Trials Sponsors Conditions Drugs Pricing

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Through study completion; an average of 1 year

Study Arms (1)

Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma

EXPERIMENTAL

Drug: CemiplimabDrug: LpilimumabDrug: Fianlimab

Interventions

CemiplimabDrug

Given by IV

Also known as: Libtayo

Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma

LpilimumabDrug

Given by IV

Also known as: Yervoy

Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

At least 18 years of age on the date of providing informed consent
All patients must be either stage III (stage IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per ATJCC 8th edition and have histologically confirmed cutaneous melanoma (including acral melanoma) that is clinically detectable and deemed completely surgically resectable

Sponsors & Collaborators

M.D. Anderson Cancer Center
Otherlead

Study Sites (1)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Rodabe N Amaria, MDCONTACT713-792-2921 rnamaria@mdanderson.org

Rodabe N Amaria, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Melanoma

Interventions

cemiplimabIpilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Rodabe N Amaria, MD
UT MD Anderson
PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodabe N Amaria, MD

CONTACT

(713) 792-2921 rnamaria@mdanderson.org

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

March 31, 2026

First Posted

April 6, 2026

Study Start

September 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

May 24, 2028

Estimated

You may not qualify if:

Primary uveal melanoma
Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion, or if given to a target lesion there is pathological evidence of disease progression in the same lesion.
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
Notes:
Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
Patients with HIV or hepatitis must be reviewed by a qualified specialist (eg, infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial.
Concurrent malignancy that is currently progressing or requiring active treatment within the past 2 years except for cancers will a negligible risk of metastasis or death (adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized early-stage prostate cancer or ductal carcinoma in situ of the breast).
Use of immunosuppressive dose of corticosteroids (≥ 10mg of prednisone or equivalent) within 14 days of the first dose of study medication. Inhaled or topical steroids are permitted, provided that they are not for treatment of an active autoimmune disorder.
Pregnant or breastfeeding women.
Received a live vaccine within 30 days of planned start of study medication.
a. Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.
Participants with a history of myocarditis.
Troponin T (TnT) or troponin I (TnI) \> 2x institutional ULN at baseline.
+7 more criteria

PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

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)

Study Arms (1)

Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations