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.
Vertebral Bone Marrow in Lung Cancer Attention Trial (VMAT) (CTMS# 21-0168)
The purpose of this study is to see whether designing radiation to spare the vertebral bone marrow can limit the rates of lymphopenia during standard of care chemoradiation therapy and in the time to count recovery in the ensuing weeks. Secondary endpoints will examine whether this leads to improved disease control whether this is predictive of improved clinical outcomes such as rates of local recurrence (LR), metastasis free survival (MFS), overall survival (OS), and progression free survival (PFS) which will be followed prospectively up to 5 years.
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).
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physicianâ??s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or
This is an international, multicenter, open-label, randomized, Phase 3 study in patients withlocally advanced, inoperable or metastatic triple-negative breast cancer (TNBC) who have not received previous therapy for advanced disease and whose tumors are either: PD-L1 negative at screening (defined using the PD-L1 IHC 22C3 assay as tumors with a combined positive score (CPS) < 10), OR PD-L1 positive at screening (defined using the PD-L1 IHC 22C3 assay as tumors with a CPS ≥ 10) if they previously received a checkpoint inhibitor in the adjuvant or neoadjuvant setting.
ORACLE: Observation of ResiduAl Cancer with Liquid biopsy Evaluation (CTMS# 22-0052)
This research is being done to see if an investigational blood test can predict whether cancer will recur (come back) after initial treatment
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.