Open-to-Accrual Therapeutic Trials - Phase II


Phase II

Protocol ID

Official Title

PI Name

Lead CRC

Disease Site

Phase

ADXS001-04  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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

GSK-205744  ClinicalTrials.gov:   NCT02929498

A Phase I/II, Open-Label, 2 Arm Study to Investigate the Safety, Clinical Activity, Pharmacokinetics and Pharmacodynamics of GSK2879552 Administered Alone or in Combination with Azacitidine, in Adult Subjects with IPSS-R High and Very High Risk Myelodysplastic Syndromes (MDS) Previously Treated with Hypomethylating Agents (HMA) J. Pantin Sandra Wall Myelodysplastic Syndromes I/II

INCB-39110-206  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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

KW-0761-014  ClinicalTrials.gov:   NCT02705105

Open-label, Multicenter, Phase 1/2 Study of Mogamulizumab in Combination with Locally Advanced or Metastatic Solid Tumors A. Nayak Lisa Marshall & Kelly Jenkins Solid Tumor Cancer and Carcinoma i/II

NLG-2104  ClinicalTrials.gov:   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

NLG-2106  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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

A011203 (Alliance)  ClinicalTrials.gov:   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)  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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

GOG-3011/FORWARD1   ClinicalTrials.gov:   NCT02631876

A Randomized, Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Adults with Folate Receptor FRA Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Primary Fallopian Tube Cancer

S. Ghamande  Renee Townsend Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Primary Fallopian Tube Cancer  II

GYN 49  ClinicalTrials.gov:   NCT02272790

A Multicentre Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer S. Ghamande Donna Wheatley Epithelial Ovarian, Fallopian Fube, or Primary Peritoneal Cancer II

ICT-8  ClinicalTrials.gov:   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

Millennium  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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 ClinicalTrials.gov:  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  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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

S1513  ClinicalTrials.gov:   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  ClinicalTrials.gov:   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  ClinicalTrials.gov:  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  ClinicalTrials.gov:   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

GOG-0286B  ClinicalTrials.gov:   NCT02065687

A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer S. Ghamande Kelly Adams Endometrial 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