NCT04967196

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

Phase 1 Study of the Administration of Ipilimumab Intra-Lymphatically Using the Sofusa® DoseConnect™ DEVICE With Nivolumab Administered IV in Patients With Metastatic Melanoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) of ipilimumab that can be administered through the DoseConnect™ device followed 30 minutes later by nivolumab intravenously (IV) on day 1 of a 21-day cycle in patients with metastatic melanoma. (Cohort A) II. To determine the maximum tolerated dose (MTD) of ipilimumab that can be administered through up to four (4) DoseConnect™ devices, followed by nivolumab IV on Day 1 of four 21-day cycle in patients with metastatic melanoma. (Cohort B) SECONDARY OBJECTIVE: I. To assess the pharmacokinetics of ipilimumab administered using the DoseConnect™ followed by nivolumab IV in patients with metastatic melanoma. (Cohort A) II. To assess the rate of Grade 3 and 4 adverse events, as well as the rate of drug discontinuation for adverse events and objective response rate (ORR) for patients who receive ipilimumab via the DoseConnect™ device for four cycles in combination with nivolumab administered as an IV infusion, without any IV administration of ipilimumab. (Cohort B) CORRELATIVE OBJECTIVE: I. To assess the changes in immunologic profile after one cycle of ipilimumab administered using the DoseConnect™ followed by nivolumab IV. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT A: Patients receive ipilimumab intra-lymphatically via DoseConnect™ on day 1 of cycle 1 and IV over 30 minutes on day 1 of cycles 2-4. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo lymphatic imaging with indocyanine green (ICG) prior to treatment start and blood sample collection throughout the study. (CLOSED TO ENROLLMENT) COHORT B: Patients receive ipilimumab intra-lymphatically via DoseConnect™ and nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study and may optionally undergo lymphatic imaging with ICG prior to treatment start. After completion of study treatment, patients are followed up every 4 months until disease progression, and then every 6 months for up to 2 years after registration.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-16
• Primary completion: 2024-04-17
• Completion: 2024-04-17
• First posted: 2021-07-19
• Last updated: 2024-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study