Trial & Business Updates:

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Amendments, Revisions, Memoranda

21CTP.HN01Phase II

Memorandum - Protocol Section 3 Clarification

Phase II Study of Amivantamab carboPlatin and pacliTaxel in recurrent metastatic Head and Neck cancer (CAPT-HN) Study Synopsis
Action CodesNR
Study Coordinator(s)Paul Swiecicki, M.D,
ParticipantsSWOG, This Trial Is NOT NCI-Supported and Receives NO FEDERAL FUNDING

Memorandum - Updated Funding Memo

APEX-MF, A Randomized Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib for Treatment-Naive, Cytopenic Myelofibrosis
Action CodesNR
Study Coordinator(s)Alexander Coltoff, MD, Aaron Gerds, M.D., Uma Borate, M.D., Xueyan Chen, M.D, Ph.D
ParticipantsThis Trial Is NOT NCI-Supported and Receives NO FEDERAL FUNDING

Memorandum 1 of 2 - IND Safety Report(s) for Nivolumab (for S1400I)

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

Memorandum 2 of 2 - IND Safety Report(s) for Ipilimumab (BMS-734016) (for S1400I)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER (LUNG-MAP)
Action CodesNR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1400IPhase III Intergroup

Memorandum 1 of 2 - IND Safety Report(s) for Nivolumab

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB FOR PREVIOUSLY TREATED PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER AND NO MATCHING BIOMARKER
Action CodesNR
Study Coordinator(s)Scott Gettinger, M.D., Lyudmila Bazhenova, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1400IPhase III Intergroup

Memorandum 2 of 2 - IND Safety Report(s) for Ipilimumab (BMS-734016)

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB FOR PREVIOUSLY TREATED PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER AND NO MATCHING BIOMARKER
Action CodesNR
Study Coordinator(s)Scott Gettinger, M.D., Lyudmila Bazhenova, M.D.
ParticipantsMembers, NCORP, Affiliates, Medical Oncologists, Pathologists, CTSU, CCTG
S1513Phase II

Memorandum - IND Withdrawal – 129716: Veliparib

Randomized Phase II Study of 2nd Line FOLFIRI versus Modified FOLFIRI with PARP Inhibitor ABT-888 (Veliparib) (NSC- 737664) in Metastatic Pancreatic Cancer
Action CodesNR
Study Coordinator(s)E. Gabriela Chiorean, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S1609Phase II

Memorandum 1 of 2 - IND Safety Report(s) for Nivolumab

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
S1609Phase II

Memorandum 2 of 2 - IND Safety Report(s) for Ipilimumab (BMS-734016)

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

Revision #6 - Version Date 8/03/2026

A Phase II/III Study of N-803 (ALT-803) plus Pembrolizumab versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)
Action CodesAC, ER
Study Coordinator(s)John Wrangle, MD, MPH, Hatim Husain, MD
S1802Phase III Intergroup

Memorandum - S1802 Specimen Collection and Submission Update

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer
Action CodesNR
Study Coordinator(s)Brian Chapin, M.D., Ana Aparicio, M.D., Amir Goldkorn, M.D., Richard Valicenti, M.D., John Gore, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - IND Safety Report(s) for Daratumumab

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)Jens Rueter, M.D., Meghna Trivedi, M.D., Douglas Reding, M.D., Banu Symington, MD
S2001Phase II

Revision #10 - Version Date 8/03/2026

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

Memorandum - Outstanding REDCap Open Queries

MELANOMA MARGINS TRIAL (MELMART-II): A Phase III, Multi-Centre, Multi-National Randomised Control Trial Investigating 1CM V 2CM Wide Excision Margins for Primary Cutaneous Melanoma
Action CodesNR

Memorandum 2 of 2 - IND Safety Report(s) for Nivolumab

Biomarker Stratified CaboZantinib and NivOlumab (BiCaZO) - A phase II study of combining cabozantinib and nivolumab in patients with advanced solid tumors stratified by tumor biomarkers
Action CodesNR
Study Coordinator(s)Siwen Hu-Liekskovan, M.D., Ph.D, Paul Swiecicki, M.D,, Katerina Politi, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum 1 of 2 - Specimen Collection Specifications

