Trial results for the Phase 1 study NCT03260504, investigating pembrolizumab in combination with aldesleukin for advanced or metastatic kidney cancer, were posted on ClinicalTrials.gov on 2025-12-08. The trial was terminated, and data showed 0 participants achieved an objective response across both dose levels.
Background
Pembrolizumab is an immunotherapy drug, a monoclonal antibody that helps the body's immune system attack cancer cells. Aldesleukin is another agent that may stimulate white blood cells to kill cancer cells. This combination was investigated for treating patients with advanced or metastatic kidney cancer, specifically including Advanced Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer, and Metastatic Clear Cell Renal Cell Carcinoma.
Trial design
The study NCT03260504 was a Phase 1 trial designed to investigate the side effects and best dose of aldesleukin when given with pembrolizumab in patients with advanced or metastatic kidney cancer. The trial enrolled 6 participants and was ultimately terminated. The conditions studied included Advanced Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer, and Metastatic Clear Cell Renal Cell Carcinoma. The interventions involved aldesleukin and pembrolizumab across two distinct dose levels: Period 1 (Dose Level 1: Pembrolizumab + SQ IL-2) and Period 2 (Dose Level 2: Pembrolizumab + Low-Dose IV Bolus IL-2).
Key results
The trial reported several key measurements:
- For "Number of Adverse Events": 3 Adverse Events (CTCAE v5.0) were observed in "Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)", and 1 Adverse Event (CTCAE v5.0) in "Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)".
- Regarding "Number of Participants With Objective Response": 0 Participants were observed in "Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)", and 0 Participants in "Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)".
- For "Number of Participants With Objective Response or Stable Disease": 2 Participants were observed in "Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)", and 1 Participant in "Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)".
- The "Progression Free Survival (PFS)" was a median of 5.27 Months (Full Range) for "Period 1: Dose Level 1 (Pembrolizumab + SQ IL-2)", and a median of 2.67 Months (Full Range) for "Period 2: Dose Level 2 (Pembrolizumab + Low-Dose IV Bolus IL-2)".
What this means
The termination of this Phase 1 trial, combined with the finding of 0 participants achieving an objective response, suggests that the combination of pembrolizumab and aldesleukin, at the dose levels tested, did not demonstrate sufficient efficacy or favorable safety profile to warrant further development in this patient population. While some participants achieved stable disease, the absence of objective responses in this small cohort of 6 patients with advanced or metastatic kidney cancer indicates a lack of promising activity for this particular regimen.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03260504, titled "Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer," were posted on 2025-12-08 on clinicaltrials.gov.