Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic
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|ClinicalTrials.gov Identifier: NCT02721732|
Recruitment Status : Recruiting
First Posted : March 29, 2016
Last Update Posted : November 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma of Unknown Primary Origin Kidney Medullary Carcinoma Malignant Germ Cell Tumor Metastatic Adrenal Gland Pheochromocytoma Metastatic Malignant Solid Neoplasm Metastatic Paraganglioma Metastatic Penile Carcinoma Paraganglioma Skin Squamous Cell Carcinoma Small Cell Carcinoma Stage IV Adrenal Cortex Carcinoma AJCC v7 Stage IV Penile Cancer AJCC v7 Stage IV Renal Cell Cancer AJCC v7 Unresectable Solid Neoplasm Vascular Neoplasm||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Other: Questionnaire Administration||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||275 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study for the Evaluation of Efficacy of Pembrolizumab (MK-3475) in Patients With Rare Tumors|
|Actual Study Start Date :||August 15, 2016|
|Estimated Primary Completion Date :||August 20, 2020|
|Estimated Study Completion Date :||August 20, 2020|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or toxicity. Patients with clinical response or disease stabilization may continue treatment for up to an additional 12 months.
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
- Non-progression rate defined as the proportion of subjects in the analysis population who have no progression of disease [ Time Frame: At 27 weeks ]Assessed by Response Evaluation Criteria in Solid Tumors 1.1 or according to tumor evaluation criteria best suitable and accepted for the tumor type evaluate. Response for the primary analysis will be determined by the investigator assessment, and a confirmation assessment is required.
- Incidence of adverse events graded using Common Terminology Criteria for Adverse Events version 4.03. [ Time Frame: Up to 27 weeks ]Safety will be assessed by quantifying the toxicities and grades experienced by subjects who have received pembrolizumab, including serious adverse events, events of clinical interest and immune-related adverse experiences.
- Response assessed according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 27 weeks ]
- Duration of response defined as time from first response to disease progression in subjects who achieve a PR or better by Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 2 years ]Summarized using Kaplan-Meier methodology using 25th, 50th (median), and 75th percentiles with associated 2-sided 95% confidence intervals, as well as percentage of censored observations.
- Progression free survival according to Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Baseline to the first documented disease progression or death due to any cause, assessed up to 27 weeks ]
- Overall survival [ Time Frame: Up to 24 months ]Summarized using Kaplan-Meier methodology using 25th, 50th (median), and 75th percentiles with associated 2-sided 95% confidence intervals, as well as percentage of censored observations.
- Non-progression-rate determined according to immune-related Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 27 weeks ]
- Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Up to 24 months ]ECOG performance status will be assessed.
- Patient responses to the select items of the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events [ Time Frame: Up to week 81 ]Will be examined over time using descriptive statistics to capture the patient symptom toxicity.
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): NCT02721732
|Contact: Aung Naingfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Aung Naing 713-563-1930|
|Principal Investigator: Aung Naing|
|Principal Investigator:||Aung Naing||M.D. Anderson Cancer Center|