Biomarker Stratified CaboZantinib and NivOlumab (BiCaZO) - A phase II study of combining cabozantinib and nivolumab in patients with advanced solid tumors stratified by tumor biomarkers
Action CodesNR
Study Coordinator(s)Siwen Hu-Liekskovan, M.D., Ph.D, Paul Swiecicki, M.D,, Katerina Politi, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2107Phase II

Memorandum - IND Safety Report(s) for Nivolumab

Randomized Phase II Trial of Encorafenib and Cetuximab with or Without Nivolumab (NSC #748726) for Patients with Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer
Action CodesNR
Study Coordinator(s)Van K. Morris, M.D., E. Scott Kopetz, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2207Phase II

Memorandum - S2207 Updated Educational Resources Available

Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients with Relapse/Refractory Large B-Cell Lymphoma
Action CodesNR
Study Coordinator(s)Jennifer Amengual, M.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - IND Safety Report(s) for Daratumumab

A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma Patients Considered Frail or Ineligible for Stem Cell Transplant Comparing Frontline Regimen Bortezomib-Lenalidomide-Dexamethasone-Lite (VRd-Lite) with Daratumumab-Lenalidomide-Dexamethasone (DRd) Followed by Len+/-Dara (R+/-D) Maintenance
Action CodesNR
Study Coordinator(s)Sikander Ailawadhi, M.D., Jing Christine Ye, M.D., MSc, Brea Lipe, MD
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS

Memorandum - IND Safety Report(s) for Daratumumab

A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis
Action CodesNR
S2303Phase II-III

Memorandum - IND Safety Report(s) for Nivolumab

Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS >/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)
Action CodesNR
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2414Phase III

Memorandum - Site Educational Webinar

INcorporating pathologic reSponse in patIents with early staGe lung cancer to optimize immunotHerapy in the adjuvanT setting (INSIGHT)
Action CodesNR
Study Coordinator(s)Jeremy Cetnar, M.D., Taofeek K. Owonikoko, M.D., Ph.D
S2419Phase II-III

Memorandum 1 of 2 - IND Safety Report(s) for Nivolumab

Phase II/III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic MO-03, or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma (BioFront Trial)
Action CodesNR
Study Coordinator(s)Pedro Barata, M.D., Ulka N. Vaishampayan, M.D., Sumanta K. Pal, M.D., David J. McConkey, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2419Phase II-III

Memorandum 2 of 2 - IND Safety Report(s) for Ipilimumab (BMS-734016)

Phase II/III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic MO-03, or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma (BioFront Trial)
Action CodesNR
Study Coordinator(s)Pedro Barata, M.D., Ulka N. Vaishampayan, M.D., Sumanta K. Pal, M.D., David J. McConkey, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2427Phase II

Revision #2 - Version Date 8/07/2026

Single Arm Phase II Study of Bladder Preservation with Immunoradiotherapy after a Clinically Meaningful Response to Neoadjuvant Therapy in Patients with Muscle Invasive Bladder Cancer (BRIGHT)
Action CodesIP, AC, ER
Study Coordinator(s)Leslie Ballas, M.D., Siamak Daneshmand, M.D., Abhishek Tripathi, M.D., Daniel Hamstra, M.D., James Yu, M.D., Mark Tyson, MD, MPH, Kent Mouw, M.D., PhD, Joshua Meeks, M.D., David J. McConkey, Ph.D.
ParticipantsALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
S2433Phase III

Memorandum - Amgen Holiday Shipping Instructions

Randomized Phase III Study of Second-Line Chemotherapy with or without Panitumumab for Locally Advanced or Metastatic KRAS Wild Type Pancreatic Adenocarcinoma
Action CodesNR
Study Coordinator(s)Rachael Safyan, M.D.
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