Trial & Business Updates:

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Activations

Closures

S2013Phase II

Temporary Closure - Effective Date 5/06/2024

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.
S2207Phase II

Partial Temporary Closure - Effective Date 4/25/2024

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 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

Amendments, Revisions, Memoranda

Memorandum 1 of 2 - Cross-Study Educational Webinar

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 2 of 2 - Site Coordinators Committee Applications

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
S1216Phase III

Memorandum - TAK-700 Treatment Update

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
Action CodesNR
Study Coordinator(s)Neeraj Agarwal, M.D., Maha H.A. Hussain, M.D., Primo N. Lara, Jr., M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Surgeons, CTSU, US INSTITUTIONS ONLY
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

Memorandum – Updated Staff Education Tools

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 CodesNR
Study Coordinator(s)Melissa Accordino, M.D.
ParticipantsALL NCORP COMPONENTS AND SUBCOMPONENTS, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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
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 1 of 2 - 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

Memorandum 2 of 2 - IND Safety Report(s) for Talazoparib (MDV3800, BMN 673)

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
S1900GPhase II

Revision #2 - Version Date 3/12/2024

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
S1900GPhase II

Memorandum 1 of 3 - Updated Frequently Asked Questions (FAQ) Document

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
S1900GPhase II

Memorandum 2 of 3 - Upcoming Cross-Study 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
S1900GPhase II

Memorandum 3 of 3 - 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 CodesNR
Study Coordinator(s)Sarah B. Goldberg, MD, MPH, D. Ross Camidge, M.D., Ph.D
ParticipantsUS INSTITUTIONS ONLY
S1900KPhase II

Memorandum 1 of 2 - Cross-Study Educational Webinar

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 CodesNR
Study Coordinator(s)Paul Paik, M.D., Xiuning Le, M.D.
ParticipantsUS INSTITUTIONS ONLY
S1900KPhase II

Memorandum 2 of 2 - 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 CodesNR
Study Coordinator(s)Paul Paik, M.D., Xiuning Le, M.D.
ParticipantsUS INSTITUTIONS ONLY
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
S1929Phase II

Memorandum - IND Safety Report(s) for Talazoparib (MDV3800, BMN 673)

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
S1937Phase III

Memorandum - Provider HCP Flyer

A Phase III Randomized Trial of Eribulin (NSC #707389) with Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy.
Action CodesNR
Study Coordinator(s)Sarmad Sadeghi, M.D.,Ph.D., Primo N. Lara, Jr., M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG
S2011Phase III

Memorandum 1 of 2 - Closure to Participant Follow-Up

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 CodesER, NR
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
S2011Phase III

Memorandum 2 of 2 - 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 CodesER, NR
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 - Data Submission Reminder

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 3/21/2024

A Cluster Randomized Trial Comparing an Educationally Enhanced Genomic Tumor Board (eGTB) Intervention to Usual Practice to Increase Evidence-Based Genome Informed Therapy
Action CodesNR
Study Coordinator(s)Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD

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
S2207Phase II

Revision #2 - Version Date 3/18/2024

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 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

Memorandum - Patient-Friendly Trial Summary and Social Media Toolkit

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

Revision #1 - Version Date 2/19/2024

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 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.
  • 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