Trial & Business Updates:

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Priority Lists

Activations

Closures

S2114Phase II

Advance Notice of Temporary Closure - Tentative Date 6/11/2025

A Randomized Phase II trial of consolidation therapy following CD19 CAR T-cell treatment for Relapsed/Refractory Diffuse Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma
Action CodesIP, AC, ER, NR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Amendments, Revisions, Memoranda

Revision #8 - Version Date 2/11/2025

Prospective Observational Cohort Study of Patients with Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
Action CodesNR
Study Coordinator(s)Justin D. Floyd, D.O., Monika Leja, M.D., Carol Fabian, M.D., Andrew Godwin, Ph.D.
ParticipantsCTSU Institutions in the United States, ECOG-ACRIN, ALLIANCE, NRG
S1701Phase II

Memorandum - IND Withdrawal of Ramucirumab, IND 139595

A Randomized Phase II trial of Carboplatin-Paclitaxel with or without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
Action CodesNR
Study Coordinator(s)Anne Tsao, M.D., Marianna Koczywas, M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG

Revision #5 - Version Date 3/07/2025

Randomized trial comparing overall survival of patients monitored with serum tumor marker directed disease monitoring (STMDDM) versus usual care in patients with metastatic hormone receptor positive breast cancer
Action CodesER
Study Coordinator(s)Melissa Accordino, M.D.
ParticipantsALL NCORP COMPONENTS AND SUBCOMPONENTS, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1800EPhase II-III

Memorandum - Updated Clinical Trial Summary: Patient-Friendly Summary and Social Media Toolkit

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 CodesER
Study Coordinator(s)Saiama Waqar, M.D., Tianhong Li, M.D., Ph.D
ParticipantsUS INSTITUTIONS ONLY

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 - 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 CodesNR
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 - IND Safety Report(s) for Atezolizumab (MPDL3280A)

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 - IND Safety Report(s) for Atezolizumab (MPDL3280A)

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
S1933Phase II Intergroup

Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)

A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status
Action CodesER
Study Coordinator(s)Raid Aljumaily, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY
S2010Phase III

Revision #2 - Version Date 02/02/2025

A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone To Improve Persistence with Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN)
Action CodesIP, AC, ER, NR
Study Coordinator(s)Norah L. Henry, M.D.,Ph.D., Dawn Hershman, M.D., M.S.
S2010Phase III

Memorandum - Updated Master Forms Set

A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone To Improve Persistence with Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN)
Action CodesIP, AC, ER, NR
Study Coordinator(s)Norah L. Henry, M.D.,Ph.D., Dawn Hershman, M.D., M.S.
S2012Phase II-III

Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)

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

Memorandum - IND Safety Report(s) for Atezolizumab (MPDL3280A)

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
S2212Phase III

Memorandum - 2212 Supplemental Treatment Form

TIL Adapted Neo adjuvant Chemotherapy Optimization in Triple negative breast cancer (SCARLET)
Action CodesNR
Study Coordinator(s)Priyanka Sharma, M.D.

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

Memorandum - Clarification To Specimen Collection

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