As an academic medical center, the Georgia Cancer Center in Augusta, GA is actively involved in cancer research for cancer patients.
Clinical trials are the last step in a carefully regulated, detailed scientific process that starts in a laboratory in cells or tissue and are then tested in humans - oftentimes years later and always after strenuous review.
Medical studies are supervised by a local physician and look at every stage of disease, from first diagnosis to advanced disease. All are designed to find, diagnose, treat or prevent cancer.
Clinical Trials Office
Health Sciences Campus
GCC - M. Bert Storey Research Building
1410 Laney Walker Boulevard, Augusta, GA 30912
| Protocol # | Title | Study Type | Department | PI Name | NCT # | Coordinator |
| AU-WF-1805CD | Implementation and Effectiveness Trial of HN-Star | NCORP | Supportive Care - Head & Neck | Ghamande, Sharad | NCT04208490 | Hannah Claussen or Melissa Thomas |
| AU-URCC21038 | URCC21038, Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti PD-L1 Immunotherapy in a Community Oncology Setting | NCORP | Observational | Ghamande, Sharad | NCT05364086 | Kim English |
| AU-TEMEC | Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men with Cancer and Androgen Deficiency | Industry/Sponsored | Supportive Care | Del Fabbro, Egidio | NCT04301765 | Harriet Boatwright |
| AU-TCBIO-001-0710 | (TCBIO-001-0710) The CARIS Biorepository Research Protocol | Industry/Sponsored | GYN/ONC - Biorespository | Ghamande, Sharad | NCT01499394 | Alex Ward |
| AU-STUDY00003849 | A Phase II Trial of Combination Therapy of Pembrolizumab and Lenvatinib in Patients with Locally Advanced or Metastatic Cervical Cancer | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT04865887 | Emily Sarria |
| AU-SOVI-2302 | A Phase 1b Dose Optimization Study of Sovilnesib (an Oral KIF18A Inhibitor) in Subjects with Advanced High Grade Serous Ovarian Cancer | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT06084416 | Gwen Stanley |
| AU-SGNDV-005 | A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2 | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT06003231 | Melissa Berry |
| AU-SAL101JG | A Phase I Open-Label, Multicenter Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of SAIL66 in Patients with CLDn6-Positive Locally Advanced or Metastatic Solid Tumors | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT05735366 | Gwen Stanley |
| AU-S2013 | Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study | NCORP | Observational | Ghamande, Sharad | NCT04871542 | Kim English |
| AU-S1933 | (S1933) A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status | NCORP | Thoracic Oncology | Raval, Girindra | NCT04310020 | Kristen Learnard |
| AU-S1918 | S1918: A Phase II/III Randomized Study of R-miniCHOP With or Without Oral Azacitidine (CC-486) in Participants Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIb Follicular Lymphoma, Transformed Lymphoma, and High-grade B-cell Lymphomas With MYC and BCL2 and/or BCL6 Rearrangements | NCORP | Diffuse Large B-Cell Lymphoma | Bryan, Locke | NCT04799275 | Savannah Crews |
| AU-S1912CD | A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT) | NCORP | Supportive Care | Ghamande, Sharad | NCT04960787 | Hannah Claussen or Melissa Thomas |
| AU-S1827 | (S1827) MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK) | NCORP | Thoracic Oncology | Ghamande, Sharad | NCT04155034 | Kristen Learnard |
| AU-S1802 | (S1802) Phase III Randomized Trial of Standard Systemic Therapy (SST) versus Standard Systemic Therapy plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer | NCORP | GU/ONC | Ghamande, Sharad | NCT03678025 | Ashlyn Stevenson |
| AU-RTOG-1216 | (RTOG 1216) Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck | NCORP | Head & Neck | Ghamande, Sharad | NCT01810913 | Ashlyn Stevenson |
| AU-PROSPECTIVE-CARDONC-REGIST | Role of Social Determinants of Health and Vascular Aging as Markers of Cardiovascular Disease due to Cancer Therapy | IIT | Cardio-Oncology Care | Guha, Avirup | N/A | Harikrishnan Hyman Kunhiraman |
| AU-PM1183-C-010-22 | Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination with Doxorubicin versus Doxorubicin Alone as First-line Treatment in Patients with Metastatic Leiomyosarcoma | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT06088290 | Emily Sarria |
