Interleukin-2 and Pembrolizumab for Metastatic Kidney Cancer
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 Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Coordinated High Dose Interleukin-2 (Aldesleukin, Proleukin™) and Pembrolizumab (Anti-PD1, Keytruda™) for Therapy of Metastatic Kidney Cancer|
- Overall Response Rate (ORR) [ Time Frame: Up to 24 months ]Overall Response According to Immune-related response criteria (irRC). Overall response rate ORR is defined with confirmation of the response status Complete Response (CR) or Partial Response (PR) among the combination treatment population patients; the binomial estimate and its one-sided 95% confidence interval will be reported. CR: Disappearance of all lesions in two consecutive observation not less than 4 weeks apart. PR: ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.
- Overall Survival (OS) of Intent to Treat (ITT) Population [ Time Frame: Up to 24 months ]Analysis: Overall Survival (OS) of ITT patients counting from the eligible date to death from any cause, or censored on end of known follow up, either within this study or in the Prometheus Laboratories sponsored PROCLAIM registry (PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy, NCT01415167).
- Progression Free Survival (PFS) [ Time Frame: Up to 24 months ]Progression-free survival (PFS) of ITT patients from the confirmed eligible date to the first occurrence of disease progression or death, from any cause, or lost to follow up, whichever is earliest; or censored at last follow-up during study. Progressive Disease (PD): At least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.
|Actual Study Start Date:||April 11, 2017|
|Estimated Study Completion Date:||December 31, 2018|
|Estimated Primary Completion Date:||December 31, 2018 (Final data collection date for primary outcome measure)|
Experimental: Pembrolizumab and Interleukin-2
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
Pembrolizumab: 200 mg every 3 weeks, 12 doses planned. This is considered the investigational part of the combination. The infusion time is 1 hour.
Other Names:Drug: Interleukin-2
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.
The treatment is organized into blocks of 9 weeks, with pembrolizumab treatment planned for weeks 1, 4 and 7. On the second and third blocks, interleukin-2 is added, for 5 doses at a time, one dose every 8 hours, on a weekly schedule on the two weeks after the week 1 and the week 4 pembrolizumab doses.
There is no dose escalation portion: The dose and schedule of IL-2 is fixed, 600,000 IU/kg/dose, with a cap of 66 mIU/dose. Doses may be omitted for safety. The dose of pembrolizumab is fixed, flat dose 200 mg/dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02964078
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Cortlin Croft 813-745-7559 firstname.lastname@example.org|
|Contact: Mayer Fishman, M.D., Ph.D. 813-745-8311 email@example.com|
|Principal Investigator: Mayer Fishman, M.D., Ph.D.|
|Sub-Investigator: Lodovico Balducci, M.D.|
|Sub-Investigator: Julie Kish, M.D.|
|Sub-Investigator: Michael Poch, M.D.|
|Sub-Investigator: Julio Pow-Sang, M.D.|
|Sub-Investigator: Wade Sexton, M.D.|
|Sub-Investigator: Jingsong Zhang, M.D.,Ph.D.|
|Principal Investigator:||Mayer Fishman, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|