Trial & Business Updates:

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Priority Lists

Activations

S1800EPhase II-III

Pre-Activation Revision - Version Date 1/15/2025

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

Closures

Amendments, Revisions, Memoranda

Memorandum - Foundation Medicin, Inc. New Headquarters

A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Action CodesNR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 1 of 2 - Updated Master Forms Set

Master Screening and Reassessment Protocol (MSRP) for the NCI myeloMATCH trials
Action CodesNR
Study Coordinator(s)Jerald P. Radich, M.D.

Memorandum 2 of 2 - Prrotocol Clarification-Standard Cytoreduction Allowed

Master Screening and Reassessment Protocol (MSRP) for the NCI myeloMATCH trials
Action CodesNR
Study Coordinator(s)Jerald P. Radich, M.D.
S1211Phase I-II

Revision #15 - Version Date 11/05/2024

A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Action CodesAC, ER
Study Coordinator(s)Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD
ParticipantsLimited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists
S1602Phase III

Memorandum - IND Safety Report(s) for BCG Tokyo – 172

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
S1803Phase III Intergroup

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)Amrita Krishnan, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1806Phase III

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

Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.
Action CodesER
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 - 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
S1900GPhase II

Memorandum - S1900G and EA5182 Upcoming Educational Webinar

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
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
S1918Phase II-III

Memorandum - Specimen Collection & Submission Instructions

A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed diffuse large B cell lymphoma, Grade IIIb Follicular Lymphoma, transformed lymphoma, and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements
Action CodesNR
Study Coordinator(s)Elizabeth Brem, M.D., Sonali Smith, M.D., Norah L. Henry, M.D.,Ph.D., Rebecca Olin, M.D., MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
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
S2007Phase II

Memorandum - S2007 Optional Refresher Training

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients with HER2-Negative Breast Cancer and Brain Metastases
Action CodesIP, AC, ER
Study Coordinator(s)Virginia Kaklamani, M.D., D.Sc
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S2010Phase III

Memorandum - Symptom Management and Survivorship Committee Winter Teleconference

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 CodesNR
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
S2013Phase II

Memorandum - Symptom Management and Survivorship Committee Winter Teleconference

Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
Action CodesNR
Study Coordinator(s)Dawn Hershman, M.D., M.S., Krishna Gunturu, M.D.

Revision #1 - Version Date for U.S. sites 10/01/2024

MELANOMA MARGINS TRIAL (MELMART-II): A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1CM V 2CM Wide Excision Margins for Primary Cutaneous Melanoma
Action CodesNR

Memorandum - DSMB Data Soft Lock Effective Date 1/31/2025

MELANOMA MARGINS TRIAL (MELMART-II): A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1CM V 2CM Wide Excision Margins for Primary Cutaneous Melanoma
Action CodesNR
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

Memorandum 1 of 2 - Updated Master Forms Set

ICE COMPRESS: Randomized Trial of Limb Cryocompression versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuroropathy
Action CodesNR

Memorandum 2 of 2 - Symptom Management and Survivorship Committee Winter Teleconference

ICE COMPRESS: Randomized Trial of Limb Cryocompression versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuroropathy
Action CodesNR

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 CodesER
S2308Phase III

Revision #1 - Version Date 10/17/2024

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
Action CodesAC, ER
Study Coordinator(s)Nilanjan Ghosh, MD, PhD
ParticipantsUS INSTITUTIONS ONLY
  • 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