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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Ipilimumab

    Drug

    Two cycles of neoadjuvant ipilimumab prior to surgical resection.

  • Nivolumab

    Drug

    two cycles of neoadjuvant nivolumab prior to surgical resection.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment: All PatientsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery.

Assess the pathologic response rate (pRR) at the time of surgery after two doses of neoadjuvant Ipilimumab and Nivolumab for patients with resectable disease that have recurred after receiving systemic anti-PD1 therapy.

Time frame
2 months

Secondary outcomes

1

Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.

Assess the safety and tolerability of Ipilimumab and Nivolumab in the study population.

Time frame
2 months
2

Rate of adverse events that occur within 30 days post-surgery.

Assess the impact of neoadjuvant ipi/nivo on morbidity of definitive surgery.

Time frame
30 days
3

Rate of Event Free Survival (EFS).

Assess EFS in the study population.

Time frame
11 years
4

Rate of Overall Survival (OS).

Assess OS in this study population.

Time frame
11 years

Other outcomes

Sponsors and contacts

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

University of Utah

Lead sponsor

Source ClinicalTrials.gov
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