Study on New Combination of Immune Therapies with or without Cobimetinib for Advanced Biliary Tract Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04941287

This clinical trial is testing a new combination of immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without an additional drug, cobimetinib, to treat advanced biliary tract cancer that cannot be removed by surgery.

Patient Parameters

Parameter	Options

Program Overview

This study is exploring whether combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, can help treat advanced biliary tract cancer that cannot be surgically removed. Atezolizumab and varlilumab are designed to help the immune system attack cancer cells, while cobimetinib works by blocking signals that help cancer cells grow. The study aims to see if this combination is more effective than using atezolizumab and varlilumab alone.

Description

The main goals of this study are to see how well the combination of atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, works in shrinking tumors and stopping cancer from growing in patients with advanced biliary tract cancer. Researchers will also look at how safe and tolerable these treatments are for patients.

Participants will be randomly assigned to one of two groups:

Group A: Will receive cobimetinib by mouth, atezolizumab by IV, and varlilumab by IV. This treatment cycle repeats every 28 days unless the cancer progresses or side effects become too severe. Participants will have regular scans and blood tests to monitor their progress.
Group B: Will receive atezolizumab and varlilumab by IV. This treatment cycle also repeats every 28 days under the same conditions as Group A. Participants will undergo the same monitoring as Group A.

After completing the study treatment, participants will have follow-up visits every three months to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

Diagnosed with biliary tract cancer and have received 1-2 prior treatments for cancer that has spread.
Must be 18 years or older.
Have a performance status that allows for daily activities with minimal restrictions.
Have adequate blood counts and organ function based on specific medical tests.
Must be able to swallow pills.
Agree to use effective birth control during the study and for 5 months after the last dose of atezolizumab.
Willing to undergo tumor biopsies and provide blood samples for research purposes.
Have a life expectancy of more than 3 months.

Exclusion Criteria

Have had a bone marrow or organ transplant.
Have received chemotherapy or radiotherapy within the last 4 weeks.
Have previously been treated with certain immune therapies or kinase inhibitors.
Have active infections or other serious medical conditions.
Have a history of severe allergic reactions to similar drugs.
Are pregnant or breastfeeding.
Have significant heart problems or uncontrolled high blood pressure.
Are taking medications that interact with the study drugs and cannot be changed.

Locations

FACILITY	ZIP	CITY	STATE
Mayo Clinic Hospital in Arizona	85054	Phoenix	Arizona
City of Hope Comprehensive Cancer Center	91010	Duarte	California
Los Angeles General Medical Center	90033	Los Angeles	California
USC / Norris Comprehensive Cancer Center	90033	Los Angeles	California
UC Irvine Health/Chao Family Comprehensive Cancer Center	92868	Orange	California
University of California Davis Comprehensive Cancer Center	95817	Sacramento	California
UCHealth University of Colorado Hospital	80045	Aurora	Colorado
UM Sylvester Comprehensive Cancer Center at Aventura	33180	Aventura	Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables	33146	Coral Gables	Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach	33442	Deerfield Beach	Florida

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