MelanomaPhase 1NCT03002376
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)
A Phase 1 study testing REGN2810 in people with Melanoma, run by Regeneron Pharmaceuticals at 8 sites in 4 countries.
Trial summary
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- REGN2810
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 10 Apr 2017to 19 Mar 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically confirmed diagnosis of stage III (unresectable) or stage IV cutaneous melanoma (non-acral lentiginous) with at least 1 lesion that is measurable by RECIST 1.1 criteria and accessible for biopsies
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Adequate hepatic function
- Adequate renal function
- Adequate bone marrow function
- Willing and able to comply with clinic visits and study-related procedures
Show all 9Show fewer
- Provide signed informed consent
- Able to understand and complete study-related questionnaires
- Anticipated life expectancy >12 weeks
Who cannot join
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
- Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway)
- Prior treatment with other immune modulating anti-cancer agents, except for remote treatment (>6 months) in adjuvant setting.
- Untreated or active brain metastases or spinal cord compression
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
- Other protocol-defined inclusion/exclusion criteria will apply
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 135-710
Severance Hospital-Yonsei University College of Medicine
Seoul
United Kingdom2 sites
Guy's Hospital and St. Thomas NHS Foundation Trust
London
Churchill Hospital
Oxford, 0X3 7LE
About this study
Official title: An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Indicators of Clinical Response in Immunomodulatory Treatment-naïve Unresectable Stage III/IV Melanoma Patients Receiving REGN2810 (Anti-PD-1)
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.
- Conditions
- Melanoma
- Being tested
- REGN2810
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN2810Drug
Also called cemiplimab, Libtayo
REGN2810 treatment
| Study group | Role | What they receive |
|---|---|---|
| REGN2810 | Experimental | REGN2810 treatment Receives: Drug: REGN2810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline
Measured: Baseline up to week 24
Secondary outcomes (6)
Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810
Measured: Baseline up to week 24
Incidence of Adverse Event (AEs) in patients treated with REGN2810
Measured: Baseline through treatment with REGN2810 (up to 48 weeks) and follow up
REGN2810 serum concentrations
Measured: Baseline up to 6 weeks following last dose of REGN2810
Anti-REGN2810 antibody levels
Measured: Baseline up to 6 weeks following last dose of REGN2810
The progression-free survival (PFS) in patients treated with REGN2810
Measured: Baseline up to 6 weeks following last dose of REGN2810
The overall response rate in patients treated with REGN2810
Measured: Baseline up to 6 weeks following last dose of REGN2810
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start10 Apr 2017
- Primary completion5 Mar 2019
- Study completion19 Mar 2020
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002376
- Sponsor's protocol ID
- R2810-ONC-1606
- Other IDs
- 2016-002755-16, 2016
- Status last verified
- Apr 2020
- First submitted
- 20 Dec 2016
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Indicators of Clinical Response in Immunomodulatory Treatment-naïve Unresectable Stage III/IV Melanoma Patients Receiving REGN2810 (Anti-PD-1)
- ClinicalTrials.gov ID
- NCT03002376
- Acronym / sponsor ID
- R2810-ONC-1606
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 23 Dec 2016 (estimated)
- 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 being conducted to compare the relationship of patient response to treatment to changes in tumor environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REGN2810 | Experimental | Drug: REGN2810REGN2810 treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed diagnosis of stage III (unresectable) or stage IV cutaneous melanoma (non-acral lentiginous) with at least 1 lesion that is measurable by RECIST 1.1 criteria and accessible for biopsies
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Adequate hepatic function
- Adequate renal function
- Adequate bone marrow function
Key exclusion criteria (6 listed)
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
- Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway)
- Prior treatment with other immune modulating anti-cancer agents, except for remote treatment (>6 months) in adjuvant setting.
- Untreated or active brain metastases or spinal cord compression
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810
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 |
|---|---|---|
| REGN2810Also: cemiplimab, LibtayoREGN2810 treatment | Drug | REGN2810 |
Primary outcome
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline
Time frame: Baseline up to week 24
6 secondary outcomes
Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810
Time frame: Baseline up to week 24
Incidence of Adverse Event (AEs) in patients treated with REGN2810
Time frame: Baseline through treatment with REGN2810 (up to 48 weeks) and follow up
REGN2810 serum concentrations
Time frame: Baseline up to 6 weeks following last dose of REGN2810
Anti-REGN2810 antibody levels
Time frame: Baseline up to 6 weeks following last dose of REGN2810
The progression-free survival (PFS) in patients treated with REGN2810
Time frame: Baseline up to 6 weeks following last dose of REGN2810
The overall response rate in patients treated with REGN2810
Time frame: Baseline up to 6 weeks following last dose of REGN2810
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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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. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN2810 in people with Melanoma, run by Regeneron Pharmaceuticals at 8 sites in 4 countries.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea, United Kingdom, Netherlands, Serbia. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline (time frame: Baseline up to week 24). 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 20 Apr 2020; AzTrials last refreshed its copy on 28 Oct 2026.