Health TrialsbyHealthPanel

IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients

ConditionsMelanoma Stage IIIMelanoma Stage IVInoperable Disease
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Interleukin-2

    Drug

    High dose interleukin-2 (HD IL2) administered week 1 and 4 of each course (approximately 12 weeks)

  • Ipilimumab

    Drug

    Low dose Ipilimumab given at time of HD IL2 administration on day 1 of the first 2 cycles of each course.

  • Nivolumab

    Drug

    Nivolumab will be given at a dose of 480 mg IV week 7 of each course.

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Response Rate

Response rate (Complete Response + Partial Response) of HD IL2 plus low dose ipilimumab followed sequentially by nivolumab in patients with inoperable stage III or stage IV melanoma who have either failed prior treatment with anti-PD1 immunotherapy (nivolumab or pembrolizumab) or have demonstrated tumor progression following such therapy.

Time frame
Up to 9 months

Secondary outcomes

1

Progression Free Survival

Progression Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression (or death if there is no progression date). Patients with neither a progression date nor date of death will be censored as of last contact.

Time frame
Up to 5 years
2

Overall Survival

Overall Survival (OS) will be measured from the initial date of treatment to the recorded date of death.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Clinigen, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now