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daNIS-3: An Open-Label, Multi-Center, Phase II Platform Study Evaluating the Efficacy and Safety of NIS793 and Other New Investigational Drug Combinations With Standard of Care (SOC) Anti-Cancer Therapy for the Second Line Treatment of Metastatic Colorect
This study evaluates the preliminary efficacy and safety of NIS793 and other novel investigational combinations with SOC anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of metastatic colorectal cancer.
postMONARCH: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib plus Fulvestrant to Placebo plus Fulvestrant in Participants with HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a
postMONARCH is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlledstudy in participants with HR+, HER2- advanced or metastatic breast cancer. This study willenroll adults who experienced disease progression on a CDK4 & 6 inhibitor and an AI in thefirst-line setting or relapse on/after a CDK4 & 6 inhibitor with ET in the adjuvant setting.
Protocol 10476: A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers (CTMS# 22-0023)
This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery (unresectable).
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.
Using Holistic Approaches to Optimize Outcomes for Latina Breast Cancer Survivors CTMS#: 22-0043
We will assess physical functioning, daily physical activity with wearable activity monitors, biological markers (serum and salivary cortisol), diet, program adherence, as well as psycho-social measures of physical, mental, and spiritual wellbeing. In addition, BCS will be asked to describe their best day possible and their typical day. We will conduct a qualitative analysis from their responses to identify endorsement of themes.
A phase 1b/2, open-label, safety, tolerability and efficacy study of NC410 plus pembrolizumab for participants with advanced unresectable and/or metastatic immune checkpoint inhibitor (ICI) refractory solid tumors or ICI naive MSS/MSI-low solid tumors (CT
This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of Pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors
Patient data acquisition and analysis approaches maximizing search for biomarkers considering clinical diagnostic diversity and genetic and epigenetic influence (CTMS# 22-0069)
This is a translational clinical study aiming to develop approaches to process effectively human tissues and identify biomarkers for painful and non-painful chemotherapy-induced peripheral neuropathy (CIPN). This study will involve obtaining two skin biopsies representing affected and non-affected parts of each patient’s limb. Painful and non-painful neuropathies will be determined by a variety of standard approaches implemented by a neurologist Dr. Bhavaraju-Sanka.