NCT06008093 |
Enrolling |
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients (TRITON)
The purpose of the study is to assess the efficacy of durvalumab plus tremelimumab in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy in metastatic NSCLC patients with non-squamous histology who have mutations and/or co-mutations in STK11, KEAP1, or KRAS. TRITON Trial Sponsor: AstraZeneca |
Robin Jacob, MD |
Dr. Robert E. Hardy Cancer Center |
NCT0601673 |
Pending |
A Phase 3 Randomized, Open-Label study of op-1250 Monotherapy vs standard of care for the treatment of ER+, HER2- Advanced or Metastatic, breast cancer following endocrine and CDK 4/6 Inhibitor Therapy ( OPERA-01)
NCT06016738 Part 1 is closed. Part 2 opens March 2025.. This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor. Sponsor: Olema Pharmaceuticals, Inc. |
Robin Jacob, MD |
Dr. Robert E. Hardy Cancer Center |
NCT06016738 |
Active |
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-01)
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor. Sponsor: Olema Pharmaceuticals, Inc. |
Robin Jacob, MD |
Dr. Robert E. Hardy Cancer Center |
NCT06096779 |
Enrolling |
A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis
The purpose of this study is to assess the safety and efficacy of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-Pugh B7 or B8 cirrhosis. Sponsor: Genentech, Inc. |
Robin Jacob, MD |
Dr. Robert E. Hardy Cancer Center |
NCT06393374 |
Enrolling |
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment. Sponsor: Merck Sharp & Dohme LLC |
Robin Jacob, MD |
Dr. Robert E. Hardy Cancer Center |
NCT06594523 |
Pending |
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis (FASCINATE-3)
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression without the worsening of steatohepatitis. Sponsor: Sagimet Biosciences Inc. |
Robin Jacob, MD |
Digestive Health (GI & Liver) |
NCT06692283 |
Pending |
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH (FASCINIT)
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment. Sponsor: Sagimet Biosciences Inc. |
Robin Jacob, MD |
Digestive Health (GI & Liver) |