Trials Sponsors Conditions Drugs Pricing

Conditions

Clinical Stage IV Merkel Cell Carcinoma AJCC v8 Merkel Cell Carcinoma Unresectable Clinical Stage III Merkel Cell Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

Objective response rate
Defined as the proportion of participants having a best objective response of complete response (CR) or partial response (PR), as determined by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Up to 5 years following completion of study treatment

Secondary Outcomes (6)

Duration of response
From the earliest date of disease response (CR or PR) 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
Disease control rate
Up to 5 years following completion of treatment
Progression free survival
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
Overall survival
From date of first dose of study treatment until the date of death from any cause, assessed up to 5 years following the completion of treatment
Disease specific survival
From date of first dose of study treatment until the date of death from Merkle cell carcinoma, assessed up to 5 years following completion of treatment

Study Arms (1)

Treatment (retifanlimab, tuparstobart, and verzistobart)

EXPERIMENTAL

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.

Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingBiological: RetifanlimabDrug: TuparstobartDrug: Verzistobart

Interventions

BiopsyProcedure

Undergo tumor biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (retifanlimab, tuparstobart, and verzistobart)

Biospecimen CollectionProcedure

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Presence of histologically confirmed, advanced or metastatic Merkel cell carcinoma (MCC), which is considered incurable with standardly available therapies
Presence of at least one MCC tumor, considered measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1

Sponsors & Collaborators

Incyte Corporation
Industrycollaborator
University of Washington
Otherlead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

BiopsySpecimen HandlingMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Polyomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic Type

Study Officials

Shailender Bhatia, MD
Fred Hutch/University of Washington Cancer Consortium
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

November 8, 2023

Actual (reported)

You may not qualify if:

Residual adverse event(s) from prior therapy grade \> 1 (National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] v 5.0) that could interfere with study endpoints or put patient safety at risk
Known active central nervous system (CNS) metastases and/or prior history of carcinomatous meningitis. (NOTE: Participants with previously treated brain metastases may participate provided that they are stable, without evidence of progression by brain imaging performed within the screening period and at least 4 weeks after the treatment of brain metastases, and any neurologic symptoms must have stabilized. Patients must not have any evidence of new or enlarging brain metastases or increasing CNS edema and must not have required steroids for this purpose for at least 7 days before the first dose of study treatment.)
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. (NOTE: 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
Previous malignant disease (other than MCC) diagnosed within 3 years from day 1 of study treatment that could interfere with study endpoints or put patient safety at risk. (NOTE: Exception will be made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ (skin, bladder, cervical, colorectal, breast) or low grade prostatic intraepithelial neoplasia or grade 1 prostate cancer. Any other neoplasm, which has been treated adequately and is adjudged by the treating investigator to have a low risk of recurrence during the study, could be enrolled only after written approval from the principal investigator or designee.)
Known active hepatitis B virus (HBV) or hepatitis C virus (HCV), defined as follows:
Active HBV is defined as a known positive hepatitis B virus surface antigen (HBsAg) result or positive total hepatitis B virus core antibody (anti-HBc) results in the absence of hepatitis B virus surface antibody (anti-HBsAb). NOTE: When HBsAg is negative and hepatitis B virus core antibody (HBcAb) is positive, HBV-deoxyribonucleic acid (DNA) should be measured. When HBV-DNA is negative, this participant could be enrolled with close monitoring of HBV activities.)
Active HCV is defined as a known positive HCV antibody result and quantitative HCV-ribonucleic acid (RNA) results greater than the lower limits of detection of the assay. (NOTE: Participants who have had definitive treatment for HCV are permitted if HCV-RNA is undetectable.)
Known uncontrolled human immunodeficiency (HIV) infection. (NOTE: HIV-positive patients may be allowed if all of the following criteria are met: CD4 count \>= 300/uL, undetectable viral load, receiving antiretroviral therapy, and risk/benefit ratio is deemed favorable when considering enrollment.)
Known active autoimmune disease, allograft requiring systemic immunosuppression, or other condition requiring chronic systemic corticosteroids (\> 10 mg/day of prednisone or equivalent). (NOTE: Exceptions will be made for patients with autoimmune conditions such as diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment; patients receiving physiologic corticosteroid replacement therapy at doses =\< 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency; patients with a condition such as asthma or chronic obstructive pulmonary disease that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections; or those who required brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication. Any other situation must be discussed with the principal investigator or designee for risk/benefit assessment.)
Immunosuppressed status due to severe uncontrolled diabetes, concurrent hematological malignancy, or other comorbidities
Known history of serious, active infections (aside from well-controlled HIV) requiring systemic antimicrobial agents within 14 days before the first dose of study treatment. (NOTE: Chronic infections such as herpes simplex virus requiring suppressive therapy may be allowed after discussion with the Principal Investigator or designee for risk/benefit assessment)
Known history of clinically significant interstitial lung disease, or active noninfectious pneumonitis
Clinically significant (i.e., active) cardiovascular disease such as cerebral vascular accident or myocardial infarction (within 6 months prior to first dose of study treatment), ongoing unstable angina or congestive heart failure ( \>= New York Heart Association Classification class II), or serious cardiac arrhythmia that could jeopardize patient safety on the study
Receipt of live vaccine(s) within 30 days of planned start of study treatment. (NOTE: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster \[chickenpox), yellow fever, rabies, bacillus calmette-guerin \[BCG\], and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed)
+2 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Treatment (retifanlimab, tuparstobart, and verzistobart)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Treatment (retifanlimab, tuparstobart, and verzistobart)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Documents

Locations