MelanomaPhase 1/2BrILlianceNCT06413680
A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body
A Phase 1/2 study testing REGN10597 and Cemiplimab in people with Melanoma and Clear-Cell Renal-Cell Carcinoma (ccRCC), run by Regeneron Pharmaceuticals at 11 sites in United States.
Trial summary
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). The study is focused on patients with certain solid tumors that are in an advanced stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC), Advanced Solid Tumors
- What is being tested?
- REGN10597 and Cemiplimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 11 sitesUnited States
- Study dates
- 23 Sep 2024to 3 Feb 2030
- Phase
- Phase 1/2
- 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
- Dose escalation cohorts:
- 1. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available
- Dose expansion cohorts:
- 1. Histologically of cytologically confirmed diagnosis of one of the following tumors with criteria, as defined in the protocol:
- Module 1, Cohort 1: anti-PD-(L)1 Progressed Melanoma or
- Module 1, Cohort 2: anti-PD-(L)1 Progressed RCC or
- Module 2, Cohort 1: 1L Melanoma ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points
Who cannot join
- Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy
- Prior treatment with anti-PD1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol
- Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs
- Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, or discontinuation of prior anti-cancer immunotherapy due to grade 3 or 4 toxicities
- Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol
- Has known allergy or hypersensitivity to components of the study drug(s)
Show all 9Show fewer
- Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study intervention
- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments
- NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
University of Chicago
Chicago, Illinois, 60637
- Recruiting
Start Midwest Cancer Research
Grand Rapids, Michigan, 49546
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Northwell Health
Lake Success, New York, 11042
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089
- Recruiting
Yale School of Medicine
North Haven, Connecticut, 06473
- Recruiting
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
Next Oncology
San Antonio, Texas, 78229
- Recruiting
The Start Center for Cancer Care
San Antonio, Texas, 78229
- Recruiting
University of California San Francisco (UCSF)
San Francisco, California, 94143
About this study
Official title: A Phase 1/2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). The study is focused on patients with certain solid tumors that are in an advanced stage.
The aim of the study is to see how safe, tolerable, and effective the study drug(s) are.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug(s)
- How much study drug(s) is in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Read the detailed description
Phase 1: Conducted in the United States only Phase 2: Conducted globally
- Being tested
- REGN10597, Cemiplimab
- Keywords
- Advanced solid organ malignancies, Locally advanced, Metastatic, Non-uveal, Unresectable, Primary or secondary resistance to programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1)
- Medical subject headings
- Melanoma, Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN10597Drug
Administered per the protocol
CemiplimabDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Monotherapy Dose Escalation | Experimental | Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D) Receives: Drug: REGN10597 |
| Phase 2: Monotherapy Dose Expansion | Experimental | Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants Receives: Drug: REGN10597 |
| Phase 1: Combination Dose Escalation | Experimental | Multiple DL Cohorts to identify the RP2D Receives: Drug: REGN10597; Drug: Cemiplimab |
| Phase 2: Combination Dose Expansion | Experimental | Cohort 1: Melanoma participants Receives: Drug: REGN10597; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Dose escalation
Measured: Up to Day 29
Incidence of Treatment-Emergent Adverse Event (TEAEs)
Dose escalation
Measured: Approximately 6 Years
Incidence of Serious Adverse Events (SAEs)
Dose escalation
Measured: Approximately 6 Years
Incidence of TEAEs leading to treatment discontinuation
Dose escalation
Measured: Approximately 6 Years
Incidence of TEAEs leading to death
Dose escalation
Measured: Approximately 6 Years
Number of participants with Grade 3 laboratory abnormalities
Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: Approximately 6 Years
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment
Dose expansion
Measured: Approximately 6 Years
Secondary outcomes (9)
ORR based on RECIST 1.1 criteria by investigator assessment
Dose escalation
Measured: Approximately 6 Years
Best Overall Response (BOR) based on RECIST 1.1 criteria
Measured: Approximately 6 Years
Duration Of Response (DOR) based on RECIST 1.1 criteria
Measured: Approximately 6 Years
Disease control rate based on RECIST 1.1
Measured: Approximately 6 Years
Time to response based on RECIST 1.1
Measured: Approximately 6 Years
Progression Free Survival (PFS) based on RECIST 1.1
Measured: Approximately 6 Years
Concentrations of REGN10597 in serum
Measured: Approximately 6 Years
Incidence of Anti-Drug Antibody (ADA) to REGN10597 over time
Measured: Approximately 6 Years
Magnitude of ADA to REGN10597 over time
Measured: Approximately 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start23 Sep 2024
- Primary completion3 Feb 2030 (estimated)
- Study completion3 Feb 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 Regeneron PharmaceuticalsThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413680
- Sponsor's protocol ID
- R10597-ONC-22114
- Other IDs
- 2025-523399-22-00, 2025
- Acronym
- BrILliance
- Status last verified
- Apr 2026
- First submitted
- 9 May 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Open-Label, Dose Escalation and Dose Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti-PD-1-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies
- ClinicalTrials.gov ID
- NCT06413680
- Acronym / sponsor ID
- BrILliance / R10597-ONC-22114
- Keywords
- Advanced solid organ malignancies, Locally advanced, Metastatic, Non-uveal, Unresectable, Primary or secondary resistance to programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 3 Feb 2030 (estimated)
- Study completion
- 3 Feb 2030 (estimated)
- First posted
- 14 May 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.
