Priority Lists
Protocol Posting of
Activations
Closures
Permanent Closure - Effective 8/24/2021
Phase III Randomized Adjuvant Study of Pembrolizumab in Muscle Invasive and Locally Advanced Urothelial Carcinoma (ambassador) Versus Observation
| Action Codes | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
| Closure Date | 2021-08-24 |
Amendments, Revisions, Memoranda
Memorandum - IND Safety Report for CC-5013 (Lenalidomide)
A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
| Action Codes | ER |
| Study Coordinator(s) | Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D. |
| Participants | Members, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU |
Revision #17 - Revision 17 was prepared to: (1) Incorporate clinical trial guidance for conduct of S1007 during the COVID-19 pandemic or similar extenuating circumstances (Sections 7.1h, 9.0 and 16.1g); (2) update the hyperlink to the SWOG Biospecimen Bank Kit Management Application (Sections 15.3b, 18.6d.2, and 18.7d.2); and (3) Incorporate administrative clarifications for tissue labelling and make contacts for the Circulating Biomarker Assessment for Late Relapse Translational Medicine (CBALR TM) Substudy more visible in the protocol (S1007 Protocol Contact Information).
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
| Action Codes | IP, ER |
| Study Coordinator(s) | Julie R. Gralow, M.D., Gabriel N. Hortobagyi, M.D., Kathy Albain, M.D., Funda Meric-Bernstam, M.D., Kevin Kalinsky, MD |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Memorandum - IND Safety Report for CC-5013 (Lenalidomide)
A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
| Action Codes | ER |
| Study Coordinator(s) | Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD |
| Participants | Limited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum (2 of 2) - IND Safety Reports for Nivolumab (BMS-936558) (S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum (1 of 2) - IND Safety Reports for Ipilimumab (BMS-734016) (S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | ER |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum (1 of 2) - IND Safety Reports for Ipilimumab (BMS-734016)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB FOR PREVIOUSLY TREATED PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER AND NO MATCHING BIOMARKER
| Action Codes | ER |
| Study Coordinator(s) | Scott Gettinger, M.D., Lyudmila Bazhenova, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum (2 of 2) IND Safety Reports for Nivolumab (BMS-936558)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB FOR PREVIOUSLY TREATED PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER AND NO MATCHING BIOMARKER
| Action Codes | ER |
| Study Coordinator(s) | Scott Gettinger, M.D., Lyudmila Bazhenova, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG |
Memorandum - Clarification of Specimen Submission
A Randomized Phase III Trial to Evaluate Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/=1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy.
| Action Codes | NR |
| Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum (1 of 2) - IND Safety Report for CC-5013 (Lenalidomide)
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
| Action Codes | NR |
| Study Coordinator(s) | Paul M. Barr, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum (2 of 2) - IND Safety Report for Obinutuzumab (Gazyva)
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
| Action Codes | NR |
| Study Coordinator(s) | Paul M. Barr, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum (1 of 2) - IND Safety Reports for Ipilimumab (BMS-734016)
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
| Action Codes | ER |
| Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum (2 of 2) - IND Safety Reports for Nivolumab (BMS-936558)
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
| Action Codes | ER |
| Study Coordinator(s) | Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum (SAE) - IND Safety Reports for Nivolumab (BMS-936558)
A Randomized Phase II/III Trial of "Novel Therapeutics" versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia Age 60 or Older
| Action Codes | ER |
| Study Coordinator(s) | Laura Michaelis, MD, Roland Walter, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Clarification of Temporary Closure
A Randomized Phase II Study of Pertuzumab and Trastuzumab (TP) compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) with HER2 Amplification
| Action Codes | NR |
| Study Coordinator(s) | Kanwal Raghav, M.D., E. Scott Kopetz, M.D., Marwan G. Fakih, M.D. |
| Participants | CTSU Institutions in the United States |
Memorandum - Spanish Model Consent Forms
Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Cytotoxic Therapy for Solid Tumors
| Action Codes | NR |
| Study Coordinator(s) | Jessica Hwang, M.D. M.P.H, Anna Lok, M.D. |
Memorandum (1 of 2) - IND Safety Reports for Ipilimumab (BMS-734016)
A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent
| Action Codes | ER |
| Study Coordinator(s) | Ari VanderWalde, M.D., Antoni Ribas, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE, US INSTITUTIONS ONLY, CTSU |
Memorandum (2 of 2) - IND Safety Reports for Nivolumab (BMS-936558)
A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent
| Action Codes | ER |
| Study Coordinator(s) | Ari VanderWalde, M.D., Antoni Ribas, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE, US INSTITUTIONS ONLY, CTSU |
Memorandum - Currently Approved Protocol Version
A Randomized Phase II Study of Ruxolitinib in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia Patients with Evidence of Molecular Disease
| Action Codes | NR |
| Study Coordinator(s) | Kendra Sweet, M.D. |
Revision #4 - Version Date 07/07/2021
Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.
