New immunotherapy cocktail shows promise for Hard-to-Treat cancers
NCT ID NCT05134948
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a fixed-dose combination of two immunotherapy drugs (relatlimab and nivolumab) in 24 Chinese patients with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety, how the drugs move through the body, and any early signs of tumor shrinkage. While not a cure, this approach aims to help the immune system better control the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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24 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Oct 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment * Participants must have received, and then progressed, or been intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists * ECOG status of 0 or 1 * Life expectancy of ≥ 12 weeks at the time of informed consent per Investigator assessment Exclusion Criteria: * Participants with history of severe and/or life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) * Participants with an active, known or suspected autoimmune disease * Participants with primary CNS tumors Other protocol-defined inclusion/exclusion criteria apply
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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.
Contacts and locations
Locations
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Local Institution - 0001
Beijing, Beijing Municipality, 100142, China
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Local Institution - 0002
Fuzhou, Fujian, 350014, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors