Clinical Trials

ANAPLASTIC GLIOMA

N0577: Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low-Grade Glioma (NCT00887146)

BRAIN METASTASES

A071701: Genomically-guided Treatment Trial in Brain Metastases (NCT03994796)

CE.7: A Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5-15 Brain Metastases (NCT03550391)

CANCER CONTROL

WF-1801: A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy (NCT03475186)

INFLAMMATORY

S1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy alone for Inflammatory Breast Cancer (NCT03598257)

NODE + / LOW RISK / HER2-

MA.39: TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer (NCT03488693)

HER2+

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)

EA1181: (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Response Part 1 Component of: The Compass HER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) (NCT04266249)

NRG-BR008: A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO*) *Her2 Radiation Optimization (HERO) NCT#05705401

HER2- 

S2007: A Phase II Trial of Sacituzumab Govitecan (IMMU-132) for Patients with HER2-Negative Breast Cancer and Brain Metastases (NCT04647916) 

CANCER CONTROL

A191901: Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions (NCT04379570)

A221803: Mepitel Film for the Reduction of Radiation Dermatitis in Breast Cancer Patients Undergoing Post-Mastectomy Radiation Therapy: A Randomized Phase III Clinical Trial (DCP) NCT#04989504

A222101: An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy

Locally Advanced or Metastatic

*ML43171: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating The Efficacy and Safety of Giredestrant Plus Everolimus Compared with Exemestane Plus Everolimus In Patients with Estrogen Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

*CELCUITY CELC-G 301: A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR- Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) NCT#05501886

ANAL

EA2176: A Phase III Study 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)

COLON

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 NCT#0571040

ESOPHAGEAL & GASTRIC

EA2183: A Phase III Study of Consolidative Radiotherapy in Patients with Oligometastatic Esophageal and Gastric Adenocarcinoma (NCT04248452)

A022102: Randomized Phase III Trial of mFOLFIRINOX +/- Nivolumab vs. FOLFOX +/- Nivolumab for First-Line Treatment of Metastatic HER2-Negative Gastroesophageal Adenocarcinoma (NCT05677490)

SMALL BOWEL

S1922: Randomized Phase II Selection Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma (NCT04205968) 

PANCREATIC

EA2186: A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT) (NCT04233866)

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 BRC1, BRCA2 or PALB2 Mutation (NCT04858334)

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)

*Actuate 1801: Phase 1/2 study of 9-ING-41, a Glycogen synthase kinase-3 beta (GSK-3β) inhibitor, as a single agent and combined with chemotherapy, in patients with refractory hematologic malignancies or solid tumors (NCT03678883)

A021806: A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer (NCT04340141)

GALLBLADDER

EA2197: Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN) – A Randomized Phase II/III Trial (NCT04559139)

CANCER CONTROL

WF-1806: Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults with Colorectal Cancer: The M&M Study (NCT03998202)

IM2021-064: Evaluating the Utility of Compression Therapy on Decreasing Chemotherapy-Induced Peripheral Neuropathy: A Pilot Clinical Study (NCT04649151)

RENAL CELL

A031704: PD-inhibitor (Nivolumab) and Ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab in metastatic untreated Renal Cell Cancer [PDIGREE] (NCT03793166) 

PROSTATE 

EA8183: A Phase III 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)

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) (NCT04134260)

GU009: Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation (Predict-RT) (NCT04513717)

GU010: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification Clinical Trial Evaluation (GUIDANCE) (NCT05050084)

GU011: A Ph II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy w/ or w/o Androgen Deprivation Therapy in Oliogometastatic Prostate Cancer (NRG PROMETHEAN) (NCT05053152)

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)

GERM CELL

S1823: A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumors (NCT04435756)

CANCER CONTROL

A222001: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation Therapy (NCT04600336)

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)

OVARIAN

OROPHARYNGEAL

EA3161: A Phase III Randomized Study of Maintenance Nivolumab Versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCC

HN005: A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early Stage, p16-Positive, Non-Smoking Associated Oropharyngeal Cancer (NCT03952585)

EA3161: A Phase III Randomized Study of Maintenance Nivolumab Versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCC (NCT03811015)

HNSCC

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: Ph II/III Trial of Chemo + Cetuximab Vs Chemo + Bevacizumab Vs Atezolizumab + Bevacizumab Following Progression on Immune Checkpoint Inhibition in Recurrent / Metastatic Head & Neck Cancers (NCT05063552)

HN009: Rand Ph II/III Trial of Radiation w/ High-Dose Cisplatin (100 mg/m2) Every Three Weeks Vs Radiation w/ Low-Dose Weekly Cisplatin (40mg/m2) for Pts w/ Locoregionally Advanced Squamous Cell Carcinoma of the Head & Neck (NCT05050162)

FOLLICULAR LYMPHOMA

MCL: *BGB-11417-201 A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Bcl-2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma (NCT04277637)

B-CELL LYMMPHOMA

*ACE-LY-312: (D8227C00001) Phase 3, Rand, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination w/ Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, & Prednisone (R-CHOP) in Subjects ≤ 65 Years w/ Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma (Open at Mercy & West Campus Only) (NCT04529772)

*ADCT 402-311: A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5) (NCT04384484)

*ML43389: An Open-Label, Multicenter, Phase II Trial Evaluating The Safety, Efficacy, And Pharmacokinetics Of Subcutaneous Mosunetuzumab Monotherapy In Patients With Select B Cell Malignancies (cohort A closed to accrual) (NCT05207670)

TRANSFORMED LYPHOMA

CLL/SLL

*M20-356: A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients with Recurring Chronic Lymphocytic Leukemia (NCT04895436)

MULTIPLE MYELOMA (MM)

