Actively Recruiting
Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies
Led by University of Kansas Medical Center · Updated on 2025-12-08
192
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 3/4 open label, randomized two cohort study (2 arms in each cohort). It is hypothesized that for people with a histologically or cytologically confirmed diagnosis of malignancy, the higher dose immunotherapy (every 6 weeks Pembrolizumab 400mg dose and every 4 weeks Nivolumab 480mg dose) has more immune-related adverse events irAEs compared to lower dose (every 3 weeks Pembrolizumab 200mg dose and every 2 weeks Nivolumab 240mg dose).
CONDITIONS
Official Title
Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and willing to sign informed consent
- Male or female aged 18 years or older
- ECOG Performance Status between 0 and 2
- For females who can have children, a negative urine pregnancy test within 72 hours before starting treatment
- Histologically or cytologically confirmed solid tumor malignancy
- Eligible to receive pembrolizumab or nivolumab therapy
- Any disease setting or line of therapy is allowed, including neoadjuvant, adjuvant, unresectable, or metastatic
- Allowed to receive standard combination therapies such as chemotherapy, targeted therapy, or biologics
- Adequate organ function as defined by specific blood counts and liver and kidney function tests
You will not qualify if you...
- Enrolled in any other therapeutic clinical trial at the same time
- Currently using or planning to use other immunotherapies or radiation
- Not recovered from immune-related adverse events of grade 2 or higher from prior immunotherapy, unless stable per investigator
- Diagnosed with psychiatric illness or in social situations limiting study compliance
- Currently pregnant or breastfeeding
- Known allergy to any component of the study drugs
- Active severe (grade 3 or higher) viral, bacterial, or fungal infection within 2 weeks before first study dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
Research Team
C
Cathey Belcher
CONTACT
K
KUCC Nurse Navigation
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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