Trial & Business Updates:

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Temporary Closure - Effective Date 10/08/2025

A Randomized Phase 2 Trial of ASTX727 and Venetoclax Compared with ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults with IDH2 Mutant AML: A myeloMATCH Substudy
Action CodesNR
Study Coordinator(s)Eric Huselton, M.D., Uma Borate, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCI Community Oncology Research Program (NCORP) Affiliates and Subaffiliates

Amendments, Revisions, Memoranda

Memorandum - IND Safety Report(s) for N-803 (ALT-803)

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 CodesNR
Study Coordinator(s)John Wrangle, MD, MPH, Hatim Husain, MD

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 Sotorasib (AMG 510)

A PHASE II STUDY OF AMG 510 IN PATIENTS WITH PREVIOUSLY TREATED STAGE IV OR RECURRENT KRAS G12C MUTATED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (ECOG-ACRIN LUNG-MAP SUB-STUDY)
Action CodesNR
S1900GPhase II

Memorandum - IND Safety Report(s) for Ramucirumab

A Randomized Phase II Study of INC280 (capmatinib) plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
Action CodesNR
Study Coordinator(s)Sarah B. Goldberg, MD, MPH, D. Ross Camidge, M.D., Ph.D
ParticipantsUS INSTITUTIONS ONLY
S1900KPhase II

Memorandum - IND Safety Report(s) for Ramucirumab

A Randomized Phase II Study of Tepotinib with or Without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
Action CodesNR
Study Coordinator(s)Paul Paik, M.D., Xiuning Le, M.D.
ParticipantsUS INSTITUTIONS ONLY
S1905Phase I-II

Memorandum - OBI-3424 Infusion Administration Timing

A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Nikolaos Papadantonakis, M.D.,Ph.D., Cecilia Yeung, M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN
S1937Phase III

Memorandum - Patient-Friendly Clinical Trial Summary

A Phase III Randomized Trial of Eribulin (NSC #707389) with Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy.
Action CodesNR
Study Coordinator(s)Sarmad Sadeghi, M.D.,Ph.D., Primo N. Lara, Jr., M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG
S2207Phase II

Memorandum 1 of 2 - IND Safety Report(s) for Zanubrutinib

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)Patrick Reagan, M.D., Alexey Danilov, M.D., Sonali Smith, M.D., Jennifer Amengual, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S2207Phase II

Memorandum 2 of 2 - 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)Patrick Reagan, M.D., Alexey Danilov, M.D., Sonali Smith, M.D., Jennifer Amengual, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

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

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

Memorandum - IND Safety Report(s) for Ramucirumab

PRAGMATICA - LUNG: A PROSPECTIVE RANDOMIZED STUDY OF RAMUCIRUMAB (LY3009806; NSC 749128) PLUS PEMBROLIZUMAB (MK-3475; NSC 776864) VERSUS STANDARD OF CARE FOR PARTICIPANTS PREVIOUSLY TREATED WITH IMMUNOTHERAPY FOR STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER
Action CodesNR
Study Coordinator(s)Karen Reckamp, M.D., Konstantin H. Dragnev, M.D.

Memorandum - IND Safety Report(s) for Ramucirumab

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

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