Priority Lists
Protocol Posting of
Activations
S1400K Activation - Effective 2/5/18
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | FBR, ER, NR |
Partial Re-Activation (Cohort 2) - Effective 1/30/18
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., Francis Giles, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Closures
Partial Permanent Closure (Cohort 34) - Effective 2/6/18
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., Francis Giles, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Partial Temporary Closure (Cohorts 1, 28, and 35) - Effective 2/26/18
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., Francis Giles, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Partial Temporary Closure (Cohort 16) - Effective 2/12/18
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., Francis Giles, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Amendments, Revisions, Memoranda
Memorandum - Abiraterone Acetate Safety Reports
Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
| Action Codes | ER |
| Study Coordinator(s) | Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D. |
| Participants | Members, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons |
Memorandum - 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 | 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 - PEGPH20 Safety Report
A Phase Ib/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) versus Modified FOLFIRINOX Alone in Patients with Good Performance Status Metastatic Pancreatic Adenocarcinoma
| Action Codes | ER |
| Study Coordinator(s) | Ramesh K. Ramanathan, M.D., Philip A. Philip, M.D.,Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum - 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 2 of 4 – Ipilimumab SR (for S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | FBR, ER, NR |
Memorandum 3 of 4 – Nivolumab SR (for S1400I)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | FBR, ER, NR |
Revision #14 (for S1400A)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | FBR, ER, NR |
Revision #12 (for S1400 and S1400K)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | FBR, ER, NR |
Memorandum 4 of 4 – Forms (S1400, S1400F), Data Entry Guidelines, S1400VCP
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | FBR, ER, NR |
Memorandum 1 of 4 - MEDI4736 Safety Report (for S1400A and S1400F)
A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
| Action Codes | FBR, ER, NR |
Memorandum 1 of 2 - 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 2 of 2 - MK-3475 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 1 of 2 - MK-3475 (Pembrolizumab) Safety Report
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 (>ypN+) After Neoadjuvant Chemotherapy.
| Action Codes | ER, NR |
| Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 2 of 2 - Updated Master Forms Set
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 (>ypN+) After Neoadjuvant Chemotherapy.
| Action Codes | ER, NR |
| Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - Cabozantinib (XL184) Safety Reports
A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511])in Metastatic Papillary Renal Carcinoma (PAPMET)
| Action Codes | ER |
| Study Coordinator(s) | Sumanta K. Pal, M.D., Primo N. Lara, Jr., M.D., Brian Shuch, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 2 of 2 - Savolitinib (AZD6094) Safety Report
A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511])in Metastatic Papillary Renal Carcinoma (PAPMET)
| Action Codes | ER |
| Study Coordinator(s) | Sumanta K. Pal, M.D., Primo N. Lara, Jr., M.D., Brian Shuch, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - 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 - MK-3475 Safety Report
A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
| Action Codes | ER |
| Study Coordinator(s) | Kari Kendra, M.D., Siwen Hu-Liekskovan, M.D., Ph.D, William Carson, III, M.D. |
| Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG |
Memorandum - Drug Supply Expiration
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 | NR |
| 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 - Message from Study Chairs
Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
| Action Codes | NR |
| 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 - MK-3475 Safety Report
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 1 of 2 - Ipilimumab Safety Reports
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., Francis Giles, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum 2 of 2 - Nivolumab Safety Reports
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., Francis Giles, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Revision #14 - Version Date 12/11/17
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., Francis Giles, MD |
| 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 |
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 |
| 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 |
| 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 |
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