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Monoclonal Antibodies

Atezolizumab + Varlilumab (+/- Cobimetinib) for Biliary Tract Cancer

Phase 2
Waitlist Available
Led By Nilofer S Azad
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed biliary tract cancer with at least 1 prior line of systemic therapy and no more than 2 prior lines of therapy in the metastatic setting
Willingness to undergo 2 sets of core needle biopsies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is investigating whether combining atezolizumab with varlilumab, with or without cobimetinib, is effective in treating biliary tract cancer that cannot be removed by surgery.

Who is the study for?
This trial is for adults with advanced biliary tract cancer that can't be surgically removed, who've had at least one but no more than two prior treatments. They must have a life expectancy over 3 months, good physical function, acceptable blood counts and organ function, agree to use contraception, and be willing to undergo biopsies. Those with certain viral infections must have undetectable viral loads.Check my eligibility
What is being tested?
The study tests combining two immune therapies (Atezolizumab and Varlilumab) with or without Cobimetinib in patients whose biliary tract cancer cannot be operated on. It explores whether this combination helps the immune system fight cancer better than just Atezolizumab and Varlilumab alone.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (like inflammation), infusion-related reactions from receiving drugs through a vein, fatigue, digestive issues such as nausea or diarrhea, liver enzyme changes indicating liver stress or damage, skin rash or itching.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My biliary tract cancer has been treated with 1 or 2 therapies after spreading.
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I am willing to have 2 sets of needle biopsies.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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I had hepatitis C but am now cured or have no detectable virus while on treatment.
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My cancer is in the bile ducts or gallbladder, but not in the Ampulla of Vater.
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I have chronic hepatitis B but it's under control with medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Progression free survival (PFS)
Secondary outcome measures
Change in T-cell populations
Immunogenicity
Overall survival (OS)
+1 more
Other outcome measures
Tumor microenvironment modulation and immunologic response

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (atezolizumab, varlilumab)Experimental Treatment6 Interventions
Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI at baseline, every 8 weeks while on treatment, and at end of treatment or progression. Patients also undergo a tumor biopsy at baseline and on day 21 of cycle 1. Patients also undergo blood sample collection on study.
Group II: Arm A (cobimetinib, atezolizumab, varlilumab)Experimental Treatment7 Interventions
Patients receive cobimetinib PO QD on days 1-21 of each cycle, atezolizumab IV over 30-60 minutes on days 1 and 15 of each cycle, and varlilumab IV over 90 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI at baseline, every 8 weeks while on treatment, and at end of treatment or progression. Patients also undergo a tumor biopsy at baseline and on day 21 of cycle 1. Patients also undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Computed Tomography
2017
Completed Phase 2
~2720
Atezolizumab
2017
Completed Phase 3
~5860
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720
Cobimetinib
2017
Completed Phase 3
~3090

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,299 Total Patients Enrolled
1 Trials studying Distal Bile Duct Adenocarcinoma
12 Patients Enrolled for Distal Bile Duct Adenocarcinoma
Nilofer S AzadPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
3 Previous Clinical Trials
133 Total Patients Enrolled
~4 spots leftby Sep 2024
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