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

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Trial Identification

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

Official Title: Pilot Trial of Nivolumab Plus Cabozantinib for Advanced Solid Tumors in Patients With HIV Infection

Study ID: NCT04514484

Conditions

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 Prostate Carcinoma
Advanced Renal Cell Carcinoma
Advanced Thyroid Gland Medullary 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

Study Description

Brief 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.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the safety of combined nivolumab and cabozantinib s-malate (XL184 \[cabozantinib\]) in human immunodeficiency virus (HIV) patients with advanced solid tumors. II. To determine the feasibility to deliver the combined nivolumab and XL184 (cabozantinib) for a minimum of 4 cycles in at least 75% of the subjects in the expanded cohort with Kaposi sarcoma (KS) or to achieve a confirmed objective response. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity in subjects with Kaposi sarcoma (KS). II. To assess the effect of treatment on participants' immune status (CD4 and CD8 cell counts) and HIV viral loads. III. To preliminarily evaluate the objective response rate (ORR) to the combination treatment in subjects with KS. EXPLORATORY OBJECTIVES: I. To assess duration of response (DOR), progression-free survival (PFS), and overall survival (OS) in subjects with KS. II. To assess the PD-L1 immunohistochemistry (IHC) status in tumors and tumor microenvironment and its association with clinical outcome. III. To assess the expression characteristics and cellular distribution of immune checkpoints (PD-L1, B7x, HHLA2, B7H3), infiltrating immune cells (CD4 T cells, CD8 T cells, regulatory T-cells \[Treg\], myeloid-derived suppressor cell \[MDSC\]), and other tumor microenvironment biomarkers (VEGF, VEGFR, MET, and AXL) in the tissue by multiplex quantitative immunofluorescence (MQIF). IV. To correlate markers of immune activation and expansion of immune cell subsets and cytokines with clinical outcomes. V. To assess the treatment effects on latent HIV reservoir. VI. To investigate the dynamic changes of immune checkpoints, angiogenesis markers, and infiltrating immune cells among subjects with available pre- and post-treatment biopsy samples (including subjects with Kaposi sarcoma \[KS\]). OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28 of each cycle and nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a computed tomography (CT) scan and/or magnetic resonance imaging (MRI) as well as blood sample collection throughout the trial. After completion of study treatment, patients are followed up for 16 weeks.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Northwestern University, Chicago, Illinois, United States

Montefiore Medical Center-Einstein Campus, Bronx, New York, United States

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States

Contact Details

Name: Haiying Cheng

Affiliation: Albert Einstein College of Medicine EDDOP

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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