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

CTSU/AGCT1531Phase III

Activation - Effective 5/8/2017

A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
Action CodesER
Study Coordinator(s)Anishka D'Souza , M.D.
ParticipantsCTSU
CTSU/NRG-BR007Phase III

Activation - Effective 6/7/21

A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score
Action CodesFBR

Closures

CTSU/EA8143Phase III

Permanent Closure - Effective 6/9/2021

A Phase III RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
Action CodesNR
Study Coordinator(s)Primo N. Lara, Jr., M.D., Brian Shuch, M.D.
ParticipantsCTSU
Closure Date2021-06-09
CTSU/EA8153Phase II

Permanent Closure - Effective 4/2/2021

Cabazitaxel with Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial
Action CodesNR
Study Coordinator(s)Paul G. Corn, M.D.
CTSU/EA9161Phase III

Permanent Closure - Effective 4/30/2021

A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
Action CodesNR
Study Coordinator(s)Mazyar Shadman, M.D., M.Ph
ParticipantsCTSU

Amendments, Revisions, Memoranda

S1600Phase III

Memorandum - Study Reminders

A Randomized Phase III Double-Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Action CodesNR
Study Coordinator(s)Jill Hamilton-Reeves, Ph.D., R.D, Jeffrey Holzbeierlein, 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
S1608Phase II Intergroup

Memorandum - S1608 Quarterly Newsletter - June 2021

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
S1703

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 CodesER, NR
Study Coordinator(s)Melissa Accordino, M.D.
ParticipantsALL NCORP COMPONENTS AND SUBCOMPONENTS, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1703

Revision #2 - Version Date 4/28/21

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 CodesER, NR
Study Coordinator(s)Melissa Accordino, M.D.
ParticipantsALL NCORP COMPONENTS AND SUBCOMPONENTS, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1803Phase III Intergroup

Memorandum - Lenalidomide Dose Escalation Clarifications

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 CodesER
Study Coordinator(s)Amrita Krishnan, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1900C

Memorandum - Talazoparib Investigator's Brochure

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 CodesNR
Study Coordinator(s)Ferdinandos Skoulidis, M.D., Ph.D, Jennifer M. Suga, M.D., MPH
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1900EPhase II

Memorandum 1 of 2- Sotorasib (AMG 510) FDA Approval

A PHASE II STUDY OF AMG 510 IN PATIENTS WITH PREVIOUSLY TREATED STAGE IV OR RECURRENT KRAS G12C MUTATED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (ECOG-ACRIN LUNG-MAP SUB-STUDY)
Action CodesNR
S1900EPhase II

Memorandum 2 of 2 - Master Forms Update

A PHASE II STUDY OF AMG 510 IN PATIENTS WITH PREVIOUSLY TREATED STAGE IV OR RECURRENT KRAS G12C MUTATED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (ECOG-ACRIN LUNG-MAP SUB-STUDY)
Action CodesNR
S1914Phase III

Memorandum - Spanish Model Consent Forms (Version Date: 12/11/20)

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC
Action CodesIP, AC, RC, ER
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
S1918Phase II-III

Memorandum - Reminder: S1918 Study Initiation Webinar: June 29, 2021, 3:00 - 5:00 pm Central Time

A Phase II/III randomized study of R-miniCHOP with or without oral azacitidine (CC-486) in participants age 75 years or older with newly diagnosed diffuse large B cell lymphoma, Grade IIIb Follicular Lymphoma, transformed lymphoma, and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements
Action CodesNR
Study Coordinator(s)Elizabeth Brem, M.D., Sonali Smith, M.D., Norah L. Henry, M.D.,Ph.D., Rebecca Olin, M.D., MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE
S2007Phase II

Memorandum - S2007 Informational Webinar: July 8, 2021, 11:30 am - 12:30 pm Central Time

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)Virginia Kaklamani, M.D., D.Sc
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

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