MelanomaPhase 2NCT07511036
PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma
A Phase 2 study testing Cemiplimab, Lpilimumab and Fianlimab in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This is a phase II study testing the safety and preliminary efficacy of triplet ICB in treatment naïve patients with clinical stage III or oligometastatic stage IV melanoma with resectable disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Cemiplimab, Lpilimumab and Fianlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 24 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients with stage IIIA and Stage IV M1d disease are excluded
- Mucosal melanoma patients are allowed but capped at 10% of the total study population
- Patients with melanoma of unknown primary are allowed, provided that complete surgical resection is planned
- Resectable in-transit metastases (up to 3 lesions) with or without nodal involvement are eligible
Show all 35Show fewer
- Clinically detectable is defined as disease which is clinically apparent and measurable according to Response Evaluation Criteria in Solid Tumors. Resectable nodal metastases should be a minimum short-axis diameter of 1.5cm, whereas the minimum size for other metastases should be 1cm.
- Eastern Cooperative Oncology Group (ECOG) PS 0-1
- Adequate bone marrow function as determined by:
- Absolute Neutrophil Count ≥ 1.5 x 109
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 75,000/mm3
- Adequate hepatic function as determined by:
- AST (aspartate aminotransferase)/ALT (alanine aminotransferase) ≤ 3x upper limit of normal (ULN)
- Alkaline phosphatase ≤2.5 x ULN
- Serum bilirubin ≤ 1.5 x ULN except in patients with clinically documented Gilbert's Syndrome
- Adequate kidney function as determined by creatine clearance ≥ 30 ml/min using the Cockcroft-Gault equation
- WOCBP* must have a negative serum (beta-hCG) at screening.
- Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence.
- Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.
- Women of childbearing potential (WOCBP)* must be willing to 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 include:
- 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; intrauterine hormone-releasing system;
- bilateral tubal occlusion/ligation;
- vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or
- sexual abstinence†, ‡.
- Pregnancy testing and contraception are required for WOCBP.
- Pregnancy testing and contraception are not required for women who are post-menopausal or permanently sterile.
- 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 subject.
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.
- WOCPB must not agree to donate eggs for purposes of assisted reproduction during the entire study and until 6 months after last treatment
- All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose
- Willing and able to comply with clinic visits and study-related procedures
- Provide informed consent signed by study patient or legally acceptable representative
Who cannot join
- Primary uveal melanoma
- Ongoing or recent (within 2 years) of active autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, and psoriasis not requiring systemic treatment.
- 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.
Show all 23Show fewer
- 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.
- 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.
- Patients with TnT or TnI 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.
- History or current evidence of significant (NCI-CTCAE grade ≥2) local or systemic infection (e.g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.
- Active infection requiring therapy.
- Known hypersensitivity to the active substances or to any of the excipients.
- Presence of a severe concurrent illness or other condition (e.g., psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol.
- Prior allogeneic stem cell transplant or solid organ transplant.
- Any medical condition that in the opinion of the investigator would make participation in the study not in the best interest of the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
M.D. Anderson Cancer Center
Houston, Texas, 77030
Rodabe N Amaria, MD, 713-792-2921, rnamaria@mdanderson.org
Rodabe N Amaria, MD
About this study
This is a phase II study testing the safety and preliminary efficacy of triplet ICB in treatment naïve patients with clinical stage III or oligometastatic stage IV melanoma with resectable disease.
Read the detailed description
Primary Objective:
- Evaluate the safety of cemiplimab, fianlimab, and ipilimumab combination in resectable clinical stage III or oligometastatic stage IV melanoma patients in the neoadjuvant setting.
Primary Endpoints
- Incidence of grade 3 or higher toxicities by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6
Secondary Objectives:
- Estimation of MPRDetermination of pCR
- Determination of objective response rate (ORR) to neoadjuvant therapy
- Determination of EFS
- Determination of RFS
- Assess distant metastasis-free survival (DMFS)
- Evaluate overall survival (OS)
- Evaluate safety of adjuvant cemiplimab and fianlimab
Secondary Endpoints
- MPR: defined as ≤10% viable tumor as evaluated by the INMC criteriapCR defined as 0% viable tumor at the time of surgical resection
- ORR: Complete response or partial response as evaluated by imaging at baseline and at the completion of neoadjuvant therapy by RECIST 1.1
- EFS: time from study treatment initiation until progression, recurrence, or death
- RFS: time from surgery until recurrence or death
- DMFS: time from study treatment initiation to time of development of distant metastasis or death
- OS: time from study treatment initiation to death
- Toxicities by (NCI-CTCAE) version 6
Exploratory Objectives:
- Evaluation of pharmacodynamic changes in the tumor microenvironment over the course of neoadjuvant therapy
- Evaluation of immunologic changes in the tumor and peripheral blood over the course of neoadjuvant therapy
- Evaluation of microbiome changes over the course of neoadjuvant therapy
- Conditions
- Melanoma
- Being tested
- Cemiplimab, Lpilimumab, Fianlimab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called Libtayo
Given by IV
LpilimumabDrug
Also called Yervoy
Given by IV
FianlimabDrug
Also called REGN3767
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma | Experimental | Not described Receives: Drug: Cemiplimab; Drug: Lpilimumab; Drug: Fianlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion24 May 2028 (estimated)
- Study completion24 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodabe N Amaria, MD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511036
- Sponsor's protocol ID
- 2025-1978
- Other IDs
- NCI-2026-02454
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma
- ClinicalTrials.gov ID
- NCT07511036
- Acronym / sponsor ID
- 2025-1978
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 24 May 2028 (estimated)
- Study completion
- 24 May 2030 (estimated)
- First posted
- 6 Apr 2026 (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.
This is a phase II study testing the safety and preliminary efficacy of triplet ICB in treatment naïve patients with clinical stage III or oligometastatic stage IV melanoma with resectable disease.
Detailed description
Primary Objective:
- Evaluate the safety of cemiplimab, fianlimab, and ipilimumab combination in resectable clinical stage III or oligometastatic stage IV melanoma patients in the neoadjuvant setting.
Primary Endpoints
- Incidence of grade 3 or higher toxicities by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6
Secondary Objectives:
- Estimation of MPRDetermination of pCR
- Determination of objective response rate (ORR) to neoadjuvant therapy
- Determination of EFS
- Determination of RFS
- Assess distant metastasis-free survival (DMFS)
- Evaluate overall survival (OS)
- Evaluate safety of adjuvant cemiplimab and fianlimab
Secondary Endpoints
- MPR: defined as ≤10% viable tumor as evaluated by the INMC criteriapCR defined as 0% viable tumor at the time of surgical resection
- ORR: Complete response or partial response as evaluated by imaging at baseline and at the completion of neoadjuvant therapy by RECIST 1.1
- EFS: time from study treatment initiation until progression, recurrence, or death
- RFS: time from surgery until recurrence or death
- DMFS: time from study treatment initiation to time of development of distant metastasis or death
- OS: time from study treatment initiation to death
- Toxicities by (NCI-CTCAE) version 6
Exploratory Objectives:
- Evaluation of pharmacodynamic changes in the tumor microenvironment over the course of neoadjuvant therapy
- Evaluation of immunologic changes in the tumor and peripheral blood over the course of neoadjuvant therapy
- Evaluation of microbiome changes over the course of neoadjuvant therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma | Experimental | Drug: Cemiplimab, Drug: Lpilimumab, Drug: Fianlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- 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
- Clinically detectable is defined as disease which is clinically apparent and measurable according to Response Evaluation Criteria in Solid Tumors. Resectable nodal metastases should be a minimum short-axis diameter of 1.5cm, whereas the minimum size for other metastases should be 1cm.
- Eastern Cooperative Oncology Group (ECOG) PS 0-1
- Adequate bone marrow function as determined by:
Key exclusion criteria (23 listed)
- Primary uveal melanoma
- Ongoing or recent (within 2 years) of active autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, and psoriasis not requiring systemic treatment.
- 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.
- 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).
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 |
|---|---|---|
| CemiplimabAlso: LibtayoGiven by IV | Drug | Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma |
| LpilimumabAlso: YervoyGiven by IV | Drug | Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma |
| FianlimabAlso: REGN3767Given by IV | Drug | Combination Cemiplimab, Fianlimab, and Ipilimumab in Melanoma |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
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 6 Apr 2026.
- UT MD Anderson WebsiteLink provided by the sponsor.
Related trials for Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Enrolling by invitationObservational study
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Melanoma, Adenocarcinoma
RecruitingPhase 1
Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
Melanoma
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.
Rodabe N Amaria, MD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab, Lpilimumab and Fianlimab in people with Melanoma, run by M.D. Anderson Cancer Center 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 35 inclusion and 23 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 6 Apr 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 Rodabe N Amaria, MD ((713) 792-2921, rnamaria@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 6 Apr 2026.