Clinical Trials

Active Trials

Dayton Clinical Oncology Program accesses clinical trials through its membership in cooperative research groups funded by the National Cancer Institute (NCI), and through the pharmaceutical industry.

For more infomation about any of the trials listed below
ask your doctor or search www.clinical trials.gov

ClinicalTrials.gov

Cancer Control

General Cancer Control Protocols for Symptom Management


  • A212102 - Blinded Reference Set for Multicancer Early Detection Blood Tests (NCT05334069) Temporarily Closed
  • A221805 - Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study (NCT04137107) Temporarily Closed
  • A222004 - A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia (NCT04939090) 
  • EA2185 - Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs (NCT04239573)
  • NRG-CC005 - FORTE (Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps) (NCT05080673)
  • S2010 - A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone to Improve Persistence With Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN) (NCT05568472)
  • URCC-16070 - Treatment of Refractory Nausea (NCT03367572)
  • URCC-18007 - Randomized Placebo Controlled Trial of Bupropion for Cancer Related Fatigue. (NCT03996265)
  • URCC-19075 - Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN) (NCT04888988)
  • URCC-21038 - 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 (NCT05364086)
  • URCC-22063 - Longitudinal Observational Trial to Uncover Subtypes of Cancer Cachexia (NCT06073431)
  • WF-1806 - Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study (NCT03998202)

Trials descriptions available on http://www.clinicaltrials.gov

Brain 

Glioblastoma / Meningioma 

  • A071702 - A Phase II Study of Checkpoint Blockade Immunotherapy in Patients With Somatically Hypermutated Recurrent Glioblastoma (NCT04145115)
  • NRG-BN003 - Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma (NCT03180268)
  • NRG-BN011 - A Phase III Trial of Gleostine® (Lomustine)-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma (NCT05095376)
  • NRG-BN012 - A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases (NCT05438212)

Trials descriptions available on http://www.clinicaltrials.gov

Breast

Cancer Control / HER2- / HER2+ / BRACA+/ Triple Negative
Metastatic / Nodal 


  • A012103 - OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy (NCT05812807)
  • CCTG MA.39 - TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer (NCT03488693)
  • EA1183 - FDG PET to Assess Therapeutic Response in Patients with Bone-dominant Metastatic Breast Cancer, FEATURE (NCT04316117)
  • EA1211 - Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial (NCT05710328)
  • EAY191-N2 - A ComboMATCH Treatment Trial EAY191-N2: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With a Frameshift or Nonsense Mutation or Genomic Deletion in NF1 (NCT05554354)
  • FB-12 (Limited Site Participation) - An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected with a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)(NCT03412643) 
  • NRG-BR007 - Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage 1, Hormone Sensitive HER2-Negative, Oncotype Recurrence Score < 18 Breast Cancer(DEBRA) De-Escalation of Breast Radiation (NCT04852887)
  • NRG-BR008 - A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO) (NCT05705401)
  • NRG-BR009 - Female Only - A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET) (NCT05879926)
  • S1703 - Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer (NCT03723928)
  • S2007 - A Phase II Trial of Sacituzumab Govitecan for Patients with HER2-Negative Breast Cancer and Brain Metastases (NCT04647916)
  • S2212 - Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study (NCTT05929768)

Trials descriptions available on http://www.clinicaltrials.gov

Gastrointestinal

Cancer Control / Colorectal / Liver / Pancreatic


  • A022004 - Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage II/III BRAF V600E Colon Cancer (NCT05710406)
  • A022101 - A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur) (NCT05673148)
  • A022102 - Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma (NCT05677490)
  • A022104 - The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer (NCT05610163)
  • EA2176 - A Randomized Phase III of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients (NCT04444921)
  • EA2182 - A Randomized Phase II Study of De-Intensified ChemoRadiation for Early- Stage Anal Squamous Cell Carcinoma (DECREASE) (NCT04166318)
  • EA2183 - A Phase III Study of Consolidative Radiotherapy in Patients with Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA) (NCT04248452) 
  • EA2192 - APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Adjuvant Chemotherapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation (NCT04858334)
  • EA2197 - Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN)- A Randomized Phase II/III Trial” (NCT04559139)
  • NRG-GI004 - 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 (NCT02997228) 
  • NRG-GI005 - Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)(NCT04068103) Temporarily Closed
  • NRG-GI008 - Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (NCT05174169) 

  • S1922 - Randomized Phase II Selection Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma (NCT04205968)
  • S2001 - Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients With Germline BRCA1 or BRCA2 Mutations (NCT04548752)
  • S2107 - Randomized Phase II Trial of Encorafenib and Cetuximab With or Without Nivolumab (NSC #748726) for Patients With Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer (NCT05308446)

Trials descriptions available on http://www.clinicaltrials.gov

Genitourinary

Bladder / Prostate / Renal / Urothelial


  • A031701 - A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations (NCT03609216)
  • A031702 - A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC) (NCT03866382)
  • A031704 - PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE] (NCT03793166)
  • A032001 - MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial Cancer (NCT05092958)
  • A032101 - A Phase 2 Trial of ADT Interruption in Patients Responding Exceptionally to AR-Pathway Inhibitor in Metastatic Hormone-Sensitive Prostate Cancer (MHSPC): A-DREAM (NCT05241860)
  • EA8184 - A Phase II 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 (NCT04597359)
  • EA8192 - A Phase II/III Trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy (NCT04628767)
  • EA8212 - A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE) (NCT05538663)
  • NRG-GU011 - A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean) (NCT05053152)
  • NRG-GU012 - Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI) (NCT05327686)
  • 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 (NCT03678025)
  • S1806 - Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806)(NCT03775265)
  • S1931 - Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial) (NCT04510597)
  • S1937 - A Phase III Randomized Trial of Eribulin (NSC #707389) With or Without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy (NCT04579224) Temporarily Closed
  • S2200 - A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2) (NCT05411081)