| Action Codes | IP, AC, ER |
| Study Coordinator(s) | Parminder Singh, M.D., Seth P. Lerner, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Clarification of Specimen Collection, Labeling, and STM, Imaging, and Clinical Exam Schedule
A Prospective Observational Cohort Study to Assess miRNA371 for Outcome Prediction in Patients with Early Stage Germ Cell Tumors
| Study Coordinator(s) | Craig R. Nichols, M.D., Lucia Nappi, M.D., Ph.D |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCORP COMPONENTS AND SUBCOMPONENTS, CTSU |
Memorandum - IND Safety Reports for Nivolumab (BMS-936558)
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
| Action Codes | NR |
| Study Coordinator(s) | Alex Herrera, M.D., Jonathan W. Friedberg, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - IND Safety Reports for Rucaparib
A PHASE II STUDY OF RUCAPARIB IN PATIENTS WITH GENOMIC LOH HIGH AND/OR DELETERIOUS BRCA 1/2 MUTATION STAGE IV NON-SMALL CELL LUNG CANCER (LUNG-MAP SUB-STUDY)
| Action Codes | ER |
| Study Coordinator(s) | Jonathan W. Riess, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Reports for AMG 510
A PHASE II STUDY OF AMG 510 IN PATIENTS WITH PREVIOUSLY TREATED STAGE IV OR RECURRENT KRAS G12C MUTATED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (ECOG-ACRIN LUNG-MAP SUB-STUDY)
| Action Codes | ER |
Revision #2 - Version Date 08/05/2021
A PHASE II STUDY OF AMG 510 IN PATIENTS WITH PREVIOUSLY TREATED STAGE IV OR RECURRENT KRAS G12C MUTATED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (ECOG-ACRIN LUNG-MAP SUB-STUDY)
| Action Codes | ER |
Memorandum - Updating "Treating Investigator"
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)
| Action Codes | NR |
| Study Coordinator(s) | Katherine Crew, M.D., M.S. |
| Participants | Limited: Institutions Listed on the Title Page |
Revision #1 - Version Date 07/28/2021
A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)
| Study Coordinator(s) | Anjali S. Advani, M.D., Nikolaos Papadantonakis, M.D.,Ph.D., Cecilia Yeung, M.D. |
| Participants | SWOG, ALLIANCE, ECOG-ACRIN |
Memorandum - IND Safety Report for Obinutuzumab (Gazyva)
A 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 (CLL): EVOLVE CLL Study.
| Action Codes | ER |
| Study Coordinator(s) | Deborah Stephens, DO, Brian T. Hill, M.D., Ph.D, John Pagel, MD, PhD, Mazyar Shadman, M.D., M.Ph, Michael J. Fisch, M.D. |
Memorandum - Spanish Model Consent Forms
Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
| Study Coordinator(s) | Dawn Hershman, M.D., M.S., Krishna Gunturu, M.D. |
Other New Items
- IP - Pts Must Be Informed
- AC - Consent Must Be Amended
- CBR - No Registration Allowed until IRB Review
- RC - Formal Re-consent Required
- FBR - Full Board Review Required
- ER - Expedited Review Acceptable
- NR - No IRB Review Required