Priority Lists
Protocol Posting of
Activations
Activation effective: October 28, 2021
Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
| Study Coordinator(s) | Rebecca Johnson, M.D. |
| Participants | NCORP, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Closures
Amendments, Revisions, Memoranda
Memorandum - Site Coordinator Committee Accepting Application for VA Representative
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 Withdrawal (IND-113918)
Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
| Action Codes | NR |
| Study Coordinator(s) | James C. Yao, M.D., Larry K. Kvols, M.D., Cesar A. Moran, M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, CTSU |
Revision #14 – Version Date 11/16/2022
A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
| Action Codes | ER |
| Study Coordinator(s) | Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD |
| Participants | Limited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists |
Memorandum - IND Safety Report(s) for TAK-700
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
| Action Codes | ER |
| Study Coordinator(s) | Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D. |
| Participants | Members, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY |
Memorandum 1 of 2 - IND Safety Report(s) for Dabrafenib
"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 2 of 2 - IND Safety Report(s) for Trametinib
"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 1 of 2 - IND Safety Report(s) for Dabrafenib
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 - IND Safety Report(s) for Trametinib
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 2 - Dissemination of Study Results to Participants
A Pragmatic Trial To Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing, Effectiveness and Risk (TrACER)
| Action Codes | ER |
| Study Coordinator(s) | Scott Ramsey, M.D., Dawn Hershman, M.D., M.S., Gary Lyman, M.D., Sean Sullivan, Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum 2 of 2 - Dissemination of Study Results to Participants (Spanish)
A Pragmatic Trial To Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing, Effectiveness and Risk (TrACER)
| Action Codes | ER |
| Study Coordinator(s) | Scott Ramsey, M.D., Dawn Hershman, M.D., M.S., Gary Lyman, M.D., Sean Sullivan, Ph.D. |
| Participants | Limited: Institutions Listed on the Title Page |
Memorandum - IND Safety Report(s) for Pembrolizumab (MK-3475)
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 |
Memorandum - IND Safety Report(s) for Pembrolizumab (MK-3475)
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 - SCQOL Committee Winter Webinar
A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
| Action Codes | NR |
| Study Coordinator(s) | Jill Hamilton-Reeves, Ph.D., R.D, Jeffrey Holzbeierlein, M.D. |
| Participants | ALLIANCE, ECOG-ACRIN, NRG, SWOG |
Memorandum - IND Safety Report(s) for BCG Tokyo – 172
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 |
Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)
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 Pembrolizumab (MK-3475)
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 #12 – Version Date 10/06/2022
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
| Action Codes | ER |
| Study Coordinator(s) | Paul M. Barr, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum - S1608 Notification of Status
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
| Action Codes | 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 Atezolizumab (MPDL3280A)
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 1 of 2 - IND Safety Report(s) for Pembrolizumab (MK-3475)
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 2 of 2 - Clarification - Pembrolizumab 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 | ER |
| Study Coordinator(s) | Karen Reckamp, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - IND Safety Report(s) for Pembrolizumab (MK-3475)
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 2 of 2 - Clarification - Pembrolizumab Investigator’s Brochure
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 Pembrolizumab (MK-3475)
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 - IND Safety Report(s) for Daratumumab
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 (MPDL3280A)
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 - New expectation and how to resolve
A Prospective Observational Cohort Study to Assess miRNA371 for Outcome Prediction in Patients with Early Stage Germ Cell Tumors
| 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 - New Investigator Brochure available
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 - IND Safety Report(s) for Talazoparib (MDV3800, BMN 673)
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 1 of 2 - New Investigator Brochure available
A Randomized Phase II Study of Carboplatin and Pemetrexed with or without Selpercatinib (LY3527723) in Participants with Non-Squamous RET Fusion-Positive Stage IV Non-Small Cell Lung Cancer and Progression of Disease on Prior RET Directed Therapy (Lung-MAP Sub-Study)
| Action Codes | ER, NR |
| Study Coordinator(s) | Jhanelle E. Gray, M.D., Yasir Y. Elamin, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #1 – Version Date 11/14/2022
A Randomized Phase II Study of Carboplatin and Pemetrexed with or without Selpercatinib (LY3527723) in Participants with Non-Squamous RET Fusion-Positive Stage IV Non-Small Cell Lung Cancer and Progression of Disease on Prior RET Directed Therapy (Lung-MAP Sub-Study)
| Action Codes | ER, NR |
| Study Coordinator(s) | Jhanelle E. Gray, M.D., Yasir Y. Elamin, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)
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 - IND Safety Report(s) for Atezolizumab (MPDL3280A)
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 - IND Safety Report(s) for Talazoparib (MDV3800, BMN 673)
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 - Patient Video Posted
Phase III trial of Nivolumab and Ipilimumab with or without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
| Study Coordinator(s) | Ulka N. Vaishampayan, M.D., Hyung L. Kim, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)
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 1 of 2 - IND Safety Report(s) for Atezolizumab (MPDL3280A)
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 |
Revision #2 – Version Date 11/02/2022
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 Pembrolizumab (MK-3475)
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 (MPDL3280A)
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 | NR |
| Study Coordinator(s) | David B. Zhen, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Revision #1 – Version Date 11/4/2022
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 | NR |
| Study Coordinator(s) | David B. Zhen, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - SCQOL Committee Winter Webinar
Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
| Action Codes | NR |
| Study Coordinator(s) | Dawn Hershman, M.D., M.S., Krishna Gunturu, M.D. |
Revision #1 – Version Date 11/22/2022
Biomarker Stratified CaboZantinib and NivOlumab (BiCaZO) - A phase II study of combining cabozantinib and nivolumab in patients with advanced solid tumors stratified by tumor biomarkers
| Action Codes | ER |
| Study Coordinator(s) | Siwen Hu-Liekskovan, M.D., Ph.D, Paul Swiecicki, M.D,, Katerina Politi, Ph.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)
S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2
| Action Codes | ER |
| Study Coordinator(s) | Benjamin L. Maughan, M.D., Sumanta K. Pal, M.D. |
| 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