← Back to Search

PD-L1 Inhibitor

Triple Immunotherapy for Merkel Cell Carcinoma (TRICK-MCC Trial)

Phase 2

Recruiting

Led By Shailender Bhatia

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance score of 0-2

Presence of histologically confirmed, advanced or metastatic Merkel cell carcinoma (MCC), which is considered incurable with standardly available therapies

Must not have

History of serious immune-related adverse events (IRAEs) from prior immunotherapy that resulted in permanent discontinuation of anti-PD-(L)1 and could jeopardize patient safety with the investigational regimen. (Any prior grade 2 or higher IRAE must be discussed with the Principal Investigator or designee for risk/benefit assessment.)

Known allergy or hypersensitivity to any component of the study drugs formulation (including excipients and additives) that could interfere with study endpoints or put patient safety at risk

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of first dose of study treatment until the earliest date of disease progression, per recist v1.1, or the date of death from any cause, if occurring sooner than progression, assessed up to 5 years following completion of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests 3 monoclonal antibodies to treat Merkle cell cancer that has spread and not responded to PD-(L)1 treatment.

Who is the study for?

Adults with advanced or metastatic Merkel Cell Carcinoma that worsened after anti-PD-(L)1 therapy, who've had at least one systemic treatment. They must be in relatively good health, not pregnant, willing to use contraception and consent to tumor biopsies. Excluded are those with autoimmune diseases, severe illnesses affecting immunity, certain heart conditions, active infections like HIV/HBV/HCV or brain metastases.

What is being tested?

The trial is testing a combination of three immunotherapy drugs (retifanlimab, tuparstobart, verzistobart) given via IV for patients whose cancer has spread and didn't respond to previous treatments. These drugs aim to boost the immune system's ability to fight cancer by targeting different checkpoints on immune cells.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs which can lead to symptoms like fatigue, coughing or shortness of breath; skin rashes; digestive issues; hormonal gland problems leading to changes in mood or behavior; and infusion-related reactions during drug administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am able to get out of my bed or chair and move around.

Select...

My Merkel cell carcinoma cannot be cured with standard treatments.

Select...

I have at least one measurable Merkel cell carcinoma tumor.

Select...

My cancer did not respond well to anti-PD-(L)1 treatment within 6 months.

Select...

My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.

Select...

I have been treated with a PD-1 or PD-L1 inhibitor before.

Exclusion Criteria

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

Select...

I had severe side effects from previous immunotherapy that made me stop treatment.

Select...

I am not allergic to any part of the study drugs.

Select...

I have a weakened immune system due to severe diabetes, blood cancer, or other serious health issues.

Select...

I have had a serious heart condition or stroke in the last 6 months.

Select...

I have not received any live vaccines in the last 30 days.

Select...

I have a history of serious lung disease or inflammation.

Select...

I have an active autoimmune disease or need daily steroids.

Select...

I have side effects from previous treatments that are mild or worse.

Select...

I have HIV that is not under control.

Select...

I have an active hepatitis B or C infection.

Select...

I haven't had cancer, except for certain skin or early stage cancers, in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of first dose of study treatment until the earliest date of disease progression, per recist v1.1, or the date of death from any cause, if occurring sooner than progression, assessed up to 5 years following completion of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of first dose of study treatment until the earliest date of disease progression, per recist v1.1, or the date of death from any cause, if occurring sooner than progression, assessed up to 5 years following completion of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of study treatment until the earliest date of disease progression, per recist v1.1, or the date of death from any cause, if occurring sooner than progression, assessed up to 5 years following completion of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective response rate

Secondary study objectives

Disease control rate

Disease specific survival

Duration of response

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (retifanlimab, tuparstobart, and verzistobart)Experimental Treatment7 Interventions

INDUCTION PHASE: Patients receive retifanlimab IV over 30 minutes every 4 weeks and tuparstobart and verzistobart IV over 30 minutes every 2 weeks. Treatment continues for up to day 169 in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography CT/MRI during screening and on study and blood sample collection on study and may undergo during screening. Patients may also undergo a tumor biopsy during screening and on study. MAINTENANCE PHASE: Patients receive retifanlimab, tuparstobart and verzistobart IV over 30 minutes every 6 weeks. Treatment continues for up to day 715 in the absence of disease progression or unacceptable toxicity. Patients undergo CT/MRI on study and blood sample collection on study and may undergo during follow-up. Patients may also undergo tumor biopsy on study and during follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Biospecimen Collection

2004

Completed Phase 3

~2030