← 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

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

TRICK-MCC Trial 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.Check my eligibility

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.See study design

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.

TRICK-MCC Trial 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.

TRICK-MCC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate

Secondary outcome measures

Disease control rate

Disease specific survival

Duration of response

+3 more

TRICK-MCC 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

~1190

Biospecimen Collection

2004

Completed Phase 2

~1700

Biopsy

2014

Completed Phase 4

~1090

Retifanlimab

2018

Completed Phase 2

~320

Computed Tomography

2017

Completed Phase 2

~2720

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,746 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

365 Previous Clinical Trials

55,275 Total Patients Enrolled

Shailender BhatiaPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

2 Previous Clinical Trials

116 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the application process for this clinical trial accessible right now?

"According to clinicaltrials.gov, recruitment into this medical trial has since concluded - with the original post being published on February 5th 2024 and edited for the last time on September 26th 2023. Nonetheless, there are a plethora of other studies actively seeking candidates at present; 2576 such trials in total."

Answered by AI

Has the FDA sanctioned this combination of retifanlimab, tuparstobart, and verzistobart as a viable treatment?

"Our team has allocated a score of 2 to the safety profile of this treatment combination, as it is only in Phase 2 trials. This suggests that while there are data on its safety, none exist attesting to its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma

2023. "Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06056895.

All > Merkel Cell Carcinoma