With new medical treatments constantly emerging, The Toledo Clinic is always looking to provide the best up-to-date care for our patients. Clinical trials provide the possibility of new solutions to health problems that did not exist before. Below is a list of current clinical trials. Please contact us for more information.
Brain
A071701
Genomically Guided Treatment Trial in Brain Mets
Breast
HER2 POSITIVE
A011801
COMPASSHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2 Positive Breast Cancer: CompassHER2 Residual Disease, a Double-Blinded, Phase 3 Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib
HER2 LOW
PN-301-21***
Phase Study to Evaluate the Efficacy and Safety of Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients with HER2 Low Breast Cancer
HER2 NEGATIVE
STML-ELA-0322***
Open Label, Multi-Center, Phase 2 Study of Elacestrant in Women and Men with CDKJ4/6 Inhibitor-Naive Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
TRIPLE NEGATIVE BREAST
METASTATIC
S2007
Phase 2 – Trial of Sacituzumab Govitecan (IMMU-132) for Patients with HER2 Negative Breast Cancer and Brain Metastases
S1703
Randomized, Non-Inferiority Tiral Comparing Overall Survival of Patients Monitored with Serum Tumor Karker Directed Disease Monitoring vs. Usual Care in Patients with Metastatic HR+ Breast Cancer
SDX-010***
Phase 1B/2 – Assessing Safety and Efficacy of Evexomastat in Combination iwht PI3Ka Inhibitor Alpelisib (PIQRAY) + Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia with Advanced Breast Cancer and a PIK3CA Mutation Who Have Progressed On or Following Endocrine Therapy + CDK4/6 Inhibitor
V2000701*** (Suspended)
Phase 3 – Evaluate Efficacy and Safety of Enobosarm in Combination wiht Abemaciclib (Enobosarm Combination Group) copared to Estrogen Block Agent (Control GTreatment Group for 2nd line Treatment of ER+HR2- Metastatic Breast Cancer in Patients Who Have Shown Previous Disease Progression on Estrogen Blocking Agent and palbociclib
Colon/Rectal/Anal
ADJUVANT
NRG-GI005
Phase 2/3 – Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients with Stage IA Colon Cancer
METASATIC
ACCRU-GI-1809***
Randomized, Phase II Study of Regorafenib Followed by Anti-EGFR Monoclonal Antibody therapy Versus the Reverse Sequencing for Metastatic Colorectal Patient who was Previously Treated with Fluoropyrimidine, Oxaliplatin and Irinotecan (REVERCE II)
s2107
Randomized, Phase II – Encorafenib and Cetuximab With or Without Nivolumab for Patients with Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer
TP-CA-004***
Tempus Colorectal Cancer Surveillance Study – Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients with Colorectal Cancer Using Comprehensive NCG Assays
GASTROINTESTINAL
PANCREATIC
EA2186
A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-F, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer
S2001
Randomized, Phase 2 Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Patients with Metastatic Pancreatic Cancer with Germline BRCA1 or BRCA2 Mutations
A021806
Phase 3 – Perioperative vs. Adjuvant Chemotherapy for Resectable Pancreatic Cancer
EA2192
Randomized, Phase 2, Double-Blind Study of Olaparib vs. Placebo Following Adjuvamt Chemotherapy in Patients with Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
GASTROESOPHAGEAL
A022001
Phase 2 Randomized, Prospective Trial of Lutetium Lu 177 Doctate PRRT vs. Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors
SMALL BOWEL
S1922
Phase 2 Selection Study of Ramucirumab and Paclitaxel vs FOLFIRI in Refractory Small Bowel Adenocarcinoma
Genitourinary
BLADDER
A031803
Phase 2- Intravesical Gemcitabine and MK-3475 in Treatment of Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
A032001
Phase 3, Randomized Trial of Maintenance Cabozantinib and Avelumab vs. Maintenance Avelumab after 1st Line Platinum-Based Chemotherapy in Patients with Metastatic Urothelial Cancer
RENAL
A031704
Phase 3- PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib with Nivolumab: Metastatic Untreated Renal Cell Cancer (PDIGREE)
PROSTATE
A031902 (Suspended)
CASPAR – A Phase 3 Trial of Enzalutamide and Rucaparib as a Novel Therapy in First-Line Metastatic Castration-Resistant Prostate Cancer
EA8184
A Phase 2 Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers
A032101
Phase 2 Trial of ADT Interruption in Patients Responding Exceptionally to AR-Pathway Inhibitor in Metastatic Hormone-Sensitive Prostate Cancer
