NCT05614453

Tislelizumab in Combination With Sitravatinib for Recurrent/Metastatic Cervical Cancer After Platinum-Based Chemotherapy

A Phase II Trial of Tislelizumab in Combination With Sitravatinib for Recurrent/Metastatic Cervical Cancer After Platinum-Based Chemotherapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Australia New Zealand Gynaecological Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the effect of the combination treatment of sitravatinib with tislelizumab in patients with Recurrent/Metastatic Cervical Cancer after Platinum-Based Chemotherapy. The main question it aims to answer is the percentage of people in the study who have a partial or complete response to the treatment. Participants will receive treatment under the care of their treating physician and will be reviewed regularly.

Detailed description

Monoclonal antibodies that target either PD-1, PD-L1, or the other checkpoint inhibitors can block binding and boost the immune response against cancer cells. However, many early-phase studies with single immune checkpoint inhibitors did not show enough power to achieve a promising clinical response, and several trials are evaluating different strategies to overcome immune tolerance via combination therapies. Combining an immunotherapeutic PD-1 checkpoint inhibitor with an agent that has both immune modulatory and antitumor properties could enhance the antitumor efficacy observed with either agent alone. Sitravatinib is a spectrum selective RTK inhibitor that inhibits several closely related RTKs, including the TAM family (Tyro3/Axl/MER), VEGFR2, KIT, and MET. Tislelizumab is a humanised IgG4-variant monoclonal antibody against PD-1. In addition to the antiangiogenesis activity of sitravatinib, sitravatinib in combination with tislelizumab may elicit greater anti-tumour activity, as sitravatinib is predicted to enhance several steps in the cancer immunity cycle that may augment the efficacy of tislelizumab. In summary, sitravatinib inhibits key molecular and cellular pathways strongly implicated in carcinogenesis and drug resistance and represents a reasonable strategy to enhance anti-tumour immunity when combined with tislelizumab. The ITTACc study aims to assess the overall response rate of the combination of tislelizumab with sitravatinib along with other key outcomes detailed below.

Conditions

• Metastatic Cervical Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab is an investigational, humanised-IgG4 monoclonal antibody with high affinity/binding specificity for PD-1. It is engineered to minimise binding to FcγR on macrophages to abrogate antibody-dependent cellular phagocytosis.
DRUG	Sitravatinib	Sitravatinib is an orally bioavailable receptor tyrosine kinase (RTK) inhibitor with potential anti-neoplastic activity.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-06-01
• Completion: 2023-06-28
• First posted: 2022-11-14
• Last updated: 2023-06-29