Priority Lists
Protocol Posting of
Activations
Phase II Expansion Cohort Activation - Effective Date 10/08/2024
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 | NR |
| Study Coordinator(s) | Anjali S. Advani, M.D., Nikolaos Papadantonakis, M.D.,Ph.D., Cecilia Yeung, M.D. |
| Participants | SWOG, ALLIANCE, ECOG-ACRIN |
Closures
Amendments, Revisions, Memoranda
Revision #9 - Version Date 8/07/2024
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 |
Memorandum - Updated LUNGMAP Training now accessible in CTSU CLASS
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 |
Memorandum - MM1YA-S01 Optional Site Initiation Training
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 | NR |
| Study Coordinator(s) | Paul Shami, M.D., Tara Lin, M.D. |
Memorandum 1 of 2 - 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 2 of 2 - IND Safety Report(s) for Ipilimumab (BMS-734016) (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 1 of 2 - IND Safety Report(s) for Nivolumab
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 Report(s) 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 - IND Safety Report(s) for BCG Tokyo – 172
A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
| Action Codes | ER |
| Study Coordinator(s) | Robert S. Svatek, M.D., Ajjai S. Alva, M.D., Seth P. Lerner, M.D., Joshua Meeks, M.D., Scott Gilbert, M.D., Rick Bangs |
| Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG |
Memorandum 1 of 2 - 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 2 of 2 - IND Safety Report(s) 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 - 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 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 |
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 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 1 of 2 - Updated Tepotinib Investigator’s Brochure
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 |
Memorandum 2 of 2 - 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 |
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 - IND Safety Report(s) for Nivolumab
Biomarker Stratified CaboZantinib and NivOlumab (BiCaZO) - A phase II study of combining cabozantinib and nivolumab in patients with advanced solid tumors stratified by tumor biomarkers
| Action Codes | ER |
| Study Coordinator(s) | Siwen Hu-Liekskovan, M.D., Ph.D, Paul Swiecicki, M.D,, Katerina Politi, Ph.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
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 | ER |
| Study Coordinator(s) | Van K. Morris, M.D., E. Scott Kopetz, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - Site Educational Webinar
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 | NR |
Memorandum 2 of 2 - 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 | NR |
Revision #3 - Version Date 3/01/2024
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 1 of 2 - Updated Master Forms Set
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 2 of 2 - 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 1 of 2 - IND Safety Report(s) for Nivolumab
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 2 of 2 - 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 - Clinical Trial Summary: Patient-Friendly Summary and Social Media Toolkit
Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
| Action Codes | ER |
| Study Coordinator(s) | Nilanjan Ghosh, MD, PhD |
| Participants | US INSTITUTIONS ONLY |
Memorandum - Clinical Trial Summary: Patient-Friendly Summary and Social Media Toolkit
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 | ER |
| 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