Trial & Business Updates:

Printer Friendly Version

Priority Lists

Activations

Closures

S2207Phase II

Partial Temporary Closure -Effective Date 8/16/2024

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

Amendments, Revisions, Memoranda

Revision #1 - Version Date 7/17/24

A Randomized Phase II Study Comparing Cytarabine +Daunurubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by MYELOMATCH; A myeloMATCH Clinical Trial
Action CodesAC, ER, NR
Study Coordinator(s)Paul Shami, M.D., Tara Lin, M.D.

Memorandum 1 of 2 - Participant Materials Now Available

A Randomized Phase II Study Comparing Cytarabine +Daunurubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by MYELOMATCH; A myeloMATCH Clinical Trial
Action CodesAC, ER, NR
Study Coordinator(s)Paul Shami, M.D., Tara Lin, M.D.

Memorandum 2 of 2 - MyeloMATCH Kick-Off Meeting

A Randomized Phase II Study Comparing Cytarabine +Daunurubicin (7+3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by MYELOMATCH; A myeloMATCH Clinical Trial
Action CodesAC, ER, NR
Study Coordinator(s)Paul Shami, M.D., Tara Lin, M.D.

Memorandum - MyeloMATCH Kick-Off Meeting

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

Memorandum - IND Safety Report(s) for Ramucirumab

A PHASE II RANDOMIZED STUDY OF RAMUCIRUMAB PLUS MK3475 (PEMBROLIZUMAB) VERSUS STANDARD OF CARE FOR PATIENTS 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)Karen Reckamp, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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 CodesER
Study Coordinator(s)John Wrangle, MD, MPH, Hatim Husain, MD
S1802Phase III Intergroup

Memorandum - Updated Funding Memo

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
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

Memorandum - IND Safety Report(s) for Avelumab

A PHASE II STUDY OF TALAZOPARIB PLUS AVELUMAB IN PATIENTS WITH STAGE IV OR RECURRENT NON-SQUAMOUS NON-SMALL CELL LUNG CANCER BEARING PATHOGENIC STK11 GENOMIC ALTERATIONS (LUNG-MAP SUB-STUDY)
Action CodesER
Study Coordinator(s)Ferdinandos Skoulidis, M.D., Ph.D, Jennifer M. Suga, M.D., MPH
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1900EPhase II

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
Study Coordinator(s)Sukhmani K. Padda, M.D., David Gerber, M.D.
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 CodesER
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 CodesER
Study Coordinator(s)Paul Paik, M.D., Xiuning Le, M.D.
ParticipantsUS INSTITUTIONS ONLY
S1918Phase II-III

Revision #2 - Version Date 5/15/2024

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 CodesIP, AC, ER, NR
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
S1918Phase II-III

Memorandum - Specimen Collection & Submission Instructions and Updated Master Forms Set

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 CodesIP, AC, ER, NR
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
S1922Phase II

Memorandum - IND Safety Report(s) for Ramucirumab

Randomized Phase II Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
Action CodesER
Study Coordinator(s)Michael J. Overman, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Memorandum - 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.
S2000Phase II

Memorandum - S2000 Change Memo (PVD 05/22/24) Clarification

A randomized phase 2 trial of encorafenib + binimetinib + nivolumab vs ipilimumab + nivolumab in BRAFV600-mutant melanoma brain metastases
Action CodesNR
Study Coordinator(s)Zeynep Eroglu, MD, M.D., Hussein A Tawbi, MD, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2011Phase III

Memorandum - IND Safety Report(s) for Avelumab

Randomized Phase II Trial Of Gemcitabine, Avelumab and Carboplatin vs. No Neoadjuvant Therapy Preceding Surgery For Cisplatin-Ineligible Muscle-Ineligible Urothelial Carcinoma: SWOG GAP TRIAL
Action CodesNR
Study Coordinator(s)Guru Sonpavde, M.D., Michael A. Liss, M.D., Seth P. Lerner, M.D., Daniel P. Petrylak, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2015Phase III

Memorandum - Outstanding Queries in REDCap

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
Study Coordinator(s)Joshua M.V. Mammen, MD,PhD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Revision #4 - Version Date 7/08/2024

A Phase II Randomized Trial of Postoperative Adjuvant Capecitabine and Temozolimide versus Observation in High-Risk Pancreatic Neuroendocrine Tumors
Action CodesAC, ER
S2206Phase III

Memorandum - IND Safety Reports for MEDI4736 (Durvalumab)

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 CodesER
Study Coordinator(s)Erin Cobain, MD, Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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

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

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 CodesER
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 CodesER
S2312Phase III

Memorandum - S2312 Kick-Off Meeting

A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with metastatic castrate-resistant prostate cancer (mCRPC), Stratified by Aggressive Variant Signature
Action CodesFBR
Study Coordinator(s)Paul G. Corn, M.D., Ana Aparicio, M.D., David VanderWeele , M.D.,Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
  • 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