Trial & Business Updates:

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Priority Lists

Activations

S1900FPhase II

Activation - Effective 7/25/2022

A Randomized Phase II Study of Carboplatin and Pemetrexed with or without Selpercatinib (LY3527723) in Participants with Non-Squamous RET Fusion-Positive Stage IV Non-Small Cell Lung Cancer and Progression of Disease on Prior RET Directed Therapy (Lung-MAP Sub-Study)
Study Coordinator(s)Jhanelle E. Gray, M.D., Yasir Y. Elamin, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Closures

Partial Closure to Accrual - Effective 6/23/22

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab
S1929Phase II

Partial Permanent Closure - Effective 8/15/2022

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

Amendments, Revisions, Memoranda

Revision # 5 - Version Date: 1/11/2022

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

Revision # 6 - Version Date: 4/1/2022

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

Memorandum - Notice of Revision Releases and Updated Master Form Set

A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER (Lung-MAP Screening Study)
Action CodesER, NR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S0820Phase III

Revision # 9 - Version Date: 6/27/2022

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)"
Action CodesER
Study Coordinator(s)Jason A. Zell, D.O.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1014Phase II

Memorandum - IND Safety Report(s) for Abiraterone

Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy, Phase II.
Action CodesER
Study Coordinator(s)Thomas W. Flaig, M.D., Maha H.A. Hussain, M.D.
ParticipantsMembers, NCORP, UCOP, Affiliates, Medical Oncologists, Surgeons

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 CodesER
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1418/BR006Phase III Intergroup

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

A Randomized Phase III Trial to Evaluate Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/=1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy.
Action CodesER
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1512Phase II

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

A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
Action CodesER
Study Coordinator(s)Kari Kendra, M.D., Siwen Hu-Liekskovan, M.D., Ph.D, William Carson, III, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG
S1607Phase II

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

A Phase II Study Of Combining Talimogene laherparepvec (T-VEC) And PD-1 Blockade With Pembrolizumab In Patients With Advanced Melanoma Who Have Progressed On Anti-PD1 Therapy
Action CodesER
Study Coordinator(s)Siwen Hu-Liekskovan, M.D., Ph.D, Antoni Ribas, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE, US INSTITUTIONS ONLY, CTSU
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 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
S1609Phase II

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

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

Memorandum (1 of 2) - Updated RAVE Display and Forms

A Randomized Phase II/III Trial of "Novel Therapeutics" versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia Age 60 or Older
Action CodesER
Study Coordinator(s)Laura Michaelis, MD, Roland Walter, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

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

A Randomized Phase II/III Trial of "Novel Therapeutics" versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia Age 60 or Older
Action CodesER
Study Coordinator(s)Laura Michaelis, MD, Roland Walter, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1616Phase III

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

A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent
Action CodesER
Study Coordinator(s)Ari VanderWalde, M.D., Antoni Ribas, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE, US INSTITUTIONS ONLY, CTSU
S1616Phase III

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

A Phase II Randomized Study of Nivolumab (NSC-748726) with Ipilimumab (NSC-732442) OR Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD-1 or Anti-PD-L1 Agent
Action CodesER
Study Coordinator(s)Ari VanderWalde, M.D., Antoni Ribas, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE, US INSTITUTIONS ONLY, CTSU

Memorandum - Patient flyer for recruitment purposes

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

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

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 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, NR
Study Coordinator(s)Amrita Krishnan, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1826Phase III Intergroup

Memorandum - IND Safety Report(s) for Nivolumab

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
Action CodesER
Study Coordinator(s)Alex Herrera, M.D., Jonathan W. Friedberg, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

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
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
S2007Phase II

Revision # 2 - Version Date: 6/10/2022

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients with HER2-Negative Breast Cancer and Brain Metastases
Action CodesER, NR
Study Coordinator(s)Virginia Kaklamani, M.D., D.Sc
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S2007Phase II

Memorandum - Clarification for Revision # 2

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients with HER2-Negative Breast Cancer and Brain Metastases
Action CodesER, NR
Study Coordinator(s)Virginia Kaklamani, M.D., D.Sc
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
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 CodesER
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
S2107Phase II

Memorandum (1 of 3) - Spanish Model Consent Form

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
S2107Phase II

Memorandum (2 of 3) - Participant Materials Now Available

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
S2107Phase II

Memorandum (3 of 3) - 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
  • 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