Trial & Business Updates:

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Priority Lists

Activations

S2107Phase II

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 CodesFBR
Study Coordinator(s)Van K. Morris, M.D., E. Scott Kopetz, M.D.
ParticipantsALL 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 CodesNR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1418/BR006Phase III Intergroup

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 CodesER
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1500Phase II

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 CodesER
Study Coordinator(s)Sumanta K. Pal, M.D., Primo N. Lara, Jr., M.D., Brian Shuch, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1512Phase II

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 CodesER
Study Coordinator(s)Kari Kendra, M.D., Siwen Hu-Liekskovan, M.D., Ph.D, William Carson, III, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG
S1605Phase II

Memorandum - IND Safety Report(s) for Atezolizumab

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Action CodesER
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
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG, CCTG
S1607Phase II

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 CodesER
Study Coordinator(s)Siwen Hu-Liekskovan, M.D., Ph.D, Antoni Ribas, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE, US INSTITUTIONS ONLY, CTSU
S1608Phase II Intergroup

Revision #11 - Version Date 5/9/2022

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action CodesIP, AC, ER
Study Coordinator(s)Paul M. Barr, M.D.
ParticipantsALL 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 CodesER
Study Coordinator(s)Karen Reckamp, M.D.
ParticipantsALL 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 CodesER
Study Coordinator(s)John Wrangle, MD, MPH, Hatim Husain, MD
S1801Phase II

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 CodesER
Study Coordinator(s)Sapna Patel, MD
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG
S1803Phase III Intergroup

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 CodesER, NR
Study Coordinator(s)Amrita Krishnan, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1806Phase III

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 CodesER
Study Coordinator(s)Parminder Singh, M.D., Seth P. Lerner, M.D.
ParticipantsALL 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 CodesNR
Study Coordinator(s)Craig R. Nichols, M.D., Lucia Nappi, M.D., Ph.D
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCORP COMPONENTS AND SUBCOMPONENTS, CTSU
S1914Phase III

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 CodesER
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.
ParticipantsCTSU Institutions in the United States
S1929Phase II

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 CodesER
Study Coordinator(s)Nagla Karim, M.D., Ph.D, Karen Reckamp, M.D., Lauren A. Byers, M.D., Carl Gay, M.D., Ph.D
S1933Phase II Intergroup

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 CodesER
Study Coordinator(s)Raid Aljumaily, M.D.
ParticipantsALL 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 CodesER
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2001Phase II

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 CodesER
Study Coordinator(s)Vincent Chung, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2012Phase II-III

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 CodesER
Study Coordinator(s)David B. Zhen, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2015Phase III

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 CodesNR
Study Coordinator(s)Joshua M.V. Mammen, MD,PhD
ParticipantsALL 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