MAY 2024 CLINICAL CORNER

Highlighted Clinical Trials Open for Enrollment

AB-101 as Monotherapy and In Combination with Rituximab in Patients with Relapsed/Refractory B-Cell Non-Hodgkins Lymphoma

This an open-label, Phase 1 / 2 trial is evaluating the safety and anti-tumor activity of AB-101 monotherapy or AB-101 in combination with Rituximab in patients with RR B-Cell NHL.  AB-101 is comprised of ex vivo-expanded allogeneic cord blood-derived natural killer (NK) cells cryopreserved in an infusion-ready suspension.  Treatment will involve a lymphodepleting regimen with Cyclophosphamide and Fludarabine, IL2, and AB 101 with or without Rituximab.  

Principal Investigator: Erin Dean, M.D. Cell: 813-418-1716

Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors

This is a phase II multicenter study of Lutetium Lu 177 Dotate (Lu-177 Dotate) in combination with Triapine vs. Lu-177 Dotate alone in metastatic well-differentiated somatostatin receptor-positive neuroendocrine tumors, after the failure of at least one prior line of systemic treatment. Subjects will be randomized 1:1 to either Lu-177 Dotate w/ oral triapine vs. Lutathera alone.   Treatment is given in 8 week cycles, with IV Lu-177 Dotate on Day 1 of each cycle, with Triapine 150 mg QD Days 1-14.  Participants can receive up to 4 Cycles of treatment. 

Principal Investigator: Kathryn Hitchcock, M.D.

Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy for Limited mCRC (ERASur)

This phase III trial compares total ablative therapy (TAT) and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The ablative local therapy will consist of stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for Limited mCRC. This study is based on current common practice, and will pragmatically evaluate the safety, benefits versus risks, and survival impact of the integration of these treatments for Limited mCRC. 

Principal Investigator: Kathryn Hitchcock, M.D.

Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study

This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.

PI: Dennie Jones, M.D.