Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma

Summary

This phase II trial investigates the side effects of tocilizumab, ipilimumab, and nivolumab in treating patients with melanoma, non-small cell lung cancer, or urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced). 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. Tocilizumab is a monoclonal antibody that may interfere with the immune system to decrease immune-related toxicities. Giving tocilizumab, ipilimumab, and nivolumab may kill more tumor cells.

Conditions

• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Locally Advanced Bladder Carcinoma
• Locally Advanced Bladder Urothelial Carcinoma
• Locally Advanced Lung Non-Small Cell Carcinoma
• Locally Advanced Renal Pelvis Carcinoma
• Locally Advanced Renal Pelvis Urothelial Carcinoma
• Locally Advanced Ureter Urothelial Carcinoma
• Locally Advanced Urethral Urothelial Carcinoma
• Malignant Solid Neoplasm
• Metastatic Bladder Carcinoma
• Metastatic Bladder Urothelial Carcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Melanoma
• Metastatic Renal Pelvis Urothelial Carcinoma
• Metastatic Ureter Urothelial Carcinoma
• Metastatic Urethral Carcinoma
• Metastatic Urethral Urothelial Carcinoma
• Pathologic Stage III Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
• Pathologic Stage IIID Cutaneous Melanoma AJCC v8
• Pathologic Stage IV Cutaneous Melanoma AJCC v8
• Stage III Bladder Cancer AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage III Renal Pelvis Cancer AJCC v8
• Stage III Ureter Cancer AJCC v8
• Stage III Urethral Cancer AJCC v8
• Stage IIIA Bladder Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Bladder Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Bladder Cancer AJCC v8
• Stage IV Lung Cancer AJCC v6
• Stage IV Renal Pelvis Cancer AJCC v8
• Stage IV Ureter Cancer AJCC v8
• Stage IV Urethral Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8
• Unresectable Melanoma

Interventions

BIOLOGICAL

Ipilimumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

BIOLOGICAL

Tocilizumab

Given SC

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Rodabe Amaria, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-23

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations