Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Advanced Malignant Solid Neoplasm
  • Advanced Differentiated Thyroid Gland Carcinoma
  • Advanced Lung Small Cell Carcinoma
  • Advanced Head and Neck Carcinoma
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Recurrent Lung Small Cell Carcinoma
  • Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8
  • Recurrent Malignant Solid Neoplasm
  • Stage III Ovarian Cancer AJCC v8
  • Castration-Resistant Prostate Carcinoma
  • Recurrent Renal Cell Carcinoma
  • Stage IIIA Lung Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Recurrent Urothelial Carcinoma
  • Stage IIIB Ovarian Cancer AJCC v8
  • Recurrent Hepatocellular Carcinoma
  • Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • HIV Infection
  • Metastatic Ovarian Carcinoma
  • Recurrent Head and Neck Carcinoma
  • Stage IV Thyroid Gland Medullary Carcinoma AJCC v8
  • Advanced Hepatocellular Carcinoma
  • Advanced Thyroid Gland Medullary Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Refractory Differentiated Thyroid Gland Carcinoma
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Metastatic Malignant Solid Neoplasm
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Recurrent Lung Non-Small Cell Carcinoma
  • Metastatic Prostate Carcinoma
  • Metastatic Triple-Negative Breast Carcinoma
  • Metastatic Head and Neck Carcinoma
  • Advanced Kaposi Sarcoma
  • Advanced Lung Non-Small Cell Carcinoma
  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Pathologic Stage III Cutaneous Melanoma AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage III Thyroid Gland Medullary Carcinoma AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Metastatic Renal Cell Carcinoma
  • Stage IVB Ovarian Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Recurrent Differentiated Thyroid Gland Carcinoma
  • Metastatic Thyroid Gland Medullary Carcinoma
  • Anatomic Stage III Breast Cancer AJCC v8
  • Recurrent Kaposi Sarcoma
  • Stage IIIC Prostate Cancer AJCC v8
  • Stage IVB Hepatocellular Carcinoma AJCC v8
  • Metastatic Lung Non-Small Cell Carcinoma
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8
  • Advanced Urothelial Carcinoma
  • Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage IVB Prostate Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Metastatic Urothelial Carcinoma
  • Recurrent Prostate Carcinoma
  • Recurrent Melanoma
  • Recurrent Ovarian Carcinoma
  • Advanced Melanoma
  • Advanced Ovarian Carcinoma
  • Stage IIIA1 Ovarian Cancer AJCC v8
  • Stage IVA Hepatocellular Carcinoma AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIID Cutaneous Melanoma AJCC v8
  • Stage IIIA Hepatocellular Carcinoma AJCC v8
  • Metastatic Melanoma
  • Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
  • Advanced Prostate Carcinoma
  • Metastatic Kaposi Sarcoma
  • Recurrent Thyroid Gland Medullary Carcinoma
  • Metastatic Lung Small Cell Carcinoma
  • Triple-Negative Breast Carcinoma
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Advanced Renal Cell Carcinoma
  • Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage III Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Metastatic Differentiated Thyroid Gland Carcinoma
  • Recurrent Triple-Negative Breast Carcinoma
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 o...

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 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 [Tregs], 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 and nivolumab intravenously (IV) over 30 minutes on day 1. 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. After completion of study treatment, patients are followed up for 16 weeks.

Tracking Information

NCT #
NCT04514484
Collaborators
Not Provided
Investigators
Principal Investigator: Haiying Cheng Albert Einstein College of Medicine EDDOP