| AU-PHRI-RADICAL-PC1 | The Role of Androgen Deprivation Therapy In CArdiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC1) | Cardio-Oncology Care | Guha, Avirup | NCT03127631 | Harikrishnan Hyman Kunhiraman | |
| AU-P9846 | (P9846) Patient-derived Models Tissue Procurement Protocol for the National Cancer Institute | NCORP | GYN/ONC - Biorespository | Ghamande, Sharad | NCT02474160 | Kim English |
| AU-NRG-HN009 | Randomized Phase II/III Trial of Radiation With High-Dose Cisplatin (100 mg/m2) Every Three Weeks Versus Radiation With Low-Dose Weekly Cisplatin (40 mg/m2) for Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) | NCORP | Head & Neck | Ghamande, Sharad | NCT05050162 | Ashlyn Stevenson |
| AU-NRG-GY031 | A Phase IB Study of Combination ATR (M1774) and BET Inhibition (ZEN003694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer | NCORP | GYN/ONC | Ghamande, Sharad | NCT05950464 | Gwen Stanley |
| AU-NRG-GY028 | NRG-GY028: A Phase IIB and Randomized Phase II Trial of Megestrol Acetate With or Without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer | NCORP | GYN/ONC | Ghamande, Sharad | NCT05538897 | Katie Dorr |
| AU-NRG-GY027 | Phase I/IB Safety and Pharmacodynamic Study of Neoadjuvant (NACT) Paclitaxel and Carboplatin With Ipatasertib as Initial Therapy of Ovarian Cancer PTMA 100805 | NCORP | GYN/ONC | Ghamande, Sharad | NCT05276973 | Gwen Stanley |
| AU-NRG-GY026 | A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma | NCORP | GYN/ONC | Ghamande, Sharad | NCT05256225 | Melissa Berry |
| AU-NRG-GY025 | A Randomized Phase II Trial of Nivolumab and Ipilimumab Compared to Nivolumab Monotherapy in Patients With Deficient Mismatch Repair System Recurrent Endometrial Carcinoma | NCORP | GYN/ONC | Ghamande, Sharad | NCT05112601 | Gwen Stanley |
| AU-NRG-GY019 | (NRG-GY019) A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum | NCORP | GYN/ONC | Ghamande, Sharad | NCT04095364 | Gwen Stanley |
| AU-NRG-GI004 | (NRG-GI004/SWOG-S1610) Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer | NCORP | GI Cancer | Ghamande, Sharad | NCT02997228 | Ashlyn Stevenson |
| AU-NRG-CC012CD | NRG-CC012CD: Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment (SYMON) | NCORP | Non-Treatment | Ghamande, Sharad | NCT06279013 | Hannah Claussen or Melissa Thomas |
| AU-NRG-CC008 | A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk] | NCORP | GYN/ONC | Ghamande, Sharad | NCT04251052 | Kim English |
| AU-NRG-BN011 | NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma | NCORP | Neuro-Oncology | Wallace, Gerald | NCT05095376 | Morgan Williams |
| AU-NMTRC014 | NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO); NMTRC014 | Industry/Sponsored | Pediatric HEM/ONC - Neuroblastoma | McDonough, Colleen | NCT02679144 | Caryn Bird |
| AU-NMTRC012 | PEDS-PLAN - Pediatric Precision Laboratory Advanced Neuroblastoma Therapy - A Study Using Molecular Guided Therapy with Induction Chemotherapy Followed by a Randomized Controlled Trial of standard Immunotherapy with or without DFMO Followed by DFMO Maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma | Industry/Sponsored | Pediatric HEM/ONC - Neuroblastoma | McDonough, Colleen | NCT02559778 | Caryn Bird |
| AU-NKT3447-101 | A Phase 1, First-In-Human, Open-Label Study to Evaluate the Safety, Tolerability, Pk, and Preliminary Anti-Tumor Activity of the Novel Orally Available Cdk2 Inhibitor NKT3447 in Adults with Advanced/Metastatic Solid Tumors | Industry/Sponsored | Solid Tumor | Ghamande, Sharad | NCT06264921 | Katie Dorr |
| AU-NEO100-01 | An Open-Label, Phase 1/2a Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or IV Gliomas with IDH1 Mutation | Industry/Sponsored | Neuro-Oncology | Wallace, Gerald | NCT02704858 | Morgan Williams |
| AU-MPCT-012L | A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of IMPT-314, a CD19/20 Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma | Industry/Sponsored | Non-Hodgkin Lymphoma | Bryan, Locke | NCT05826535 | Mandy Spires |
| AU-MORAB-202-G000-201 | A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRa)-Targeting Antibody-Drug Conjugate (ADC) in Subjects with Selected Tumor Types | Industry/Sponsored | Solid Tumor | Ghamande, Sharad | NCT04300556 | Katie Dorr |
