P2, N=29, Recruiting, Sun Yat-sen University | Unknown status --> Recruiting | Trial completion date: Aug 2021 --> Aug 2025 | Trial primary completion date: Jul 2020 --> Aug 2022

over 1 year ago

Enrollment open • Trial completion date • Trial primary completion date • Tumor mutational burden

TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)

TMB-H • MSI-H/dMMR

Keytruda (pembrolizumab) • BAT1306

over4years

PCOX: PD-1 Antibody Combined With COX Inhibitor in MSI-H/dMMR or High TMB Colorectal Cancer (clinicaltrials.gov)

P2, N=27, Recruiting, Sun Yat-sen University | N=54 --> 27 | Trial completion date: Dec 2019 --> Aug 2021 | Trial primary completion date: Dec 2019 --> Jul 2020

over 4 years ago

Enrollment change • Trial completion date • Trial primary completion date • Tumor Mutational Burden • PD(L)-1 Biomarker

TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)

TMB-H • MSI-H/dMMR

Keytruda (pembrolizumab) • BAT1306

5years

PD-1 blockade combined with COX inhibitor in patients with MSI-H/dMMR or high TMB, advanced or metastatic colorectal cancer (PCOX study). (ASCO-GI 2020)

Patients with MSI-H/dMMR or POLE mutation advanced or metastatic colorectal cancer received PD-1 blockade (pembrolizumab 200mg, q3w; or BAT 1306 100mg, q3w; or nivolumab 3mg per kilogram, q2w) plus COX inhibitor (celebrex 400mg or aspirin 200mg, p.o. qd). The combination of PD-1 blockade plus COX inhibitor was associated with higher response rates in advanced or metastatic colorectal cancer patients with MSI-H/dMMR or POLE mutation than anti-PD-1 alone as historical controls. Clinical trial information: NCT03638297. Research Funding: None

5 years ago

Clinical • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker

POLE (DNA Polymerase Epsilon)

Keytruda (pembrolizumab) • Opdivo (nivolumab) • BAT1306