Trial & Business Updates:

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Priority Lists

Activations

Activation - Effective 1/16/20

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 CodesFBR, NR
Study Coordinator(s)Ferdinandos Skoulidis, M.D., Ph.D, Jennifer M. Suga, M.D., MPH
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Closures

CTSU/EAE161Phase III Intergroup

Permanent Closure - Effective 1/9/20

Perfusion CT to Predict Progression-free Survival and Response Rate in Bevacizumab and Paclitaxel Treatment of Platinum-Resistant Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Carcinoma
Action CodesNR
Study Coordinator(s)Priyanka Sharma, M.D.
ParticipantsCTSU
Closure Date2020-01-08
CTSU/EAY131Phase II Intergroup

Partial Temporary Closure (Subprotocol Z1H) - Effective 1/8/20

Molecular Analysis for Therapy Choice (MATCH)
Action CodesNR
Study Coordinator(s)Victor Villalobos, MD, PhD
ParticipantsCTSU
S1418/BR006Phase III Intergroup

Partial Temporary Closure: BAHO Substudy - Effective Immediately

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
S1609Phase II

Partial Permanent Closure (Cohort #26 and #52) - Effective 2/3/20

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

Partial Temporary Closure (Cohort #35) - Effective 2/4/20

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

Amendments, Revisions, Memoranda

Memorandum 2 of 2 - Tissue Submission Preference

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 1 of 2 - Webinar for S1900B and S1900C

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
S1014Phase II

Revision #7 – Version Date 1/7/20

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
S1221Phase I-II

Memorandum 1 of 2 - Dabrafenib Mesylate 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 Dimethyl Sulfoxide 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
S1320Phase II

Memorandum 1 of 2 - Dabrafenib Mesylate 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
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU
S1320Phase II

Memorandum 2 of 2 - Trametinib Dimethyl Sulfoxide 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
Study Coordinator(s)Alain P. Algazi, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CTSU

Memorandum 1 of 2 - MEDI4736 (druvalumab) 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

Memorandum 2 of 2 - 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
S1512Phase II

Memorandum - Spanish Model Consent Form Revision #5 (Version Date 11/1/19)

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
S1602Phase III

Memorandum 1 of 2 - BCG - Japan Safety Report

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
S1602Phase III

Memorandum 2 of 2 - Drug Preparation and Administration Reminder

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
S1605Phase II

Revision #7 – Version Date 6/26/19

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Action CodesER, NR
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
S1605Phase II

Memorandum - Atezolizumab Safety Report

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Action CodesER, NR
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

Revision #6 – Version Date 11/12/19

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 - Nivolumab (BMS-936558) Safety Report

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 - Nivolumab (BMS-936558) Safety Report

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 - Reoccurring Monthly Meeting

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.
S1616Phase III

Memorandum 1 of 2 - Spanish Consent Form for Revision #6 (Version Date 11/8/19)

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 (BMS-936558) 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 Report

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.
S1701Phase II

Memorandum - Master Forms Set Update

A Randomized Phase II trial of Carboplatin-Paclitaxel with or without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma
Action CodesNR
Study Coordinator(s)Anne Tsao, M.D., Marianna Koczywas, M.D.
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG
S1801Phase II

Memorandum - Spanish Model Consent Form Revision #4 (Version Date 11/1/19)

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 - Eligibility Clarification

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)Amrita Krishnan, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1806Phase III

Memorandum - Atezolizumab Safety Report

Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.
Action CodesER
Study Coordinator(s)Parminder Singh, M.D., Seth P. Lerner, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CCTG
S1820Phase II

Memorandum- Protocol Specific Requirements Training Clarification

A Randomized Trial of the Altering Intake, Managing Symptoms Intervention for Bowel Dysfunction in Rectal Cancer Survivors Compared to a Healthy Living Education Control: A Feasibility and Preliminary Efficacy Study (AIMS-RC)
Action CodesNR
Study Coordinator(s)Virginia Sun, R.N., Ph.D
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1826Phase III Intergroup

Memorandum 2 of 2 - Nivolumab (BMS-936558) Safety Report

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
S1826Phase III Intergroup

Memorandum 1 of 2 - Brentuximab vedotin (SGN-35) Safety Report

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
S1827Phase III

Memorandum - Confidentiality Acknowledgement Update

A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation in Small-Cell Lung Cancer
Action CodesIP, AC, ER
Study Coordinator(s)Chad Rusthoven, M.D., Paul Brown, M.D., Jeffrey Wefel, Ph.D., Abhijit Patel, M.D.,Ph.D., Justin Honce, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 1 of 2 - Rucaparib Dose Adherence

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, NR
Study Coordinator(s)Jonathan W. Riess, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 2 of 2 - 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, NR
Study Coordinator(s)Jonathan W. Riess, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - Webinar for S1900C and S1900B

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 CodesFBR, NR
Study Coordinator(s)Ferdinandos Skoulidis, M.D., Ph.D, Jennifer M. Suga, M.D., MPH
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