| AU-MK-2870-005 | A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095) Protocol Number: 005-01/ENGOT-en23/GOG-309 | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT06132958 | Melissa Berry |
| AU-MDS-AML-REGISTRY | Connect® MDS and AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry | Industry/Sponsored | HEM/ONC - Registry | Mian, Mohammad | NCT01688011 | Gita Giddens or Sharmin Khan |
| AU-M-2018-344 | A Multi-Center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects with Relapsed and/or Refractory Diffuse Large B Cell Lymphoma | Industry/Sponsored | Diffuse Large B-Cell Lymphoma | Kota, Vamsi | NCT04792489 | Amanda Spires |
| AU-LUNG-MAP | (LUNG-MAP) A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study) | NCORP | Thoracic Oncology | Raval, Girindra | NCT03851445 | Kristen Learnard |
| AU-KT-US-484-0136 | An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma | Industry/Sponsored | Large B-Cell Lymphoma | Kota, Vamsi | NCT05605899 | Becky Paynter |
| AU-KO-MEN-007 | Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination with Ziftomenib (KO-539) or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination with Ziftomenib for the Treatment of Patients with Acute Myeloid Leukemia | Industry/Sponsored | Acute Myeloid Leukemia | Cortes, Jorge | NCT05735184 | Mandy Spires |
| AU-J2J-MC-JZLH | A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2-Early Breast Cancer with an Increased Risk of Recurrence | Industry/Sponsored | Breast Cancer | Raval, Priyanka | NCT05514054 | Morgan Williams |
| AU-IOV-LUN-202 | (LN-145) A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer | Industry/Sponsored | Thoracic Oncology | Kota, Vamsi | NCT04614103 | Kristen Learnard |
| AU-IM048022 | A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Treatment after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM) | Industry/Sponsored | Multiple Myeloma | Keruakous, Amany | NCT05827016 | Sarah Leathers |
| AU-HQP1351CU101 | A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered Hqp1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) And Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) | Industry/Sponsored | Chronic Myeloid Leukemia | Cortes, Jorge | NCT04260022 | Thalyta Freitas |
| AU-HPV-VAC-PP | (HPV-VAC-PP) Immunogenicity, Compliance, Knowledge and Attitudes in Postpartum Women during a Two Dose 9-valent HPV Vaccination Series | Industry/Sponsored | Prevention - HPV | Zahler-Miller, Carolyn | NCT04311528 | Angela Goebel |
| AU-GOG-3086 | REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) versus Investigators Choice (IC) Chemotherapy in Women with Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1) | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT05870748 | Rebecca Scholer |
| AU-GOG-3083 | A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients with P53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT05611931 | Melissa Berry |
| AU-GOG-3043 | A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial) | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT04831580 | Emily Sarria |
| AU-GCC1953 | Expanded Cccess for Indoximod in Combination With Chemotherapy for Pediatric Patients With Relapsed Brain Cancer | IIT | Pediatric - Brain Cancer | Johnson, Theodore | N/A | Robin Dobbins |
| AU-GCC2020 | Repurposing Ibrutinib for Chemo-immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer | IIT | Pediatric - Brain Cancer | Johnson, Theodore | NCT05106296 | Robin Dobbins |
| AU-GCC1949 | Phase 2 Trial of Indoximod with Chemotherapy and Radiation for Children with Progressive Brain Tumors or Newly Diagnosed DIPG | IIT | Pediatric - Brain Cancer | Johnson, Theodore | NCT04049669 | Robin Dobbins |
| AU-GCC-23-021 | The Effect of Low-Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy | IIT | GYN/ONC | Johnson, Marian Symmes | NCT05980169 | Katie Dorr or Rebecca Scholer |
| AU-GCC-23-018A | Androgen Deprivation Therapy Mediated Cardiovascular Disease and Vascular Aging in Men with Prostate Cancer: Racial Difference, and Role of NAD+ | IIT | Cardio-Oncology Care | Guha, Avirup | N/A | Harikrishnan Hyman Kunhiraman |
