Trial & Business Updates:

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Priority Lists

Activations

CTSU/EAY131Phase II Intergroup

Pre-Activation

Molecular Analysis for Therapy Choice (MATCH)
Action CodesER
Study Coordinator(s)Victor Villalobos, MD, PhD
ParticipantsCTSU

Closures

Amendments, Revisions, Memoranda

S0777Phase III Intergroup

Memorandum - CC-5013 Safety Report

A Randomized Phase III Trial of CC-5013 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant
Action CodesER
Study Coordinator(s)Brian G.M. Durie, M.D., Bart Barlogie, M.D.,Ph.D.
ParticipantsMembers, NCORP, Medical Oncologists, Pathologists, Affiliates, CTSU
S0819Phase III Intergroup

Memorandum

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Action CodesNR
Study Coordinator(s)Roy S. Herbst, M.D., Ph.D, Edward Kim, M.D., David R. Gandara, M.D., Thomas J. Semrad, M.D., Fred R. Hirsch, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, CTSU Institutions in the United States
S1117Phase II Intergroup

Memorandum - CC-5013 Safety Report

A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Action CodesER
ParticipantsAffiliates, NCORP, Medical Oncologists, Members, CTSU
S1310Phase II

Memorandum - Image Submission

Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer
Action CodesNR
Study Coordinator(s)Richard D. Kim, M.D., Anthony El-Khoueiry, M.D.
ParticipantsMembers, NCORP, Affiliates
S1312Phase I

Re-Activated to Dose Level 3, One additional slot opened

A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination with CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients with Relapsed/Refractory CD22-Positive Acute Lymphoblastic Leukemia (including B-ALL, Mixed Phenotypic Leukemia and Burkitt's Leukemia)
Action CodesER
Study Coordinator(s)Anjali S. Advani, M.D., Michaela Liedtke, MD
ParticipantsLimited: Institutions Listed on the Title Page
S1316Phase III

Memorandum - Master Form Set

Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Action CodesER, NR
Study Coordinator(s)Robert S. Krouse, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1316Phase III

Revision #2

Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Action CodesER, NR
Study Coordinator(s)Robert S. Krouse, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1400Phase II-III Intergroup

Memorandum 1 of 3 - MEDI4736 Safety Report (for S1400A)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER, NR
Study Coordinator(s)Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1400Phase II-III Intergroup

Memorandum 2 of 3 - GDC-0032 Safety Report (for S1400B)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER, NR
Study Coordinator(s)Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1400Phase II-III Intergroup

Memorandum 3 of 3 - Request for Application for New Drugs

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER, NR
Study Coordinator(s)Vassiliki A. Papadimitrakopoulou, M.D., Roy S. Herbst, M.D., Ph.D, Fred R. Hirsch, M.D.,Ph.D., Philip C. Mack, Ph.D., David R. Gandara, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG

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