May 2023 CLINICAL CORNER

mollie
Daniel J. Indelicato, M.D., (far left) shares a moment in the lobby with Mollie Mulholland (far right) and her family in 2023.

“It’s hard to have hope in the middle of a storm like the cancer diagnosis of your child. However, proton therapy was the key to Mollie’s survival. We got the best treatment available to her,” said parents Fiona and Declan Mulholland during a follow-up visit in Jacksonville more than four years after their daughter’s treatment for a rare tumor, rhabdomyosarcoma.

Mollie was two years old when she was diagnosed with the tumor, and the recommended treatment was a combination of chemotherapy and radiation. Because of the location of the tumor near her eye, proton therapy could both deliver effective doses of radiation and possibly reduce the severity of side effects. Today, Mollie is seven years old, and her most recent scans show the residual tumor is stable. The family is cautiously optimistic as Mollie approaches five years post diagnosis this summer.

The Mulhollands described their return visit in April 2023 to the UF Health Proton Therapy Institute and Jacksonville as a healing trip.


New Clinical Trials Open for Enrollment

Nautilus: OKI-179 Plus Binimetinib in Patients with NRAS-mutated Melanoma

This Phase 2 trial is assessing the efficacy of oral OKI-179 combined with binimetinib in patients with advanced (unresectable Stage III/IV) NRAS-mutated melanoma previously treated with or ineligible for immune checkpoint inhibitors (ICI).  OKI-179 is a novel, selective, and orally available largazole-derived HDAC inhibitor. This trial will also assess efficacy, safety, and tolerability of this treatment combination.

Principal Investigator: Bently Doonan, M.D. 

A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer

This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev)(NUC-3373 Q1 week versus Q2 weeks on a 28-day cycle) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer.  The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms.

Principal Investigator: Thom George, M.D. 

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. 

Study of LY3537982 in Cancer Patients with KRAS G12C Mutation

This open label Phase 1 study is evaluating the safety, tolerability and efficacy of an oral KRAS G12C inhibitor (LY3539782) in patients with KRAD G12C mutant solid tumors.  LY3539782 is daily oral medication given in 21 day cycles, either as monotherapy or in combination with pembrolizumab. Enrollment opportunities are available for KRAS-inhibitor naïve NSCLC as well as NSCLC with prior exposure to KRAS-inhibitors, with future enrollment opportunities for colorectal and pancreatic cancers.  Subjects must have a documented KRAS G12C mutation in tumor tissue or circulating tumor DNA, be able to tolerate oral therapy, and have no remaining appropriate standard of care treatment options. 

Principal Investigator: Thom George, M.D.