Cancer patients may not need lifelong immunotherapy, study suggests
NCT ID NCT04157985
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at people with advanced solid tumors (like lung, bladder, or melanoma) who had been on immunotherapy for one year and whose disease was stable. Half stopped treatment and half continued. The goal was to see if stopping early affected how long until the cancer progressed. The results help doctors decide the best length of treatment.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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161 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Nov 2025
- 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.
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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: * All patients must have an advanced solid tumor malignancy (specifically NSCLC, bladder, HNSCC, renal, melanoma, cervical, Merkel cell, MMR/MSI \[colon, rectal, cholangio, esophageal, ovarian, uterine\], anal, gastric and GE junction, hepatocellular, triple negative breast cancer) that is being treated with a PD-1/PD-L1 inhibitor including pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab according to standard of care treatment. * Patients who initially started treatment with another agent in combination with the PD-1/PD-L1 inhibitor, i.e. chemotherapy, ipilumumab, are eligible. * Patients must have at least stable disease as evidenced by scans performed within 6 weeks of randomization. * Signed Informed consent allowing randomization to stopping immunotherapy at 1 year ± 6 weeks versus continued treatment beyond 1 year. * Patients can have measurable or non-measurable disease per RECIST v1.1. * Patients cannot be enrolled in a clinical trial. Exclusion Criteria: * Patients with documented progressive disease prior to randomization. * Patients with an immune-related toxicity preventing the continuation of treatment beyond 1 year at the treating physician's discretion.
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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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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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