Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT02035657
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02035657
Study Brief:
Protocol Section:
NCT02035657