Comparing immune side effects of higher versus lower dosing schedules of pembrolizumab and nivolumab for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized Phase 3/4 study with two cohorts, each containing two dosing arms, comparing higher less-frequent versus lower more-frequent standard dosing of pembrolizumab and nivolumab. The primary focus is on immune-related adverse events (irAEs) while allowing standard-of-care combination agents and any disease setting or line of therapy. Adults with histologically or cytologically confirmed solid tumors who are eligible for these PD‑1 inhibitors and have adequate organ function and ECOG 0–2 can enroll. The design aims to directly compare safety profiles of the different standard dosing strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• The University of Kansas Cancer Center
  Westwood, Kansas, United States Recruiting

Study contacts

• Principal investigator: Anup Kasi, MD — University of Kansas Medical Center
• Study coordinator: KUCC Nurse Navigation
• Email: CTNurseNav@kumc.edu
• Phone: 913-945-7552

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.