PRL-02-1001
Open Label, Multicenter Study of Intramuscular PRL-02-Depot in Patients with Advanced Prostate Cancer
HEAD and NECK
Hematology
LEUKEMIA
A041701 (currently suspended)
Phase 2/3 – Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults with AML Receiving Intensive Induction Chemotherapy
EA9171
Phase 2 – Study of Adding Anti-PD-1 Pembrolizumb to Tyrosine Kinase Inhibitors – Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease
S1925
Randomized, Phase 2 Early Intervention of Venetoclax and Obinutuzumab vs. Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
MYELOMA
EAA181
Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
BMS-IM048-022***
EPhase 3, Stage 2, Randomized, Multi-Center, Controlled Open-Label Comparing Iberdomide Maintenance to Lenalidomide Maintenance therapy after Autologous Stem Cell Transplantation in Patients with Newly Diagnosed Multiple Myeloma
EAA173
Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)
FOLLICULAR LYMPHOMA
S1608
Randomized Phase 2 Trial in Early Relapsing or Refractory Follicular Lymphoma
NCT03269669
FOLLICULAR AND LARGE B-CELL LYMPHOMA
M23-362***
M23-362: Open Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Follicular Lymphoma Grade 1-3a when Administered in the Outpatient Setting
Lung
NON-SMALL CELL
A151216
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing (ALCHEMIST – component study to E4512 and A081105)
S2302
Pragmatic Lung: Prospective Randomization Study of Ramucircumab Plus Pembrolizumab vs. Standard of Care for Participants Previously Treated with Immunotherapy for Stage 4 or Recurrent Non-Small Cell Lung Cancer
A081801
Integration of Immunotherapy into Adjuvant Therapy for Resected Non-Small Cell Lung Cancer (NSCLC): ALCHEMIST Chemo-IO
EA5191
Randomized, Phase 2 trial – Cabozantinib and Cabozantinib + Nivolumab vs Standard Chemotherapy in Patients Previously Treated Non-Small Cell Lung Cancer (NSCLC)
EA5182
Randomized, Phase 3 – Combination of Osimertinib and Bevacizumab vs. Osimertinib Alone as 1st Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)
E4512
Phase 3 – Double-Blind, Surgically Resected Early Stage Non-Small Cell Lung Cancer (NSCLC) – Critzotinib vs. Placebo for Patients with Tumors Harboring Anaplastic Lymphoma Kinase Fusion Protein
NCT02201992
EA5163
INSIGNA: Randomized Phase 3 – First line Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Post-Progression in Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Immuno-biomarker Signature-Drive Analysis
SGN35-033***
Phase 2, Brentuximab Vedotin in Combination with Pembrolizumab in Subjects with Metastatic Solid Malignancies After Progression on Prior PD-1 Inhibitor Treatment (Relapsed or Refractory Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer)
SMALL CELL
HLX10-005***
Randomized, Open-Label, HLX10 + Chemotherapy (Carboplatinum-Etoposide) in Comparison with Atezolizumab plus Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer
Melanoma
EA6192
Phase 2 – Study of Biomarker Driven Early Discontinuation of Anti PD-1 Therapy in Patients with Advanced Melanoma
HBI-8000-303***
Randomized, Double-Blind, Phase 3: HBI-8000 combined with Nivolumab vs. Placebo with Nivolumab in Patients with Unresectable or Metastatic Melanoma not Previously Treated with PD-1 or PD-L1 Inhibitors
SGN35-33***
Phase 2, Brentuximab Vedotin in Combination with Pembrolizumab in Subjects with Metastatic Solid Malignancies After Progression on Prior PD-1 Inhibitor Treatment (Metastatic Cutaneous Melanoma)
Neuroendocrine
A021602
Randomized, Double-Blind Phase 3 Study of Cabozantinib vs. Placebo in Patients with Advanced Neuroendocrine Tumors After Progression of Everolimus (CABINET)
S2012
Randomized Phase 2/3 1st Line Platinum/Etoposide With or Without Atezolizumab in Patients with Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Cancer
A022001
Randomized, Phase 2, Prospective Trial of Lutetium Lu 177 Dotatate PRR vs. Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors
Solid Tumors
ORACLE (GUARDANT)***
Observation of Residual Cancer with Liquid Biopsy Evaluation
F8394-201
Phase 2, Assess Efficacy and Safety of FORE8394, An Inhibitor of BRAF Class I and Class II Alterations in Participants with Cancer Harboring BRAF Alterations
Unspecified Cancer Related Issues
EAY-191
Molecular Analysis for Combination Therapy Choice