Priority Lists
Protocol Posting of
Activations
Activation - Effective 09/19/22
S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2
| Action Codes | FBR, ER |
| Study Coordinator(s) | Benjamin L. Maughan, M.D., Sumanta K. Pal, M.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Closures
Temporary Closure – Effective 10/05/2022
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 |
Amendments, Revisions, Memoranda
Memorandum - Updated Master Forms Set
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 - Patient and Investigator Letters
EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study.
| Action Codes | IP, NR |
| Study Coordinator(s) | Christopher W. Ryan, M.D., Elisabeth I. Heath, M.D., Primo N. Lara, Jr., M.D., Ganesh S. Palapattu, M.D., Philip C. Mack, Ph.D. |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU |
Revision #14 – Version Date 07/22/2022
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 - 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 |
Revision #15 – Version Date 09/06/2022
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 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 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 - 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 |
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 - Permanent Closure & Investigator and Participant Letters
A Randomized Phase II trial of Carboplatin-Paclitaxel with or without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
| Action Codes | IP, ER |
| Study Coordinator(s) | Anne Tsao, M.D., Marianna Koczywas, M.D. |
| Participants | SWOG, ALLIANCE, ECOG-ACRIN, NRG |
Memorandum - 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 1 of 2 - N-803 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, NR |
| Study Coordinator(s) | John Wrangle, MD, MPH, Hatim Husain, MD |
Memorandum 2 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, NR |
| 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 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 - IND Safety Report(s) for SGN-35 (Brentuximab Vedotin)
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 |
Revision #2 – Version Date 07/06/2022
A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)
| Action Codes | ER |
| Study Coordinator(s) | Veena Shankaran, M.D. |
| Participants | ALL NCI Community Oncology Research Program (NCORP) Affiliates and Subaffiliates |
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 - Site Activation Encouragement
A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.
| Action Codes | NR |
| Study Coordinator(s) | Deborah Stephens, DO, Brian T. Hill, M.D., Ph.D, John Pagel, MD, PhD, Mazyar Shadman, M.D., M.Ph, Michael J. Fisch, M.D. |
Memorandum - 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 - 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 - 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 |
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 Ibrutinib (PCI-32765)
A Phase II Randomized Study of Ibrutinib and Rituximab with or without Venetoclax in Previously Untreated Waldenstrom's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)
| Action Codes | ER |
| Study Coordinator(s) | Sikander Ailawadhi, 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 | ER |
| Study Coordinator(s) | David B. Zhen, MD |
| Participants | ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS |
Memorandum - IND Safety Report(s) for XL184 (Cabozantinib)
S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2
| Action Codes | FBR, ER |
| Study Coordinator(s) | Benjamin L. Maughan, M.D., Sumanta K. Pal, M.D. |
| 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