A phase Ib/II single-arm study evaluating the safety and efficacy ofcombined immunotherapy with mFOLFOX6, bevacizumab and atezolizumabin advanced-stage biliary cancer - COMBATBI

niversity Hospital Essen0 sites35 target enrollmentMarch 18, 2021

Conditionsadvanced biliary tract cancer (BTC)MedDRA version: 27.0Level: PTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTecentriq Avastin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: advanced biliary tract cancer (BTC)
Sponsor: niversity Hospital Essen
Enrollment: 35
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 18, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Hospital Essen

Eligibility Criteria

Inclusion Criteria

•Subjects must fulfill all of the following criteria for study entry:
•1\. Signed informed consent form
•2\. Age \= 18 years by the time of inclusion in the study
•3\. Ability to comply with the study protocol, in the investigator’s judgment
•4\. Histologically confirmed advanced BTC
•5\. Patient must have received at least one prior line of systemic therapy in advanced\-stage BTC
•6\. Adjuvant or neoadjuvant chemotherapy is allowed, provided it is completed at least 6 months before start of study treatment.
•7\. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 (see Appendix VI)
•8\. Life expectancy \> 12 weeks
•9\. Measurable disease, according to RECIST v1\.1\. Lesions intended to be biopsied should not be defined as target lesions.

Exclusion Criteria

•1\. Malignancies other than BTC within 3 years prior to C1D1 with the exception of those with a negligible risk of metastasis or death (e.g., expected 5\-year overall survival \> 90%) treated with expected curative outcome
•2\. Patients with known microsatellite instability high (MSI\-H) status. Patients with unknown MSI status are eligible and the MSI status will be analyzed retrospectively. Patients who are then determined to be MSI high will be allowed to continue the study treatment, but will be replaced by microsatellite\-stable (MSS) or MSI\-low tumors.
•3\. Untreated CNS metastases. Treatment of brain metastases, either by surgical or radiation techniques must have been completed at least 4 weeks prior to initiation of study treatment.
•4\. Radiation therapy within 21 days prior to C1D1 and/or persistence of radiation\-related adverse effects
•5\. Prior allogeneic bone marrow transplantation or solid organ transplant for another malignancy in the past
•6\. Spinal cord compression not definitively treated with surgery and/or radiation
•7\. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
•8\. Uncontrolled tumor pain.
•9\. Treatment with any investigational agent or approved therapy within 14 days or two investigational agent half\-lives (whichever is longer) prior to C1D1
•10\. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti\-PD\-1 and anti\-PD\-L1 or VEGF/VEGFR inhibitors