Clinical Corner
Clinical Trials + Updates
Clinical Trial Highlight: Refractory Cancers
This month, we’re highlighting several clinical trials currently recruiting patients with refractory malignancies.
Refractory Solid Tumor Studies
TAS-102 in Patients with Advanced Solid Tumors With Renal Impairment:
This is a Phase 1, open-label study to evaluate the safety, tolerability and pharmacokinetics of TAS-102 in patients with advanced solid tumors with varying degrees of renal impairment.
Principal Investigator: Thomas George, MD, cell 352.339.6672
NCI-MATCH or EAY131:
This is a phase II basket trial that studies how well molecular targeted treatment works in patients with progressive solid tumors or lymphomas. Patients with genetic abnormalities such as mutations, amplifications or translocations, may benefit more from treatment, which targets their tumor’s particular genetic abnormality.
Principal Investigator: Thomas George, MD, cell 352.339.6672
DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (SWOG1609):
This phase II umbrella trial is a sister study to the NCI-MATCH but specifically for rare histologies (nearly 50 such diagnoses) who have been screened with next generation sequencing for MATCH, but for whom do not have a molecular treatment match. Treatment for all such patients includes nivolumab and ipilimumab.
Principal Investigator: Thomas George, MD, cell 352.339.6672
Testing Combination Treatments in Patients with Advanced Gastric Cancer (FRACTION-GC):
This multi-arm platform study tests Nivolumab in combination with other IO therapies compared to Nivolumab in combination with Ipilimumab in patients with metastatic esophagogastric adenocarcinoma. Patients with HER2 positive tumor must have been treated with trastuzumab prior to enrollment.
Principal Investigator: Thomas George, MD, cell 352.339.6672
Durvalumab (Anti-PD-L1 Antibody) as Monotherapy and in Combination in Subjects with Lymphoma or Chronic Lymphocytic Leukemia (FUSION NHL 001 Study):
This open label phase II study is testing the safety and activity of durvalumab alone or in combination with lenalidomide and rituximab, ibrutinib or bendamusting and rituximab in patients with refractory lymphoma or CLL
Principle Investigator: Nam Dang, MD, PhD, cell 352.226.6684
TAS-102 in Previously Treated Unresectable or Metastatic Squamous Cell Lung Carcinoma (UF-STO-LUNG-003):
This open label phase II study is designed to evaluate the activity of TAS-102 in previously treated unresectable or metastatic squamous non-small cell cancer after progression through or intolerance to prior systemic therapy. Prior treatment must have included all FDA-approved standard or targeted therapies when appropriate.
Principal Investigator: Dennie Jones, MD, cell 904.571.0342
A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies:
This is a phase I/II trial to evaluate the safety, tolerability, dose-limiting toxicities and antitumor activity of INCAGN01876 (GITR-agonist) in combination with nivolumab and ipilimumab in adult subjects with a number of advanced and refractory solid tumors who have not had prior immunotherapies.
Principal Investigator: Thomas George, MD, cell 352.339.6672
Refractory Malignant Hematology Studies
Phase I/II Clinical Trial of Oral Ciproflaxacin and Etoposide in Subjects with Resistant Acute Myeloid Leukemia (AML)
This is an investigator-initiated clinical trial that is based on Dr. Robert Hromas’ discovery of the importance of the Metnase complex in repairing chemotherapy-related DNA damage in leukemia. Ciprofloxacin has been identified as a Metnase inhibitor that chemosensitizes leukemic myeloblasts to etoposide chemotherapy. The primary aims are to determine the maximum tolerated dose of ciprofloxacin that can be given in combination with a fixed dose of etoposide and determine the efficacy of the combination treatment in adults with resistant AML.
Principal Investigator: Randy Brown, MD, cell 859.221.6828
Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma (PANORAMA 3)
This is a Phase 2 study to investigate the safety and efficacy of three different regimens of panobinostat in combination with subcutaneous bortezomib and dexamethasone for patients with Relapsed or relapsed/refractory multiple myeloma. Patients can only have received 1-3 prior lines of therapy, must have had prior IMiD exposure, and cannot be relapsed or refractory to bortezomib.
Principal Investigator: Jan Moreb, MD cell: 352.219.3787
A Study of Melflufen in Combination with Dexamethasone in Relapsed Refractory Multiple Myeloma Patients (HORIZON)
This Phase 2 study will evaluate melflufen in combination with dexamethasone in the treatment of relapsed refractory multiple myeloma in adult patients with disease refractory to pomalidomide and/or daratumumab. Patients must have received at least 2 prior lines of therapy, including an IMiD and proteasome inhibitor, and is refractory to pomalidomide and/or Daratumumab.
Principal Investigator: Jan Moreb, MD cell: 352.219.3787