Nivolumab, Cabozantinib S-Malate, and Ipilimumab in Treating Patients With Recurrent Stage IV Non-small Cell Lung Cancer

Conditions

• Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
• Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
• Stage IV Lung Non-Small Cell Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib — DRUG
  Given PO
• Ipilimumab — BIOLOGICAL
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

This partially randomized phase II trial studies how well nivolumab, cabozantinib s-malate, and ipilimumab work in treating patients with stage IV non-small cell lung cancer that has come back. 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. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab, cabozantinib s-malate, and ipilimumab may work better than cabozantinib s-malate alone in treating patients with stage IV non-small cell lung cancer.

Key Dates

Start date

May 7, 2018

Status verified

Sep 2023

Primary completion

May 9, 2022

Completion

Dec 21, 2022

Study Design

Enrollment

3 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (nivolumab)
  Patients receive nivolumab IV over 60 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (nivolumab, cabozantinib)
  Patients receive nivolumab IV over 60 minutes on day 1 and cabozantinib s-malate PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm C (nivolumab, cabozantinib, ipilimumab)
  Patients receive nivolumab IV over 60 minutes on day 1, cabozantinib s-malate PO daily on days 1-28, and ipilimumab IV over 90 minutes every 8 weeks. Cycles for nivolumab and cabozantinib s-malate repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm T (Targeted cohort; nivolumab, cabozantinib)
  Patients with ROS1 gene rearrangement, MET exon 14 splice mutations, MET high amplification, or RET gene rearrangement receive nivolumab IV over 60 minutes on day 1 and cabozantinib s-malate PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Every 3 months up to 4 years and 2 months ]

Locations (468)

Find similar trials in Anchorage, AK

Related Studies

• Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Anchorage, Alaska
• Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
  PHASE3 · Recruiting · National Cancer Institute (NCI) · Anchorage, Alaska