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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04514484
Phase
PHASE1
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cabozantinib S-malate — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Nov 22, 2021
Status verified
May 2026
Primary completion
Nov 11, 2024
Completion
Feb 6, 2027

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cabozantinib s-malate, nivolumab)
    Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab 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 CT scan and/or MRI as well as blood sample collection throughout the trial.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Related coverage on Hipa.ai

Find similar trials in Chicago, IL

By condition
HIVMelanomaKidney cancer
By specialty
Infectious diseaseOncologySkin cancerDermatologyUrology
By research site
Northwestern University· Chicago, ILMontefiore Medical Center-Einstein Campus· The Bronx, NYUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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