Testing the Addition of Immunotherapy Before Surgery for Patients With Sarcomatoid Mesothelioma

Conditions

• Pleural Biphasic Mesothelioma
• Pleural Sarcomatoid Mesothelioma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — BIOLOGICAL
  Given IV
• Ipilimumab — BIOLOGICAL
  Given IV
• Surgical Procedure — PROCEDURE
  Undergo surgery
• Computed Tomography — PROCEDURE
  undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Positron Emission Tomography — PROCEDURE
  Undergo PET

Study Details

This phase II trial evaluates the safety and effectiveness of giving immunotherapy (nivolumab and ipilimumab) before surgery for controlling disease in patients with stage I-IIIa sarcomatoid mesothelioma. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving immunotherapy before surgery may be more effective at controlling disease in patients with sarcomatoid mesothelioma than giving immunotherapy alone.

Key Dates

Start date

Nov 27, 2024

Status verified

Jun 2026

Primary completion

Dec 15, 2026

Completion

Dec 15, 2026

Study Design

Enrollment

26 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (nivolumab, ipilimumab, surgery)
  Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.

Primary Outcome Measure

Surgery Rate [ Time Frame: immediately after the completion of neoadjuvant immunotherapy and surgery ]

Central Contacts

• Aaron Mansfield, MD
  507-293-0569
  [email protected]
• Colleen Watt
  [email protected]

Locations (132)

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