Can lower doses of immunotherapy be safer without losing effectiveness?
NCT ID NCT07174453
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study looks at whether giving a lower dose of immunotherapy (pembrolizumab or nivolumab) causes fewer serious side effects than the standard higher dose. About 192 adults with solid tumors will be randomly assigned to receive either the higher or lower dose. The main goal is to compare the number of severe immune-related side effects between the two groups.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Kansas Cancer Center
RECRUITINGWestwood, Kansas, 66205, United States
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