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). The study is focused on patients with certain solid tumors that are in an advanced stage.
The aim of the study is to see how safe, tolerable, and effective the study drug(s) are.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug(s)
- How much study drug(s) is in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
Detailed description
Phase 1: Conducted in the United States only Phase 2: Conducted globally
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Monotherapy Dose Escalation | Experimental | Drug: REGN10597Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D) |
| Phase 2: Monotherapy Dose Expansion | Experimental | Drug: REGN10597Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants |
| Phase 1: Combination Dose Escalation | Experimental | Drug: REGN10597, Drug: CemiplimabMultiple DL Cohorts to identify the RP2D |
| Phase 2: Combination Dose Expansion | Experimental | Drug: REGN10597, Drug: CemiplimabCohort 1: Melanoma participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available
- 1. Histologically of cytologically confirmed diagnosis of one of the following tumors with criteria, as defined in the protocol:
- Module 1, Cohort 1: anti-PD-(L)1 Progressed Melanoma or
- Module 1, Cohort 2: anti-PD-(L)1 Progressed RCC or
- Module 2, Cohort 1: 1L Melanoma ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points
Key exclusion criteria (9 listed)
- Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy
- Prior treatment with anti-PD1/PD-L1, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol
- Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs
- Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, or discontinuation of prior anti-cancer immunotherapy due to grade 3 or 4 toxicities
- Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol
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 |
|---|---|---|
| REGN10597Administered per the protocol | Drug | Phase 1: Combination Dose Escalation, Phase 1: Monotherapy Dose Escalation, Phase 2: Combination Dose Expansion, Phase 2: Monotherapy Dose Expansion |
| CemiplimabAdministered per the protocol | Drug | Phase 1: Combination Dose Escalation, Phase 2: Combination Dose Expansion |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Up to Day 29
Dose escalation
Incidence of Treatment-Emergent Adverse Event (TEAEs)
Time frame: Approximately 6 Years
Dose escalation
Incidence of Serious Adverse Events (SAEs)
Time frame: Approximately 6 Years
Dose escalation
Incidence of TEAEs leading to treatment discontinuation
Time frame: Approximately 6 Years
Dose escalation
Incidence of TEAEs leading to death
Time frame: Approximately 6 Years
Dose escalation
Number of participants with Grade 3 laboratory abnormalities
Time frame: Approximately 6 Years
Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment
Time frame: Approximately 6 Years
Dose expansion
9 secondary outcomes
ORR based on RECIST 1.1 criteria by investigator assessment
Time frame: Approximately 6 Years
Best Overall Response (BOR) based on RECIST 1.1 criteria
Time frame: Approximately 6 Years
Duration Of Response (DOR) based on RECIST 1.1 criteria
Time frame: Approximately 6 Years
Disease control rate based on RECIST 1.1
Time frame: Approximately 6 Years
Time to response based on RECIST 1.1
Time frame: Approximately 6 Years
Progression Free Survival (PFS) based on RECIST 1.1
Time frame: Approximately 6 Years
Concentrations of REGN10597 in serum
Time frame: Approximately 6 Years
Incidence of Anti-Drug Antibody (ADA) to REGN10597 over time
Time frame: Approximately 6 Years
Magnitude of ADA to REGN10597 over time
Time frame: Approximately 6 Years
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 28 Apr 2026.
- BrILlianceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing REGN10597 and Cemiplimab in people with Melanoma and Clear-Cell Renal-Cell Carcinoma (ccRCC), run by Regeneron Pharmaceuticals at 11 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 7 inclusion and 9 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 28 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 11 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Up to Day 29). The study lists 7 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 28 Apr 2026.