NCT07174453 Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies
| NCT ID | NCT07174453 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Kansas Medical Center |
| Condition | Solid Tumor Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2025-10-07 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 192 participants in total. It began in 2025-10-07 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility Criteria
Inclusion Criteria: 1. Ability of participant to understand this study, and participant willingness to sign a written informed consent. 2. Males and females age ≥ 18 years 3. ECOG Performance Status (PS) 0 - 2 (Appendix A.) 4. Females of childbearing potential must have a negative urine pregnancy test 72 hours prior to initiating treatment. 5. Histologically or cytologically confirmed diagnosis of solid tumor malignancy 6. Eligible to receive pembrolizumab or nivolumab based therapy 7. 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 8. 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 Criteria: 1. Simultaneously enrolled in any therapeutic clinical trial 2. Concurrent or planned use of other immunotherapies or radiation 3. 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. 4. Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements 5. Currently pregnant or breastfeeding 6. Has a known allergic reaction to any excipient contained in the study drug formulation 7. 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.
Contact & Investigator
Anup Kasi, MD
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT07174453 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07174453 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 192 participants.
Is NCT07174453 currently recruiting?
Yes, NCT07174453 is actively recruiting participants. Contact the research team at CTNurseNav@kumc.edu for enrollment information.
Where is the NCT07174453 trial being conducted?
This trial is being conducted at Westwood, United States.
Who is sponsoring the NCT07174453 clinical trial?
NCT07174453 is sponsored by University of Kansas Medical Center. The principal investigator is Anup Kasi, MD at University of Kansas Medical Center. The trial plans to enroll 192 participants.