CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02964078
NCT02964078Phase 2Completed
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Coordinated High Dose Interleukin-2 (Aldesleukin, Proleukin™) and Pembrolizumab (Anti-PD1, Keytruda™) for Therapy of Metastatic Kidney Cancer

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Nov 15, 2016·Updated Apr 2, 2026

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Interleukin-2 for Kidney Cancer. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The main purpose of this study is to evaluate the effects of the interleukin-2 given in combination with pembrolizumab. Interleukin-2 (IL-2) is also called aldesleukin, or Proleukin™. Pembrolizumab is also called Keytruda™, or anti-PD-1 antibody.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, Prometheus Laboratories

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 15, 2016
Enrollment StartApr 25, 2017
Primary CompletionMar 26, 2019
Study CompletionOct 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.6 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab: 200 mg every 3 weeks, 12 doses planned. This is considered the investigational part of the combination. The infusion time is 1 hour.

Interleukin-2drug

Interleukin-2: 8 admissions to hospital, each with 5 doses planned. This is considered the standard part of the combination. The standard interleukin-2 dose is 600,000 international units per kilogram per dose, with a maximum of 66,000,000 (for patients over 110 kg, which is 242 pounds). The dose is usually set at the start of the treatment and not adjusted. The infusion time is 15 minutes.