Trial results for study NCT04902040, which included atezolizumab as an intervention, were posted on ClinicalTrials.gov on 2026-03-18. The study investigated plinabulin in combination with radiation and immunotherapy for patients with select advanced cancers after progression on PD-1 or PD-L1 targeted antibodies. Key measurements showed objective tumor response rates of 2 participants and disease control rates ranging from 2 to 6 participants in specific plinabulin combination arms.
Background
Atezolizumab is a PD-L1 targeted antibody. This Phase 1b/II trial (NCT04902040) focused on patients with advanced cancers who had previously progressed on PD-1 or PD-L1 targeted antibodies, exploring new combination strategies. The trial aimed to evaluate plinabulin, a drug designed to block tumor growth by targeting blood vessels and killing tumor cells, in conjunction with radiation therapy and immunotherapy.
Trial design
The study, titled "Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies," was a Phase 1b/II trial that enrolled 19 participants. The trial was terminated. It included patients with Advanced Bladder Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Melanoma, and Advanced Merkel Cell Carcinoma. Interventions included plinabulin, radiation therapy, and immunotherapies such as atezolizumab, avelumab, durvalumab, nivolumab, and pembrolizumab. The trial aimed to study the side effects and best dose of plinabulin in these combinations.
Key results
The trial reported objective tumor response rates (ORR), defined as complete response (CR) plus partial response (PR), and disease control rates (DCR), defined as CR plus PR plus stable disease (SD), for specific combination arms:
- For the group receiving radiation therapy (RTX) + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W), the Objective Tumor Response Rate (ORR) was observed in 2 participants.
- For the group receiving RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W), the Objective Tumor Response Rate (ORR) was observed in 2 participants.
- For the group receiving RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W), the Disease Control Rate (DCR) was observed in 6 Participants.
- For the group receiving RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W), the Disease Control Rate (DCR) was observed in 2 Participants.
What this means
The posted results provide early-phase data on the efficacy of plinabulin in combination with radiation and immunotherapy for patients with advanced cancers who have progressed after prior treatment with PD-1 or PD-L1 targeted antibodies like atezolizumab. While the trial was terminated and involved a small number of participants, the observed objective responses and disease control in specific plinabulin combinations with pembrolizumab or nivolumab offer insights into potential strategies for this challenging patient population. Further research would be needed to determine the clinical significance of these findings.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04902040, titled "Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies," were posted on 2026-03-18 on clinicaltrials.gov.