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

Palo Alto (17 mi)

Overseen byNilofer S. Azad

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Varlilumab is an immune agonist antibody that may further strengthen the immune system's attack on the cancer. Cobimetinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving atezolizumab in combination with varlilumab and cobimetinib may work better than atezolizumab and varlilumab alone in treating patients with unresectable biliary tract cancer.

Eligibility Criteria

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.

Inclusion Criteria

My biliary tract cancer has been treated with 1 or 2 therapies after spreading.

I am willing to have 2 sets of needle biopsies.

I am 18 years old or older.

I am fully active and can carry on all pre-disease activities without restriction.

I had hepatitis C but am now cured or have no detectable virus while on treatment.

My cancer is in the bile ducts or gallbladder, but not in the Ampulla of Vater.

I have chronic hepatitis B but it's under control with medication.

Exclusion Criteria

I have a history of heart problems.

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

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

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

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

Treatment Details

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.

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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: