Trial & Business Updates:

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Priority Lists

Activations

Initial Activation - Effective Date 4/01/2025

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 CodesFBR
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

Closures

Amendments, Revisions, Memoranda

S1602Phase III

Revision # 6 - Version Date 3/11/2025

A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Non-Muscle Invasive Bladder Cancer
Action CodesER
Study Coordinator(s)Robert S. Svatek, M.D., Ajjai S. Alva, M.D., Seth P. Lerner, M.D., Joshua Meeks, M.D., Scott Gilbert, M.D., Rick Bangs
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG

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 CodesER
Study Coordinator(s)Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD
S1905Phase I-II

Memorandum 1 of 2 - Site Activation Updates

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 CodesIP, AC, RC, ER, NR
Study Coordinator(s)Anjali S. Advani, M.D., Nikolaos Papadantonakis, M.D.,Ph.D., Cecilia Yeung, M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN
S1905Phase I-II

Revision # 4 - Version Date 2/11/2025

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 CodesIP, AC, RC, ER, NR
Study Coordinator(s)Anjali S. Advani, M.D., Nikolaos Papadantonakis, M.D.,Ph.D., Cecilia Yeung, M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN
S1905Phase I-II

Memorandum 2 of 2 - Updated Master Forms Set

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 CodesIP, AC, RC, ER, NR
Study Coordinator(s)Anjali S. Advani, M.D., Nikolaos Papadantonakis, M.D.,Ph.D., Cecilia Yeung, M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN
S1914Phase III

Memorandum - Termination of Submission of Images to IROC Ohio for Central Review

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC
Action CodesNR
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

Revision # 11 - Version Date 3/03/2025

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 CodesIP, AC, ER
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

Revision # 6 - Version Date 3/03/2025

A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status
Action CodesIP, AC, ER
Study Coordinator(s)Raid Aljumaily, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY
S2012Phase II-III

Revision #4 - Version Date 3/13/2025

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 CodesIP, AC, ER
Study Coordinator(s)David B. Zhen, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2200Phase II

Revision #5 - Version Date 3/03/2025

S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2
Action CodesER
Study Coordinator(s)Benjamin L. Maughan, M.D., Sumanta K. Pal, 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 CodesER
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 CodesER
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 CodesER
S2408Phase III

Revision #2 - Version Date 2/17/2025

A Randomized Phase III Blinded Trial of lanreotide for the Prevention of Postoperative Pancreatic Fistula
Action CodesAC, ER
Study Coordinator(s)Robert S. Krouse, M.D.
S2414Phase III

Memorandum 2 of 2 - S2414 Optional Training Recordings Available

INcorporating pathologic reSponse in patIents with early staGe lung cancer to optimize immunotHerapy in the adjuvanT setting (INSIGHT)
Action CodesER, NR
Study Coordinator(s)Jeremy Cetnar, M.D., Taofeek K. Owonikoko, M.D., Ph.D
S2414Phase III

Memorandum 1 of 2 - Clinical Trial Summary: Patient-Friendly Summary and Social Media Toolkit

INcorporating pathologic reSponse in patIents with early staGe lung cancer to optimize immunotHerapy in the adjuvanT setting (INSIGHT)
Action CodesER, NR
Study Coordinator(s)Jeremy Cetnar, M.D., Taofeek K. Owonikoko, 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