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Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma

NCT04967196 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-12-10

No results posted yet for this study

Summary

This phase I trial identifies the best dose of ipilimumab that can be administered through the DoseConnect™ device followed by nivolumab in treating patients with stage III melanoma that cannot be removed by surgery (unresectable) or stage IV melanoma that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Conditions

  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Melanoma
  • Unresectable Melanoma

Interventions

BIOLOGICAL

Ipilimumab

Given via DoseConnect device or IV

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Lymph Node Assessment

Undergo lymphatic imaging with ICG

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

Principal Investigators

  • Anastasios Dimou, M.D. · Mayo Clinic in Rochester

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2024-04-17
Completion
2024-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04967196 on ClinicalTrials.gov