Trial & Business Updates:

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Priority Lists

Activations

Activation - Effective Date 8/03/2026

A Randomized Phase II Study of Sacituzumab Govitecan alone, Ivonescimab alone, or Sacituzumab Govitecan and Ivonescimab in Participants with Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)
Action CodesFBR
Study Coordinator(s)Susan Scott, M.D., Jonathan W. Riess, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2207Phase II

Reactivation - Effective Date 8/03/2026

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)Jennifer Amengual, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Closures

Permanent Closure - Effective Date 8/15/2026

Phase 2 Study of Paclitaxel + Ipatasertib in Taxane-Refractory Patients with AKT-Altered Advanced Non-Breast Solid Tumors
Action CodesNR

Permanent Closure of Step 1 Registration - Effective Date 8/15/2026

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 CodesER
Study Coordinator(s)Melissa Accordino, M.D.
ParticipantsALL NCORP COMPONENTS AND SUBCOMPONENTS, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2212Phase III

PRO Sub-Study Closure - Effective Date 8/06/2026

Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
Action CodesNR
Study Coordinator(s)Priyanka Sharma, M.D.

Amendments, Revisions, Memoranda

21CTP.LEUK01Phase II

Memorandum - Upcoming Temporary Pause to Accrual

A Phase II Trial of Asciminib, Dasatinib, Prednisone, and Blinatumomab for Patients with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia
Action CodesNR
Study Coordinator(s)Anjali S. Advani, M.D., Michaela Liedtke, MD
ParticipantsSWOG, This Trial Is NOT NCI-Supported and Receives NO FEDERAL FUNDING

Revision #2 - Version Date 4/13/2026

A Randomized Phase 2 Trial of ASTX727 and Venetoclax Compared with ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults with IDH2 Mutant AML: A myeloMATCH Substudy
Action CodesNR
Study Coordinator(s)Eric Huselton, M.D., Uma Borate, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCI Community Oncology Research Program (NCORP) Affiliates and Subaffiliates

Memorandum 1 of 2 - SWOG Specimen Tracking System Updates

A Randomized Phase 2 Trial of ASTX727 and Venetoclax Compared with ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults with IDH2 Mutant AML: A myeloMATCH Substudy
Action CodesNR
Study Coordinator(s)Eric Huselton, M.D., Uma Borate, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCI Community Oncology Research Program (NCORP) Affiliates and Subaffiliates

Memorandum 2 of 2 - IND Safety Report(s) for Venetoclax (ABT-199)

A Randomized Phase 2 Trial of ASTX727 and Venetoclax Compared with ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults with IDH2 Mutant AML: A myeloMATCH Substudy
Action CodesNR
Study Coordinator(s)Eric Huselton, M.D., Uma Borate, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, ALL NCI Community Oncology Research Program (NCORP) Affiliates and Subaffiliates
MM1OA-S04Phase II

Memorandum - IND Safety Report(s) for Venetoclax (ABT-199)

A Phase 2 trial of ASTX727 with standard duration versus shorter duration of venetoclax in genomically heterogenous AML among adults aged 60 or older and less fit for intensive therapy: a myeloMATCH substudy.
Action CodesNR
Study Coordinator(s)Uma Borate, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG

Memorandum - SWOG Specimen Tracking System Updates

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

Memorandum 1 of 2 - IND Safety Report(s) for Nivolumab (for S1400I)

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

Memorandum 2 of 2 - IND Safety Report(s) for Ipilimumab (BMS-734016) (for S1400I)

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

Memorandum 1 of 2 - 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 CodesNR
Study Coordinator(s)Scott Gettinger, M.D., Lyudmila Bazhenova, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1400IPhase III Intergroup

Memorandum 2 of 2 - IND Safety Report(s) for Ipilimumab (BMS-734016)

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 CodesNR
Study Coordinator(s)Scott Gettinger, M.D., Lyudmila Bazhenova, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1609Phase II

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

DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action CodesNR
Study Coordinator(s)Sandip Patel, MD, Young Chae, MD, MPh, Razelle Kurzrock, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1609Phase II

Memorandum 2 of 2 - IND Safety Report(s) for Ipilimumab (BMS-734016)

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

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 CodesNR
Study Coordinator(s)Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD

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 CodesNR
Study Coordinator(s)Sukhmani K. Padda, M.D., David Gerber, M.D.

Memorandum 1 of 2 - Protocol Clarifications

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 - IND Safety Report(s) for Venetoclax (ABT-199)

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.
S2005Phase II Intergroup

Memorandum - IND Safety Report(s) for Venetoclax (ABT-199)

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

Memorandum 1 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 CodesNR
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 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 CodesNR
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 CodesNR
Study Coordinator(s)Van K. Morris, M.D., E. Scott Kopetz, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2200Phase II

Memorandum - 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 CodesNR
Study Coordinator(s)Benjamin L. Maughan, M.D., Sumanta K. Pal, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 1 of 2 - Non-US, Latin American Participation

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
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 CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D., Jing Christine Ye, M.D., MSc, Brea Lipe, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2212Phase III

Memorandum - S2212 PRO CTCAE Clarification

Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
Action CodesNR
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 CodesNR
S2303Phase II-III

Memorandum - 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 CodesNR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2419Phase II-III

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

Phase II/III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic MO-03, or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma (BioFront Trial)
Action CodesNR
Study Coordinator(s)Pedro Barata, M.D., Ulka N. Vaishampayan, M.D., Sumanta K. Pal, M.D., David J. McConkey, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2419Phase II-III

Memorandum 2 of 2 - IND Safety Report(s) for Ipilimumab (BMS-734016)

Phase II/III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic MO-03, or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma (BioFront Trial)
Action CodesNR
Study Coordinator(s)Pedro Barata, M.D., Ulka N. Vaishampayan, M.D., Sumanta K. Pal, M.D., David J. McConkey, 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