Results from a Phase II trial investigating pembrolizumab in combination with chemoradiation (carboplatin and paclitaxel) and lenvatinib mesylate for non-metastatic esophageal or esophageal/gastroesophageal junction cancer were posted on 2026-06-23. The study reported 0 participants achieved a pathological complete response and 0 participants achieved a clinical complete response. Additionally, 0 participants showed immune-mediated tumor cytotoxicity.
Background
Pembrolizumab (Keytruda) is an immunotherapy drug. Lenvatinib mesylate is an anti-cancer drug. Carboplatin and paclitaxel are chemotherapy drugs. This combination regimen was investigated for non-metastatic esophageal or esophageal/gastroesophageal junction cancer, specifically targeting clinical stages I, II, and III gastroesophageal junction adenocarcinoma.
Trial design
This was a Phase II trial (NCT04929392) enrolling 3 participants. The study focused on patients with non-metastatic esophageal or esophageal/gastroesophageal junction cancer, including Clinical Stage I, II, IIA, IIB, and III Gastroesophageal Junction Adenocarcinoma AJCC v8. Participants received a combination of carboplatin, paclitaxel, pembrolizumab, and lenvatinib mesylate.
Key results
The trial reported the following key measurements for the treatment arm (Chemoradiation, Pembrolizumab, Lenvatinib):
- Pathological Complete Response (CR): 0 participants achieved a pathological complete response.
- Clinical Complete Response (CR): 0 participants achieved a clinical complete response.
- Immune-mediated Tumor Cytotoxicity: 0 participants showed immune-mediated tumor cytotoxicity.
- Adverse Events: 3 participants experienced adverse events.
- Disease-free Survival (DFS): The median DFS was NA months (95% Confidence Interval: NA).
- Overall Survival (OS): The median OS was NA months (95% Confidence Interval: NA).
What this means
The results from this Phase II trial, with an enrollment of only 3 participants, indicate that no pathological or clinical complete responses were observed, nor was immune-mediated tumor cytotoxicity detected among the participants. All 3 participants experienced adverse events. The median disease-free survival and overall survival data were not available ("NA"). Due to the very limited sample size and the absence of positive efficacy signals in the reported outcomes, definitive conclusions regarding the efficacy of this combination regimen for non-metastatic esophageal or esophageal/gastroesophageal junction cancer cannot be drawn from this data alone. Further research with larger cohorts would be necessary to assess the potential of this therapeutic approach.
Source
The trial results were posted on 2026-06-23 on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT04929392.