Trial & Business Updates:

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Priority Lists

Disease Committee Last Changed
Breast Cancer
Cancer Care Delivery
comboMATCH
Early Therapeutics & Rare Cancers
Gastrointestinal Cancer
Genitourinary Cancer
Immunomolecular Therapeutics
Leukemia
Lung Cancer
LungMAP
Lymphoma
Melanoma
Myeloma
Other
Palliative and End of Life Care Committee
Prevention & Epidemiology
Symptom Control and Quality of Life
Scroll Table

Protocol Posting of

Activations

S1609Phase II

Partial Reactivation - Cohorts 12, 24 - Effective 8/2/18

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
S1701Phase II

Activation - Effective 8/9/18

A Randomized Phase II trial of Carboplatin-Paclitaxel with or without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
Action CodesFBR
Study Coordinator(s)Anne Tsao, M.D., Marianna Koczywas, M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG

Closures

CTSU/R1306Phase II Intergroup

Permanent Closure effective 12/20/17

A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)
Action CodesER
Study Coordinator(s)Anne Tsao, M.D., Megan E. Daly, M.D.
ParticipantsCTSU
Closure Date2017-12-20
S1609Phase II

Partial Temporary Closure (Cohort 25) - Effective 8/21/18

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

Amendments, Revisions, Memoranda

S1221Phase I-II

Memorandum - 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
S1222Phase III

Memorandum - Kuhn Laboratory Campus Closure on 8/15/2018

Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial In Postmenopausal Patients With Hormone-Receptor Positive Stage IV Breast Cancer.
Action CodesNR
Study Coordinator(s)George Somlo, M.D., Halle C.F. Moore, M.D., Daniel F. Hayes, M.D.
ParticipantsNCORP, Affiliates, Members, Medical Oncologists, Surgeons
S1316Phase III

Revision #13 - Version Date 6/27/18

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

Memorandum 1 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 CodesER, NR
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1320Phase II

Memorandum 2 of 2 - Translational Medicine is now active as of 8/15/2018

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Action CodesER, NR
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1400

Memorandum 1 of 6 - MEDI4736 Safety Report (for S1400A, S1400F)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, ER
S1400

Memorandum 2 of 6 - Taselisib Safety Report (for S1400B)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, ER
S1400

Memorandum 3 of 6 - Palbociclib Safety Report (for S1400C)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, ER
S1400

Memorandum 4 of 6 - Tremelimumab Safety Report (for S1400F)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, ER
S1400

Memorandum 5 of 6 - Ipilimumab Safety Report (for S1400I)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, ER
S1400

Memorandum 6 of 6 - Nivolumab Safety Report (for S1400I)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, ER
S1400

Revision #21 (S1400G) - Version Date 7/16/18

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, ER
S1400

Revision #18 (S1400G) - Version Date 4/18/18

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, ER
S1400

Revision #20 (S1400A, S1400F) - Version Date 7/10/18

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesIP, AC, ER
S1404Phase III

Memorandum - 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
S1416Phase II-III Intergroup

Memorandum 2 of 2 - Updated Spanish Translated Model Consent Form (Revision 2, 5/31/18), Informed Consent Addendum (Revision 2, 5/31/18) and Certificate of Translation

Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer (TNBC) and/or BRCA Mutation-Associated Breast Cancer, with or without Brain Metastases
Action CodesNR
Study Coordinator(s)Eve Rodler, M.D., Priyanka Sharma, M.D., Julie R. Gralow, M.D.
ParticipantsCTSU
S1416Phase II-III Intergroup

Memorandum 1 of 2 - Kuhn Laboratory Campus Closure on 8/15/2018

Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer (TNBC) and/or BRCA Mutation-Associated Breast Cancer, with or without Brain Metastases
Action CodesNR
Study Coordinator(s)Eve Rodler, M.D., Priyanka Sharma, M.D., Julie R. Gralow, M.D.
ParticipantsCTSU
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
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

Memorandum - Trametinib Safety Report

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
S1602Phase III

Memorandum - Drug Supply

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
S1608Phase II Intergroup

Memorandum 1 of 2 - Obinutuzumab (Gazyva) Safety Report

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action CodesER
Study Coordinator(s)Paul M. Barr, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY
S1608Phase II Intergroup

Memorandum 2 of 2 - TGR-1202 Safety Report

Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Action CodesER
Study Coordinator(s)Paul M. Barr, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, US INSTITUTIONS ONLY
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
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
S1612

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

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