NCT04562129 IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
| NCT ID | NCT04562129 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Condition | Melanoma Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2020-09-24 |
| Primary Completion | 2026-07 |
Trial Parameters
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Brief Summary
The purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma.
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed metastatic melanoma. This includes American Joint Committee on Cancer (AJCC) stage IV or advanced/inoperable stage III. This also includes patients with a history of lower stage melanoma and subsequent recurrent metastatic disease that is either locally/regionally advanced/inoperable disease or distant metastases * Measurable disease, according to RECIST version 1.1 * Must be free of active brain metastasis by contrast-enhanced CT/MRI scans within 4 weeks prior to enrollment. If known to have prior brain metastases, these must have been adequately managed with standard of care radiation therapy, stereotactic radiosurgery or surgery prior to registration on the study. * Must have previously received anti-PD1 immunotherapy (nivolumab or pembrolizumab) and later experienced disease progression. * Must not have received systemic therapy or radiotherapy (including SRS) within the preceding 3 weeks. Patients must have recovered
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