Objective Response RatePrimary· While on study, at the end of each 6 week cycle; if off study, every 3 months, UP TO 3 YEARS
The phase II portion of the study looks to define the objective response rate (using immune-related RECIST) of ALT-803 added to nivolumab in patients with advanced and unresectable non-small cell lung cancer.
Objective response rate will be defined by the best overall response, which is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmati
Group
Value
95% CI
Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve)
1
Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor)
2
Progression-Free Survival (PFS)Secondary· Up to 6 months
Time from randomization to disease progression or death.
Group
Value
95% CI
Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve)
5.8
4.2 – 7.1
Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor)
3.2
2.1 – 4.5
Overall Survival (OS)Secondary· From first dose until death or last known alive, up to 15 months.
Overall Survival (OS) was defined as the time from first dose of study treatment until death from any cause. Participants without a death event at the time of data cutoff were censored at the date of last known survival status.
Group
Value
95% CI
Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve)
12.4
10.1 – 14.8
Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor)
9.6
8.0 – 11.2
Duration of Response (DoR)Secondary· Up to 6 months
Duration of Response (DoR) was defined as the time from the first documented objective response (CR or PR) until disease progression or death. Participants who had not progressed or died at the time of the data cutoff were censored at the date of last adequate tumor assessment. DoR was evaluated only in participants who achieved an objective response.
Group
Value
95% CI
Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve)
4.6
3.8 – 5.9
Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor)
3.1
2.4 – 4.2
Adverse events — posted to ClinicalTrials.gov
Time frame: 5 years, 4 months, 7 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the study is to define the safety and tolerability of this drug combination. The study will also define the response rate of patients with advanced and unresectable NSCLC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical University of South Carolina
Last refreshed: 17 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02523469.