Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Advanced Head and Neck Carcinoma
  • Advanced Kaposi Sarcoma
  • Advanced Differentiated Thyroid Gland Carcinoma
  • Advanced Hepatocellular Carcinoma
  • Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Metastatic Head and Neck Carcinoma
  • Recurrent Lung Small Cell Carcinoma
  • Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Recurrent Thyroid Gland Medullary Carcinoma
  • Refractory Differentiated Thyroid Gland Carcinoma
  • Stage IV Renal Cell Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Metastatic Melanoma
  • Advanced Lung Non-Small Cell Carcinoma
  • Stage IVA Ovarian Cancer AJCC v8
  • Recurrent Malignant Solid Neoplasm
  • Stage IV Prostate Cancer AJCC v8
  • Metastatic Kaposi Sarcoma
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Renal Cell Carcinoma
  • Stage IIIA Hepatocellular Carcinoma AJCC v8
  • HIV Infection
  • Metastatic Differentiated Thyroid Gland Carcinoma
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Prostate Carcinoma
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Metastatic Urothelial Carcinoma
  • Stage IV Thyroid Gland Medullary Carcinoma AJCC v8
  • Recurrent Ovarian Carcinoma
  • Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Advanced Lung Small Cell Carcinoma
  • Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Metastatic Thyroid Gland Medullary Carcinoma
  • Stage IIIC Prostate Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Advanced Urothelial Carcinoma
  • Anatomic Stage III Breast Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8
  • Recurrent Kaposi Sarcoma
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Metastatic Triple-Negative Breast Carcinoma
  • Advanced Malignant Solid Neoplasm
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Recurrent Triple-Negative Breast Carcinoma
  • Stage IVB Lung Cancer AJCC v8
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IVA Hepatocellular Carcinoma AJCC v8
  • Stage IVB Hepatocellular Carcinoma AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Recurrent Renal Cell Carcinoma
  • Recurrent Differentiated Thyroid Gland Carcinoma
  • Metastatic Ovarian Carcinoma
  • Advanced Melanoma
  • Stage III Prostate Cancer AJCC v8
  • Triple-Negative Breast Carcinoma
  • Stage III Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Recurrent Head and Neck Carcinoma
  • Recurrent Melanoma
  • Advanced Ovarian Carcinoma
  • Advanced Prostate Carcinoma
  • Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Metastatic Hepatocellular Carcinoma
  • Pathologic Stage IIID Cutaneous Melanoma AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Metastatic Malignant Solid Neoplasm
  • Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8
  • Pathologic Stage III Cutaneous Melanoma AJCC v8
  • Metastatic Lung Small Cell Carcinoma
  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8
  • Stage IIIA1 Ovarian Cancer AJCC v8
  • Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8
  • Stage IVB Prostate Cancer AJCC v8
  • Recurrent Prostate Carcinoma
  • Stage III Renal Cell Cancer AJCC v8
  • Stage III Thyroid Gland Medullary Carcinoma AJCC v8
  • Stage IIIB Ovarian Cancer AJCC v8
  • Recurrent Hepatocellular Carcinoma
  • Recurrent Urothelial Carcinoma
  • Castration-Resistant Prostate Carcinoma
  • Advanced Renal Cell Carcinoma
  • Advanced Thyroid Gland Medullary Carcinoma
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