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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

Must not have

History of certain cardiac dysfunctions

Prior treatment with certain immune checkpoint inhibitors or pathway-targeting agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart problems.

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I have previously been treated with specific immune or targeted therapy.

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I haven't taken any immune-weakening drugs in the last 2 weeks.

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I do not have severe liver disease, active TB, or serious infections.

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I am not using birth control pills containing ethinyl estradiol with cobimetinib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Progression free survival (PFS)

Secondary study objectives

Change in T-cell populations

Immunogenicity

Overall survival (OS)

+1 more

Other study objectives

Tumor microenvironment modulation and immunologic response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1180

Computed Tomography

2017

Completed Phase 2

~2790