Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy.
Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response.
Eligibility criteria
Qualifiers
Subjects aged ≥ 18 years.
Histologically confirmed Stage IIIB-D or Stage IV recurrent metastatic melanoma that is resectable or borderline resectable as determined by a Surgical Oncologist.
Recurrent disease at eligibility must have been confirmed with biopsy after receiving prior anti-PD1 based systemic therapy (either adjuvant, neoadjuvant, or definitive therapy).
ECOG Performance Status ≤ 1.
Disqualifiers
Prior exposure to anti-CTLA4 therapy.
Receiving other investigational agents currently or within 28 days of study treatment.
Prior systemic anti-cancer therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
Prior radiotherapy 45 days prior to the first dose of study treatment.
Trial design
Treatments tested in this trial
- Ipilimumab
- Nivolumab
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov