Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies

Part of paid clinical trials in Westwood, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT07174453
Phase
PHASE3
Status
Recruiting
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Conditions

  • Solid Tumor Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Immunotherapy
  • Pembrolizumab — DRUG
    Immunotherapy

Study Details

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).

Key Dates

Start date
Oct 7, 2025
Status verified
Dec 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2029

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Pembrolizumab Cohort- Dose: 200 mg Route: IV Schedule: Once every 3 weeks Overall Treatment Duration per Participation: Average of 12 months Cycle Length: Per SOC (3 weeks) Nivolumab Cohort- Dose: 240 mg Route: IV Schedule: Once every 2 weeks Overall Treatment Duration per Participation: Average of 12 months Cycle Length: Per SOC (2 weeks)
  • Experimental: Arm 2
    Nivolumab Cohort- Dose: 480 mg Route: IV Schedule: Once every 4 weeks Overall Treatment Duration per Participant: Average of 12 months Cycle length: Per SOC (4 weeks) Pembrolizumab Cohort- Dose: 400 mg Route: IV Schedule: Once every 6 weeks Overall Treatment Duration per Participant: Average of 12 months Cycle length: Per SOC (6 weeks)

Primary Outcome Measure

Proportions of grade ≥3 immune related adverse events (irAEs) between the two arms in each cohort [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Kansas Cancer CenterWestwoodKansas66205
KUCC Navigation
[email protected]
913-945-7552

Find similar trials in Westwood, KS

By research site
The University of Kansas Cancer Center· Westwood, KS

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