Advanced MelanomaPhase 2NCT06594991
A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma
A Phase 2 study testing Fianlimab, Cemiplimab and Ipilimumab in people with Advanced Melanoma, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
Trial summary
The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- Fianlimab, Cemiplimab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 12 sitesUnited States
- Study dates
- 10 Sep 2024to Sep 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of informed consent
- Patient/legal authorized representative (LAR) must be able to provide informed consent.
- Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III/IV or metastatic stage IV cutaneous or mucosal melanoma that has progressed on PD-1/PD-L1 therapy:
- o For Cohort A, the patient's melanoma must have progressed on prior PD-1 monotherapy
- For Cohort B, the patient's melanoma must have progressed on prior combination PD-1 + LAG-3 blockade
- Note: Intervening lines of targeted therapy, chemotherapy, bispecific (e.g. IMCgp100) and cell-based therapies are permitted between last ICI-based therapy and the start of study therapy
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- Note: For cohort A, peptide and mRNA vaccines may have been combined with PD-1 monotherapy as long as no other checkpoint inhibitors were concomitantly administered. For cohort B, peptide and mRNA vaccines may have been combined with combined PD-1 + LAG-3 blockade as long as no other checkpoint inhibitors were concomitantly administered Note: Prior PD-1 monotherapy (Cohort A) or PD-1 and LAG-3 blockade (Cohort B) may have been given in the neoadjuvant or adjuvant setting as long as progression is documented within 3 months of the final dose neoadjuvant/adjuvant therapy
- Patients must have measurable disease as defined by RECIST v1.1 o Note: Lesions previously injected with Talimogene laherparepvec or other local therapies may not be selected as target lesions unless they have demonstrated subsequent growth after injection
- If a suitable archival tissue sample is available, the patient must be willing to have this specimen submitted for research. If an archival sample is not available, the patient is still a candidate for the trial, and every reasonable effort will be made to obtain a biopsy if deemed safe
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- ° Adequate laboratory function at screening, defined as:
- ° Hemoglobin ≥ 10 gm/dL (≥ 6.2 mmol/L)
- ° Platelet count ≥ 100 × 10^9 /L
- °Serum direct bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN. (Total bilirubin < 3 mg/dL for subjects with Gilbert's disease)
- No signs of active coronary ischemia, including ECG changes or elevated troponin if clinically indicated
- Calculated creatinine clearance (CrCl) ≥30 mL/min based on the Cockcroft-Gault equation
- All immune-related adverse events (irAE's) from prior ICI based therapy must have improved to Grade 1 or lower with the following exception. Patients with stable adrenal insufficiency are eligible as long as 1) they are asymptomatic at the time of consent on a stable steroid replacement regimen and 2) are on daily steroid replacement of 7.5mg prednisone equivalent or less.
- All women of childbearing potential (WOCBP)* or sexually active men must practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures in women include
- o Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening,
- Intrauterine device (IUD),
- Intrauterine hormone-releasing system (IUS),
- Bilateral tubal ligation,
- Vasectomized partner,† and/or
- Sexual abstinence.‡,§
- Male study participants with WOCBP partners are required to use condoms unless they are vasectomized† or practice sexual abstinence.‡,§
- * WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to Clinical Trial Facilitation Group (CTFG) guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
- Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.
Who cannot join
- Uveal melanoma
- Untreated central nervous system (CNS) metastases or leptomeningeal involvement; patients with brain metastases definitively treated with surgery or stereotactic radiosurgery (SRS) are permitted
- Receipt of the following prior therapies:
- For Cohort A: Any prior anti-LAG-3 (e.g., relatlimab) or CTLA-4 (e.g., ipilimumab) directed therapy, unless it was given in the adjuvant or neoadjuvant setting and the last dose was given more than three months prior to disease recurrence
- For Cohort B: Any prior CTLA-directed therapy (e.g., ipilimumab), unless it was given in the adjuvant or neoadjuvant setting and the last dose was given more than three months prior to disease recurrence
- Prior Grade 3 or greater neurologic toxicity associated with a prior line of ICI therapy
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- Any prior myocarditis associated with ICI therapy
- Prior Grade 3 or greater colitis or enteritis requiring hospitalization
- Concurrent systemic steroid therapy higher than physiologic dose steroid replacement (>7.5 mg/day of prednisone or equivalent), given within 14 days of starting treatment, or other immunosuppressive medications within 14 days of the start of treatment. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
- Receipt of a live vaccine within 30 days of planned start of study medication
- Significant infection requiring systemic antibiotics within 2 weeks of the planned start of study medication (e.g., pneumonia, cellulitis)
- Uncontrolled (i.e., unstable) concomitant medical condition or organ system dysfunction which, in the treating Investigator's opinion, could compromise the patient's safety or compliance with the study procedures.
- Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the treating investigator
- History of severe hypersensitivity reactions to any unknown allergens or any components of the study drugs (active ingredients or excipients)
- Has uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection; or has a diagnosis of immunodeficiency. Notes:
- Patients will be tested for hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening.
- Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) 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 hepatitis B (HBsAg+) 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. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.
- Patients who are 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) may be enrolled into the study.
- Patients who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 14 days of the first dose of study drug.
- Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific circumstances where local regulations permit, a person who has been imprisoned may be permitted to continue as a participant.)
- Participants who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g., transmissible infection)
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Postow, MD contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
James Smithy, MD, 646-888-6782
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
James Smithy, MD, 646-888-6782
- Recruiting
Hackensack Meridian Health (Data Collection Only)
Hackensack, New Jersey, 07601
Andrew Pecora, MD, 844-346-7222
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
James Smithy, MD, 646-888-6782
- Recruiting
Hartford Healthcare Alliance (Data Collection Only)
Hartford, Connecticut, 06102
Jaykumar Thumar, MD, 860-676-7000
- Recruiting
MD Anderson Cancer Center (Data Collection Only)
Houston, Texas, 77030
Hussein Tawbi, MD, PhD, 855-701-7200
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Inderjit Mehmi, MD, 310-231-2121
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
James Smithy, MD, 646-888-6782
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
James Smithy, MD, 646-888-6782
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
James Smithy, MD, 646-888-6782
- Recruiting
Stanford University (Data Collection Only)
Stanford, California, 94305
Allison Betof Warner, MD, PhD, 650-724-9707
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
James Smithy, MD, 646-888-6782
About this study
Official title: A Phase 2 Study of Fianlimab, Cemiplimab, and Ipilimumab in Anti-PD-1 Refractory Melanoma
The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma.
- Conditions
- Advanced Melanoma
- Being tested
- Fianlimab, Cemiplimab, Ipilimumab
- Keywords
- Fianlimab, Cemiplimab, Ipilimumab, anti-PD-1 refractory melanoma, unresectable Stage III/IV melanoma, 24-166
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FianlimabDrug
Fianlimab IV given every three weeks
CemiplimabDrug
Cemiplimab IV given every three weeks
IpilimumabDrug
Ipilimumab will be give every 6 weeks continuously
| Study group | Role | What they receive |
|---|---|---|
| Refractory melanoma after PD-1 monotherapy (Cohort A) | Experimental | All patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously. For all patients, fianlimab and Ccemiplimab will initially be co-administered and then followed by ipilimumab on D1 of each cycle per institutional standards. Receives: Drug: Fianlimab; Drug: Cemiplimab; Drug: Ipilimumab |
| Refractory melanoma after combined PD-1 and LAG-3 blockade (Cohort B) | Experimental | All patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously. For all patients, fianlimab and Ccemiplimab will initially be co-administered and then followed by ipilimumab on D1 of each cycle per institutional standards. Receives: Drug: Fianlimab; Drug: Cemiplimab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine best objective response rate (ORR) (cohort A)
by RECIST v1.1
Measured: 6 weeks
Determine best objective response rate (ORR) (cohort B)
by RECIST v1.1
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be enrolled in parallel across two independent cohorts, each with a nonrandomized two stage trial design. Cohort A (46 patients) will include patients whose melanoma progressed on prior anti-PD-1 monotherapy, and Cohort B (42 patients) will include patients whose melanoma has progressed on prior PD-1 and LAG-3 blockade.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- James Smithy, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594991
- Sponsor's protocol ID
- 24-166
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Fianlimab, Cemiplimab, and Ipilimumab in Anti-PD-1 Refractory Melanoma
- ClinicalTrials.gov ID
- NCT06594991
- Acronym / sponsor ID
- 24-166
- Conditions
- Advanced Melanoma
- Keywords
- Fianlimab, Cemiplimab, Ipilimumab, anti-PD-1 refractory melanoma, unresectable Stage III/IV melanoma, 24-166
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether the combination of fianlimab, cemiplimab, and ipilimumab is a safe and effective treatment that causes few or mild side effects for locally advanced or metastatic, unresectable, refractory melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be enrolled in parallel across two independent cohorts, each with a nonrandomized two stage trial design. Cohort A (46 patients) will include patients whose melanoma progressed on prior anti-PD-1 monotherapy, and Cohort B (42 patients) will include patients whose melanoma has progressed on prior PD-1 and LAG-3 blockade.