| AU-GCC-22-044 | Evaluation of Cholecalciferol (VitD3) Maintenance Supplementation in Patients With Multiple Myeloma (MM) Undergoing Transplantation and in Combination With Lenalidomide Maintenance | IIT | Multiple Myeloma | Keruakous, Amany | NCT05846880 | Megan Johnson |
| AU-GCC-22-037 | Genetic Testing in Minorities - I (GTM-I) Towards Universal Paired Tumor/Germline Genetic Testing in Solid Tumor Patients | IIT | Solid Tumor | Henson, John | N/A | John Henson, MD |
| AU-EA9181 | (EA9181) A Phase III Randomized Trial of Steroids +Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-positive Acute Lymphoblastic Leukemia in Adults | NCORP | Acute Lymphoblastic Leukemia | Kota, Vamsi | NCT04530565 | Sarah Leathers |
| AU-EA6141 | 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 | NCORP | Melanoma | Ghamande, Sharad | NCT02339571 | Ashlyn Stevenson |
| AU-DCP-002 | (DCP-002) Early Onset Malignancies Initiative (EOMI): Molecular profiling of Breast, Prostate, Colorectal, Liver, Kidney, and Multiple Myeloma among Racially and Ethnically Diverse Populations | NCORP | Biorepository | Ghamande, Sharad | N/A | Kim English |
| AU-DCP-001 | (DCP-001) Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP) | NCORP | Screening | Ghamande, Sharad | N/A | Kim English |
| AU-D419CR00035 | An Observational Multi-Center Study to Evaluate Real-World Treatment Outcomes of Durvalumab-based Regimens in Hepatobiliary Cancers | Industry/Sponsored | GI Cancer - Observational | Nayak, Asha | N/A | Ashlyn Stevenson |
| AU-CTA-2101 | Phase 1b/2a Study of CTO1681 for the Prevention and Treatment of Cytokine Release Syndrome in Patients with Diffuse Large B-Cell Lymphoma Receiving Chimeric Antigen Receptor T-Cell Therapy | Industry/Sponsored | Cytokine Release Syndrome | Cortes, Jorge | NCT05905328 | Thalyta Freitas |
| AU-CB10A | A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ANTLER) | Industry/Sponsored | B-Cell Non-Hodgkin Lymphoma | Kota, Vamsi | NCT04637763 | Megan Johnson |
| AU-CABL001AUS06T | Asciminib as Initial Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase | Industry/Sponsored | Chronic Myeloid Leukemia | Cortes, Jorge | NCT05143840 | Thalyta Freitas |
| AU-BP1001-201-AML | (BP1001-201-AML) A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination with Venetoclax plus Decitabine in Patients with Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS) Who Are Ineligible for Intensive Induction Therapy | Industry/Sponsored | Acute Myeloid Leukemia | Kota, Vamsi | NCT02781883 | Sarah Leathers |
| AU-BCC015 | (BCC015) Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma | Industry/Sponsored | Pediatric HEM/ONC - Neuroblastoma | McDonough, Colleen | NCT04301843 | Caryn Bird or Archana Laknaur |
| AU-BCC018 | A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma | Industry/Sponsored | Pediatric HEM/ONC - Neuroblastoma | McDonough, Colleen | NCT05489887 | Caryn Bird or Archana Laknaur |
| AU-APEC14B1 | (APEC14B1) The Project: Every Child Protocol; A Registry, Eligibility, Screening, Biology and Outcome Study | Industry/Sponsored | Pediatric HEM/ONC - Observational | McDonough, Colleen | NCT02402244 | Caryn Bird or Archana Laknaur |
| AU-AHOD2131 | AHOD2131, A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immunooncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma | NCORP | Pediatric HEM/ONC - Observational | McDonough, Colleen | NCT05675410 | Savannah Crews |
| AU-AHEP1531 | (AHEP1531) Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) | NCORP | Pediatric HEM/ONC - Observational | McDonough, Colleen | NCT03533582 | Caryn Bird or Archana Laknaur |
| AU-AGCT1531 | (AGCT1531) A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors | NCORP | Pediatric HEM/ONC - Germ Cell Tumors | McDonough, Colleen | NCT03067181 | Caryn Bird or Archana Laknaur |
| AU-AALL1732 | (AALL1732) A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy | NCORP | Pediatric HEM/ONC - Acute Lymphoblastic Leukemia | McDonough, Colleen | NCT03959085 | Caryn Bird or Archana Laknaur |
| AU-A151216 | (A151216 ALCHEMIST) Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) | NCORP | Thoracic Oncology | Ghamande, Sharad | NCT02194738 | Kristen Learnard |
