NCT03274258

Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well nivolumab and ipilimumab work in treating patients with kidney cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, 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 OBJECTIVES: I. To determine the objective response rate (ORR) of patients with locally advanced or metastatic renal medullary carcinoma (RMC) treated with combination of nivolumab plus ipilimumab. SECONDARY OBJECTIVES: I. To determine the efficacy and safety of the combination of nivolumab plus ipilimumab in patients with RMC. II. To evaluate potential biomarkers for patient stratification and treatment response, as well as tumor antigen-specific immune responses, such as antibody and T cell responses, as surrogates for anti-tumor activity. OUTLINE: Patients receive nivolumab intravenously (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 day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

Conditions

• Kidney Medullary Carcinoma
• Loss of INI 1 Protein Expression
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Ipilimumab	Given IV
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2017-12-13
• Primary completion: 2025-11-21
• Completion: 2025-11-21
• First posted: 2017-09-06
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study