Last updated on October 2018

Ipilimumab With or Without Nivolumab in Treating Patients With Melanoma That Is Stage IV or Stage III and Cannot Be Removed by Surgery


Brief description of study

This randomized phase II trial studies how well ipilimumab with or without nivolumab work in treating patients with melanoma that is stage IV or stage III and cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of tumor cells to grow and spread.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To compare progression free survival (PFS) of patients with advanced melanoma refractory to an anti-PD-1 or anti-PD-L1 agent, treated with combination therapy ipilimumab plus nivolumab versus ipilimumab alone.

SECONDARY OBJECTIVES:

I. To estimate difference in T-cell infiltrate between on-study biopsy samples of patients who respond to combination therapy (including confirmed and unconfirmed, complete and partial response per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) as compared to those who do not respond.

II. To evaluate the objective response rate (ORR), defined as confirmed complete or partial response per RECIST 1.1, in each treatment arm.

III. To evaluate the overall survival (OS) of patients in each treatment arm. IV. To evaluate the toxicity profile of patients in each treatment arm.

TERTIARY OBJECTIVES:

I. To assess the marginal prognostic value of baseline T-cell density, T-cell receptor (TCR) clonality, and mutational load in terms of response.

II. To assess the joint prognostic value of T-cell density, TCR clonality, and mutational load in terms of response.

III. To identify T-cell poor subtype(s) that are associated with response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 1 year.

Clinical Study Identifier: NCT03033576

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John A. Keech

MultiCare Gig Harbor Medical Park
Gig Harbor, WA United States
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John A. Keech

Tacoma/Valley Radiation Oncology Centers-Gig Harbor
Gig Harbor, WA United States
2.63miles
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John A. Keech

MultiCare Tacoma General Hospital
Tacoma, WA United States
7.52miles
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Mehmet S. Copur

Franciscan Research Center-Northwest Medical Plaza
Tacoma, WA United States
7.79miles
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Mehmet S. Copur

Northwest Medical Specialties PLLC
Tacoma, WA United States
7.79miles
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John A. Keech

Tacoma/Valley Radiation Oncology Centers-Saint Joe's
Tacoma, WA United States
7.79miles
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