Pembrolizumab and Ibrutinib in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT03021460|
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : December 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma Stage III Skin Melanoma Stage IIIA Skin Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma||Drug: Ibrutinib Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. To evaluate the overall response rate (ORR) in patients with advanced melanoma receiving ibrutinib and pembrolizumab.
I. To assess the safety and adverse-event profiles of combination of ibrutinib with pembrolizumab in patients with advanced melanoma.
II. To evaluate the progression-free-survival (PFS) in patients advanced melanoma receiving ibrutinib and pembrolizumab.
III. To evaluate the duration of response, overall survival (OS) in patients with advanced melanoma receiving ibrutinib and pembrolizumab.
IV. To assess the effect of treatment with ibrutinib and pembrolizumab on Th1/Th2 immune polarity.
I. To assess the CD8 T cell response to multiple melanoma-associated antigens, and to correlate CD8 T cell responses with changes in Th1/Th2 immune polarity.
II. To assess changes in plasma cytokines induced by treatment with ibrutinib and pembrolizumab.
III. To assess the change in potential biomarkers, such as tumor-bound and soluble PD-L1 levels and tumor-infiltrating lymphocytes, that may correlate with treatment responses.
Patients receive ibrutinib orally (PO) daily on days 1-28 of course 1 and days 1-21 of course 2 and subsequent courses. Patients also receive pembrolizumab intravenously (IV) over 30 minutes on day 8 of course 1 and day 1 of course 2 and subsequent courses. Course 1 continues for 28 days and subsequent courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pembrolizumab in Combination With Ibrutinib in the Treatment of Unresectable or Metastatic Melanoma|
|Actual Study Start Date :||January 31, 2017|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||February 1, 2021|
Experimental: Treatment (ibrutinib, pembrolizumab)
Patients receive ibrutinib PO daily on days 1-28 of course 1 and days 1-21 of course 2 and subsequent courses. Patients also receive pembrolizumab IV over 30 minutes on day 8 of course 1 and day 1 of course 2 and subsequent courses. Course 1 continues for 28 days and subsequent courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Tumor response rate defined as the percentage of patients whose objective disease status meets the criteria for Response Evaluation Criteria in Solid criteria for partial or complete response on two consecutive disease evaluations at least 6 weeks apart [ Time Frame: Up to 5 years ]Tumor response rate will be assessed patients treated with pembrolizumab and ibrutinib.
- Duration of response [ Time Frame: Up to 5 years ]For those patients who disease had a partial or complete response to treatment on two consecutive disease evaluations at least 6 weeks apart, the duration of treatment response is defined as the time from registration to disease progression.
- Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]For each type of toxicity reported, the proportion of patients experiencing a severe level of that toxicity will be determined. For each agent, the total dose delivered as a percentage of the starting dose will be determined.
- Overall survival [ Time Frame: From registration to death due to any cause, assessed up to 5 years ]Will be estimated using the Kaplan-Meier method.
- Progression free survival [ Time Frame: From registration to documentation of first disease progression or death due to any cause, assessed up to 5 years ]Will be estimated using the Kaplan-Meier method.
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): NCT03021460
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Matthew S. Block|
|Principal Investigator:||Matthew Block||Mayo Clinic|