Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma

NCT07527325 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: STUDY00000745UCI 24-123
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, open label clinical trial determining efficacy of Fianlimab in combination with Cemiplimab in subjects with Melanoma. These are subjects who will have surgery to remove their cancer.

Conditions

Melanoma (Skin)

Outcome Measures

Primary Outcomes (2)

• Major Pathologic Response (MPR) Rate by RECIST v1.1

  Evaluate the major pathologic response (MPR), defined as pathologic complete response (pCR) + pathologic near complete response (pnCR) after treatment with dual checkpoint blockade in the index lymph node of Cohort 2 and Cohort 3

  16 months

• Major Pathologic Response (MPR) Rate by RECIST v1.1

  Evaluate the MPR rate in the primary cutaneous melanoma site after wide local excision (if wide local excision was deferred after diagnostic biopsy)

  16 months

Secondary Outcomes (6)

• Major Pathologic Response (MPR) Rate by RECIST v1.1

  16 months

• Objective Response Rate (ORR) by RECIST v1.1

  16 months

• Event-Free Survival (EFS)

  28 months

• Number of Patients with Adverse Events

  28 months

• Number of Patients with Immune Related Adverse Events

  28 months

Study Arms (3)

3 doses of neoadjuvant of Fianlimab in combination with Cemiplimab

EXPERIMENTAL

3 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 13 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks

Drug: Fianlimab; Drug: Cemiplimab

6 doses of neoadjuvant Fianlimab in combination with Cemiplimab

EXPERIMENTAL

6 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 10 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks

Drug: Fianlimab; Drug: Cemiplimab

8 doses of neoadjuvant Fianlimab in combination with Cemiplimab

EXPERIMENTAL

8 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 8 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks

Drug: Fianlimab; Drug: Cemiplimab

Interventions

Fianlimab DRUG

Given IV

3 doses of neoadjuvant of Fianlimab in combination with Cemiplimab; 6 doses of neoadjuvant Fianlimab in combination with Cemiplimab; 8 doses of neoadjuvant Fianlimab in combination with Cemiplimab

Cemiplimab DRUG

Given IV

3 doses of neoadjuvant of Fianlimab in combination with Cemiplimab; 6 doses of neoadjuvant Fianlimab in combination with Cemiplimab; 8 doses of neoadjuvant Fianlimab in combination with Cemiplimab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years at the time of signing informed consent form (ICF) and able to independently complete informed consent. A certified translator must be used in the completion of informed consent for non-English speaking individuals.
• Patients must have surgically resectable, macroscopic Stage IIIB-D cutaneous melanoma or oligometastatic resectable stage IV (M1a, M1b, and M1c) melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria. Patients are eligible at the time of the initial diagnosis or recurrence after previous surgery. Patients should have \> 1 RECIST measurable lesion.
• Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at initial screening.
• Life expectancy of at least 12 weeks.
• Adequate bone marrow, liver, and renal function:
• Hemoglobin \>8.0 g/dL
• Platelets \>75/mm3
• ANC \>1.5/mm3
• Creatinine Clearance \> 30mL/min
• AST and ALT less than 3 times the Upper Limit of Normal. participants with Gilbert's syndrome are excluded if total bilirubin \> 3.0 × ULN; or direct bilirubin \> 1.5 × ULN
• Total Bilirubin \< 3.1.
• Albumin ≥ 3.0 g/dL
• Absolute neutrophil count ≥ 1.5 × 109/L
• Absolute lymphocyte count ≥ 0.5 × 109/L
• Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment.

You may not qualify if:

• Participants with visceral, bone, or brain metastases.
• Participants with a local recurrence in scar or surgical bed of the primary melanoma as the sole site of disease.
• Participants with N1a or N2a only disease.
• Participants with a diagnosis of acral, ocular or mucosal melanoma.
• Participants with a history of a malignant disease that can interfere with interpretation of study results.
• Participants with previous treatment with investigational or standard immunotherapy for melanoma or other malignancy.
• Patients with a history of myocarditis.
• Patients with a TnT or troponin I (TnI) \> 2x institutional ULN at baseline. Patients with Troponin T (TnT) or troponin levels between \> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.
• Participants with known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Known hypersensitivity to the active substances or to any of the excipients.
• Participants with a known history of chronic viral infections as indicated below.
• Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible.
• HIV infection with CD4 count \<200/microliter as measured within screening time period. Patients with HIV infectious should be on combination antiretroviral medication.
• History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
• Participants with a history of allogeneic tissue/solid organ transplant.

Sponsors & Collaborators

• University of California, Irvine: lead
• UC Cancer Consortium: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Warren Chow, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HS Clinical Professor

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)