Clinical Trials

CANCER RESEARCH

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Breast

Principal Investigator: Jane Skelton, MD

Sponsor/Study ID: Agendia FLEX

Protocol Description: MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)

National Clinical Trials Identifier: NCT03053193

Principal Investigator: Naomi Dempsey, MD

Sponsor/Study ID: Alliance A011801

Protocol Description: The CompassHER2 trials (COMprehensive use of Pathologic Response ASSessment to optimize therapy in HER2-positive breast cancer): CompassHER2 Residual Disease (RD), a double-blinded, phase III randomized trial of T-DM1 and placebo compared with T-DM1 and tucatin

National Clinical Trials Identifier: NCT04457596

Gastrointestinal

Principal Investigator: Stephen Grabelsky, MD

Sponsor/Study ID: Astellas 8951-CL-5201

Protocol Description: A Phase 2, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

National Clinical Trials Identifier: NCT03816163

Principal Investigator: Warren Brenner, MD

Sponsor/Study ID: Novocure EF-27

Protocol Description: Panova-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with gemcitabine and nab-paclitaxel for front-line treatment of locally-advanced pancreatic adenocarcinoma

National Clinical Trials Identifier: NCT03377491

Principal Investigator: Warren Brenner, MD

Sponsor/Study ID: Signatera/BESPOKE 20-041-NCP

Protocol Description: BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

Open to stage I and IV as of 7/11/22. Stage II and III on hold for analysis

National Clinical Trials Identifier: NCT04264702

Principal Investigator: Warren Brenner, MD

Sponsor/Study ID: Gritstone GO-010

Protocol Description: A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination with Immune Checkpoint Blockade for Patients with Metastatic Colorectal Cancer

National Clinical Trials Identifier: NCT05141721

Principal Investigator: Warren Brenner, MD

Sponsor/Study ID: Aravive AVB500-PC-005

On hold until opening of Phase 2

Protocol Description: A Phase 1b/2 Randomized Study of AVB-S6-500 plus Nabpaclitaxel and Gemcitabine in Patients with Locally Advanced or Metastatic Pancreatic Adenocarcinoma

National Clinical Trials Identifier: NCT04983407

Lymphoma/Leukemia

Principal Investigator: Spencer Bachow, MD

Sponsor/Study ID: LOXO-BTK-20020

Protocol Description: A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-321).

National Clinical Trials Identifier: NCT04666038

GENITOURINARY

Principal Investigator: Alan Koletsky, MD

Sponsor/Study ID: MSKCC / Pfizer C16-174

Protocol Description: DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

National Clinical Trials Identifier: NCT03574571

HEAD AND NECK

Principal Investigator: Michael Kasper, MD

Sponsor/Study ID: Monopar Therapeutics MNPR-301-001

Protocol Description: A Phase 2b/3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of clonidine mucoadhesive buccal tablet to placebo to prevent chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer

National Clinical Trials Identifier: NCT04648020

SKIN

Principal Investigator: Hilary Gomolin, MD

Sponsor/Study ID: HUYA Bioscience International HBI-8000-303

Protocol Description: A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined with Nivolumab versus Placebo with Nivolumab in Patients with Unresectable or Metastatic Melanoma Not Previously Treated with PD-1 or PD-L1 Inhibitors

National Clinical Trials Identifier: NCT04674683

Lung

Principal Investigator: Matthen Mathew, MD

Sponsor/Study ID: Merck MK7684A-003

Protocol Description: A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 with Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer

PI change in process

National Clinical Trials Identifier: NCT04738487

Principal Investigator: Warren Brenner, MD

Sponsor/Study ID: Biodesix BDX-00146

Protocol Description: An Observational Study Assessing the Clinical Effectiveness of VeriStrat® and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer

National Clinical Trials Identifier: NCT03289780

Principal Investigator: Matten Mathew, MD

Sponsor/Study ID: Merck MK-7684A-008

Protocol Description: A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer

National Clinical Trials Identifier: NCT05224141

Principal Investigator: Matten Mathew, MD

Sponsor/Study ID: AstraZeneca SAVANNAH D5084C00007

Protocol Description: A Phase II, Single Arm Study Assessing the Efficacy of Osimertinib in Combination with Savolitinib in Patients with EGFRm+ and MET+, Locally Advanced or Metastatic Non-Small Cell Lung Cancer who have Progressed Following Treatment with Osimertinib (The SAVANNAH Study)