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) 

MYELODYSPLASTIC SYNDROME (MDS)

NHLBI-MDS: The National Myelodysplastic Syndromes Natural History Study (NCT02775383)

FOLLICULAR LYMPHOMA

S1608: Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma (NCT03269669)

S1918: A Phase II/III Randomized Study of R-miniCHOP with or without CC-486 (oral azacytidine) in patients 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 (NCT04799275)

INCMOR-208-301: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab in Patients with Relapsed / Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma (NCT04680052)

SMOLDERING MYELOMA

EAA173: Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM) (NCT03937635)

CNS LYMPHOMA

A051901: Phase I Trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma (NCT04609046)

B-CELL LYMPHOMA

S1918: A Phase II/III Randomized Study of R-MiniCHOP with or without CC-486 (Oral Azacitidine) 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 (NCT047992750)

TRANSFORMED LYMPHOMA

S1918: A Phase II/III Randomized Study of R-MiniCHOP with or without CC-486 (Oral Azacitidine) 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 (NCT047992750) 

CHRONIC LYMPHOCYTIC LEUKEMIA / SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL)

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): EVLOVE CLL/SLL Study (NCT04269902)

NON-SMALL CELL

A151216: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) (screening trial for A081801 & E4512) (NCT02194738)

A081801: Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (NCT04267848) 

*AVANZAR D926NC00001: A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (NCT05687266)

*EQ143-301: EQRX International, Inc. Eq143-301: A Randomized, Three-Arm, Open-Label Phase 3b Clinical Trial Of Aumolertinib, Versus Aumolertinib With Chemotherapy, Versus Osimertinib For Patients With Metastatic NSCLC And An EGFR Mutation (NCT05493501)

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)

E4512: A Phase III Double-Blind 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)

EA5181: Randomized Phase III Trial of MEDI4736 (Durvalumab) as Concurrent and Consolidative Therapy Alone for Unresectable Stage 3 NSCLC (NCT04092283)

EA5182: Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (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)

S1933: A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status (NCT04310020)

SMALL CELL

LU007: Randomized Phase II/III Trial of Consolidation Radiation +Immunotherapy for ES-SCLC: RAPTOR Trial (NCT04402788)

S1827: MRI Brain Surveillance Alone Versus MRI and Prophylactic (PCI): A Radiation Trial in Small-Cell Lung Cancer (NCT04155034)

A021602: Randomized Double-Blinded Ph III Study of Cabozantinib Vs Placebo in Pts w/ Advanced Neuroendocrine Tumors After Progression on Prior Therapy (DCP) (NCT03375320)

S2012: Randomized Ph II/III Trial of First Line Platinum / Etoposide w/ or w/o Atezolizumab in Pt w/ Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)

A021901: Randomized Phase II Trial of Lutetium Lu 177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors

MOONSHOT

10323: Cancer Moonshot Biobank Research Protocol

COMBOMATCH

EAY191: Molecular Analysis for Combination Therapy Choice (ComboMATCH) (NCT05554328)

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: A ComboMATCH Treatment Trial (NCT05554354)

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)

EAY191- S3: Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane- Refractory Participants with AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial (NCT05564377)

TISSUE PROCUREMENT

10323: Cancer Moonshot Biobank Research Protocol (NCT04314401) 

CANCER CONTROL / CCDR

A211901: Reaching Cancer Survivors who Smoke Using Text-Based Cessation Interventions (DCP) (NCT05008848)

A222004: A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia (NCT04939090)

EAQ202: Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials (DCP) (Breast Cancer, Non-Hispanic White & Leukemia/Lymphoma Cohorts Closed to Accrual) (NCT05108298)

GY022: Assessment of Carboplatin Clearance Predictors: A PK Study on NCI-Sponsored Clinical Trials or Standard of Care Treatments Using Carboplatin (NCT03997370)

S1912CD: A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (NCT04960787)

S2013: Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study (NCT04871542)

S2108CD: A Cluster Randomized Trial Comparing An Educationally Enhanced Genomic Tumor Board (EGTB) Intervention to Usual Practice to Increase Evidence-Based Genome- Informed Therapy (NCT05455606)

WF-1805CD: Implementation and Effectiveness of HN-STAR (NCT04208490)

WF-1901: Internet-delivered Management of Pain Among Cancer Treatment Survivors (NCT04462302)

PATIENT READY TRIALS

The trials below are not yet IRB approved, but are available as patients are identified.

HEME

Renal Cell

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)

MELANOMA 

EA6192: A Phase II Study of Biomarker Driven Early Discontinuation of anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-STOP) (NCT04462406)

S2000: A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab + vs Ipilimumab + Nivolimab in BRAF-V600 Mutant Melanoma with Brain Metastases (NCT04511013)

SQUAMOUS CELL

*Alpha Tau: A Prospective International Multicenter, Pivotal, Single Arm, Open Label Clinical Study to Assess the Efficacy and Safety of Intratumoral Alpha DaRT224 for the Treatment of Patients with Recurrent Cutaneous Squamous Cell Carcinoma (NCT05781555)

CANCER SCREENING

*2021-05: Specimen Collection Study to Evaluate Biomarkers in Subjects with Cancer

*CORE-HH: Harbinger Health Collection of Blood and Tissue Samples from Cancer and Non- Cancer Subjects for Validation of a Novel Blood-Based Multi-Cancer Screening Test (NCT05435066)

*THR-CS-001: Detecting Cancers Earlier through Elective Plasma-Based Cancer-SEEK Testing- Ascertaining Serial Cancer Patients to Enable New Diagnostic II (DETECT-ASCEND 2) (STODDARD only)

A212102: Blinded Reference Set for Multicancer Early Detection Blood Tests