JANUARY 2023 CLINICAL CORNER

Study reports results of phase 1-2 clinical trial of sotorasib in KRAS G12C-mutated advanced pancreatic cancer

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The KRAS G12C inhibitor sotorasib achieved anticancer activity with an acceptable safety profile in heavily pretreated patients with KRAS G12C-mutated metastatic pancreatic cancer.

UF Health was a study location for a multicenter phase 1-2 trial showing that the KRAS G12C inhibitor sotorasib achieved anticancer activity with an acceptable safety profile in heavily pretreated patients with KRAS G12C-mutated metastatic pancreatic cancer.

Thomas George, M.D., FACP, a professor of the division of hematology & oncology in the University of Florida College of Medicine, was a coauthor on the study, published in January in the New England Journal of Medicine. George also serves as associate director for clinical research at the UF Health Cancer Center and director of the GI Oncology Program at UF.

The study reported an objective response rate of 21.1% and a median time-to-response of 1.5 months, with 84% of patients experiencing disease control. Median progression-free survival was 4 months and overall survival was 6.9 months. The study population comprised 38 patients across multiple centers.

The CodeBreaK 100 trial was funded by Amgen. The work was also supported in part by the National Institutes of Health (P30 CA008748, P30 CA016672, 1UL1 TR003167), the Cancer Prevention and Research Institute of Texas (RP150535), and the Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy at MD Anderson Cancer Center.


New Clinical Trials Open for Enrollment

IMMCo-01: Atezolizumab Plus Tivozanib in Immunologically Cold Tumors

This Phase 1/2, multi-cohort trial tests the combination anti-PDL1 immune checkpoint inhibition in combination with VEGF-receptor tyrosine kinase inhibitor in cancers that historically do not respond to immunotherapy alone  Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade, even in tumors which are traditionally thought to be unresponsive to IO monotherapy.  This study aims to evaluate the combination of the IO CPI Atezolizumab and oral VEGF-TKI, Tivozanib in the following tumor types: bile duct and gallbladder cancers, HR-/HER2+ breast cancer, Grade 2 or 3, well or moderately differentiated neuroendocrine cancer, platinum resistant ovarian cancers, soft tissue sarcomas, prostate and vulvar cancers. To qualify, patients must have progressed on at least one line of systemic therapy, with no prior exposure to checkpoint inhibitors or VEGFR-TKI, and do not have high tumor mutational burden, mismatch repair deficiency, or microsatellite instability high status.

Principal Investigators: 

Jonathan Chatzkel, M.D.
215-593-5602                                                                              

Brian Ramnaraign, M.D.
201-600-7758

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer (MIBC)

The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. Enfortumab vedotin is a type of targeted therapy called an antibody‒drug conjugate. Antibody‒drug conjugates consist of a monoclonal antibody chemically linked to a drug. The monoclonal antibody part of enfortumab vedotin binds to a protein called nectin-4, which is found on the surface of most bladder cancer cells. Combining a PD-1 inhibitor with EV may result in improved responses leading to prolonged PFS and OS.  

Principal Investigator:

Jonathan Chatzkel, M.D.: 215-593-5602

Trial of Atezolizumab and Bevacizumab With SRF388 or Placebo in Patients With Hepatocellular Carcinoma

SRF388 is a fully human IgG1 monoclonal antibody that blocks IL-27 mediated expression of inhibitory cell surface receptors. IL-27 is believed to play a role in pathogenesis and/or resistance in the tumor microenvironment of HCC.  This Phase 2 trial is designed to evaluate the efficacy and safety of SRF388 in combination with atezolizumab plus bevacizumab compared to placebo in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC. 

Principal Investigator:

Ilyas Sahin, M.D.
854-265-6187

Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission

A Phase 2, open-label, non-randomized study evaluating the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, & 5 of each cycle, in patients 61 years or older with acute myeloid leukemia (AML).

Principal Investigator: 

Jack Hsu, M.D. 
352-672-0704