Locally Advanced MelanomaNCT07223411
Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma
An observational study of Locally Advanced Melanoma, run by John Kirkwood at 1 site in United States.
Trial summary
This translational study will examine the immune effector responses of patients who received a two-drug combination for first line therapy by examining tumor and peripheral blood of participants with unresectable locally advanced or metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Melanoma
- What is being tested?
- Fianlimab + Cemiplimab and Relatlimab + Nivolumab
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to 1 Nov 2031
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Study participants who met inclusion criteria for clinical trial NCT06246916
Who may be able to join
- Study participants who meet inclusion criteria for the HCC 24-056 study will be eligible for this study.
- Participants must be willing to provide additional samples beyond what is required of them in HCC 24-056. These include:
- 3 additional tumor biopsies
- 3 additional blood draws
- Participants must have biopsiable non-target disease amenable to at least 3 biopsies.
- Must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 1. Study participants who do not qualify to enroll in the HCC 24-056 study will not be eligible for this study.
- -
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, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Danielle L Bednarz, RN, 4126231191, bednarzdl@upmc.edu
Amy Rose, RN, 4126478587, kennaj@upmc.edu
About this study
Official title: Dose-response Analysis of Nivolumab/Relatlimab in the Fixed-dosed Combination 'Opdualag' vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood for Participants With Unresectable or Metastatic Melanoma: A Corollary Study of HCC 24-056 (NCT06246916)
This translational study will examine the immune effector responses of patients who received a two-drug combination for first line therapy by examining tumor and peripheral blood of participants with unresectable locally advanced or metastatic melanoma.
Read the detailed description
Cutaneous melanoma is an aggressive skin cancer which, in the metastatic setting, has a historic 5-year survival rate of <30%. In 2023, about 97,610 new cases of melanoma were estimated to occur in the US, with about 7,990 deaths. GLOBACON reported 324,635 cases of melanoma globally in 2020, which constituted about 1.7% of all cancers and 57,043 melanoma-associated deaths.
The parent trial of this corollary study is a randomized, open-label, multicenter phase 3 study comparing the anti-tumor activity of fixed-dose combination (FDC) of fianlimab + cemiplimab versus the FDC of relatlimab + nivolumab (referred to as Opdualag™) in participants with unresectable or metastatic melanoma (stage III-IV). This corollary study will explore the immunological response of CD8, CD4, and other immune cells in the blood and tumor microenvironment of patients in response to the provided treatments.
- Conditions
- Locally Advanced Melanoma
- Being tested
- Fianlimab + Cemiplimab, Relatlimab + Nivolumab
- Keywords
- immune checkpoint inhibitor, immunological response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fianlimab + CemiplimabDrug
Patients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916
Relatlimab + NivolumabDrug
Also called Opdualag
Patients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916
| Study group | Role | What they receive |
|---|---|---|
| fianlimab + cemiplimab | Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916. Receives: Drug: Fianlimab + Cemiplimab | |
| Opdualag (relatlimab + nivolumab) | Patients who received Opdualag (relatlimab + nivolumab) under protocol NCT06246916. Receives: Drug: Relatlimab + Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-cell analysis of CD4+ T cells
Single-cell RNAseq analysis of CD8+ T cells and other immune cells in blood and tumor biopsies.
Measured: Up to 39 months
Secondary outcomes (3)
Immunological response of CD4+ T cells
Single-cell analysis of CD4+ T cell (frequency) and other immune cells in blood and tumor biopsies. Analysis of single-cell RNA-seq data to obtain gene module scores for each CD4+ T cell or myeloid cell in whole blood and tumor biopsies will be classified as binary: 1 (co-expressing cytotoxic and exhaustion gene modules) or 0 (no co-expression).
Measured: Up to 39 months
Multiplexed immunofluorescence
Degree of immune infiltration major immune subsets in the tumor microenvironment. The density of immune cells relative to the total number of cells in the tumor tissue will be calculated for each patient.