| AU-A052101 | A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy with Zanubrutinib as Upfront Treatment in Older Patients with Mantle Cell Lymphoma | NCORP | Mantle Cell Lymphoma | Bryan, Locke | NCT05976763 | Savannah Crews |
| AU-64007957MMY1008 | A Phase 1 Randomized, Open-Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants with Relapsed/Refractory Multiple Myeloma | Industry/Sponsored | Multiple Myeloma | Keruakous, Amany | NCT06425991 | Megan Johnson |
| AU-611255 | (BMT Repository) Protocol for a Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries | Industry/Sponsored | BMT - Observational | Kota, Vamsi | NCT04920474 | Gita Giddens, Courtney Corley or Kimberly Green |
| AU-611164 | (BMT Repository) Protocol for a Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries | Industry/Sponsored | BMT - Observational | Kota, Vamsi | NCT01166009 | Gita Giddens, Courtney Corley or Kimberly Green |
| AU-587 | A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants who are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab | Industry/Sponsored | Patients in F/U that received Pembrolizumab | Ghamande, Sharad | NCT03486873 | Katie Dorr |
| AU-4010-01-001 | (TESARO 4010-01-001) Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with advanced Solid Tumors | Industry/Sponsored | Solid Tumor | Ghamande, Sharad | NCT02715284 | Ashlyn Stevenson |
| AU-2079199 | Global Cardio Oncology Registry | Industry/Sponsored | Cardio-Oncology Care | Guha, Avirup | N/A | Harikrishnan Hyman Kunhiraman |
| AU-10-CBA | 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 | Industry/Sponsored | HEM/ONC CBU- Observational | Kota, Vamsi | NCT01351545 | Gita Giddens, Courtney Corley or Kimberly Green |
| AU-TERN-701-1012 | A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants with Chronic Myeloid Leukemia | Industry/Sponsored | Chronic Myeloid Leukemia | Cortes, Jorge | NCT06163430 | Thalyta Freitas |
| AU-MYELOMATCH | Master Screening and Reassessment Protocol (MSRP) for Tier Advancement in the NCI myeloMATCH Clinical Trials | NCORP | HEM/ONC - Screening | Kota, Vamsi | NCT05564390 | Sarah Leathers |
| AU-54767414MMY2095 | Pilot Study of Daratumumab in Combination with Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-CyBorD) in Newly Diagnosed Multiple Myeloma Patients with Renal Failure | Industry/Sponsored | Multiple Myeloma | Keruakous, Amany | NCT06142396 | Amanda Spires |
| AU-A051902 | A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas | NCORP | T-Cell Lymphoma | Bryan, Locke | NCT04803201 | Becky Paynter |
| AU-NXP800-101 | A Phase 1 Clinical Study of NXP800 in Subjects with Advanced Cancers and Expansion in Subjects with Ovarian Cancer | Industry/Sponsored | GYN/ONC | Ghamande, Sharad | NCT05226507 | Katie Dorr |
| AU-NRG-CC010 | A Phase III Trial of the Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer | NCORP | Supportive Care | Ghamande, Sharad | NCT05646316 | Kim English |
| AU-MM1YA-S01 | A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH Clinical Trial | NCORP | Acute Myeloid Leukemia | Kota, Vamsi | NCT05554406 | Sarah Leathers |
| AU-MM1OA-EA02 | A Randomized Phase II Study of Venetoclax and HMA-based Therapies for the Treatment of Older and Unfit Adults with Newly Diagnosed FLT3-mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial | NCORP | Acute Myeloid Leukemia | Kota, Vamsi | NCT06317649 | Sarah Leathers |
| AU-MA-GVHD-401 | A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE) | Industry/Sponsored | Observational | Kota, Vamsi | NCT05919511 | Gita Giddens or Sharmin Khan |
| AU-S2308 | Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma | NCORP | Follicular Lymphoma | Bryan, Locke | NCT06337318 | Becky Paynter |
| AU-ARST2031 | A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS) | NCORP | Pediatric HEM/ONC - Rhabdomyosarcoma | McDonough, Colleen | NCT04994132 | Caryn Bird or Archana Laknaur |
| AU-SN-C-00014 | Assessment of Chimerism and Relapse Post-Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test (ACROBAT) | Industry/Sponsored | BMT - Observational | Kota, Vamsi | NCT04635384 | Harriet Boatwright |
| AU-S1914 | (S1914) A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC | NCORP | Thoracic Oncology | Raval, Girindra | NCT04214262 | Kristen Learnard |
