Priority Lists
Protocol Posting of
Activations
Closures
Amendments, Revisions, Memoranda
Memorandum 2 of 4 - Nivolumab (BMS-936558) 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 1 of 4 - Ipilimumab (BMS-734016) 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 4 of 4 - Talazoparib Safety Report (for S1400G)
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 4- Nivolumab (BMS-936558) Investigator’s Brochure (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 - Ipilimumab (BMS-734016) 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 - Cabozatinib 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 - Atezolizumab Safety Report
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 - Spanish-translated Model Consent Form and Consent Addendum (Version Date: 07/01/20)
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
| Action Codes | NR |
| Study Coordinator(s) | Paul M. Barr, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
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 |
| 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 - Nivolumab (BMS-936558) Safety Report
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 - Nivolumab (BMS-936558) Safety Report
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 - Updated Master Forms
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 | NR |
| 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 (BMS-734016) 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 (BMS-936558) 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 - Atezolizumab Safety Report
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 - AE Form Update in Rave
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 |
| Study Coordinator(s) | Karen Reckamp, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - Master Forms Set and Funding Memorandum Update
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, NR |
| Study Coordinator(s) | Amrita Krishnan, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 2 of 2 - Daratumumab (rHuPH20) Safety Report
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, NR |
| Study Coordinator(s) | Amrita Krishnan, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Atezolizumab Safety Report
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, CCTG |
Memorandum - Nivolumab (BMS-936558) Safety Report
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 - 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 |
| Study Coordinator(s) | Jonathan W. Riess, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Updated Master Form Set
A PHASE II STUDY OF SELPERCATINIB (LOXO-292) IN PATIENTS WITH RET FUSION-POSITIVE STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (LUNG-MAP SUB-STUDY)
| Action Codes | IP, AC, ER, NR |
Revision #2 - Version Date 7/8/20
A PHASE II STUDY OF SELPERCATINIB (LOXO-292) IN PATIENTS WITH RET FUSION-POSITIVE STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (LUNG-MAP SUB-STUDY)
| Action Codes | IP, AC, ER, NR |
Memorandum 1 of 2 - Talazoparib Safety Report
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 2 of 2 - Avelumab (MSB0010718C; Bavencio)Safety Report
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 - Ateolizumab Safety Report
A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC
| Action Codes | ER |
| 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 |
Memorandum 1 of 2 - Ateolizumab Safety Report
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 2 of 2 - Talazoparib Safety Report
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 - Ateolizumab Safety Report
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., Timur Mitin, M.D.,Ph.D., Antoinette J. Wozniak, M.D. |
| Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG, US INSTITUTIONS ONLY |
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