Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer

Conditions

• Adrenal Cortical Carcinoma
• Locally Advanced Adrenal Cortex Carcinoma
• Stage III Adrenal Cortex Carcinoma
• Stage IV Adrenal Cortex Carcinoma AJCC v8
• Unresectable Adrenal Cortex Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

This phase II trial tests how well cabozantinib in combination with pembrolizumab works in treating patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Cabozantinib inhibits receptor tyrosine kinases, which are receptors commonly over-expressed by tumor cells. This may result in an inhibition of both tumor growth and blood vessel formation, eventually leading to a decrease in tumor size or extent in the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Adding cabozantinib to pembrolizumab may be more effective at treating patients with adrenal cortical cancer than giving these drugs alone.

Key Dates

Start date

Jan 15, 2025

Status verified

Feb 2026

Primary completion

Dec 16, 2027

Completion

Dec 16, 2028

Study Design

Enrollment

21 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (cabozantinib, pembrolizumab)
  Patients receive cabozantinib orally (PO) once daily (QD) on days 1-21 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) at screening and then every 12 weeks on study and undergo collection of blood samples at screening, on study, and at end of treatment. Patients without archival tissue also undergo biopsy at screening.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Every 12 weeks, assessed up to 2 years ]

Central Contacts

• Shahid S. Ahmed, MBBS
  404-778-1900
  [email protected]

Locations (2)

Find similar trials in Atlanta, GA

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