An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)

Study Purpose

This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

  • - 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 - Provide signed informed consent - Able to understand and complete study-related questionnaires - Anticipated life expectancy >12 weeks Key

    Exclusion Criteria:

    - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03002376
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Regeneron Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trial Management
Principal Investigator Affiliation Regeneron Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Korea, Republic of, Netherlands, Serbia, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul National Univesity Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National Univesity Hospital

Seoul, , 03080

Site Contact

844-734-6643

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 05505

Site Contact

844-734-6643

Samsung Medical Center, Seoul, Korea, Republic of

Status

Suspended

Address

Samsung Medical Center

Seoul, , 135-710

Site Contact

844-734-6643

Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital-Yonsei University College of Medicine

Seoul, ,

Site Contact

844-734-6643

Radboud University Medical Center, Nijmegen, Netherlands

Status

Recruiting

Address

Radboud University Medical Center

Nijmegen, , 6500 HB

Site Contact

844-734-6643

Military Medical Academy, Belgrade, Serbia

Status

Recruiting

Address

Military Medical Academy

Belgrade, , 11000

Site Contact

844-734-6643

London, United Kingdom

Status

Recruiting

Address

Guy's Hospital and St. Thomas NHS Foundation Trust

London, ,

Site Contact

844-734-6643

Churchill Hospital, Oxford, United Kingdom

Status

Recruiting

Address

Churchill Hospital

Oxford, , 0X3 7LE

Site Contact

844-734-6643

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