Pending to re-open on Protocol V7.0

National Clinical Trials Identifier: NCT03778229

General Oncology

Principal Investigator:

Sponsor/Study ID: City of Hope National Medical Center 96144

Protocol Description: Molecular Genetic Studies of Cancer Patients and Their Relatives

National Clinical Trials Identifier:
No NCT # GENETICS STUDY

  • Personal history or family history of cancer suggestive of presence of an inherited predisposition
  • In a group known or suspected to have increased risk of carrying genetic alteration or of sustaining exposure that would place them at risk of cancer
  • Willing historian to provide information or access
  • Young age cancer diagnosis
  • Multiple primary neoplasms in affected member
  • Presence of rare tumor types in family
  • Congenital malformations
  • Any other family clustering of cancer
  • Any other cancer-predisposing genetic disease/conditions

Neurology and Neuro-Oncology

Principal Investigator: Sajeel Chowdhary, MD

Sponsor/Study ID: Denovo DB102-01

Protocol Description: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1

National Clinical Trials Identifier: NCT03776071

Principal Investigator: Sajeel Chowdhary, MD

Sponsor/Study ID: National Cancer Institute/Alliance N0577

Protocol Description: Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

National Clinical Trials Identifier: NCT00887146

Principal Investigator:

Sponsor/Study ID: Scripps 1R01CA229737-07

Protocol Description: Clinical Translation of Precision Medicine Testing Utilizing 3 Dimensional Primary Tumor Cell Culture

Enrollment paused pending revised protocol

National Clinical Trials Identifier:
No NCT #

  • Patients scheduled to have surgery for removal of brain tumor.
  • Age: 18 years and older.

Principal Investigator: Sajeel Chowdhary, MD

Sponsor/Study ID: Alliance A071701

Protocol Description: Genetic Testing in Guiding Treatment for Patients with Brain Metastases

National Clinical Trials Identifier: NCT03994796

Principal Investigator: Sajeel Chowdhary, MD

Sponsor/Study ID: Alliance A071401

Protocol Description: Phase II Trial of SMO/AKT/NF2/CDK Inhibitors in Progressive Meningiomas With SMO/AKT/NF2/CDK Pathway Mutations

Effective 10/03/2022 abemaciclib cohort closed to accrual. AKT1, PIK3CA, PTE cohorts remain open to accrual

National Clinical Trials Identifier: NCT02523014

Principal Investigator: Samuel Richter, MD

Sponsor/Study ID: Canadian Clinical Trial Group (CCTG) CE.7

Protocol Description: A Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5-15 Brain Metastases

National Clinical Trials Identifier: NCT03550391

Principal Investigator: Sajeel Chowdhary, MD

Sponsor/Study ID: NRG Oncology NRG-BN010

Protocol Description: A Safety Run-in and Phase II Study Evaluating the Efficacy, Safety, and Impact on the Tumor Microenvironment of the Combination of Tocilizumab, Atezolizumab, and Fractionated Stereotactic Radiotherapy in Recurrent Glioblastoma

Accrual opened to the safety run-in portion at dose level 2 (tocilizumab 8 mg/kg).

National Clinical Trials Identifier: NCT04729959

Principal Investigator: Sajeel Chowdhary, MD

Sponsor/Study ID: Novocure EF-32 (TRIDENT)

Protocol Description: A Pivotal Randomized, Open-Label Study of Optune® (TTFields, 200kHz) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

National Clinical Trials Identifier: NCT04471844

SOLID TUMORS

Principal Investigator: Warren Brenner, MD

Sponsor/Study ID: Medicenna MDNA11-01

Protocol Description: A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination with Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors ABILITY (A Beta-only IL-2 ImmunoTherapY) STUDY

National Clinical Trials Identifier: NCT05086692