IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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
Qualifiers
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.
Disqualifiers
Patients who have had systemic therapy for melanoma or radiotherapy within 3 weeks prior to registering on the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier. Patients with a history of endocrinopathies (e.g. hypothyroidism) are eligible if they are stable on hormone replacement therapy. Patients with a history of adrenal insufficiency are not eligible.
Patients may not be receiving any other investigational agents.
Patients with active brain metastasis are excluded
Patients with clinically significant cardiovascular or cerebrovascular disease
Trial design
Treatments tested in this trial
- Interleukin-2
- Ipilimumab
- Nivolumab
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Clinigen, Inc.
Collaborator
Source ClinicalTrials.gov