Clinical Trials

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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

Cancer Control

General Cancer Control Protocols for Symptom Management


  • A222004 - A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia (NCT04939090)
  • URCC-16092 - Phase II Study of Low-Dose Ibuprofen for Cognitive Impairment in Cancer Patients Receiving Chemotherapy (NCT03186638)
  • URCC-18007 - Randomized Placebo Controlled Trial of Bupropion for Cancer Related Fatigue. (NCT03996265)

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

Brain 

Glioblastoma / Meningioma 

  • NRG-BN003 - Phase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma (NCT03180268)
  • NRG-BN007 - A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients With Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma (NCT04396860)

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

Breast

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


  • A011801- The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): CompassHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib (NCT04457596)
  • A191901-Optimizing Endochrine Therapy Through Motivational Interviewing and Text Interventions (NCT04379570)
  • AFT-25-Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low Risk DCIS: A Phase III Prospective Randomized Trial (NCT02926911)
  • EA1181- (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete responsePart 1 Component of:The CompassHER2 Trials (COMprehensive use of Pathologic response ASSessment to optimize therapy in HER2-positive breast cancer)(NCT04266249)
  • EA1183-FDG PET to Assess Therapeutic Response in Patients with Bone-dominant Metastatic Breast Cancer, FEATURE (NCT04316117)
  • FB-12-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-BR003 - Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node- Positive or High-Risk Node-Negative Triple Negative Invasive Breast Cancer(NCT02488967)
  • NRG-BR004-A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NCT03199885)
  • 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)

  • 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)
  • S1904 - Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Increase Chemoprevention Informed Choice Among Women With Atypical Hyperplasia or Lobular Carcinoma In Situ - Making Informed Choices on Incorporating Chemoprevention Into Care (MiChoice (NCT04496739) Temporarily Closed
  • S2007 - A Phase II Trial of Sacituzumab Govitecan for Patients with HER2-Negative Breast Cancer and Brain Metastases (NCT04647916)
  • URCC-16070 - Treatment of Refractory Nausea (NCT03367572)


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

Gastrointestinal

Cancer control / Colorectal / Liver / Pancreatic

  • A021502 - Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair (NCT02912559)
  • A021703- Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients With Previously Untreated Metastatic Colorectal Cancer (SOLARIS) (NCT04094688)
  • A021806-A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer (NCT04340141)
  • A221805- Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study (NCT04137107)
  • 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) Temporarily Closed
  • EA2185- Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs (NCT04239573)
  • EA2186-A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naive Metastatic Pancreatic Cancer (GIANT) (NCT04233866)
  • EA2187- A Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma (NCT04175912) Temporarily Closed
  • 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)
  • S0820 - Double-blind Placebo-controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers for Patients with Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES) (NCT01730937)

  • 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)
  • 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

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)
  • A031803- Phase II Trial of Intravesical Gemcitabine and MK-3475 (Pembrolizumab) in the Treatment of Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NCT04164082)
  • A031902- CASPAR, A Phase III Trial of Enzalutamide and Rucaparib as a Novel Therapy in First-Line Metastatic Castration-resistant Prostate Cancer (NCT: 04455750)
  • AFT-19 - A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer (NCT03009981)
  • EA8183 - A Phase III Double Blinded Study of Early Intervention after RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE) (NCT04484818)
  • 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)
  • NRG-GU002 - Trial Of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or without Adjuvant Docetaxel (NCT03070886)
  • NRG-GU008-Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer After Radical Prostatectomy(INNOVATE*)
    INtensifying treatment for NOde positive prostate cancer by VArying the hormonal ThErapy (NCT04134260)
  • 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)
  • 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)
  • WF-1802 - Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW)(NCT03963739)

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

GYN

Uterine / Ovarian / Endometrial


  • NRG-GY006 - 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.(NCT02466971) Temporarily Closed

  • NRG-GY014- A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma (NCT03348631) Temporarily Closed
  • NRG-GY018 - A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer (NCT03914612)
  • 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 (NCT04095364)
  • NRG-GY020-A Phase III Randomized Trial of Radiation +/- MK-3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer (NCT04214067)
  • RTOG-0724-Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy ( NCT00980954)

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

Head & Neck

  • EA2174 -A Phase II/III Study of Peri-Operative Nivolumab and Ipilimumab in Patients With Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma ( NCT03604991)
  • 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)
  • 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)
  • WF-1805CD- Implementation and Effectiveness Trial of HN-STAR (NCT0420849)

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

Leukemia

ALL / AML / CML

  • A041702-A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥ 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL) (NCT03737981)
  • 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) Temporarily Closed
  • A151216 - (ALCHEMIST) Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (NCT02194738)
  • A171901-Older Non-Small Cell Lung Cancer Patients (>/=70 Years of Age) Treated with First-Line MK-3475 (Pembrolizumab) +/- Chemotherapy (Oncologist's/Patient's Choice) (NCT04533451)
  • 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)
  • EA5163 - INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis (NCT03793179)
  • EA5181-Randomized Phase III Trial of MEDI4736 (durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC (NCT04092283)
  • 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)
  • EA5191-A Randomized Phase II Trial of Cabozantinib and Cabozantinib Plus Nivolumab Versus Standard Chemotherapy in Patients with Previously Treated Non-Squamous NSCLC (NCT04310007)
  • 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-CC003 - Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer (NCT02635009)
  • 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)
  • 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)
  • S1914-A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC (NCT04334941)
  • S1929- Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC) (NCT04334941)
  • S1933-A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status (NCT04310020)

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


  • 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)
  • EA6191- The BAMM2 (BRAF, Autophagy, MEK inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib with or without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma (NCT04527549)
  • EA6192-A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop)(NCT04462406)
  • 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)
  • S1801-A Phase II Randomized Study of Adjuvant vs. Neoadjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma (NCT03698019)
  • 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

  • EAA171 - Optimizing Prolonged Treatment in Myeloma Using MRD Assessment (OPTIMUM) (NCT03941860)
  • 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)
  • 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


  • A091802-Phase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)(NCT03944941)
  • A151804-Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events (NCT04242095)

  • EAY131- Molecular Analysis for Therapy Choice (MATCH) (NCT02465060)
  • NCICOVID-NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study (NCT04387656)
  • NHLBI-MDS - The National Myelodysplastic Syndromes Natural History Study (NCT02775383)
  • NRG-GY022-Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin (NCT03997370)

  • S1609 - DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors (NCT02834013)
  • URCC-19075 - Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN) (NCT04888988)
  • WF-1901-Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)(NCT04462302)
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