Trials descriptions available on http://www.clinicaltrials.gov

GYN

Uterine / Ovarian / Endometrial


  • EAY191-N4 - A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients With Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers: A ComboMATCH Treatment Trial (NCT05554328)

Trials descriptions available on http://www.clinicaltrials.gov

Head & Neck


  • EA3132 - Adjuvant Radiotherapy with or without Cisplatin for P53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) (NCT02734537)
  • EA3191 - A Phase II Randomized Trial of Adjuvant Therapy with Pembrolizumab after Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma with High Risk Features (NCT04671667)
  • EA3202 - A Phase II/III Trial of Chemotherapy + Cetuximab vs Chemotherapy + Bevacizumab vs Atezolizumab + Bevacizumab Following Progression on Immune Checkpoint Inhibition in Recurrent/Metastatic Head and Neck Cancers (NCT05063552) 
  • EA3211 - Phase III Randomized Trial of Immunotherapy With or Without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma (NCT05721755)
  • 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) (NCT05050162)

Trials descriptions available on http://www.clinicaltrials.gov

Leukemia

ALL / AML / CML


  • S1925 - Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab Versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study (NCT04269902)

Trials descriptions available on http://www.clinicaltrials.gov

Lung

NSCLC / SCLC / Squamous Cell


  • A081801 - Integration of Immunotherapy into Adjuvant Therapy for Resected NSCLC: ALCHEMIST CHEMEO-10 (NCT04267848) 
  • A082002 - A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer (NCT04929041)
  • A151216 - (ALCHEMIST) Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (NCT02194738)
  • E4512 - (ALCHEMIST) Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein (NCT02201992)
  • EA5182 - Randomized Phase III Study of Combination AZD9291 (osimer1nib) and Bevacizumab versus AZD9291 (osimertinib) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC) (NCT04181060)
  • LUNGMAP - A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study) (NCT02154490)
  • NRG-LU002 - Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial (NCT03137771) Temporarily Closed
  • NRG-LU007 - Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLCL RAPTOR trial (NCT04402788)
  • NRG-LU008 - Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer (NCT05624996)
  • S1900E - A Phase II Study of AMG 510 in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY) (NCT04625647)
  • S1900G - A Randomized Phase II Study of INC280 (Capmatinib) Plus Osimertinib With or Without Ramucirumab in Participants With EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study) (NCT05642572)
  • S1914 - A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC (NCT04334941)
  • S2302 - PRAGMATICA - LUNG: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non- Small Cell Lung Cancer (NCT05633602)

Trials descriptions available on http://www.clinicaltrials.gov

Lymphoma

Mantle Cell / Refractory


  • A051701 - Randomized phase II/III study of venetoclax (ABT-199) plus chemoimmunotherapy for MYC/BCL2 double-hit and double expressing lymphomas (NCT03984448) Temporarily Closed
  • 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 (NCT04803201)
  • ANHL1931 - A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (NCT04759586)
  • S1918 - A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants are 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 (NCT04799275) 

Trials descriptions available on http://www.clinicaltrials.gov

Melanoma

Advanced / Refractory / BRAFV600 Mutant


  • A091903 - A Randomized Phase II Trial of Adjuvant Nivolumab With or Without Cabozantinib in Patients With Resected Mucosal Melanoma (NCT05111574) Temporarily Closed
  • 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 (NCT02339571)
  • EA6194 - Phase II Randomized Study of Neoadjuvant Pembrolizumab Alone or in Combination with CMP-001 in Patients with Operable Melanoma: Efficacy and Biomarker Study (NCT04708418)
  • S2000 - A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab VS Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases (NCT04511013)

Trials descriptions available on http://www.clinicaltrials.gov

Myeloma

  • AFT-41 (Limited Site Participation) - A Phase II Study of Lenalidomide, Ixazomib, Dexamethasone, and Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma (NCT04009109)
  • EAA173 - Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM) (NCT03937635)
  • EAA181 - Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended For Early Autologous Transplantation (NCT04566328)
  • NHLBI-MDS - The National Myelodysplastic Syndromes Natural History Study (NCT02775383)
  • S1803 - Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients With Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study) ( NCT04071457) 

Trials descriptions available on http://www.clinicaltrials.gov

Other


  • A151804 - Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events (NCT04242095)
  • EAY191 - Molecular Analysis for Combination Therapy Choice (ComboMATCH) (NCT05564377)
  • EAY191-E4 - A ComboMATCH Treatment Trial E4: Nilotinib and Paclitaxel in Patients With Prior Taxane-Treated Solid Tumors (NCT05554341)
  • EAY191-S3 - Phase 2 Study of Paclitaxel + Ipatasertib in Taxane-Refractory Participants With AKT-Altered Advanced Non-Breast Solid Tumors (A ComboMATCH Treatment Trial) (NCT05554380)
  • S2013 - Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study (NCT04871542)

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