The purpose of this Phase 2 study is to 1. find out if the study drugs (ipilimumab plus nivolumab) in combination with cryotherapy will help participants with metastatic or locally advanced soft tissue sarcoma;. 2. find out how safe are ipilimumab plus nivolumab given in combination with cryotherapy, and what side effects may be related to treatment. 3. find out how do the study drugs in combination with cryotherapy work in soft tissue sarcoma.
Primary Objectives: 1\) Assess whether the rate of clinical benefit is sufficiently high to merit promise for further study Secondary Objectives: 1. Characterize the 6-month progression-free survival rate 2. Assess whether the treatment yields a reasonably safe and tolerable profile
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Ipilimumab 1 mg/kg, injection
Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
Nivolumab 3 mg/kg, injection
Stanford Medical Center
Stanford, California, United States
Clinical Response
Clinical benefit was assessed on the basis of clinical response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria: * Complete response (CR) = Disappearance of all target lesions; all lymph nodes \< 10 mm on the short axis; no new lesions. * Partial response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions; no new lesions. * Stable disease (SD) = Small changes that do not meet any of the above criteria; no new lesions. * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s). Clinical benefit was defined as CR + PR. The primary outcome is expressed as the total number of participants who receive clinical benefit within 14 weeks, a number without dispersion. Rates of all clinical responses are reported.
Time frame: 14 weeks
Related Adverse Events (Toxicity)
Adverse events were assessed per CTCAE version 5. The outcome is those adverse events experienced by participants that were determined to be possibly, probably, or definitely-related to study treatment. Serious adverse events are identified by the term "SAE." Results are presented as the number of related adverse events by preferred term that occurred. The data are numbers without dispersion.
Time frame: 24 months
Immune-related Clinical Response (irRECIST) Rate
The immune-related (ir) clinical response will be assessed per the immune-related Response Evaluation Criteria in Solid Tumors (ir-RECIST) criteria, as follows: * Complete response (CR) = Disappearance of all lesions, with any pathological lymph nodes having a reduction in short axis to \< 10 mm; no new lesions \> 5 × 5 mm in size. * Partial response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions. * Stable disease (SD) = Small changes that do not meet any of the these criteria; no new lesions \> 5 × 5 mm in size. * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions with the sum of diameters increasing ≥ 5 mm, and/or the appearance of 1+ new lesion(s). Note that irRECIST differs from RECIST criteria. The outcome is expressed as the total number of participants who achieve a ir-clinical response (ie, CR + PR) by 16 weeks, a number without dispersion.
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Time frame: 16 weeks
Progression-free Survival (PFS)
Progression-free survival (PFS) is a measure of participants remaining alive without disease progression. The outcome is expressed as the total number of participants remaining alive without disease progression at 6 months after consent, a number without dispersion.
Time frame: 6 months