Status:
RECRUITING
Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Solid Tumor Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Ability of participant to understand this study, and participant willingness to sign a written informed consent.
- Males and females age ≥ 18 years
- ECOG Performance Status (PS) 0 - 2 (Appendix A.)
- Females of childbearing potential must have a negative urine pregnancy test 72 hours prior to initiating treatment.
- Histologically or cytologically confirmed diagnosis of solid tumor malignancy
- Eligible to receive pembrolizumab or nivolumab based therapy
- Any disease setting (neoadjuvant, adjuvant, unresectable, metastatic) or any line of therapy is allowed. NOTE: Standard of care combination agents(chemotherapy, targeted therapy, biologics) are allowed because irAEs are the primary objective
- Adequate organ function, defined as follows:
- Leukocytes (White Blood Cell \[WBC\]) \>1.0 K/UL Absolute Neutrophil Count \>1.0 K/UL Platelets \> 50 K/UL Hemoglobin ≥ 7 g/dL Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation Total bilirubin ≤ 1.5 x ULN Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
Exclusion
- Simultaneously enrolled in any therapeutic clinical trial
- Concurrent or planned use of other immunotherapies or radiation
- Has not recovered from irAEs due to prior immunotherapy treatment (\>=grade 2 is considered not recovered). Conditions that meet grade 2 criteria but are considered clinically stable at the discretion of the investigator will be allowed.
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- Currently pregnant or breastfeeding
- Has a known allergic reaction to any excipient contained in the study drug formulation
- Active Grade 3 (per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 ) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT07174453
Start Date
October 7 2025
End Date
October 1 2029
Last Update
December 8 2025
Active Locations (1)
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1
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205