A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)
A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)
This will be a long-term multi-center study to comprehensively study patients with primary liver cancer (PLC).ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that START-001 is a two-part, open label, FIH Phase 1/2 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of STAR0602 as a monotherapy in subjects with advanced solid tumors. ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI 4736) (T300+D) in Advanced Hepatocellular Carcinomas with Child-Pugh-B Cirrhosis (STRIDE in CP-B)Phase II Single Arm Study of Tremelimumab and Durvalumab (MEDI 4736) (T300+D) in Advanced Hepatocellular Carcinomas with Child-Pugh-B Cirrhosis (STRIDE in CP-B)This is a single-arm, phase II study of patients with advanced HCC with Child-Pugh B cirrhosis who are eligible for first-line treatment with T300+D.ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

Phase II Trial of Zanzalintinib (XL-092) in Combination with Durvalumab plus Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)Phase II Trial of Zanzalintinib (XL-092) in Combination with Durvalumab plus Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)Phase II trial evaluating the combination of XL-092 with durvalumab and tremelimumab in unresectable HCC. This phase II trial design will be preceded by a safety lead in of 9-12 patients.NCT06698250Sukeshi Patel Arora, MD

A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid TumorsA Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid TumorsDose-Escalation Part (Part 1)Primary Objectives:•To assess the safety and tolerability of YL217 in patients with advanced solid tumors•To determine the maximum tolerated dose (MTD) of YL217 in patients with advanced solid tumorsBackfill Part (Part 2)Primary Objectives:•To further evaluate the safety and tolerability of YL217 in patients with advanced solid tumors•To determine the recommended dose(s) for expansion (RDE(s)) of YL217 in patients with advanced solid tumorsDose-Expansion Part (Part 3)Primary Objectives:•To further evaluate the efficacy of YL217 at the RDE(s) in patients with the selected advanced solid tumors such as colorectal adenocarcinoma, gastric, esophageal or gastroesophageal junction adenocarcinoma, and pancreatic adenocarcinoma•To determine the recommended phase 2 dose (RP2D) of YL217NCT06859762Sukeshi Patel Arora, MD

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Colorectal Cancer (FRUITION)A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Colorectal Cancer (FRUITION)This will be a multi-center, randomized phase II trial of fruquintinib + TAS-102 as compared to fruquintinib.NCT06992258Sukeshi Patel Arora, MD

Modulation of Sorafenib induced autophagy using hydroxychloroquine in hepatocellular cancer Modulation of Sorafenib induced autophagy using hydroxychloroquine in hepatocellular cancer The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ would lead to disease stability in patients with advanced hepatocellular cancer (HCC).NCT03037437Sukeshi Patel Arora, MD

Biomarker development for predicting immune checkpoint therapy efficacy of hepatocellular carcinoma (CTMS# 22-0050)Biomarker development for predicting immune checkpoint therapy efficacy of hepatocellular carcinoma (CTMS# 22-0050)We propose to test whether H1 and H2 clustering can distinguish patients responsive or resistant to the combination therapy with immunotherapy in a prospective clinical study.ClinicalTrials.gov registration not requiredSukeshi Patel Arora, MD

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480), Bortezomib, and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMMA Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480), Bortezomib, and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMMTo compare the progression-free survival (PFS) of mezigdomide (CC-92480, also known as BMS-986348), bortezomib and dexamethasone (MeziVd) to that of pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM)NCT05519085Matthew Butler, MD

S2302, PRAGMATICA – LUNG - A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small S2302, PRAGMATICA – LUNG - A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small 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.ClinicalTrials.gov registration not requiredSherri Cervantez, MD