Trial & Business Updates:

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Priority Lists

Activations

Closures

CTSU/EAY131Phase II Intergroup

Partial Permanent Closure (Subprotocols: EAY131-F, EAY131-G, and EAY131-S2) - Effective 4/1/2019

Molecular Analysis for Therapy Choice (MATCH)
Action CodesER
Study Coordinator(s)Victor Villalobos, MD, PhD
ParticipantsCTSU
S1320Phase II

Memorandum - Permanent Closure Step 1 (Lead-in Continuous Dosing) - Effective 04/19/2019

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Action CodesER, NR
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1609Phase II

Partial Temporary Closure (Cohort #11) - Effective 4/16/19, 2:00 p.m. PT

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

Partial Temporary Closure (Cohort #36) - Effective 4/19/19, 2:00 p.m. PT

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

Amendments, Revisions, Memoranda

Memorandum - Updated Master Forms Set

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
S1014Phase II

Memorandum - Abiraterone Acetate Safety Report

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
S1207Phase III

Memorandum - Corrections to Spanish-Translated Model Consent Form (Version Date: 10/24/18)

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study- evaluating everolimus with endocrine therapy.
Action CodesNR
Study Coordinator(s)Mariana Chavez-MacGregor, M.D., Lajos Pusztai, M.D., D.Ph
ParticipantsCTSU (U.S. and Canadian Institutions Only), NCORP, Affiliates, Members, Medical Oncologists, Surgeons, INCAN, NSABP
S1318Phase II

Memorandum - Blinatumomab (AMG 103) Safety Report

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
S1320Phase II

Revision #10 - Version 03/12/2019

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Action CodesER, NR
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU

Memorandum 2 of 2 - Tremelimumab Safety Report (for S1400F)

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

Memorandum 1 of 2 - MEDI4736 (Durvalumab) Safety Report (for S1400A and S1400F)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesER
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1404Phase III

Memorandum - MK-3475 Safety Report

A Phase III Randomized Trial of Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High-Risk Resected Melanoma
Action CodesER
Study Coordinator(s)Kenneth F. Grossmann, M.D., Ph.D, Sapna Patel, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1418/BR006Phase III Intergroup

Memorandum - MK-3475 (Pembrolizumab) Safety Report

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 (>ypN+) After Neoadjuvant Chemotherapy.
Action CodesER
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1500Phase II

Revision #11 - Version Date 03/14/19

A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511])in Metastatic Papillary Renal Carcinoma (PAPMET)
Action CodesNR
Study Coordinator(s)Sumanta K. Pal, M.D., Primo N. Lara, Jr., M.D., Brian Shuch, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1507Phase II Intergroup

Revision #3 - Version Date 3/15/19

A Phase II Trial Of Trametinib with Docetaxel in Patients with Kras Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies.
Action CodesIP, ER
Study Coordinator(s)Shirish M. Gadgeel, M.D., Philip C. Mack, Ph.D., Jonathan W. Riess, M.D.
ParticipantsCTSU
S1512Phase II

Memorandum 1 of 2 - MK-3475 Safety Report

A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
Action CodesER, NR
Study Coordinator(s)Kari Kendra, M.D., Siwen Hu-Liekskovan, M.D., Ph.D, William Carson, III, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG
S1512Phase II

Memorandum 2 of 2 - Updated Funding Memo (Version 3/04/2019) is now available on the CTSU website

A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
Action CodesER, NR
Study Coordinator(s)Kari Kendra, M.D., Siwen Hu-Liekskovan, M.D., Ph.D, William Carson, III, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG
S1600Phase III

Memorandum - Master Forms Update

A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Action CodesNR
Study Coordinator(s)Jill Hamilton-Reeves, Ph.D., R.D, Jeffrey Holzbeierlein, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG
S1607Phase II

Memorandum 1 of 2 - MK-3475 Safety Report

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, NR
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
S1607Phase II

Memorandum 2 of 2 - Updated Master Forms Set

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, NR
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

Memorandum - Funding Memo Version Date 3/22/2019

Randomized Trial of Prophylactic Antiviral Therapy in Patients with Current or Past Hepatitis B Virus (HBV) Infection Receiving Cytotoxic Therapy for Solid Tumors
Action CodesNR
Study Coordinator(s)Jessica Hwang, M.D. M.P.H, Anna Lok, M.D.

Revision #4 - Version Date 3/20/19

A Feasibility Trial of Neoadjuvant Cisplatin - Pemetrexed - Atezolizumab with Adjuvant Maintenance Atezolizumab in Resectable Malignant Pleural Mesothelioma
Action CodesER, NR
Study Coordinator(s)Anne Tsao, M.D.

Memorandum - Updated Master Forms Set

A Feasibility Trial of Neoadjuvant Cisplatin - Pemetrexed - Atezolizumab with Adjuvant Maintenance Atezolizumab in Resectable Malignant Pleural Mesothelioma
Action CodesER, NR
Study Coordinator(s)Anne Tsao, M.D.

Memorandum - Funding Memo Version Date 3/01/2019

A Phase II Study of Isatuximab (SAR650984) for Patients with Previously Treated AL Amyloidosis
Action CodesNR
Study Coordinator(s)Vaishali Sanchorawala, M.D., Terri Parker, M.D.

Memorandum - Forms Update

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 - Master Forms Set Updated

A Phase II Randomized Study of Adjuvant versus Neoadjuvant Pembrolizumab for Clinically Detectable Stage III-IV High-risk Melanoma.
Action CodesNR
Study Coordinator(s)Sapna Patel, MD
S1802Phase III Intergroup

Memorandum - Master Forms Set Update

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

Memorandum - Rucaparib Safety Report

A PHASE II STUDY OF RUCAPARIB IN PATIENTS WITH GENOMIC LOH HIGH AND/OR DELETERIOUS BRCA 1/2 MUTATION STAGE IV NON-SMALL CELL LUNG CANCER (LUNG-MAP SUB-STUDY)
Action CodesER
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Other New Items

  • 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