Open-to-Accrual Therapeutic Trials - Phase II

Phase II

Protocol ID

Official Title

PI Name

Lead CRC

Disease Site


C-550-01  NCT03495882

A Phase 1/2, Open-Label, Multi-Arm Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination with AGEN2034 in Subjects with Metastatic or Locally Advanced Solid Tumors, and Expansion into Select Solid Tumors Protocol Type: Treatment S. Ghamande Donna Wheatley Advanced Solid Tumors 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 Renee Townsend 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

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

5F9003  NCT02953509 

A Phase 1b/2 Trial of Hu5F9-G4 in Combination with Rituximab in Patients with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma L. Bryan Sandra Wall Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma 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 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

CX-839-008  ClinicalTrials,gov:   NCT03428217

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Cabozantinib vs. Placebo with Cabozantinib in Patients with Advanced or Metastatic Renal Cell Carcinoma J. Parikh Kelly Jenkins Renal Cell Carcinoma 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

GOG-3028/C-750-01  NCT03894215

A Two-arm, Randomized, Non-comparative, Phase 2 Trial of AGEN2034 (Anti-PD-1) as a Monotherapy or Combination Therapy With AGEN1884 (Anti-CTLA4) or With Placebo in Women With Recurrent Cervical Cancer (Second Line) - RaPiDS S. Ghamande Renee Townsend Cervical Cancer 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 Renee Townsend Cervical Cancer II

MK7339-002  NCT03742895 

A Phase 2 Study of Olaparib Monotherapy in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer A. Nayak Sandra Wall HRRm or HRD Positive Advanced Cancer Solid Tumors 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

NRG-GY017  NCT03738228

Anti PD-L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer S. Ghamande Joni Shortt Cervical 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

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

SGN22E-001  NCT03219333

A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Recived Immune Checkpoint Inhibitor (CPI) Therapy J. Parikh Kelly Jenkins Urothelial Cancer II

SGNTV-002  NCT03657043

Open Label Phase 2 Study of Tisotumab Vedotin for Patients with Platinum-Resistant Ovarian Cancer with a Safety Run-in of a Dose-Dense Regimen S. Ghamande Donna Wheatley Ovarian Cancer II

BST002  NCT03435848

A Phase 2b, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults with Newly-Diagnosed Acute Myeloid Leukemia, Not Eligible for Standard Induction Therapy V. Kota Sandra Wall Acute Myeloid Leukemia 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

NRG-LU002  NCT03137771

Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial S. Ghamande Kelly Adams Non-Small Cell Lung 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