This phase II trial studies how well ipilimumab and nivolumab with cryotherapy work for the treatment of soft tissue sarcoma that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cryotherapy is a procedure that uses extreme cold to kill cancer cells. Cryotherapy may also increase the response to immunotherapy. Giving ipilimumab and nivolumab together with cryotherapy may improve clinical outcomes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04118166.
PRIMARY OBJECTIVE:
I. Assess whether the rate of clinical benefit is sufficiently high to merit promise for further study.
SECONDARY OBJECTIVES:
I. Characterize the 6 month progression free survival (PFS) rate.
II. Assess whether the treatment yields a reasonably safe and tolerable profile.
EXPLORATORY OBJECTIVES:
I. Correlate the mutation burden by next generation sequencing (NGS) with response.
II. Correlate PDL1 expression with response.
III. Correlate tumor infiltrating lymphocytes/macrophages with response.
OUTLINE:
Patients receive ipilimumab intravenously (IV) and nivolumab IV over 2 hours on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Between cycles 1 and 2, patients undergo cryotherapy. Beginning cycle 5, patients receive nivolumab IV over 1 hour on day 1. Cycles repeat every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 35 days.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorKristen Nooshin Ganjoo
