Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02748564|
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : September 11, 2018
This study will evaluate the safety and tolerability of IL-2 when given in combination with pembrolizumab to patients with advanced melanoma. Aldesleukin may stimulate white blood cells to melanoma cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving aldesleukin and pembrolizumab may kill more tumor cells.
There are two parts to this study:
- Phase Ib: To determine the safety and side effects of increasing doses of IL-2 in combination with pembrolizumab
- Phase II: Once the maximum tolerated dose of IL-2 is determined, additional patients will be treated to determine if it is effective against the cancer.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma Stage III Mucosal Melanoma of the Head and Neck Stage IIIA Skin Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma Stage IVA Mucosal Melanoma of the Head and Neck Stage IVB Mucosal Melanoma of the Head and Neck Stage IVC Mucosal Melanoma of the Head and Neck||Biological: Aldesleukin Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. To determine an optimal tolerated dose (OTD) of aldesleukin (interleukin [IL]-2) that is effective and tolerable in combination with pembrolizumab.
II. To characterize the efficacy of the OTD of IL-2 in combination with pembrolizumab.
I. To characterize the safety of IL-2 in doses ranging up to the Food and Drug Administration (FDA)- approved dose when administered in combination with pembrolizumab.
II. To characterize clinical endpoints, including overall survival, progression-free survival, and complete response rate.
I. To characterize immune parameters in the blood and tumor microenvironment and cellular and molecular features of the tumor tissue that correlate with response to combination therapy for study as potential predictive biomarkers.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 every 3 weeks and aldesleukin IV every 8 hours for up to 14 doses at weeks 4, 7, 16, 19, 28, and 31 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months up to 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/II Trial of Interleukin-2 in Combination With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma|
|Actual Study Start Date :||March 21, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Treatment (pembrolizumab, aldesleukin)
Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks and aldesleukin IV every 8 hours for up to 14 doses at weeks 4, 7, 16, 19, 28, and 31 in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Best overall response rate as assessed by Response Evaluation Criteria in Solid Tumors version 1.1, with the modification that progressive disease must be confirmed on a subsequent scan [ Time Frame: Up to 36 weeks ]Estimated using OTD of IL-2 and pembrolizumab with 95% confidence interval with borders +/- 15%
- Complete response rate [ Time Frame: Up to 36 months ]
- Incidence of adverse events as evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 [ Time Frame: Up to 30 days after last dose of treatment ]
- Overall survival [ Time Frame: Up to 2 years ]Estimated using Kaplan-Meier curves
- Progression-free survival [ Time Frame: Up to 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748564
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Howard L. Kaufman 732-235-8098 email@example.com|
|Principal Investigator: Howard L. Kaufman|
|Principal Investigator:||Ann (Annie) Silk||Rutgers Cancer Institute of New Jersey|