Anti-PD-1 Antibody Combined With Histone Deacetylase Inhibitor in Patients With Advanced Cervical Cancer
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
Cervical cancer is the second-most common cancer in the world and is a leading cause of
cancer death among women in developing countries. Cisplatin-based chemotherapy +/-
bevacizumab have been recommended as the first-line treatment for patients who present with
metastatic (e.g. stage IVB), persistent, or recurrent cervical cancer. However, patients in
this setting are rarely curable. Pembrolizumab has been approved for second-line treatment in
patients with advanced PD-L1-positive cervical cancer. However, the response rate achieved by
PD-1 inhibitors as monotherapy is only modest. Preclinical studies found that in mouse models
of B-cell lymphoma, adding a histone deacetylase (HDAC) inhibitor sensitized cancers to
anti-PD-1 therapy. Recently, combination treatment of HDAC inhibitors with immune checkpoint
inhibitors is widely investigated and has promising results in several cancer types.
Toripalimab is a humanized IgG4 monoclonal antibody against PD-1. Chidamide is a class I HDAC
inhibitor. Here we conducted a phase Ib/II, single-arm, multi-center study to evaluate the
efficacy and safety of toripalimab in combination with chidamide in patients with metastatic,
persistent, or recurrent cervical cancer.