Loading clinical trials...

Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

Phase II Study of Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

NCT06365619•University of Utah

View on ClinicalTrials.gov

Summary

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 while receiving or within 3 months of completion of adjuvant anti-PD1 therapy.
•ECOG Performance Status ≤ 1.
•Adequate organ function as defined as:
•* Hematologic:
•* Absolute neutrophil count (ANC) ≥ 1500/mm3
•* Platelet count ≥ 100,000/mm3
•* Hemoglobin ≥ 10 g/dL
•* Hepatic:
+16 more criteria

Exclusion Criteria

•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.
•Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
•Active infection requiring the use of systemic antibiotics.
•Systemic steroid therapy greater than physiologic equivalent (10mg prednisone/day) or any other form of systemic immunosuppressive therapy within 7 days prior to registration.
•Active secondary malignancy, unless the malignancy is not expected to interfere with the evaluation of safety
•Known brain metastases or cranial epidural disease.
•Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
•--Cardiovascular disorders:
+14 more criteria

Locations (1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Key Dates

Start Date

February 1, 2026

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2029

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Melanoma

Interventions

Ipilimumab

DRUG

Nivolumab

DRUG

Contacts

Kaitlin Stephens

CONTACT

801-213-8494 kaitlin.stephens@hci.utah.edu

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers