Trial & Business Updates:

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Priority Lists

Activations

Activation - Effective Date 8/04/2025

A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention called Current Together After Cancer (CTAC) to Promote Guideline-Concordant Colorectal Cancer Surveillance
Action CodesFBR
Study Coordinator(s)Christine Veenstra, MD

Activation - Effective Date 8/04/2025

A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention called Current Together After Cancer (CTAC) to Promote Guideline-Concordant Colorectal Cancer Surveillance
Action CodesFBR
Study Coordinator(s)Christine Veenstra, MD

Closures

Amendments, Revisions, Memoranda

S0931Phase III

Closure to Participant Follow Up - Effective Date 9/01/2025

EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study.
Action CodesNR
Study Coordinator(s)Christopher W. Ryan, M.D., Elisabeth I. Heath, M.D., Primo N. Lara, Jr., M.D., Ganesh S. Palapattu, M.D., Philip C. Mack, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1802Phase III Intergroup

Memorandum - Patient-Friendly Trial Summary and Social Media Toolkit

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
Action CodesNR
Study Coordinator(s)Brian Chapin, M.D., Ana Aparicio, M.D., Amir Goldkorn, M.D., Richard Valicenti, M.D., John Gore, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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
S1806Phase III

Revision #10 - Version Date 7/15/2025

Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.
Action CodesAC, ER
Study Coordinator(s)Parminder Singh, M.D., Seth P. Lerner, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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 CodesER

Memorandum 1 of 2 - Buccal Swab Collection Kit Ordering Memorandum Clarification

A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.
Action CodesNR
Study Coordinator(s)Deborah Stephens, DO, Brian T. Hill, M.D., Ph.D, John Pagel, MD, PhD, Mazyar Shadman, M.D., M.Ph, Michael J. Fisch, M.D.

Memorandum 2 of 2 - Updated Master Forms Set

A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.
Action CodesNR
Study Coordinator(s)Deborah Stephens, DO, Brian T. Hill, M.D., Ph.D, John Pagel, MD, PhD, Mazyar Shadman, M.D., M.Ph, Michael J. Fisch, M.D.

Memorandum - Patient-Friendly Trial Summary and Social Media Toolkit

Phase III trial of Nivolumab and Ipilimumab with or without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
Action CodesIP, AC, ER
Study Coordinator(s)Ulka N. Vaishampayan, M.D., Hyung L. Kim, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2005Phase II Intergroup

Memorandum - IND Safety Report(s) for Ibrutinib (PCI-32765)

A PHASE II RANDOMIZED STUDY COMPARING IBRUTINIB AND RITUXIMAB VS. VENETOCLAX AND RITUXIMAB IN PREVIOUSLY UNTREATED WALDENSTROM'S MACROGLOBULINEMIA (WM) /LYMPHOPLASMACYTIC LYMPHOMA (LPL)
Action CodesER
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2206Phase III

Memorandum 1 of 2 - SWOG S2206 PRO CTCAE Form Update

A Randomized trial of neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone for Adults with MammaPrint Ultrahigh (MP2) hormone receptor (HR) positive /Human Epidermal Growth Factor receptor (HER2) negative stage II-III breast cancer
Action CodesNR
Study Coordinator(s)Erin Cobain, MD, Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2206Phase III

Memorandum 2 of 2 – Toxicity Assessment Clarification

A Randomized trial of neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone for Adults with MammaPrint Ultrahigh (MP2) hormone receptor (HR) positive /Human Epidermal Growth Factor receptor (HER2) negative stage II-III breast cancer
Action CodesNR
Study Coordinator(s)Erin Cobain, MD, Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2207Phase II

Memorandum 1 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 CodesER, NR
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 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 CodesER, NR
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, NR
  • 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