Trial & Business Updates:

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Priority Lists

Activations

Activation - Effective Date 9/9/2021

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 CodesNR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Closures

Amendments, Revisions, Memoranda

S1418/BR006Phase III Intergroup

Memorandum - PPD Kit Ordering Clarification

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
S1600Phase III

Memorandum - Updated Master Forms Set

A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Action CodesNR
Study Coordinator(s)Jill Hamilton-Reeves, Ph.D., R.D, Jeffrey Holzbeierlein, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG
S1600Phase III

Revision #3 - Version Date 8/9/2021

A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Action CodesNR
Study Coordinator(s)Jill Hamilton-Reeves, Ph.D., R.D, Jeffrey Holzbeierlein, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG
S1608Phase II Intergroup

Memorandum - S1608 Quarterly Newsletter – September 2021

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action CodesNR
Study Coordinator(s)Paul M. Barr, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY

Memorandum - Slides and Recordings for S1614 Training Webinar

Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Cytotoxic Therapy for Solid Tumors
Action CodesNR
Study Coordinator(s)Jessica Hwang, M.D. M.P.H, Anna Lok, M.D.
S1712Phase II

Memorandum - Updated Ruxolitinib Drug Order Form and Master Forms Set

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 CodesNR
Study Coordinator(s)Kendra Sweet, M.D.
S1826Phase III Intergroup

Memorandum - S1826 Quarterly Newsletter – September 2021

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 CodesER
Study Coordinator(s)Alex Herrera, M.D., Jonathan W. Friedberg, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Memorandum - IND Safety Reports for Rucaparib

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 CodesER
Study Coordinator(s)Jonathan W. Riess, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - IND Safety Reports for Rucaparib

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 CodesER
Study Coordinator(s)Jonathan W. Riess, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1914Phase III

Memorandum - Change in Tube Ordering Information

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 - Eligibility Criterion, Section 5.2a.2, Reminder

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

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