Trial & Business Updates:

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Amendments, Revisions, Memoranda

21CTP.HN01Phase II

Memorandum - Updated Contact Information for SWOG Biospecimen Bank Lab #201

Phase II Study of Amivantamab carboPlatin and pacliTaxel in recurrent metastatic Head and Neck cancer (CAPT-HN) Study Synopsis
Action CodesNR
Study Coordinator(s)Paul Swiecicki, M.D,
ParticipantsSWOG, This Trial Is NOT NCI-Supported and Receives NO FEDERAL FUNDING
21CTP.LEUK01Phase II

Memorandum - Updated Contact Information for SWOG Biospecimen Bank Lab #200

A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Patients with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Michaela Liedtke, MD
ParticipantsSWOG, This Trial Is NOT NCI-Supported and Receives NO FEDERAL FUNDING
S1318Phase II

Memorandum - Dasatinib (BMS-354825) (NSC-732517) Expiration

A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - IND Safety Report(s) for Nivolumab (for S1400I)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesNR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1400IPhase III Intergroup

Memorandum - IND Safety Report(s) for Nivolumab

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB FOR PREVIOUSLY TREATED PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER AND NO MATCHING BIOMARKER
Action CodesNR
Study Coordinator(s)Scott Gettinger, M.D., Lyudmila Bazhenova, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1609Phase II

Memorandum - IND Safety Report(s) for Nivolumab

DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action CodesNR
Study Coordinator(s)Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1800EPhase II-III

Memorandum - S1800E Upcoming Educational Webinar

A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or without Cemiplimab for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)
Action CodesNR
Study Coordinator(s)Saiama Waqar, M.D., Tianhong Li, M.D., Ph.D
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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 CodesNR
Study Coordinator(s)Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD

Memorandum - IND Safety Report(s) for Nivolumab

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 CodesNR
Study Coordinator(s)Siwen Hu-Liekskovan, M.D., Ph.D, Paul Swiecicki, M.D,, Katerina Politi, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2107Phase II

Memorandum - IND Safety Report(s) for Nivolumab

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 CodesNR
Study Coordinator(s)Van K. Morris, M.D., E. Scott Kopetz, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2207Phase II

Memorandum - IND Safety Report(s) for Tazemetostat

Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapse/Refractory Large B-Cell Lymphoma
Action CodesNR
Study Coordinator(s)Jennifer Amengual, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - IND Safety Report(s) for Daratumumab

A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma Patients Considered Frail or Ineligible for Stem Cell Transplant Comparing Frontline Regimen Bortezomib-Lenalidomide-Dexamethasone-Lite (VRd-Lite) with Daratumumab-Lenalidomide-Dexamethasone (DRd) Followed by Len+/-Dara (R+/-D) Maintenance
Action CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D., Jing Christine Ye, M.D., MSc, Brea Lipe, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2210Phase II

Memorandum - Healthcare Provider Handout available

S2210, "Targeted Neoadjuvant Treatment for Patients with Localized Prostate Cancer and Germline DNA Repair Deficiency"
Action CodesER
Study Coordinator(s)Heather H. Cheng, M.D., PhD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - IND Safety Report(s) for Daratumumab

A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis
Action CodesNR
S2303Phase II-III

Memorandum - IND Safety Report(s) for Nivolumab

Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS >/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)
Action CodesNR
ParticipantsALL 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