Priority Lists
Protocol Posting of
Activations
Activation - Effective 08/22/22
A Cluster Randomized Trial Comparing an Educationally Enhanced Genomic Tumor Board (eGTB) Intervention to Usual Practice to Increase Evidence-Based Genome Informed Therapy
Action Codes | ER |
Study Coordinator(s) | Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD |
Closures
Amendments, Revisions, Memoranda
Memorandum - Updated Master Forms Set and Updated Funding Memo
A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Action Codes | NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #10 – Version Date 08/12/2022
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)"
Action Codes | ER |
Study Coordinator(s) | Jason A. Zell, D.O. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - IND Safety Report(s) for Blinatumomab (AMG 103)
A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
Action Codes | ER |
Study Coordinator(s) | Anjali S. Advani, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Nivolumab (for 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 - IND Safety Report(s) for Atezolizumab (MPDL3280A)
Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Action Codes | ER |
Study Coordinator(s) | Peter C.V. Black, M.D., Parminder Singh, M.D., Seth P. Lerner, M.D., David J. McConkey, Ph.D., Rick Bangs |
Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG, CCTG |
Memorandum - IND Safety Report(s) for Talimogene laherparepvec (T-VEC, IMLYGIC)
A Phase II Study Of Combining Talimogene laherparepvec (T-VEC) And PD-1 Blockade With Pembrolizumab In Patients With Advanced Melanoma Who Have Progressed On Anti-PD1 Therapy
Action Codes | ER |
Study Coordinator(s) | Siwen Hu-Liekskovan, M.D., Ph.D, Antoni Ribas, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE, US INSTITUTIONS ONLY, CTSU |
Memorandum - IND Safety Report(s) for Ublituximab (TGR-1202)
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action Codes | ER |
Study Coordinator(s) | Paul M. Barr, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum - IND Safety Report(s) for Nivolumab
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 - IND Safety Report(s) for Nivolumab
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 - IND Safety Report(s) for Atezolizumab (MPDL3280A)
A Feasibility Trial of Neoadjuvant Cisplatin - Pemetrexed - Atezolizumab with Adjuvant Maintenance Atezolizumab in Resectable Malignant Pleural Mesothelioma
Action Codes | ER |
Study Coordinator(s) | Anne Tsao, M.D. |
Revision #1 – Version Date 06/15/2022
A Phase II/III Study of N-803 (ALT-803) plus Pembrolizumab versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)
Action Codes | IP, AC, RC, ER |
Study Coordinator(s) | John Wrangle, MD, MPH, Hatim Husain, MD |
Memorandum 1 of 3 - IND Safety Report(s) for Daratumumab
Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Action Codes | ER |
Study Coordinator(s) | Amrita Krishnan, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 2 of 3 - Updated Master Forms Set
Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Action Codes | ER |
Study Coordinator(s) | Amrita Krishnan, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 3 of 3 - Study Drug Expiration Reminder
Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Action Codes | ER |
Study Coordinator(s) | Amrita Krishnan, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #6 – Version Date 06/07/2022
Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Action Codes | ER |
Study Coordinator(s) | Amrita Krishnan, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)
Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.
Action Codes | ER |
Study Coordinator(s) | Parminder Singh, M.D., Seth P. Lerner, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Nivolumab
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 | ER |
Study Coordinator(s) | Alex Herrera, M.D., Jonathan W. Friedberg, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Revision #7 – Version Date 08/03/2022
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 | ER |
Study Coordinator(s) | Katherine Crew, M.D., M.S. |
Participants | Limited: Institutions Listed on the Title Page |
Memorandum - IND Safety Report(s) for OBI-3424
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)
Action Codes | ER |
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(s) for Atezolizumab (MPDL3280A)
A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC
Action Codes | NR |
Study Coordinator(s) | Megan E. Daly, M.D., Charles Simone, II, M.D., Karen Kelly, M.D., Jeffrey Bradley, M.D., Arta Monjazeb, M.D., Jessica Bauman, M.D., Rojano Kashani, Ph.D. |
Participants | CTSU Institutions in the United States |
Revision #4 – Version Date 06/10/2022
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 | NR |
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 - IND Safety Report(s) for Atezolizumab (MPDL3280A)
Phase II Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (SCLC)
Action Codes | ER |
Study Coordinator(s) | Nagla Karim, M.D., Ph.D, Karen Reckamp, M.D., Lauren A. Byers, M.D., Carl Gay, M.D., Ph.D |
Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)
A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status
Action Codes | ER |
Study Coordinator(s) | Raid Aljumaily, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)
NASSIST (Neoadjuvant Chemoradiation +/- Immunotherapy before Surgery for Superior Sulcus Tumors): A Randomized Phase II Trial of Trimodality +/- Atezolizumab in Resectable Superior Sulcus Non-Small Cell Lung Cancer
Action Codes | ER |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Ibrutinib (PCI-32765)
A Phase II Randomized Study of Ibrutinib and Rituximab with or without Venetoclax in Previously Untreated Waldenstrom's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
Action Codes | ER |
Study Coordinator(s) | Sikander Ailawadhi, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)
Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC#783608) in Patients with Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)
Action Codes | ER |
Study Coordinator(s) | David B. Zhen, MD |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #1 – Version Date 05/09/2022
Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
Action Codes | ER |
Study Coordinator(s) | Dawn Hershman, M.D., M.S., Krishna Gunturu, M.D. |
Memorandum - IND Safety Report(s) for Nivolumab
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
Action Codes | NR |
Study Coordinator(s) | Van K. Morris, M.D., E. Scott Kopetz, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
- 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