (PLD) is Indicated

(OSU-15125) David O’Malley, MD

Phase I/IIa Dose-Escalation and Cohort Expansion Study for Safety, Tolerability and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors
(OSU-16195) David O’Malley, MD

Phase I/II Study of Medi4736 Alone or in Combination With Adxs11-001 in Recurrent/Persistent or Metastatic Cervical or HPV+ Head and Neck Cancer
(OSU-16180) David O'Malley, MD


Phase II Study of Atezolizumab (MPDL3280A) in Combination With Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer
(OSU-17099) David O’Malley, MD

Randomized, Open-Label, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Avelumab (MSB0010718c) in Combination With and/or Following Chemotherapy in Patients With Previously Untreated Epithelial Ovarian Cancer
(OSU-16081) David O’Malley, MD 

Head and Neck

Open-Label, Randomized, Two-Arm, Phase III Study of Nivolumab in Combination With Ipilimumab vs. Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First-Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
(OSU-16134) David Carbone, MD, PhD

Randomized Phase III Trial of Cisplatin-Based Chemotherapy (CRT) +/- Nivolumab (ANTI-PD-1) in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma (With Phase I Lead in)
(RTOG-3504) Kai He, MD, PhD

 Phase II Investigation of Adjuvant Combined Cisplatin and Radiation With Pembrolizumab in Resected HNSCC
(OSU-15184) Matthew Old, MD

Hematologic Malignancies and BMT

Phase II Trial of Ibrutinib and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin’s Lymphoma
(OSU-16077) Lapo Alinari, MD, PhD

Phase I Study of Ipilimumab and Nivolumab in Advanced HIV Associated Tumors With an Expansion Cohort in HIV-Associated Solid Tumors
(AMC-095) Robert Baiocchi, MD, PhD

Phase II Trial of Nivolumab for HTLV-Associated Adult T Cell Leukemia/Lymphoma
(OSU-17027) Jonathan Brammer, MD

Phase I/II Study Evaluating Brentuximab Vedotin in Combination With Nivolumab in Patients With Relapsed or Refractory Hodgkin Lymphoma After Failure of Frontline Therapy
(OSU-15164) Beth Christian, MD

Phase II, Multicenter Trial of Nivolumab and Brentuximab Vedotin in Patients With Untreated Hodgkin Lymphoma Over the Age of 60 Years or Unable to Receive Standard Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) Chemotherapy

(OSU-15239Beth Christian, MD

Phase II Study of Pembrolizumab (MK-3475) in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) or Relapsed or Refractory Richter Syndrome (rrRS)
(OSU-15215) Beth Christian, MD

 Pilot Study of Atezolizumab (MPDL3280A) Following Adoptive Cell Transfer in Active Hematologic or Solid Tumor Malignancies
(OSU-17092) Steve Devine, MD

Phase Ib Study of the Safety and Pharmacokinetics of Atezolizumab (Anti−Pd-L1 Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Patients With Multiple Myeloma (Relapsed/Refractory and Post-Autologous Stem Cell Transplantation)  
(OSU-16178) Craig Hofmeister, MD

Phase Ib, Multicenter, Open-Label Study to Determine the Recommended Dose and Regimen of Durvalumab (Medi4736) Either as Monotherapy or in Combination With Pomalidomide (POM) With or Without Low-Dose Dexamethasone (Dex) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
(OSU-15196) Craig Hofmeister, MD

Phase Ib Trial of Pembrolizumab (MK-3475) in Combination With Dinaciclib (MK-7965) in Subjects With Hematologic Malignancies (KEYNOTE-155)
(OSU-16014) Jeffrey Jones, MD

Phase I/Ib Study of the PD-1 Antibody Pembrolizumab in Combination With Ibrutinib in Relapsed/Refractory Non-Hodgkins Lymphoma (NHL)  
(OSU-16070) Kami Maddocks, MD

Phase I/II Study of the PD-1 Antibody Nivolumab in Combination With Lenalidomide in Relapsed/Refractory Non-Hodgkin Lymphoma (NHL) and Hodgkin Disease (HD)
(OSU-16167) Kami Maddocks, MD

Melanoma

Randomized, Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma
(ECOG-EA6134) Joanne Jeter, MD

Phase I/II Trial of Pembrolizumab in Combination With Imatinib in Patients With Locally Advanced or Metastatic Melanoma With c-KIT Mutation or Amplification
(OSU-15280) Joanne Jeter, MD

Phase II and Pilot Trial of PD-1 Blockade With MK-3475 (Pembrolizumab) in Patients With Resectable or Unsectable Desmoplastic Melanoma (DM)
(SWOG-S1512) Kari Kendra, MD, PhD


Phase III, Randomized Trial Comparing Physician/Patient Choice of Either High-Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients With High-Risk Resected Melanoma
(SWOG-S1404) Kari Kendra, MD, PhD

Neuroendocrine

Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)
(OSU-15244) Manisha Shah, MD

Thoracic

Phase II Study of MEDI4736(Durvalumab) and Tremelimumab Alone or in Combination With High or Low-Dose Radiation in Metastatic Colorectal and NSCLC
(OSU-17195) Erin Bertino, MD

Phase Ib Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Pembrolizumab in Subjects With Selected Hyaluronan-High Solid Tumors

(OSU-15219) Erin Bertino, MD

Phase I/Ib, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination With Atezolizumab Therapy in Patients With Selected Incurable Cancers
(OSU-16051) Erin Bertino, MD

Phase II, Open-Label, Multicenter, Single-Arm Study to Investigate the Efficacy and Safety Of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Patients With Stage IB, II or IIIA Resectable and Untreated Non-Small Cell Lung Cancer
(OSU-16157) David Carbone, MD, PhD

Phase II Fast Real-Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)
(OSU-16136) Kai He, MD, PhD

Phase II, Dose-Escalation and Cohort-Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
(OSU-16120) Kai He, MD, PhD

 Open-Label, Randomized, Phase III Trial of Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy vs. Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
(OSU-15127) Greg Otterson, MD

 Randomized, Phase II Study Evaluating Pembrolizumab vs. Topotecan in the Second-Line Treatment of Patients With Small Cell Lung Cancer  
(OSU-16285) Greg Otterson, MD

Phase I, Open-Label, Multicenter, Safety Study of Nivolumab (BMS-936558) in Combination With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel/Carboplatin in Stage IIIb/IV Non-Small Cell Lung Cancer or Nab- Paclitaxel in Recurrent Metastatic Breast Cancer
(OSU-14250) Greg Otterson, MD

Randomized, Multicenter, Double-Blind, Phase III Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-Based First-Line Chemotherapy
(OSU-15171) Greg Otterson, MD

Randomized Phase II Trial Evaluating the Optimal Sequencing of PD-1 Inhibition With Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer

(OSU-16074) Greg Otterson, MD

Open-Label, Single-Arm, Phase II Study of Nivolumab in Combination With Ipilimumab as First Line-Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)
(OSU-16086) Greg Otterson, MD

 
 
  Featured Trial From Nationwide Children's Hospital
 
 

Nationwide Children's Hospital

Phase I, Multicenter Open-Label, Dose De-Escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non-Central Nervous System Tumors that are Amenable to Direct Injection
PI: Keri Streby, MD keri.streby@nationwidechildrens.org
NCT: 02756845   
SPONSOR:
Amgen 

 
 
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