Open-to-Accrual Therapeutic Trials - Phase II

Phase II

Protocol ID

Official Title

PI Name

Lead CRC

Disease Site


ADXS001-04  NCT02291055

Phase 1-2 Study of MEDI4736 Alone or in Combination with ADXS11-001 in Recurrent/Persistent or Metastatic Cervical or HPV Positive Metastatic Head and Neck Cancer S. Ghamande Renee Townsend Cervical Cancer I/II

C-700-01  NCT01772004

A Phase 1 / 2, Open-Label, Multiple Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN2034 in Subjects With Metastatic or Locally Advanced Solid Tumors, With Expansion to Second-Line Cervical Cancer S. Ghamande Lisa Marshall & Kelly Jenkins Cervical Cancer 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 Breast 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 Adenocarcinoma 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

NLG-2106  NCT02835729

A Phase 1b/Randomized Phase 2a Trials of Indoximod in Combination with Idarubicin and Cytarabine in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) J. Pantin Sandra Wall Acute Myeloid Leukemia  ia/IIb

CC-16053  NCT03257722

A Phase Ib /II Trial of Pembrolizumab and Idelalisib in Patients with Non-Small Cell Lung Cancer (NSCLC) Z. Hao Lisa Marshall & Kelly Jenkins Non-Small Cell Lung Cancer (NSCLC) Ib/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

A011203 (Alliance)  NCT02311933

A Randomized Phase II Trials of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer S. Ghamande Inquiries  Breast Cancer II

CA018005 (Fraction-RCC)  NCT02996110

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-Oncology Study of Participants with Advanced Renal Cell Carcinoma  J. Parikh Lisa Marshall & Kelly Jenkins Renal Cell Carcinoma II

CL-PTL-126  NCT03073525

A Randomized, Intra-patient Crossover, Safety, Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients with Advanced Gynecological Cancers S. Ghamande Melissa James Gynecological Cancer II

GOG-0238  NCT00492778

A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus S. Ghamande Kelly Adams Uterine Carcinoma II

ICT-8  NCT02802267 

Efficacy Study of Inecalcitol in combination with demethylating agent in Acute Myeloid Leukemia patients unfit for standard chemotherapy J. Pantin  Sandra Wall Acute Myeloid Leukemia II

Inovio HPV-201  NCT03180684   

A Phase 2, Randomized, Open Label, Efficacy Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA® 2000 Alone or in Combination With Imiquimod, for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous lntraepithelial Lesion (HSIL) of the Vulva Protocol D. Ferris Angela Goebel HPV Related HIgh Grade Squamous Intraepithelia Lesion (HSIL) II

LION C-145 04  NCT03108495  

A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma S. Ghamande Donna Wheatley Cervical Cancer II

MEI-011  NCT03151304 

A Two-Stage, Open-Label Followed by Placebo-Controlled Phase 2 Study of Pracinostat and Azacitidine in Patients with IPSS-R High and Very High Risk Myelodysplastic Syndromes Previously Untreated with Hypomethylating Agents Protocol Type: Treatment J. Pantin Sandra Wall Myelodysplastic Syndromes II

Millennium  NCT02725268 

A Phase 2, Randomized study of MLN0128 (a Dual TORC1/2 Inhibitor), MLN0128+MLN1117 (a PI3kalpha inhibitor), Weekly Paclitaxel, or the Combination of Weekly Paclitaxel and MLN0128 in Women with Advanced, Recurrent, or Persistent Endometrial Cancer S. Ghamande Melissa James Endometrial Cancer II

MORAB  NCT02289950 

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Peglyated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer S. Ghamande Donna Wheatley  Ovarian Cancer II

NMTRC014  ClinicalTrials,gov:  NCT02679144 

NMTT - Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO); NMTRC014  C, McDonough Kimberly Gray Neuroblastoma II

NRG-GY006  NCT02466971  

A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer S. Ghamande Kelly Adams Uterine Cervical or Vaginal Cancer II

NU-16H07  NCT03077828


(NU-16H07) Phase II Trial of Pembrolizumab in Combination with ICE Salvage Chemotherapy for Relapsed/Refractory Hodgkin Lymphoma  L. Bryan Sandra Wall Hodgkin Lymphoma II

ONT-380-206  NCT02614794 

Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2 positive Breast Carcinoma H. Boppidi Sandra Wall Breast Carcinoma II

S1318  NCT02143414 

 A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednizone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients Greater than or Equal to 65 Years of age with Newly Diagnosed Philadelphia-Chromosome Negative (PH negative) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients Greater than or Equal to 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (PH Positive) ALL S. Ghamande Inquiries  Acute Lymphoblastic Leukemia II

S1416  NCT02595905 

Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer S. Ghamande Sandra Wall Breast Cancer II

S1513  NCT02890355 

Randomized Phase II Study of 2nd Line FOLFIRI Versus Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC-737664) in Metastatic Pancreatic Cancer S. Ghamande Inquiries Pancreatic Cancer II

CONCERTO  NCT02889900 

A Single Arm Phase IIb Study to Assess the Efficacy and Safety of the Combination of Cediranib and Olaparib in Women with Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer S. Ghamande Melissa James Ovarian, Fallopian Tube, or Primary Peritoneal Cancer IIb

2215-CL-0201  NCT02752035

A Phase 2/3 Multicenter, Open-label, 3-arm, 2-stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy J. Pantin Sandra Wall Acute Myeloid Leukemia II/III

EA6141  NCT02339571 

Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab In Patients with Unresectable Stage III or Stage IV Melanoma S. Ghamande Inquiries Melanoma II/III

NRG-GY009  NCT02839707

A Randomized, Phase II/III Study of Pegylated Lipsomal Doxorubicin and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer S. Ghamande Melissa James Ovarian Cancer II/III

RTOG-1216  ClinicalTrials,gov:  NCT01810913 

Randomized Phase II/III Trials of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Celuximab for High-Risk Squamous Cell Cancer of the Head and Neck S. Ghamande Inquiries Head and Neck Squamous Cell Cancer II/III