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Melanoma (Skin)Phase 2NCT07527325

Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma

A Phase 2 study testing Fianlimab and Cemiplimab in people with Melanoma (Skin), run by University of California, Irvine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Melanoma (Skin)
What is being tested?
Fianlimab and Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Dec 2026to 1 Feb 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • ≥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
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  • 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.
  • Females of childbearing potential and males must be willing and able to use a highly effective method of contraception to avoid pregnancy for the duration of the study and for at least 6 months after the last dose of study treatment. Acceptable means of contraception are listed in the fianlimab institutional brochure.
  • Male participants must be willing to abstain from donating sperm from the time of enrollment until 6 months after administration of study interventions.

Who cannot join

  • 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.
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  • 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.
  • Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable during Screening.
  • 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.
  • Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents except for the following: . The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.
  • Participants with a history of allogeneic tissue/solid organ transplant.
  • Live vaccine within 30 days of the planned administration of a study drug.
  • Positive pregnancy test during screening. Pregnant or lactating women are prohibited from enrolling in this study.
  • Participants must not have any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chao Family Comprehensive Cancer Center University of California, Irvine contact

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical contact

United States1 site

  • Chao Family Comprehensive Cancer Center University of California, Irvine

    Orange, California, 92868

Other trials in United States

About this study

Official title: Fianlimab and Cemiplimab as Total Neoadjuvant Therapy (TNT) For Melanoma

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)
Being tested
Fianlimab, Cemiplimab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07527325
Study groupRoleWhat they receive
3 doses of neoadjuvant of Fianlimab in combination with CemiplimabExperimental3 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
Receives: Drug: Fianlimab; Drug: Cemiplimab
6 doses of neoadjuvant Fianlimab in combination with CemiplimabExperimental6 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
Receives: Drug: Fianlimab; Drug: Cemiplimab
8 doses of neoadjuvant Fianlimab in combination with CemiplimabExperimental8 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
Receives: Drug: Fianlimab; Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 16 months

  2. 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)

    Measured: 16 months

Secondary outcomes (6)

  1. 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) in Cohort 1.

    Measured: 16 months

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

    Sum of Complete Response (CR) and Partial Response (PR) by RECIST v 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR for each dose cohort.

    Measured: 16 months

  3. Event-Free Survival (EFS)

    Determine the event-free survival (EFS) for each cohort. EFS is measured from the date of randomization to the first date of any of the following occurrences: disease progression that preclude surgery, toxicity from neoadjuvant treatment that precludes surgery, inability to surgically resect the primary lesion or undergo TLND, disease progression, toxic effects of adjuvant treatment if indicated, surgical complications, melanoma recurrence after surgery during the follow up period, or death from any cause.

    Measured: 28 months

  4. Number of Patients with Adverse Events

    Number of Patients who received at least one dose of Fianlimab with Cemiplimab with any reported Adverse Events (AEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.

    Measured: 28 months

  5. Number of Patients with Immune Related Adverse Events

    Number of Patients who received at least one dose of Fianlimab with Cemiplimab with reported immune related AEs (irAEs) using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.

    Measured: 28 months

  6. Number of Patients who Discontinued Treatment Due to Reported Adverse Events

    Number of Patients who received at least one dose of Fianlimab with Cemiplimab requiring discontinuation of therapy due to reported AEs using the CTCAE version 5.0 for reporting of nonhematologic AEs and modified criteria for hematologic AEs.

    Measured: 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study startDec 2026 (estimated)
  3. Primary completion1 Feb 2029 (estimated)
  4. Study completion1 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07527325
Sponsor's protocol ID
STUDY00000745
Other IDs
UCI 24-123
Status last verified
Jun 2026
First submitted
7 Apr 2026
Last updated
11 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fianlimab and Cemiplimab in people with Melanoma (Skin), run by University of California, Irvine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathologic Response (MPR) Rate by RECIST v1.1 (time frame: 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07527325.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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