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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT04596033
Eligibility Criteria:
Inclusion Criteria:
* Consents to study procedures
* Diagnosis of one of the following solid tumors: cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), renal cell carcinoma (RCC), small cell lung cancer (SCLC), cutaneous squamous cell carcinoma (CSCC), anal squamous cell carcinoma (ASCC), merkel cell carcinoma (MCC).
* Received, been intolerant of, or been ineligible to receive standard of care treatment regimen.
* Measurable disease per RECIST criteria
* Life expectancy \> 6 months and ECOG status 0 or 1
* Capacity to tolerate lymphodepletion (SHD group only) and IL-2 therapy
* Tumor tissue available
* Willing to use contraceptives for 90 days after receiving GEN-011, and not currently pregnant.
* Adequate blood, liver, kidney, and lung function
* Sufficient stimulatory neoantigens identified in ATLAS
Exclusion Criteria:
* Receiving immunosuppressive medications
* Serious ongoing viral, bacterial, or fungal infection
* History of cardiac arrhythmias or significant heart block
* History of leptomeningeal carcinomatosis
* Active autoimmune disease
* Portal vein thrombosis
* Malignant disease other than those treated in this study
* Receiving other investigational anti-cancer therapy
* Prior stem cell or solid organ transplant
* Primary immune deficiency disease
* Significant ongoing toxicities from prior therapies
* A history of allergic reaction to sulfur derivatives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04596033
Study Brief:
Protocol Section:
NCT04596033