Priority Lists
Protocol Posting of
Activations
Partial Reactivation (Cohort 11) - Effective May 28, 2019
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action Codes | ER, NR |
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 |
Partial Reactivation (Cohorts 12 and 29) - Effective May 15, 2019
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action Codes | ER, NR |
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 |
Activation - Effective Date 5/17/19
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 | NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Closures
Partial Permanent Closure (Arm 3) - Effective June 6, 2019
Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Action Codes | ER |
Study Coordinator(s) | Robert S. Krouse, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Partial Temporary Closure (Cohort 17) - Effective May 29, 2019
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action Codes | ER, NR |
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 |
Temporary Closure Effective 05/16/2019
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 | AC, ER |
Study Coordinator(s) | Kanwal Raghav, M.D., E. Scott Kopetz, M.D., Marwan G. Fakih, M.D. |
Participants | CTSU Institutions in the United States |
Amendments, Revisions, Memoranda
Memorandum - IND Withdrawal and Drug Accountability and Disposition Reminder
A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer
Action Codes | ER |
Study Coordinator(s) | Robert P. Whitehead, M.D. |
Participants | Members, NCORP |
Memorandum - OSI-774 (Erlotinib)Safety Report
A Phase II Study of OSI-774 (NSC-718781) in Patients with Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
Action Codes | ER |
Study Coordinator(s) | Michael S. Gordon, M.D., Primo N. Lara, Jr., M.D., Paul H. Gumerlock, Ph.D. |
Participants | Members, NCORP, UCOP, Medical Oncologists, Surgeons, Pathologists, ECOG |
Memorandum - IND Withdrawal for IND # 59699: Epothilone B Analog (BMS – 247550) and Drug Accountability and Disposition Reminder
A Phase I Pharmacokinetic Study of Epothilone B Analogue BMS-247550 (NSC-710428D) in Patients with Advanced Malignancies and Varying Levels of Liver Dysfunction.
Action Codes | ER |
Study Coordinator(s) | Angela M. Davies, M.D., Timothy W. Synold, Pharm. D., Chris Takimoto, M.D. |
Participants | Limited: Institutions Listed on the Title Page |
Memorandum 1 of 2 - Dabrafenib Safety Report
"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action Codes | IP, AC, ER |
Study Coordinator(s) | Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D. |
Participants | Limited: Institutions Listed on the Title Page |
Memorandum 2 of 2 - Trametinib Safety Report
"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action Codes | IP, AC, ER |
Study Coordinator(s) | Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D. |
Participants | Limited: Institutions Listed on the Title Page |
Revision #11 - Version Date 04/17/2019
"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action Codes | IP, AC, ER |
Study Coordinator(s) | Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D. |
Participants | Limited: Institutions Listed on the Title Page |
Memorandum - Blinatumomab Safety Report
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 1 of 2 - Dabrafenib Safety Report
A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Action Codes | ER |
Study Coordinator(s) | Alain P. Algazi, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU |
Memorandum 2 of 2 - Trametinib Safety Report
A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Action Codes | ER |
Study Coordinator(s) | Alain P. Algazi, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU |
Memorandum 1 of 6 - MEDI4736 (Durvalumab) Safety Report (for S1400A and S1400F)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action Codes | ER, NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 2 of 6 - GDC-0032 (Taselisib) Safety Report (for S1400B)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action Codes | ER, NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 3 of 6 - Tremelimumab Safety Report (for S1400F)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action Codes | ER, NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 4 of 6 - Ipilimumab Safety Report (S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action Codes | ER, NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 5 of 6 - Nivolumab Safety Report (for S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action Codes | ER, NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 6 of 6 - Revision #27 (S1400I) - Version Date 4/3/19
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action Codes | ER, NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Ipilimumab Safety Report
A Phase III Randomized Trial of Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High-Risk Resected Melanoma
Action Codes | ER |
Study Coordinator(s) | Kenneth F. Grossmann, M.D., Ph.D, Sapna Patel, MD |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Trametinib Safety Report
A Phase II Trial Of Trametinib with Docetaxel in Patients with Kras Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies.
Action Codes | ER |
Study Coordinator(s) | Shirish M. Gadgeel, M.D., Philip C. Mack, Ph.D., Jonathan W. Riess, M.D. |
Participants | CTSU |
Memorandum - Atezolizumab Safety Reports
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 |
Revision # 4 - Version Date 04/04/2019
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, NR |
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 2 of 2 – Nivolumab (BMS-936558) Safety Report
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action Codes | ER, NR |
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 1 of 2 – Ipilimumab (BMS-734016) Safety Report
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action Codes | ER, NR |
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 - Nivolumab Safety Reports
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 |
Revision #3 - Version Date 04/15/2019
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 | AC, ER |
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 - Master Forms Update
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 | AC, ER |
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 1 of 2 - Ipilimumab Safety Report
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, NR |
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- Nivolumab Safety Report
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, NR |
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 - Atezolizumab Safety Reports
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. |
Memorandum - Ramucirumab Investigator's Brochure
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 | NR |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #2 - Version Date 04/10/2019
A Phase II Randomized Study of Adjuvant versus Neoadjuvant Pembrolizumab for Clinically Detectable Stage III-IV High-risk Melanoma.
Action Codes | ER |
Study Coordinator(s) | Sapna Patel, MD |
Memorandum - Drug Order Request Form
A phase III randomized trial of gemcitabine, cisplatin, and nab-paclitaxel versus gemcitabine and cisplatin in newly diagnosed, advanced biliary tract cancers
Action Codes | NR |
Study Coordinator(s) | Rachna T. Shroff, MD, MS |
Memorandum - Rucaparib Safety Report
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 |
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