Trial results for a combination of Nivolumab and ALT-803 in patients with pretreated, advanced or metastatic non-small cell lung cancer were posted on ClinicalTrials.gov on 2026-02-17. The Phase 1/2 study primarily defined the safety and tolerability of the drug combination, observing dose-limiting toxicities across different cohorts. The trial also reported objective response rates and progression-free survival.
Background
Nivolumab is an established immunotherapy. The trial investigated its combination with ALT-803 for patients with Non-small Cell Lung Cancer, specifically those with advanced or metastatic disease who had been pretreated.
Trial design
This completed Phase 1/2 trial (NCT02523469) enrolled 67 participants with Non-small Cell Lung Cancer. The study's purpose was to define the safety and tolerability of the ALT-803 and Nivolumab combination, as well as to determine the response rate in patients with advanced and unresectable NSCLC. Participants were assigned to different cohorts based on the dose of ALT-803 received in combination with Nivolumab 3 mg/kg.
Key results
The trial reported on the presence or absence of dose-limiting toxicities (DLTs) and objective response rates, along with progression-free survival.
- For the outcome 'Presence or Absence of a Dose Limiting Toxicity (DLT) of ALT-803 in Combination With Nivolumab':
- In Cohort 1 (ALT-803 6 µg/kg + Nivolumab 3 mg/kg), 0 Participants experienced a DLT.
- In Cohort 2 (ALT-803 10 µg/kg + Nivolumab 3 mg/kg), 0 Participants experienced a DLT.
- In Cohort 3 (ALT-803 15 µg/kg + Nivolumab 3 mg/kg), 0 Participants experienced a DLT.
- In Cohort 4 (ALT-803 20 µg/kg + Nivolumab 3 mg/kg (RP2D)), 1 Participant experienced a DLT.
- For 'Objective Response Rate':
- In Arm A (RP2D ALT-803 + Nivolumab (Nivo-naïve)), 1 Participant achieved an objective response.
- In Arm B (RP2D ALT-803 + Nivolumab (Nivo-progressor)), 2 Participants achieved an objective response.
- For 'Progression-Free Survival (PFS)':
- In Arm A (RP2D ALT-803 + Nivolumab (Nivo-naïve)), the median PFS was 5.8 months.
- In Arm B (RP2D ALT-803 + Nivolumab (Nivo-progressor)), the median PFS was 3.2 months.
What this means
The low number of dose-limiting toxicities observed across most cohorts, with only 1 participant experiencing a DLT at the highest tested dose of ALT-803 20 µg/kg, suggests a generally tolerable safety profile for the combination of ALT-803 and Nivolumab in this patient population. The objective response rates of 1 participant in the nivolumab-naïve arm and 2 participants in the nivolumab-progressor arm, along with median progression-free survival values of 5.8 months and 3.2 months respectively, provide initial insights into the potential efficacy of this combination in pretreated advanced NSCLC. These results support further investigation into the combination's therapeutic potential.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02523469, titled 'ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer,' were posted on 2026-02-17 on clinicaltrials.gov.