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

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

National Clinical Trials Identifier: NCT04264702

PENDING SITE ACTIVATION

Lymphoma/Leukemia

Principal Investigator: Spencer Bachow, MD

Sponsor/Study ID: Nordic Nanovector LYMRIT-37-01

Protocol Description: A phase I/II study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin ® ) antibody-radionuclide conjugate for treatment of relapsed non-Hodgkin lymphoma

National Clinical Trials Identifier: NCT01796171

Principal Investigator:

Sponsor/Study ID: ABBVIE M16-191

Protocol Description: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Navitoclax in Combination with Ruxolitinib Versus Ruxolitinib in Subjects with Myelofibrosis (TRANSFORM-1)

National Clinical Trials Identifier: NCT04472598

Principal Investigator:

Sponsor/Study ID: TG Therapeutics U2-VEN-207

Protocol Description: ULTRA-V: Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)

National Clinical Trials Identifier: NCT03801525

GENITOURINARY

Principal Investigator: Stephen Grabelsky, MD

Sponsor/Study ID: IMV Inc. P1719-SUR-Z11

Protocol Description: A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPXSurvivac in combination with Low Dose Cyclophosphamide and Pembrolizumab, in Subjects with Selected Advanced and Recurrent Solid Tumours

Only bladder cohort is open

National Clinical Trials Identifier: NCT03836352

Principal Investigator: Spencer Bachow, MD

Sponsor/Study ID: Bristol-Myers Squibb CA209-901

Protocol Description: Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer

Open for Cisplatin eligible patients only

National Clinical Trials Identifier: NCT03036098

Principal Investigator: Alan Koletsky, MD

Sponsor/Study ID: Seattle Genetics SGN-22e-002

Protocol Description: A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

Cisplatin NOT eligible. Only cohort open is MIBC

National Clinical Trials Identifier: NCT03288545

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: Merck MK-3475-630

Protocol Description: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

National Clinical Trials Identifier: NCT03833167

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: Harold Richter, MD

Sponsor/Study ID: Merck MK-7339-008

Protocol Description: A Phase 3 Study of Pembrolizumab in Combination with Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

National Clinical Trials Identifier: NCT03976362

Principal Investigator: Spencer Bachow , MD

Sponsor/Study ID: Fujirebio Diagnostics, Inc. FDI-209

Protocol Description: A Prospective Longitudinal Collection of Peripheral Blood to Support the Validation of Biomarkers as an Aid in Monitoring Disease in Patients with all Stages of Lung Cancer

Effective 1/31/2021: closed to NSCLC enrollment. Only individuals diagnosed with SCLC may enroll into the study.

National Clinical Trials Identifier:
No NCT number

  • Age ≥ 22 years
  • Histologic/pathologic confirmation of lung cancer
  • Any stage of disease
  • Any treatment time point
  • Individuals with a history of malignant disease other than lung cancer that was resected greater than 5 years ago and are currently in remission are eligible

Principal Investigator: Samuel Richter, MD

Sponsor/Study ID: NRG Oncology NRG-LU005

Protocol Description: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

National Clinical Trials Identifier: NCT03811002

Principal Investigator: Matthen 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)

PI change in process

National Clinical Trials Identifier: NCT03778229

Principal Investigator: Harold Richter, MD

Sponsor/Study ID: Astra Zeneca D4194C00008

Protocol Description: Prospective, Interventional Pilot Study of Mobile Devices and Digital Applications to Detect Early Pneumonitis and Other Pulmonary Adverse Events in Unresectable Stage III Non-Small Cell Lung Cancer Patients on Durvalumab

National Clinical Trials Identifier: NCT04381494

Principal Investigator: Spencer Bachow, MD

Sponsor/Study ID: Calithera CX-839-014

Protocol Description: A Phase 2 Randomized, Multicenter, Double-Blind Study of the Glutaminase Inhibitor Telaglenastat with Pembrolizumab and Chemotherapy Versus Placebo with Pembrolizumab and Chemotherapy in First-Line, Metastatic KEAP1/NRF2-Mutated, Nonsquamous, Non-Small Cell Lung Cancer (NSCLC)

National Clinical Trials Identifier: NCT04265534

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: Sajeel Chowdhary, MD

Sponsor/Study ID: State of Florida FCBTR

Protocol Description: Florida Center for Brain Tumor Research

National Clinical Trials Identifier: NCT00811148

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 due to COVID restrictions.

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: Penn State Registry

Protocol Description: NeMeRe, a Multi-Institutional Retrospective and Prospective Registry of Neoplastic Meningitis in Adults

National Clinical Trials Identifier:
No NCT #

  • Adults 18 years and older diagnosed and treated with neoplastic meningitis.

Principal Investigator: Sajeel Chowdhary, MD

Sponsor/Study ID: NRG Oncology NRG-CC003

Protocol Description: Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer

National Clinical Trials Identifier: NCT02635009

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: Samuel Richter, MD

Sponsor/Study ID: Alliance A071801

Protocol Description: Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

National Clinical Trials Identifier: NCT04114981

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: 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