Clinical trial · Interventional
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
A Proof-of-Concept Clinical Trial of Intratumoral Injection of GLA-SE, a Toll-like Receptor-4 Agonist, in Patients With Merkel Cell Carcinoma
NCT02035657CI-TRIAL-00033299completedPhase 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 is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
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 |
|---|---|---|---|
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GLA-SE | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GLA-SE
- description
- Glucopyranosyl Lipid A in Stable Emulsion
- interventionNames
- Biological: GLA-SE
Primary outcomes (1)
- measure
- Safety and feasibility
- timeFrame
- 1 year
- description
- The number of treatment-related adverse events
Secondary outcomes (2)
- measure
- Clinical efficacy and Immunogenicity
- timeFrame
- 1 Year
- description
- The secondary objectives are to assess the clinical efficacy of as well as the immunological effects of GLA-SE in patients with MCC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease. * Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection. * ECOG performance status score 0, 1 or 2 * ≥ 18 years of age * Life expectancy of ≥ three months. * Adequate neutrophil and platelet counts * Adequate renal and hepatic function * Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy * Use of effective contraception * Signed informed consent document * Members of all genders, races and ethnic groups are eligible for this trial Exclusion Criteria: * Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment * No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents * Active, untreated brain metastases * Pregnant or nursing * Use of any systemic immunosuppressive agents * Immunosuppressed patients * Uncontrolled depression or other major psychiatric disorder
References
Publications (0)
Data not yet available
No reference posted for this study.