NCT02595866 · STUDY IN CONTEXT

Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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, 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.

Participants who received at least 1 dose of the study drug.

→

primary · POSTED

This includes the occurrence of grade 2 or higher AEs. 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.

Participants who received at least 1 dose of the study drug

→

primary · POSTED

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.

Participants who received at least 1 dose of the study drug.

→

secondary · POSTED

Defined as the proportion of participants who achieved complete response (CR) or partial response (PR) 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.

Analysis is based on all participants who have received at least one dose of study treatment. Participants with missing outcomes considered nonresponders. Participants without progression were censored at the last disease assessment date. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.

→

secondary · POSTED

Assessed using RECIST 1.1, "Lugano Criteria" for Malignant Lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method.

All participants who receive at least one dose of study drug. Participants without documented progressive disease or death will be censored at the last disease assessment date. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.

→

secondary · POSTED

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.

Analysis is based on all participants who received at least one dose of study drug. Participants without documented progression were censored at the last disease assessment date. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-skin-cancer-metastatic-7fd9803d
nct id: NCT02595866
trial label: Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0000
source section id
NCT02595866-om-0000
source outcome index
0
endpoint
Frequency of Observed Adverse Events (AEs)
endpoint definition
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, 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.
time origin
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least 1 dose of the study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0001
source section id
NCT02595866-om-0001
source outcome index
1
endpoint
Incidence of Immune-related Events of Clinical Interest (irECI)
endpoint definition
This includes the occurrence of grade 2 or higher AEs. 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.
time origin
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least 1 dose of the study drug
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0002
source section id
NCT02595866-om-0002
source outcome index
2
endpoint
Incidence of cART-related ECIs of Grade 2 or Higher AEs
endpoint definition
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.
time origin
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received at least 1 dose of the study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0003
source section id
NCT02595866-om-0003
source outcome index
3
endpoint
Objective Response Rate (Cohorts 1-3)
endpoint definition
Defined as the proportion of participants who achieved complete response (CR) or partial response (PR) 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.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Analysis is based on all participants who have received at least one dose of study treatment. Participants with missing outcomes considered nonresponders. Participants without progression were censored at the last disease assessment date. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0004
source section id
NCT02595866-om-0004
source outcome index
4
endpoint
Progression-free Survival (Cohorts 1-3)
endpoint definition
Assessed using RECIST 1.1, "Lugano Criteria" for Malignant Lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method.
time origin
From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 25 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants who receive at least one dose of study drug. Participants without documented progressive disease or death will be censored at the last disease assessment date. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0005
source section id
NCT02595866-om-0005
source outcome index
5
endpoint
Duration of Response (Cohorts 1-3)
endpoint definition
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.
time origin
Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Analysis is based on all participants who received at least one dose of study drug. Participants without documented progression were censored at the last disease assessment date. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0000
arm key
OG000
arm label
Cohort 1 (Pembrolizumab and cART)
regimen
Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0000
arm key
OG001
arm label
Cohort 2 (Pembrolizumab and cART)
regimen
Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0000
arm key
OG002
arm label
Cohort 3 (Pembrolizumab and cART)
regimen
Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0000
arm key
OG003
arm label
Cohort 4 (Pembrolizumab and cART)
regimen
Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0000
arm key
OG004
arm label
Total
regimen
Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0001
arm key
OG000
arm label
Cohort 1 (Pembrolizumab and cART)
regimen
Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0001
arm key
OG001
arm label
Cohort 2 (Pembrolizumab and cART)
regimen
Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0001
arm key
OG002
arm label
Cohort 3 (Pembrolizumab and cART)
regimen
Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0001
arm key
OG003
arm label
Cohort 4 (Pembrolizumab and cART)
regimen
Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0001
arm key
OG004
arm label
Total
regimen
Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
58
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0002
arm key
OG000
arm label
Cohort 1 (Pembrolizumab and cART)
regimen
Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
outcome key
om-0002
arm key
OG001
arm label
Cohort 2 (Pembrolizumab and cART)
regimen
Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02595866-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
harm key
EG000
source section id
NCT02595866-ae
event group key
EG000
event group label
Cohort 1 (Pembrolizumab and cART)
serious affected
8
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months.
event definition
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, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
harm key
EG001
source section id
NCT02595866-ae
event group key
EG001
event group label
Cohort 2 (Pembrolizumab and cART)
serious affected
8
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months.
event definition
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, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
harm key
EG002
source section id
NCT02595866-ae
event group key
EG002
event group label
Cohort 3 (Pembrolizumab and cART)
serious affected
6
serious at risk
12
other affected
12
other at risk
12
frequency threshold
5
collection period
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months.
event definition
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, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
harm key
EG003
source section id
NCT02595866-ae
event group key
EG003
event group label
Cohort 4 (Pembrolizumab and cART)
serious affected
9
serious at risk
24
other affected
24
other at risk
24
frequency threshold
5
collection period
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months.
event definition
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, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-skin-cancer-metastatic-7fd9803d
nct id
NCT02595866
harm key
EG004
source section id
NCT02595866-ae
event group key
EG004
event group label
Total
serious affected
31
serious at risk
58
other affected
58
other at risk
58
frequency threshold
5
collection period
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months.
event definition
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, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice