Priority Lists
Protocol Posting of
Activations
Closures
Partial Temporary Closure -Effective Date 8/16/2024
Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapse/Refractory Large B-Cell Lymphoma
| Action Codes | NR |
| Study Coordinator(s) | Patrick Reagan, M.D., Alexey Danilov, M.D., Sonali Smith, M.D., Jennifer Amengual, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Amendments, Revisions, Memoranda
Revision #1 - Version Date 7/17/24
A Randomized Phase II Study Comparing Cytarabine +Daunurubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by MYELOMATCH; A myeloMATCH Clinical Trial
| Action Codes | AC, ER, NR |
| Study Coordinator(s) | Paul Shami, M.D., Tara Lin, M.D. |
Memorandum 1 of 2 - Participant Materials Now Available
A Randomized Phase II Study Comparing Cytarabine +Daunurubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by MYELOMATCH; A myeloMATCH Clinical Trial
| Action Codes | AC, ER, NR |
| Study Coordinator(s) | Paul Shami, M.D., Tara Lin, M.D. |
Memorandum 2 of 2 - MyeloMATCH Kick-Off Meeting
A Randomized Phase II Study Comparing Cytarabine +Daunurubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by MYELOMATCH; A myeloMATCH Clinical Trial
| Action Codes | AC, ER, NR |
| Study Coordinator(s) | Paul Shami, M.D., Tara Lin, M.D. |
Memorandum - MyeloMATCH Kick-Off Meeting
Master Screening and Reassessment Protocol (MSRP) for the NCI myeloMATCH trials
| Action Codes | NR |
| Study Coordinator(s) | Jerald P. Radich, M.D. |
Memorandum - IND Safety Report(s) for Ramucirumab
A PHASE II RANDOMIZED STUDY OF RAMUCIRUMAB PLUS MK3475 (PEMBROLIZUMAB) VERSUS STANDARD OF CARE FOR PATIENTS PREVIOUSLY TREATED WITH IMMUNOTHERAPY FOR STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (LUNG-MAP NON-MATCHED SUB-STUDY)
| Action Codes | ER |
| Study Coordinator(s) | Karen Reckamp, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for N-803 (ALT-803)
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 | ER |
| Study Coordinator(s) | John Wrangle, MD, MPH, Hatim Husain, MD |
Memorandum - Updated Funding Memo
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
| Action Codes | NR |
| Study Coordinator(s) | Brian Chapin, M.D., Ana Aparicio, M.D., Amir Goldkorn, M.D., Richard Valicenti, M.D., John Gore, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - 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 - IND Safety Report(s) for Avelumab
A PHASE II STUDY OF TALAZOPARIB PLUS AVELUMAB IN PATIENTS WITH STAGE IV OR RECURRENT NON-SQUAMOUS NON-SMALL CELL LUNG CANCER BEARING PATHOGENIC STK11 GENOMIC ALTERATIONS (LUNG-MAP SUB-STUDY)
| Action Codes | ER |
| Study Coordinator(s) | Ferdinandos Skoulidis, M.D., Ph.D, Jennifer M. Suga, M.D., MPH |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Sotorasib (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 |
| Study Coordinator(s) | Sukhmani K. Padda, M.D., David Gerber, M.D. |
Memorandum - IND Safety Report(s) for Ramucirumab
A Randomized Phase II Study of INC280 (capmatinib) plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
| Action Codes | ER |
| Study Coordinator(s) | Sarah B. Goldberg, MD, MPH, D. Ross Camidge, M.D., Ph.D |
| Participants | US INSTITUTIONS ONLY |
Memorandum - IND Safety Report(s) for Ramucirumab
A Randomized Phase II Study of Tepotinib with or Without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
| Action Codes | ER |
| Study Coordinator(s) | Paul Paik, M.D., Xiuning Le, M.D. |
| Participants | US INSTITUTIONS ONLY |
Revision #2 - Version Date 5/15/2024
A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) 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
| Action Codes | IP, AC, ER, NR |
| Study Coordinator(s) | Elizabeth Brem, M.D., Sonali Smith, M.D., Norah L. Henry, M.D.,Ph.D., Rebecca Olin, M.D., MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - Specimen Collection & Submission Instructions and Updated Master Forms Set
A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) 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
| Action Codes | IP, AC, ER, NR |
| Study Coordinator(s) | Elizabeth Brem, M.D., Sonali Smith, M.D., Norah L. Henry, M.D.,Ph.D., Rebecca Olin, M.D., MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - IND Safety Report(s) for Ramucirumab
Randomized Phase II Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
| Action Codes | ER |
| Study Coordinator(s) | Michael J. Overman, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum - Updated Master Forms Set
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 - S2000 Change Memo (PVD 05/22/24) Clarification
A randomized phase 2 trial of encorafenib + binimetinib + nivolumab vs ipilimumab + nivolumab in BRAFV600-mutant melanoma brain metastases
| Action Codes | NR |
| Study Coordinator(s) | Zeynep Eroglu, MD, M.D., Hussein A Tawbi, MD, M.D. |
| Participants | ALLIANCE, ECOG-ACRIN, NRG, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Avelumab
Randomized Phase II Trial Of Gemcitabine, Avelumab and Carboplatin vs. No Neoadjuvant Therapy Preceding Surgery For Cisplatin-Ineligible Muscle-Ineligible Urothelial Carcinoma: SWOG GAP TRIAL
| Action Codes | NR |
| Study Coordinator(s) | Guru Sonpavde, M.D., Michael A. Liss, M.D., Seth P. Lerner, M.D., Daniel P. Petrylak, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Outstanding Queries in REDCap
MELANOMA MARGINS TRIAL (MELMART-II): A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1CM V 2CM Wide Excision Margins for Primary Cutaneous Melanoma
| Action Codes | NR |
| Study Coordinator(s) | Joshua M.V. Mammen, MD,PhD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #4 - Version Date 7/08/2024
A Phase II Randomized Trial of Postoperative Adjuvant Capecitabine and Temozolimide versus Observation in High-Risk Pancreatic Neuroendocrine Tumors
| Action Codes | AC, ER |
Memorandum - IND Safety Reports for MEDI4736 (Durvalumab)
A Randomized trial of neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone for Adults with MammaPrint Ultrahigh (MP2) hormone receptor (HR) positive /Human Epidermal Growth Factor receptor (HER2) negative stage II-III breast cancer
| Action Codes | ER |
| Study Coordinator(s) | Erin Cobain, MD, Lajos Pusztai, M.D., D.Ph |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Daratumumab
A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma Patients Considered Frail or Ineligible for Stem Cell Transplant Comparing Frontline Regimen Bortezomib-Lenalidomide-Dexamethasone-Lite (VRd-Lite) with Daratumumab-Lenalidomide-Dexamethasone (DRd) Followed by Len+/-Dara (R+/-D) Maintenance
| Action Codes | ER |
Memorandum - IND Safety Report(s) for Daratumumab
A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis
| Action Codes | ER |
Memorandum - IND Safety Report(s) for Ramucirumab
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
| Action Codes | ER |
| Study Coordinator(s) | Karen Reckamp, M.D., Konstantin H. Dragnev, M.D. |
Memorandum - IND Safety Report(s) for Ramucirumab
Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS ≥ 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)
| Action Codes | ER |
Memorandum - S2312 Kick-Off Meeting
A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with metastatic castrate-resistant prostate cancer (mCRPC), Stratified by Aggressive Variant Signature
| Action Codes | FBR |
| Study Coordinator(s) | Paul G. Corn, M.D., Ana Aparicio, M.D., David VanderWeele , M.D.,Ph.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
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