| AU-MVT-601-056 | Relugolix Versus Leuprolide in Patients with Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV) | Cardio-Oncology Care | Guha, Avirup | NCT05605964 | Harikrishnan Hyman Kunhiraman | |
| AU-LTFS | An Observational Long-term Follow-up Study of Patients Who Received Prior Caribou Cell Therapy | Industry/Sponsored | BMT - Observational | Kota, Vamsi | NCT05332054 | Megan Johnson |
| AU-ACCL20N1CD | Financial Distress during Treatment for Pediatric Acute Lymphoblastic Leukemia in the United States | NCORP | Acute Lymphoblastic Leukemia - Observational | Ghamande, Sharad | NCT04928599 | Caryn Bird or Archana Laknaur |
| AU-A041501 | A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL | NCORP | Acute Lymphoblastic Leukemia | Kota, Vamsi | NCT03150693 | Sarah Leathers |
| AU-WF-2301CD | WF-2301 CD: Multi-site Community Oncology Planning for the CONNECT Intervention Targeting Lung Cancer Caregivers | NCORP | Thoracic Oncology | Ghamande, Sharad | NCT06383988 | Hannah Claussen or Melissa Thomas |
| AU-URCC-23086CD | URCC-23086CD: Sexual Orientation and Gender Identity Data Collection in Community Oncology Practice | NCORP | Non-Treatment | Ghamande, Sharad | NCT05845476 | Hannah Claussen or Melissa Thomas |
| AU-LND-300 | (RECOVER) A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression | Industry/Sponsored | Psychiatry & Health Behavior | Rosenquist, Peter | NCT03887715 | Laryssa McCloud or Tess Dzurny |
| AU-1640358 | Impacting Cancer Health Disparities and Facilitating Cancer Health Equity in Breast, Multiple Myeloma, and Prostate Cancers in Underserved and Minority Populations: The cancer-Community Awareness Access Research & Education II (c-CARE II) Initiative | IIT | Prevention | Tingen, Martha | N/A | |
| AU-AAML1831 | A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations | NCORP | Pediatric HEM/ONC - Acute Myeloid Leukemia | McDonough, Colleen | NCT04293562 | Caryn Bird or Archana Laknaur |
| AU-AGCT1532 | Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours | NCORP | Pediatric HEM/ONC - Germ Cell Tumors | McDonough, Colleen | NCT02582697 | Caryn Bird or Archana Laknaur |
| AU-ALTE03N1 | Key Adverse Events after Childhood Cancer | NCORP | Pediatric HEM/ONC - Observational | McDonough, Colleen | NCT00082745 | Caryn Bird or Archana Laknaur |
| AU-ALTE05N1 | Umbrella Long-Term Follow-Up Protocol | NCORP | Pediatric HEM/ONC - Observational | McDonough, Colleen | NCT00736749 | Caryn Bird or Archana Laknaur |
| AU-AREN03B2 | Renal Tumors Classification, Biology, and Banking Study | NCORP | Pediatric HEM/ONC - Renal Tumors | McDonough, Colleen | NCT00898365 | Caryn Bird or Archana Laknaur |
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Most clinical trials are classified into one of three phases.
These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often and what dose is safe. Cancer patients who enroll in these trials have already tried other treatment options.
A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer and typically enrolls fewer than a hundred patients.
In a Phase III trial, a participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics and cancer centers nationwide.
The maker of an approved drug may study it further in a phase IV trial to evaluate the side effects, risks and benefits of a drug over a longer period of time and in a larger number of people.
Before a patient is enrolled in a clinical trial, the individual is carefully screened against a set of criteria designed to identify a group of people that are as similar as possible.
Qualification for a trial depends on a variety of factors including stage of disease, existing health conditions and other factors. The patient then goes through what is known as “informed consent” where the goals of the trial, why it is needed and how it will work are explained in easily understandable terms. Patients should take the time to discuss all the details of a clinical trial with their doctor and family before agreeing to participate. Questions to consider include information about costs, time commitments, and potential benefits as well as side effects. This may vary, based on where the new therapy or tool is in the development and testing process.
