Priority Lists
Protocol Posting of
Activations
Re-Activation - Effective Date 11/22/19
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action Codes | IP, AC, ER, NR |
Study Coordinator(s) | Paul M. Barr, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Re-Activation - Effective 11/18/19
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 |
Closures
Partial Permanent Closure - Effective Date 12/2/19
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 | AC, 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 |
Permanent Closure - Effective 12/15/19
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 |
Amendments, Revisions, Memoranda
Memorandum 2 of 2 - 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 1 of 2 - Durvalumab and Tremelimumab IBs (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 - 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 |
Revision #11 - Version Date 11/13/19
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 | AC, 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 - 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 |
Study Coordinator(s) | Lajos Pusztai, M.D., D.Ph |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - Cabozantinib (XL184) 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 1 of 2- Laboratory Holiday Hours
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 2 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 | 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 - Temporary Closure Continues
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 3 of 3 - 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 |
S1607: Memorandum 1 of 3 - Spanish Consent (Version Date: 9/4/2019)
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 3 - Laboratory Holiday 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 |
Revision #6 - Version Date 10/16/19
Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action Codes | IP, AC, ER, NR |
Study Coordinator(s) | Paul M. Barr, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY |
Memorandum - Nivolumab (BMS-936558) Safety Report
DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action Codes | ER, NR |
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 | IP, ER |
Study Coordinator(s) | Laura Michaelis, MD, Roland Walter, MD |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 of 2 - Laboratory Holiday 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 |
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 |
Revision #2 – Version Date 9/26/19
A Randomized Phase II Study of Ruxolitinib in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia Patients with Evidence of Molecular Disease
Action Codes | AC, ER |
Study Coordinator(s) | Kendra Sweet, M.D. |
Memorandum - Pembrolizumab (MK-3475) 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 | ER |
Study Coordinator(s) | Karen Reckamp, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum 1 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 |
Study Coordinator(s) | Sapna Patel, MD |
Participants | SWOG, ALLIANCE, ECOG-ACRIN, NRG |
Memorandum 2 of 2 - Spanish Consent (Version Date: 10/16/2019)
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 - Drug Expiration
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 | NR |
Study Coordinator(s) | Amrita Krishnan, M.D. |
Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
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, 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 |
Study Coordinator(s) | Jonathan W. Riess, 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