Measured: Up to 39 months
Multiplexed immunofluorescence
Frequencies of major immune subsets in the tumor microenvironment. The density of immune cells relative to the total number of cells in the tumor tissue will be calculated for each patient.
Measured: Up to 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start19 Nov 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced MelanomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Kirkwood
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, John Kirkwood, University of Pittsburgh
- Investigators
- John M Kirkwood, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223411
- Sponsor's protocol ID
- HCC 25-009
- Status last verified
- Nov 2025
- First submitted
- 30 Oct 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Analysis of Nivolumab/Relatlimab in the Fixed-dosed Combination 'Opdualag' vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood for Participants With Unresectable or Metastatic Melanoma: A Corollary Study of HCC 24-056 (NCT06246916)
- ClinicalTrials.gov ID
- NCT07223411
- Acronym / sponsor ID
- HCC 25-009
- Conditions
- Locally Advanced Melanoma
- Keywords
- immune checkpoint inhibitor, immunological response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- John KirkwoodUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 31 Oct 2025 (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 translational study will examine the immune effector responses of patients who received a two-drug combination for first line therapy by examining tumor and peripheral blood of participants with unresectable locally advanced or metastatic melanoma.
Detailed description
Cutaneous melanoma is an aggressive skin cancer which, in the metastatic setting, has a historic 5-year survival rate of <30%. In 2023, about 97,610 new cases of melanoma were estimated to occur in the US, with about 7,990 deaths. GLOBACON reported 324,635 cases of melanoma globally in 2020, which constituted about 1.7% of all cancers and 57,043 melanoma-associated deaths.
The parent trial of this corollary study is a randomized, open-label, multicenter phase 3 study comparing the anti-tumor activity of fixed-dose combination (FDC) of fianlimab + cemiplimab versus the FDC of relatlimab + nivolumab (referred to as Opdualag™) in participants with unresectable or metastatic melanoma (stage III-IV). This corollary study will explore the immunological response of CD8, CD4, and other immune cells in the blood and tumor microenvironment of patients in response to the provided treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fianlimab + cemiplimab | – | Drug: Fianlimab + CemiplimabPatients who received fianlimab + cemiplimab treatment under protocol NCT06246916. |
| Opdualag (relatlimab + nivolumab) | – | Drug: Relatlimab + NivolumabPatients who received Opdualag (relatlimab + nivolumab) under protocol NCT06246916. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study participants who met inclusion criteria for clinical trial NCT06246916
Key inclusion criteria (6 listed)
- Study participants who meet inclusion criteria for the HCC 24-056 study will be eligible for this study.
- Participants must be willing to provide additional samples beyond what is required of them in HCC 24-056. These include:
- Participants must have biopsiable non-target disease amenable to at least 3 biopsies.
- Must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (2 listed)
- 1. Study participants who do not qualify to enroll in the HCC 24-056 study will not be eligible for this study.
- -
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 |
|---|---|---|
| Fianlimab + CemiplimabPatients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916 | Drug | fianlimab + cemiplimab |
| Relatlimab + NivolumabAlso: OpdualagPatients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916 | Drug | Opdualag (relatlimab + nivolumab) |
Primary outcome
Single-cell analysis of CD4+ T cells
Time frame: Up to 39 months
Single-cell RNAseq analysis of CD8+ T cells and other immune cells in blood and tumor biopsies.
3 secondary outcomes
Immunological response of CD4+ T cells
Time frame: Up to 39 months
Multiplexed immunofluorescence
Time frame: Up to 39 months
Multiplexed immunofluorescence
Time frame: Up to 39 months
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 26 Nov 2025.
- Individual participant dataSharing planned: No
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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.
John M Kirkwood, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Melanoma, run by John Kirkwood 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 6 inclusion and 2 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 26 Nov 2025. 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.
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 Danielle L Bednarz, RN (4126231191, bednarzdl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-cell analysis of CD4+ T cells (time frame: Up to 39 months). 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 26 Nov 2025.