Clinical trial · Interventional
An Exploratory Tumor Biopsy-driven Study to Understand the Relationship Between Biomarkers and Clinical Response in Melanoma Patients Receiving REGN2810 (Anti-PD-1)
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)
NCT03002376CI-TRIAL-00044736completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| REGN2810 | Drug | Cemiplimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- REGN2810
- description
- REGN2810 treatment
- interventionNames
- Drug: REGN2810
Primary outcomes (1)
- measure
- Correlation between changes in the tumor microenvironment and the change in tumor volume following REGN2810 treatment versus baseline
- timeFrame
- Baseline up to week 24
Secondary outcomes (6)
- measure
- Correlation between baseline tumor characteristics and the change in tumor volume following treatment in REGN2810
- timeFrame
- Baseline up to week 24
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.