Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV

Summary

This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.

Conditions

• Advanced Prostate Carcinoma
• Advanced Renal Cell Carcinoma
• Advanced Thyroid Gland Medullary Carcinoma
• Advanced Differentiated Thyroid Gland Carcinoma
• Advanced Head and Neck Carcinoma
• Advanced Hepatocellular Carcinoma
• Advanced Kaposi Sarcoma
• Advanced Lung Non-Small Cell Carcinoma
• Advanced Lung Small Cell Carcinoma
• Advanced Malignant Solid Neoplasm
• Advanced Melanoma
• Advanced Ovarian Carcinoma
• Advanced Triple-Negative Breast Carcinoma
• Advanced Urothelial Carcinoma
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Castration-Resistant Prostate Carcinoma
• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• HIV Infection
• Metastatic Differentiated Thyroid Gland Carcinoma
• Metastatic Head and Neck Carcinoma
• Metastatic Hepatocellular Carcinoma
• Metastatic Kaposi Sarcoma
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Lung Small Cell Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Metastatic Ovarian Carcinoma
• Metastatic Prostate Carcinoma
• Metastatic Renal Cell Carcinoma
• Metastatic Thyroid Gland Medullary Carcinoma
• Metastatic Triple-Negative Breast Carcinoma
• Metastatic Urothelial Carcinoma
• Recurrent Differentiated Thyroid Gland Carcinoma
• Recurrent Head and Neck Carcinoma
• Recurrent Hepatocellular Carcinoma
• Recurrent Kaposi Sarcoma
• Recurrent Lung Non-Small Cell Carcinoma
• Recurrent Lung Small Cell Carcinoma
• Recurrent Malignant Solid Neoplasm
• Recurrent Melanoma
• Recurrent Ovarian Carcinoma
• Recurrent Prostate Carcinoma
• Recurrent Renal Cell Carcinoma
• Recurrent Thyroid Gland Medullary Carcinoma
• Recurrent Triple-Negative Breast Carcinoma
• Recurrent Urothelial Carcinoma
• Refractory Differentiated Thyroid Gland Carcinoma
• Stage III Differentiated Thyroid Gland Carcinoma AJCC v8
• Stage III Hepatocellular Carcinoma AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage III Renal Cell Cancer AJCC v8
• Stage III Thyroid Gland Medullary Carcinoma AJCC v8
• Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8
• Stage IV Hepatocellular Carcinoma AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Prostate Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Stage IV Thyroid Gland Medullary Carcinoma AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Haiying Cheng · Albert Einstein College of Medicine EDDOP

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-22

Primary Completion

2024-11-11

Completion

2027-02-06

FDA Drug

Yes

Countries

• United States

Study Locations