Trial & Business Updates:

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Priority Lists

Activations

Activation - Effective 12/14/20

A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.
Action CodesNR
Study Coordinator(s)Deborah Stephens, DO, Brian T. Hill, M.D., Ph.D, John Pagel, MD, PhD, Mazyar Shadman, M.D., M.Ph, Michael J. Fisch, M.D.
S2001Phase II

Activation - Effective 12/04/2020

Parallel Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib as Maintenance Therapy in Two Cohorts of Metastatic Pancreatic Cancer Patients with DNA Damage Repair Defects
Action CodesFBR
Study Coordinator(s)Vincent Chung, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2007Phase II

Activation - Effective 12/15/20

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients with HER2-Negative Breast Cancer and Brain Metastases
Action CodesNR
Study Coordinator(s)Andrew J. Brenner, MD,PhD, Virginia Kaklamani, M.D., D.Sc
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Closures

Amendments, Revisions, Memoranda

S0520Phase II

Memorandum - IND Withdrawal

Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
Action CodesNR
Study Coordinator(s)Steven Bernstein, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S0520Phase II

Memorandum - IND Withdrawal

Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
Action CodesNR
Study Coordinator(s)Steven Bernstein, M.D., Thomas P. Miller, M.D., Lisa M. Rimsza, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists
S1005Phase II

Memorandum - IND Withdrawal

A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
Action CodesNR
Study Coordinator(s)Ramesh K. Ramanathan, M.D., Hagen F. Kennecke, M.D.
ParticipantsMedical Oncologists, Members, NCORP, Affiliates
S1014Phase II

Memorandum - Abiraterone 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
S1108Phase II

Memorandum - IND Withdrawal

Phase II Trial of the Aurora Kinase A Inhibitor, MLN8237, in Peripheral T-Cell Non-Hodgkin Lymphoma
Action CodesNR
Study Coordinator(s)Paul M. Barr, M.D., Jonathan W. Friedberg, M.D., Daruka Mahadevan, M.D.,Ph.D.
ParticipantsMembers, NCORP, Affiliates, CTSU
S1207Phase III

Revision #12 - Version Date: 10/21/20

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, Instituto Nacional de Cancerología (INCan), México, NSABP
S1211Phase I-II

Memorandum - BMS Holiday Closure

A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Action CodesNR
Study Coordinator(s)Saad Usmani, M.D., Sikander Ailawadhi, M.D., Jatin Shah, MD
ParticipantsLimited: Institutions Listed on the Title Page , Members, NCORP, Affiliates, Medical Oncologists, Pathologists

Memorandum 1 of 5 - MEDI4736 (durvalumab) Safety Report (for S1400F)

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

Memorandum 2 of 5 - Talazoparib Safety Report (for S1400G)

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

Memorandum 3 of 5 - Nivolumab Investigator Brochure (for S1400I)

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

Memorandum 4 of 5 - Ipilimumab Safety Report (for S1400I)

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

Memorandum 5 of 5 - Nivolumab Safety Report (for S1400I)

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

Memorandum - Ipilimumab (BMS-734016) 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 - Clarification of Missed Dose due to Toxicity

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 CodesNR
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
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 - Holiday Lab Closure

A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma (DM)
Action CodesNR
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 -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
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 - Talimogene Laherparepvec 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 - Holiday Lab 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 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
S1608Phase II Intergroup

Memorandum - Updated Spanish-translated Model Consent Form (Version Date: 09/15/20)

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

Memorandum 1 of 2 - Ipilimumab (BMS-734016) 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
S1609Phase II

Memorandum 2 of 2 - 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
S1613Phase II

Memorandum - Protean Holiday Closure

A Randomized Phase II Study of Pertuzumab and Trastuzumab (TP) compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) with HER2 Amplification
Action CodesNR
Study Coordinator(s)Kanwal Raghav, M.D., E. Scott Kopetz, M.D., Marwan G. Fakih, M.D.
ParticipantsCTSU Institutions in the United States
S1616Phase III

Memorandum 1 of 3 - Ipilimumab (BMS-734016) 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, NR
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 3 - 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, NR
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 3 of 3 - Holiday Lab 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 CodesER, NR
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

Revision #3 – Version Date 10/12/20

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

Memorandum - Sanofi GV Holiday Closure

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 - Updated Master Forms Set

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
S1712Phase II

Memorandum - Updated Drug Order From

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 Forms

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 CodesNR
Study Coordinator(s)Karen Reckamp, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1803Phase III Intergroup

Memorandum - Daratumumab (rHuPH20) Safety Report

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 CodesIP, AC, ER
Study Coordinator(s)Amrita Krishnan, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1803Phase III Intergroup

Revision #3 - Version Date 10/22/20

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 CodesIP, AC, ER
Study Coordinator(s)Amrita Krishnan, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1806Phase III

Memorandum 1 of 2 -Atezolizumab Safety Report

Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.
Action CodesER, NR
Study Coordinator(s)Parminder Singh, M.D., Seth P. Lerner, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1806Phase III

Memorandum 2 of 2 -Master Forms Update

Phase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer.
Action CodesER, NR
Study Coordinator(s)Parminder Singh, M.D., Seth P. Lerner, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1826Phase III Intergroup

Memorandum 1 of 2 - Health Canada No Objection Letter and CCTG Participation

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, NR
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 2 of 2 - Nivolumab (BMS-936558) Safety Reports

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, NR
Study Coordinator(s)Alex Herrera, M.D., Jonathan W. Friedberg, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Memorandum 1 of 2 - Updated Forms

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
S1900BPhase II

Memorandum - Updated Forms

A PHASE II STUDY OF SELPERCATINIB (LOXO-292) IN PATIENTS WITH RET FUSION-POSITIVE STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (LUNG-MAP SUB-STUDY)
Action CodesNR

Memorandum 1 of 3 - Updated Forms

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

Memorandum 2 of 3 - Avelumab Safety Report

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

Memorandum 3 of 3 - Talazoparib Safety Report

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 CodesIP, AC, ER
Study Coordinator(s)Ferdinandos Skoulidis, M.D., Ph.D, Jennifer M. Suga, M.D., MPH
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1914Phase III

Memorandum-Atezolizumab Safety Report

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC
Action CodesER
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
S1929Phase II

Memorandum 1 of 2 - Talazoparib Safety Report

Phase II Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (SCLC)
Action CodesIP, AC, ER
Study Coordinator(s)Nagla Karim, M.D., Ph.D, Karen Reckamp, M.D., Lauren A. Byers, M.D., Carl Gay, M.D., Ph.D
S1929Phase II

Memorandum 2 of 2 - Atezolizumab Safety Report

Phase II Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (SCLC)
Action CodesIP, AC, ER
Study Coordinator(s)Nagla Karim, M.D., Ph.D, Karen Reckamp, M.D., Lauren A. Byers, M.D., Carl Gay, M.D., Ph.D
S1933Pilot

Memorandum- Atezolizumab Safety Report

A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status
Action CodesER
Study Coordinator(s)Raid Aljumaily, M.D., Timur Mitin, M.D.,Ph.D., Antoinette J. Wozniak, M.D.
ParticipantsALLIANCE, ECOG-ACRIN, NRG, SWOG, US INSTITUTIONS ONLY
  • 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