Trial & Business Updates:

Printer Friendly Version

Priority Lists

Activations

S2013Phase II

Reactivation to Cohort 2 - Effective Date 11/15/2024

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

Closures

Permanent Closure - Effective Date 12/16/2024

A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)
Action CodesNR
Study Coordinator(s)Veena Shankaran, M.D.
ParticipantsALL NCI Community Oncology Research Program (NCORP) Affiliates and Subaffiliates
S2013Phase II

Partial Permanent Closure to Cohort 1 - Effective Date 11/15/2024

Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
Action CodesAC, ER, NR
Study Coordinator(s)Dawn Hershman, M.D., M.S., Krishna Gunturu, M.D.
S2207Phase II

Partial Temporary Closure - Effective Date 10/29/2024

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, 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

Amendments, Revisions, Memoranda

Memorandum - Fall 2024 Lung-MAP Update Meeting Materials Posted

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 - Updated Master Forms Set

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 CodesNR
Study Coordinator(s)Paul Shami, M.D., Tara Lin, M.D.

Memorandum - Reassessment Specimen Submission Timing Clarification

Master Screening and Reassessment Protocol (MSRP) for the NCI myeloMATCH trials
Action CodesNR
Study Coordinator(s)Jerald P. Radich, M.D.
S1318Phase II

Memorandum - IND Safety Report(s) for Blinatumomab (AMG 103)

A Phase II Study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia Chromosome Negative (Ph-) Acute Lymphocytic Leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dastainib-Sensitive Mutations or Kinase Fusions (DSMKF)
Action CodesER
Study Coordinator(s)Anjali S. Advani, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - IND Safety Report(s) for Nivolumab (for S1400I)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1400IPhase III Intergroup

Memorandum - IND Safety Report(s) for Nivolumab

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB FOR PREVIOUSLY TREATED PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER AND NO MATCHING BIOMARKER
Action CodesER
Study Coordinator(s)Scott Gettinger, M.D., Lyudmila Bazhenova, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
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
S1609Phase II

Memorandum - IND Safety Report(s) for Nivolumab

DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action CodesER
Study Coordinator(s)Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1613Phase II

Revision #9 - Version Date 10/01/2024

A Randomized Phase II Study of Pertuzumab and Trastuzumab (TP) compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) with HER2 Amplification
Action CodesIP, AC, RC, ER
Study Coordinator(s)Kanwal Raghav, M.D., E. Scott Kopetz, M.D., Marwan G. Fakih, M.D.
ParticipantsCTSU Institutions in the United States

Memorandum - IND Safety Report(s) for Pembrolizumab (MK-3475)

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
S1801Phase II

Memorandum - IND Safety Report(s) for Pembrolizumab (MK-3475)

A Phase II Randomized Study of Adjuvant versus Neoadjuvant Pembrolizumab for Clinically Detectable Stage III-IV High-risk Melanoma.
Action CodesER
Study Coordinator(s)Sapna Patel, MD
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG
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
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
S1900JPhase II

Memorandum - Approved Translated Spanish Participant-Friendly Summary

A Phase II Study of Amivantamab SC (subcutaneous) in Participants Previously Treated with High MET-Amplification for Stage IV or Recurrent Non-Small-Cell Lung Cancer (Lung-MAP Sub-Study)
Action CodesNR
Study Coordinator(s)Shirish M. Gadgeel, M.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 CodesAC, ER
Study Coordinator(s)Paul Paik, M.D., Xiuning Le, M.D.
ParticipantsUS INSTITUTIONS ONLY
S1900KPhase II

Revision #2 - Version Date 9/25/2024

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 CodesAC, ER
Study Coordinator(s)Paul Paik, M.D., Xiuning Le, M.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
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 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
S2001Phase II

Memorandum - IND Safety Report(s) for Pembrolizumab (MK-3475)

Parallel Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib as Maintenance Therapy in Two Cohorts of Metastatic Pancreatic Cancer Patients with DNA Damage Repair Defects
Action CodesER
Study Coordinator(s)Vincent Chung, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2005Phase II Intergroup

Memorandum - Site Activation Notice

A PHASE II RANDOMIZED STUDY COMPARING IBRUTINIB AND RITUXIMAB VS. VENETOCLAX AND RITUXIMAB IN PREVIOUSLY UNTREATED WALDENSTROM'S MACROGLOBULINEMIA (WM) /LYMPHOPLASMACYTIC LYMPHOMA (LPL)
Action CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2007Phase II

Memorandum - Site Educational Webinar

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

Revision #6 - Version Date 9/09/2024

Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study
Action CodesAC, ER, NR
Study Coordinator(s)Dawn Hershman, M.D., M.S., Krishna Gunturu, M.D.
S2013Phase II

Revision #5 - Version Date 11/01/2023

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

Memorandum 1 of 2 - IND Safety Report(s) for XL184 (Cabozantinib)

Biomarker Stratified CaboZantinib and NivOlumab (BiCaZO) - A phase II study of combining cabozantinib and nivolumab in patients with advanced solid tumors stratified by tumor biomarkers
Action CodesER
Study Coordinator(s)Siwen Hu-Liekskovan, M.D., Ph.D, Paul Swiecicki, M.D,, Katerina Politi, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 2 of 2 - IND Safety Report(s) for Nivolumab

Biomarker Stratified CaboZantinib and NivOlumab (BiCaZO) - A phase II study of combining cabozantinib and nivolumab in patients with advanced solid tumors stratified by tumor biomarkers
Action CodesER
Study Coordinator(s)Siwen Hu-Liekskovan, M.D., Ph.D, Paul Swiecicki, M.D,, Katerina Politi, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2107Phase II

Memorandum - IND Safety Report(s) for Nivolumab

Randomized Phase II Trial of Encorafenib and Cetuximab with or Without Nivolumab (NSC #748726) for Patients with Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer
Action CodesER
Study Coordinator(s)Van K. Morris, M.D., E. Scott Kopetz, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2200Phase II

Memorandum 1 of 2 - 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
S2200Phase II

Memorandum 2 of 2 - IND Safety Report(s) for XL184 (Cabozantinib)

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 - Updated Paxman Materials Available for Site Use

ICE COMPRESS: Randomized Trial of Limb Cryocompression versus Continuous Compression Versus Low Cyclic Compression for the Prevention of Taxane-Induced Peripheral Neuroropathy
Action CodesNR
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, 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
S2212Phase III

Memorandum - IND Safety Report(s) for Pembrolizumab (MK-3475)

TIL Adapted Neo adjuvant Chemotherapy Optimization in Triple negative breast cancer (SCARLET)
Action CodesER
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

Memorandum 1 of 2 - 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 2 of 2 - IND Safety Report(s) for Pembrolizumab (MK-3475)

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 1 of 2 - 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

Memorandum 2 of 2 - IND Safety Report(s) for Nivolumab

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
  • 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