Priority Lists
Protocol Posting of
Activations
Activation - Effective 10/14/20
A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor Induction with Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
Action Codes | FBR |
Activation Effective 11/16/2020
Phase III trial of Nivolumab and Ipilimumab with or without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
Action Codes | FBR |
Study Coordinator(s) | Ulka N. Vaishampayan, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Closures
Permanent Closure - Effective 12/15/2020
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 |
Permanent Closure (Cohort 35 & 48) - Effective 11/17/20
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 |
Amendments, Revisions, Memoranda
Memorandum - FMI and Kit Vendor Holiday Closures
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 - Inotuzumab Ozogamicin Safety Report
A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
Action Codes | ER |
Study Coordinator(s) | Anjali S. Advani, M.D., Michaela Liedtke, MD |
Participants | Limited: Institutions Listed on the Title Page |
Memorandum -Source Documentation Request
Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Action Codes | NR |
Study Coordinator(s) | Robert S. Krouse, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum 1 of 5 - MEDI476 (durvalumab) 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 2 of 5 - 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 5 - 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 5 of 5 - Ipilimumab 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 3 of 5 - 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 1 of 2 - 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 2 of 2 - MK-3475 (Pembrolizumab) 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 - MK-3475 (Pembrolizumab) Safety Reports
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 (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy.
Action Codes | NR |
Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - MK-3475 (Pembrolizumab) Safety Report
A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
Action Codes | NR |
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 2 of 2 - Holiday Laboratory Closure
A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
Action Codes | NR |
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 - 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 1 of 2 - MK-3475 (Pembrolizumab) 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, 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 - Holiday Laboratory Closure
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 1 of 3 - 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 3 - 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 3 of 3 - Maintenance Therapy Clarification
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 - Holiday Lab Closure
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 3 - 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, 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 3 - 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, 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 3 of 3 - Holiday Laboratory Closure
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 Report
A Feasibility Trial of Neoadjuvant Cisplatin - Pemetrexed - Atezolizumab with Adjuvant Maintenance Atezolizumab in Resectable Malignant Pleural Mesothelioma
Action Codes | ER, NR |
Study Coordinator(s) | Anne Tsao, M.D. |
Memorandum - Olaparib (AZD2281) Safety Reports
A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer
Action Codes | ER |
Study Coordinator(s) | Reshma Jagsi, M.D. |
Participants | ALLIANCE, ECOG-ACRIN, NRG |
Memorandum - MK-3475 (Pembrolizumab) Safety Report
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 - Spanish-Translated Version of the Model Consent Form for Revision #6 (Version Date 7/24/20)
A Phase II Randomized Study of Adjuvant versus Neoadjuvant Pembrolizumab for Clinically Detectable Stage III-IV High-risk Melanoma.
Action Codes | ER, NR |
Study Coordinator(s) | Sapna Patel, MD |
Participants | SWOG, ALLIANCE, ECOG-ACRIN, NRG |
Memorandum 2 of 2 - MK-3475 (Pembrolizumab) Safety Report
A Phase II Randomized Study of Adjuvant versus Neoadjuvant Pembrolizumab for Clinically Detectable Stage III-IV High-risk Melanoma.
Action Codes | ER, NR |
Study Coordinator(s) | Sapna Patel, MD |
Participants | SWOG, ALLIANCE, ECOG-ACRIN, NRG |
Memorandum - 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 | IP, AC, ER |
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, NR |
Study Coordinator(s) | Parminder Singh, M.D., Seth P. Lerner, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - S1826 Quarterly Newsletter - November 2020
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, NR |
Study Coordinator(s) | Alex Herrera, M.D., Jonathan W. Friedberg, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum 2 of 2 - Nivolumab (BMS-936558) Safety Reports
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, NR |
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, NR |
Study Coordinator(s) | Jonathan W. Riess, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #3 – Version Date 10/6/20
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 | 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, NR |
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 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, NR |
Study Coordinator(s) | Ferdinandos Skoulidis, M.D., Ph.D, Jennifer M. Suga, M.D., MPH |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum- Atezolizumab 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, NR |
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 – Spanish-Translated Version of the Model Consent Form for Revision #2 (Version Date 8/20/20)
Randomized Phase II Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
Action Codes | NR |
Study Coordinator(s) | Michael J. Overman, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE |
Memorandum 1 of 2 - Atezolizumab 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, NR |
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, NR |
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- Atezolizumab 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, NR |
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