NCT04648319

A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma

A Pilot Study of BMS-936558 With Stereotactic Ablative Radiation Therapy After Induction Chemotherapy in Cholangiocarcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an Open-label, single-arm, multicenter Phase II pilot study to assess the efficacy and safety of BMS-936558 with stereotactic ablative radiation therapy after induction chemotherapy in cholangiocarcinoma.

Detailed description

The current standard regimen for advanced biliary tract cancers as per NCCN guidelines (version 2.2019) is gemcitabine plus cisplatin. However, since no single chemotherapy agent or combination regimen has consistently led to durable tumor regression, prevention of recurrent obstruction following palliative intervention, and extension of survival beyond 8 to 15 months, there is a pressing need for new treatment approaches in patients with dismal prognosis. Recent discoveries in tumor immunology, paralleled by technological advances in radiation therapy, have provided promising role for combining ablative radiotherapy with targeted immune modulators (El Chediak et al., 2017). objectives: Primary: To evaluate the progression-free survival (PFS) at 8 months and the disease control rate (DCR) in patients with non-resectable locally-advanced or metastatic or recurrent intrahepatic or extrahepatic cholangiocarcinoma (CCA) following BMS-936558 /stereotactic ablative radiation therapy (SBRT) treatment. Secondary: 1\) To evaluate the overall survival (OS) rate in patients with advanced intrahepatic or extrahepatic CCA following BMS-936558/SBRT treatment. . 3\) To evaluate tumor response rates at the primary and secondary sites using the response evaluation criteria in solid tumors (RECIST1.1) criteria. 4\) To evaluate the duration of response at non-irradiated tumor sites in patients with Stage IV disease. 5\) To evaluate the following biomarkers: CD3+, CD4+, and CD8+ T cell infiltration, and changes in PD-L1 expression at baseline and following first cycle of BMS-936558 and SBRT. 6\) To assess the safety and tolerability of BMS-936558/SBRT according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAEv5). 7\) To assess the quality of life of the patients through completed FACT-Hep questionnaires.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	BMS-936558	BMS-936558 followed by 30 grays of 3 to 5 fractions of high dose SBRT followed by monthly BMS-936558 until progression

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-01-17
• Completion: 2022-01-17
• First posted: 2020-12-01
• Last updated: 2022-02-23

Locations

4 sites across 3 countries: Belgium, Lebanon, Luxembourg