Pembrolizumab in Treating Patients With HIV and Relapsed, Refractory, or Disseminated Malignant Neoplasms
|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: NCT02595866|
Recruitment Status : Recruiting
First Posted : November 4, 2015
Last Update Posted : January 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|AIDS-Related Non-Hodgkin Lymphoma HIV Infection Locally Advanced Lung Non-Small Cell Carcinoma Locally Advanced Malignant Neoplasm Locally Advanced Malignant Solid Neoplasm Metastatic Hepatocellular Carcinoma Metastatic Lung Non-Small Cell Carcinoma Metastatic Malignant Neoplasm Metastatic Malignant Solid Neoplasm Metastatic Melanoma Recurrent Cutaneous Melanoma Recurrent Hepatocellular Carcinoma Recurrent Hodgkin Lymphoma Recurrent Kaposi Sarcoma Recurrent Lung Non-Small Cell Carcinoma Recurrent Malignant Neoplasm Recurrent Non-Hodgkin Lymphoma Refractory Classic Hodgkin Lymphoma Refractory Hodgkin Lymphoma Refractory Malignant Neoplasm Refractory Malignant Solid Neoplasm Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIA Hepatocellular Carcinoma AJCC v7 Stage IIIA Lung Non-Small Cell Cancer AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIB Hepatocellular Carcinoma AJCC v7 Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IIIC Hepatocellular Carcinoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 Stage IV Lung Non-Small Cell Cancer AJCC v7 Stage IVA Hepatocellular Carcinoma AJCC v7 Stage IVB Hepatocellular Carcinoma AJCC v7 Unresectable Melanoma||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of MK-3475 (Pembrolizumab) in Patients With Human Immunodeficiency Virus (HIV) and Relapsed/Refractory or Disseminated Malignant Neoplasm|
|Actual Study Start Date :||February 3, 2016|
|Estimated Primary Completion Date :||July 1, 2020|
Experimental: Treatment (pembrolizumab and cART)
Patients receive pembrolizumab IV over 30 minutes on day 1. Patients continue receiving their recommended combination antiretroviral therapy orally daily. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Frequency of observed adverse events (AEs) [ Time Frame: Up to 90 days after the last dose of trial treatment ]Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs (SAEs), laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type.
- Incidence of immune-related events of clinical interest (ECIs), which include the occurrence of grade 2 or higher AEs [ Time Frame: Up to 90 days after the last dose of trial treatment ]Will be graded using CTCAE version 4.0 (version 5.0 beginning April 1, 2018). Any AE of unknown etiology associated with study therapy will be evaluated to determine if it is possibly an ECI of a potentially immunologic etiology or related to combination antiretroviral therapy (cART). All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type.
- Incidence of cART-related ECIs of grade 2 or higher AEs [ Time Frame: Up to 90 days after the last dose of trial treatment ]Will be graded using CTCAE version 4.0 (version 5.0 beginning April 1, 2018). Any AE of unknown etiology associated with study therapy will be evaluated to determine if it is possibly an ECI of a potentially immunologic etiology or related to cART. All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type.
- Objective response rate [ Time Frame: Up to 1 year ]Defined as the proportion of patients who have achieved completer response (CR) or partial response (PR). Assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, "Lugano Criteria" for Malignant Lymphoma or other tumor-specific criteria. Analyzed using Clopper-Pearson 95% confidence intervals.
- Progression-free survival [ Time Frame: From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 1 year ]Assessed using RECIST 1.1, "Lugano Criteria" for Malignant Lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method.
- Duration of response [ Time Frame: Interval between the date of first response (CR/PR) and the date of progression, assessed up to 1 year ]Defined in participants experiencing CR or PR using RECIST 1.1, "Lugano Criteria" for malignant lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method.
- Overall survival [ Time Frame: From the first dose of study drug to death due to any cause, assessed up to 1 year ]Summarized statistically using Kaplan-Meier method.
- Best objective response rate (partial response + completion response)(Cohort 4) [ Time Frame: Up to 1 year ]Determined by modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group (ACTG) criteria.
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): NCT02595866
|United States, California|
|Zuckerberg San Francisco General Hospital||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Chia-Ching (Jackie) Wang 415-476-4082 Paul.Couey@ucsf.edu|
|Principal Investigator: Chia-Ching (Jackie) Wang|
|UCSF Medical Center-Parnassus||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Lawrence Fong 877-827-3222|
|Principal Investigator: Lawrence Fong|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|Contact: Mario Sznol 203-785-5702|
|Principal Investigator: Mario Sznol|
|United States, Louisiana|
|Louisiana State University Health Science Center||Recruiting|
|New Orleans, Louisiana, United States, 70112|
|Contact: Thomas M. Reske 504-568-2428 email@example.com|
|Principal Investigator: Thomas M. Reske|
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center||Suspended|
|Baltimore, Maryland, United States, 21287|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Robert Yarchoan 800-411-1222|
|Principal Investigator: Robert Yarchoan|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Marc S. Ernstoff 800-767-9355 firstname.lastname@example.org|
|Principal Investigator: Marc S. Ernstoff|
|Laura and Isaac Perlmutter Cancer Center at NYU Langone||Recruiting|
|New York, New York, United States, 10016|
|Contact: Mohammad Maher Abdul-Hay 212-263-4434 email@example.com|
|Principal Investigator: Mohammad Maher Abdul-Hay|
|Mount Sinai Hospital||Suspended|
|New York, New York, United States, 10029|
|United States, Washington|
|Cancer Immunotherapy Trials Network||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Thomas S. Uldrick 206-667-7485 firstname.lastname@example.org|
|Principal Investigator: Thomas S. Uldrick|
|Principal Investigator:||Thomas S Uldrick||Cancer Immunotherapy Trials Network|