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)

GLIOBLASTOMA

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)

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)

TRIPLE NEGATIVE

BR003: A Randomized Phase III 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 (NCT03463954)

C4161001: Phase 1/2A Dose Escalation, Finding and Expansion Study Evaluation Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of PF-07104091 as a Single Agent and in Combination Therapy (NCT04553133)

WO39391: A Phase III, Randomized, Open-Label Study Comparing Atezolizumab (Anti-PD-L1 Antibody) in Combination with Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients with Operable Triple Negative Breast Cancer (NCT03498716)

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)

HER2-

C4161001: Phase 1/2A Dose Escalation, Finding and Expansion Study Evaluation Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of PF-07104091 as a Single Agent and in Combination Therapy (NCT04553133)

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

POST NEOADJUVANT

A011202: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (CT1-3N1) who have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy (NCT01901094)

CANCER CONTROL

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

COLORECTAL

A021703: Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS) (NCT04094688)

COLON

A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair (NCT02912559)

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)

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)

ESOPHAGEAL & GASTRIC

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

SMALL BOWEL

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

CHOLANGIOCARCINOMA

EA2187: A Phase 2 Study of Pevonedistat in Combination with Carboplatin with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma (NCT04175912)

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)

RECTAL

EA2201: A Phase II Study of Neoadjuvant Nivolumab Plus Ipilimumab and Short Course Radiation in MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma (NCT04751370)

GALLBLADDER

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

CANCER CONTROL

A221805: Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study (NCT04137107)

S0820: A Double-Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) (NCT01349881)

S1820: A Randomized Trial of the Altering Intake Managing Symptoms Intervention for Bowel Dysfunction in Rectal Cancer Survivors Compared to a Healthy Living Education Control: A Feasibility and Preliminary Efficacy Study (AIMS-RC) (NCT04205955)

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

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)

BLADDER

A031901: Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial (NCT04637594)

EA8185: Phase II Study of Bladder Sparing Chemoradiation with Durvalumab in Clinical Stage III, Node Positive Bladder Cancer (INSPIRE) (NCT04216290)

S1937: A Phase III Randomized Trial of Eribulin 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)

PROSTATE

A031902: (CASPAR) A Phase III Trial of Enzalutamide and Rucaparib as a Novel Therapy in First Line Metastatic Castration-resistant Prostate Cancer (NCT04455750)

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)

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)

WF-1802: Influence of Primary Treatment for Prostate Cancer on Work Experience (PCW) (NCT03963739)

OVARIAN

OROPHARYNGEAL

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)

STAGE III-IVB

HN004: Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin (NCT03258554)

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)

ORAL MUCOSITIS

MNPR-301-001: A Phase 2b/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Clonidine Mucoadhesive Buccal Tablet to Placebo to Prevent Chemotherapy-Induced Severe Oral Mucositis in Patients with Oropharyngeal Cancer (NCT04648020)

MULTIPLE MYELOMA (MM)

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

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 + 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)

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)

HODGKIN LYMPHOMA

S1826: A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma (NCT03907488)

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)

MANTLE CELL LYMPHOMA (MCL)

EA4181: A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A) and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients ≤ 70 years old with Untreated Mantle Cell Lymphoma (NCT04115631)

B-CELL LYMPHOMA

ADCT-402-201: A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A051701: Randomized Phase II/III Study of Venetoclax (ABT 199) Plus Chemoimmunothreapy for MYC/BCL2 Double-Hit and Double-Expressing Lymphomas (NCT03984448)

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 MYELOID LEUKEMIA (CML)

EA9171: A Phase II Study of adding the anti-PD-1 antibody pembrolizumab to tyrosine kinase inhibitors in patients with chronic myeloid leukemia and persistently detectable minimal residual disease

CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

EA9161: A Randomized Phase III Study of the addition of Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

U2-VEN-207: Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL) (NCT03801525)

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)

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: 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

C4161001: Phase 1/2A Dose Escalation, Finding and Expansion Study Evaluation Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti Tumor Activity of PF-07104091 as a Single Agent and in Combination Therapy (NCT04553133)

CC003: Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer (NCT02635009)

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)

S1929: Phase II Randomized Study of Maintenance Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES0SCLS) (NCT04334941)

NCI Match

EAY131: Screening for Treatment Assignment Based on Genetic Testing (Molecular Analysis for Therapy Choice [MATCH]) (NCT02465060)

TISSUE PROCUREMENT

10323: Cancer Moonshot Biobank Research Protocol (NCT04314401)

RARE TUMORS

S1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors (NCT02834013)

SOLID TUMORS

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)

CANCER CONTROL / CCDR

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

EAQ171CD: Implementing a Virtual Tobaccoe Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0" (NCT03808818)

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)

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

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

MELANOMA

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)

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

MERKEL CELL

EA6174: A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma (NCT03712695)