| Arm | Type | Receives |
|---|---|---|
| Refractory melanoma after PD-1 monotherapy (Cohort A) | Experimental | Drug: Fianlimab, Drug: Cemiplimab, Drug: IpilimumabAll patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously. For all patients, fianlimab and Ccemiplimab will initially be co-administered and then followed by ipilimumab on D1 of each cycle per institutional standards. |
| Refractory melanoma after combined PD-1 and LAG-3 blockade (Cohort B) | Experimental | Drug: Fianlimab, Drug: Cemiplimab, Drug: IpilimumabAll patients will receive intravenous Fianlimab and Cemiplimab every three weeks continuously. Ipilimumab will be given every 6 weeks continuously. For all patients, fianlimab and Ccemiplimab will initially be co-administered and then followed by ipilimumab on D1 of each cycle per institutional standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Age ≥ 18 years at the time of informed consent
- Patient/legal authorized representative (LAR) must be able to provide informed consent.
- Patient must have a histologically confirmed diagnosis of locally advanced unresectable stage III/IV or metastatic stage IV cutaneous or mucosal melanoma that has progressed on PD-1/PD-L1 therapy:
- o For Cohort A, the patient's melanoma must have progressed on prior PD-1 monotherapy
- Patients must have measurable disease as defined by RECIST v1.1 o Note: Lesions previously injected with Talimogene laherparepvec or other local therapies may not be selected as target lesions unless they have demonstrated subsequent growth after injection
Key exclusion criteria (22 listed)
- Uveal melanoma
- Untreated central nervous system (CNS) metastases or leptomeningeal involvement; patients with brain metastases definitively treated with surgery or stereotactic radiosurgery (SRS) are permitted
- Receipt of the following prior therapies:
- Prior Grade 3 or greater neurologic toxicity associated with a prior line of ICI therapy
- Any prior myocarditis associated with ICI therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FianlimabFianlimab IV given every three weeks | Drug | Refractory melanoma after PD-1 monotherapy (Cohort A), Refractory melanoma after combined PD-1 and LAG-3 blockade (Cohort B) |
| CemiplimabCemiplimab IV given every three weeks | Drug | Refractory melanoma after PD-1 monotherapy (Cohort A), Refractory melanoma after combined PD-1 and LAG-3 blockade (Cohort B) |
| IpilimumabIpilimumab will be give every 6 weeks continuously | Drug | Refractory melanoma after PD-1 monotherapy (Cohort A), Refractory melanoma after combined PD-1 and LAG-3 blockade (Cohort B) |
Primary outcome
Determine best objective response rate (ORR) (cohort A)
Time frame: 6 weeks
by RECIST v1.1
Determine best objective response rate (ORR) (cohort B)
Time frame: 6 weeks
by RECIST v1.1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Postow, MD contact
James Smithy, MD principal investigator
Memorial Sloan Kettering Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fianlimab, Cemiplimab and Ipilimumab in people with Advanced Melanoma, run by Memorial Sloan Kettering Cancer Center at 12 sites 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 29 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 James Smithy, MD (646-888-6782, smithyj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine best objective response rate (ORR) (cohort A) (time frame: 6 weeks). 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?
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 7 Oct 2026.