Priority Lists
Protocol Posting of
Activations
Activation - Effective 6/6/2022
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 | FBR |
Study Coordinator(s) | Van K. Morris, M.D., E. Scott Kopetz, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Closures
Amendments, Revisions, Memoranda
Memorandum - Upcoming Webinar and Posting of Lung-MAP Update Meeting Slides and Video
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 - IND Safety Report(s) for MK-3475 (Pembrolizumab)
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 | ER |
Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memoradum - IND Safety Report(s) for XL184 (Cabozantinib)
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 - IND Safety Report(s) for MK-3475 (Pembrolizumab)
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 - IND Safety Report(s) for Atezolizumab
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 - IND Safety Report(s) for MK-3475 (Pembrolizumab)
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 |
Revision #11 - Version Date 5/9/2022
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action Codes | IP, AC, ER |
Study Coordinator(s) | Paul M. Barr, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum - IND Safety Report(s) for MK-3475 (Pembrolizumab)
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 | ER |
Study Coordinator(s) | Karen Reckamp, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for MK-3475 (Pembrolizumab)
A Phase II/III Study of N-803 (ALT-803) plus Pembrolizumab versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)
Action Codes | ER |
Study Coordinator(s) | John Wrangle, MD, MPH, Hatim Husain, MD |
Memorandum - IND Safety Report(s) for MK-3475 (Pembrolizumab)
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 |
Participants | SWOG, ALLIANCE, ECOG-ACRIN, NRG |
Memorandum - Archival Specimens
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 - IND Safety Report(s) for Atezolizumab
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 |
Memorandum - Specimen and Data Submission Reminders
A Prospective Observational Cohort Study to Assess miRNA371 for Outcome Prediction in Patients with Early Stage Germ Cell Tumors
Action Codes | NR |
Study Coordinator(s) | Craig R. Nichols, M.D., Lucia Nappi, M.D., Ph.D |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCORP COMPONENTS AND SUBCOMPONENTS, CTSU |
Memorandum - IND Safety Report(s) for Atezolizumab
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 - IND Safety Report(s) for Atezolizumab
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 - IND Safety Report(s) for Atezolizumab
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. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum - IND Safety Report(s) for Atezolizumab
NASSIST (Neoadjuvant Chemoradiation +/- Immunotherapy before Surgery for Superior Sulcus Tumors): A Randomized Phase II Trial of Trimodality +/- Atezolizumab in Resectable Superior Sulcus Non-Small Cell Lung Cancer
Action Codes | ER |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for MK-3475 (Pembrolizumab)
Parallel Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib as Maintenance Therapy in Two Cohorts of Metastatic Pancreatic Cancer Patients with DNA Damage Repair Defects
Action Codes | ER |
Study Coordinator(s) | Vincent Chung, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Atezolizumab
Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC#783608) in Patients with Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)
Action Codes | ER |
Study Coordinator(s) | David B. Zhen, MD |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - New Protocol-Specific Requirement (PSR) - Site Approval Form
MELANOMA MARGINS TRIAL (MELMART-II): A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1CM V 2CM Wide Excision Margins for Primary Cutaneous Melanoma
Action Codes | NR |
Study Coordinator(s) | Joshua M.V. Mammen, MD,PhD |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
- 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