Trial & Business Updates:

Printer Friendly Version

Priority Lists

Activations

S1609Phase II

Partial Reactivation (Cohort 27) - Effective 11/19/18

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

Activation - Effective 12/3/2018

A phase III randomized trial of gemcitabine, cisplatin, and nab-paclitaxel versus gemcitabine and cisplatin in newly diagnosed, advanced biliary tract cancers
Action CodesFBR

Closures

CTSU/A061402Phase III Intergroup

Permanent Closure - Effective 11/27/18

Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment with Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy
Action CodesER
ParticipantsCTSU
Closure Date2018-11-27

Amendments, Revisions, Memoranda

Memorandum - LUNGMAP and S1900A Pre-Activation Release

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
S0820Phase III

Memorandum - Funding Memo Update

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 CodesNR
Study Coordinator(s)Jason A. Zell, D.O.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1014Phase II

Memorandum - Abiraterone Acetate Safety Reports

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 - Updated BAHO Master Forms Set

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 CodesER
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
S1221Phase I-II

Memorandum 1 of 2 - Dabrafenib Safety Report

"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action CodesER
Study Coordinator(s)Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1221Phase I-II

Memorandum 2 of 2 - Trametinib Safety Report

"Phase I/II Study of the Safety and Efficacy of the AKT Inhibitor GSK2141795 in Combination with Dabrafenib and Trametinib in Patients with BRAF Mutant Cancer."
Action CodesER
Study Coordinator(s)Antoni Ribas, M.D., Bartosz Chmielowski, M.D., Ph.D, Roger S. Lo, M.D., Ph.D, Alain P. Algazi, M.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1316Phase III

Memorandum - Staff Letter Template

Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Action CodesNR
Study Coordinator(s)Robert S. Krouse, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S1320Phase II

Revision #9 - Version Date 10/25/2018

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Action CodesAC
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1320Phase II

Memorandum 1 of 2 - Dabrafenib Safety Report

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Action CodesAC
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1320Phase II

Memorandum 2 of 2 - Trametinib Safety Report

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

Memorandum 1 of 3 - Ipilimumab Safety Report (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 3 - Nivolumab Safety Report (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 3 of 3 - Forms (S1400F) and Labs Funding (S1400I)

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 1 of 2 - Ipilimumab 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
S1404Phase III

Memorandum 2 of 2 - 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
S1404Phase III

Revision #11 - Version Date 10/10/2018

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
S1406Phase II

Memorandum - Vemurafenib Safety Report

Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer
Action CodesER
Study Coordinator(s)E. Scott Kopetz, M.D., Heinz- Josef Lenz, M.D.
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, NR
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1500Phase II

Memorandum - Cabozantinib Safety Report

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 CodesER, NR
Study Coordinator(s)Sumanta K. Pal, M.D., Primo N. Lara, Jr., M.D., Brian Shuch, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - Forms Change

Prospective Evaluation of Carvedilol vs No treatment in Prevention of Cardiac Dysfunction in Women with Metastatic HER-2+ Breast Cancer.
Action CodesNR
Study Coordinator(s)Justin D. Floyd, D.O., Monika Leja, M.D., Carol Fabian, M.D., Andrew Godwin, Ph.D.
ParticipantsCTSU Institutions in the United States, ECOG-ACRIN, ALLIANCE, NRG
S1507Phase II Intergroup

Memorandum - Trametinib Safety Reports

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 CodesER
Study Coordinator(s)Shirish M. Gadgeel, M.D., Philip C. Mack, Ph.D., Jonathan W. Riess, M.D.
ParticipantsCTSU
S1512Phase II

Memorandum - 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
Study Coordinator(s)Kari Kendra, M.D., Siwen Hu-Liekskovan, M.D., Ph.D, William Carson, III, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG
S1605Phase II

Memorandum - Atezolizumab Safety Reports

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Action CodesER
Study Coordinator(s)Peter C.V. Black, M.D., Parminder Singh, M.D., Seth P. Lerner, M.D., David J. McConkey, Ph.D., Rick Bangs
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG, CCTG
S1607Phase II

Memorandum - 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
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
S1608Phase II Intergroup

Memorandum - Updated Spanish Translated Model Consent Form and Certificate of Translation available

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action CodesER, NR
Study Coordinator(s)Paul M. Barr, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY
S1609Phase II

Memorandum 2 of 2 - Nivolumab Safety Reports

DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action CodesER, NR
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 1 of 2 - Ipilimumab Safety Reports

DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors
Action CodesER, NR
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 - Nivolumab Safety Reports

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 - Nivolumab Safety Reports

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- Ipilimumab Safety Report

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- Nivolumab Safety Report

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 - Atezolizumab Safety Reports

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

Memorandum - Slide Set for Staff Education

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 - LUNGMAP and S1900A Pre-Activation Release

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 CodesNR
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