Trial & Business Updates:

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Priority Lists

Activations

S1914Phase III

Activation - Effective 3/25/20

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC
Action CodesFBR
Study Coordinator(s)Megan E. Daly, M.D., Charles Simone, II, M.D., Karen Kelly, M.D., Jeffrey Bradley, M.D., Arta Monjazeb, M.D., Jessica Bauman, M.D., Rojano Kashani, Ph.D.
ParticipantsCTSU Institutions in the United States

Closures

Permanent Closure - Effective 4/15/20

A Pragmatic Trial To Evaluate a Guideline-Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing, Effectiveness and Risk (TrACER)
Action CodesER
Study Coordinator(s)Scott Ramsey, M.D., Dawn Hershman, M.D., M.S., Gary Lyman, M.D., Sean Sullivan, Ph.D.
ParticipantsLimited: Institutions Listed on the Title Page
S1609Phase II

Permanent Closure (Cohort #22) - Effective 3/11/20

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

Partial Temporary Closure (Cohort 2) - Effective 4/6/20

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

Amendments, Revisions, Memoranda

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

Memorandum - MK-3475 (Pembrolizumab) 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 CodesIP, AC, ER
Study Coordinator(s)Kenneth F. Grossmann, M.D., Ph.D, Sapna Patel, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Revision #15 – Version Date 2/19/20

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 CodesIP, AC, ER
Study Coordinator(s)Kenneth F. Grossmann, M.D., Ph.D, Sapna Patel, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1418/BR006Phase III Intergroup

Memorandum 2 of 3 - Updated Funding Memorandum

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 CodesIP, AC, ER, NR
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1418/BR006Phase III Intergroup

Memorandum 3 of 3 - 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 (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy.
Action CodesIP, AC, ER, NR
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1418/BR006Phase III Intergroup

Revision #7 – Version Date 2/28/20

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 CodesIP, AC, ER, NR
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1418/BR006Phase III Intergroup

Memorandum 1of 3– S1418 BAHO Sample Collection and Submission is on Hold

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 CodesIP, AC, ER, NR
Study Coordinator(s)Lajos Pusztai, M.D., D.Ph
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1500Phase II

Memorandum - Cabozantinib Safety Reports

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
S1512Phase II

Memorandum 1 of 2 - MK-3475 (Pembrolizumab) Safety Report

A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
Action CodesIP, AC, ER, 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 - Laboratory Holiday Closure

A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
Action CodesIP, AC, ER, 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

Revision #6 – Version Date 2/19/20

A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
Action CodesIP, AC, ER, 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
S1605Phase II

Memorandum - Atezolizumab Safety Report

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 1 of 2 - MK-3475 (Pembrolizumab)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 CodesIP, AC, ER
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 - Laboratory Holiday Closure

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 CodesIP, AC, ER
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

Revision #7 - Version Date 2/19/20

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 CodesIP, AC, ER
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 - 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

Memorandum - Spanish Translated Model Consent Form (Version 6/3/19)

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 - Laboratory Holiday Closure

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 CodesNR
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.
S1712Phase II

Memorandum - Updated Master Forms Set

A Randomized Phase II Study of Ruxolitinib in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia Patients with Evidence of Molecular Disease
Action CodesNR
Study Coordinator(s)Kendra Sweet, M.D.

Memorandum - Updated Master Forms

A Prospective Observational Cohort Study to Develop a Predictive Model of Taxane-Induced Peripheral Neuropathy in Cancer Patients
Action CodesNR
Study Coordinator(s)Meghna Trivedi, M.D., Dawn Hershman, M.D., M.S., Daniel Hertz, PharmD, Ph.D., Stephanie Smith, RN, MSN, OCN
ParticipantsALL NCORP COMPONENTS AND SUBCOMPONENTS, SWOG

S1800A – Revision #3 - Version Date 2/21/20

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 CodesIP, AC, ER
Study Coordinator(s)Karen Reckamp, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum – MK-3475 (Pembrolizumab) Safety Report

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 CodesIP, AC, ER
Study Coordinator(s)Karen Reckamp, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1801Phase II

Memorandum - MK-3475 (Pembrolizumab) Safety Report

A Phase II Randomized Study of Adjuvant versus Neoadjuvant Pembrolizumab for Clinically Detectable Stage III-IV High-risk Melanoma.
Action CodesIP, AC, ER
Study Coordinator(s)Sapna Patel, MD
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG
S1801Phase II

Revision #5 – Version Date 2/19/20

A Phase II Randomized Study of Adjuvant versus Neoadjuvant Pembrolizumab for Clinically Detectable Stage III-IV High-risk Melanoma.
Action CodesIP, AC, ER
Study Coordinator(s)Sapna Patel, MD
ParticipantsSWOG, ALLIANCE, ECOG-ACRIN, NRG
S1803Phase III Intergroup

Memorandum - MRD Specimen Submission 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 CodesNR
Study Coordinator(s)Parminder Singh, M.D., Seth P. Lerner, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS, CCTG

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
Study Coordinator(s)Jonathan W. Riess, 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