Trial · NCT02595866
Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer
NCT02595866, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2024-07-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer. Trials, record NCT02595866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02595866
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer
- NCT number
- NCT02595866
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 58 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
AIDS-Related Non-Hodgkin Lymphoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Hepatocellular Carcinoma, HIV Infection, Kaposi Sarcoma, Locally Advanced Lung Non-Small Cell Carcinoma, Locally Advanced Malignant Solid Neoplasm, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Non-Hodgkin Lymphoma, Recurrent Classic Hodgkin Lymphoma, Recurrent Malignant Neoplasm, Refractory Classic Hodgkin Lymphoma, Refractory Malignant Neoplasm, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Unresectable Melanoma
- Interventions
- Antiretroviral Therapy, Biopsy, Biospecimen Collection, Computed Tomography, Pembrolizumab, Positron Emission Tomography
- First posted
- 2015-11-04
- Last updated
- 2024-08-09
- Results first posted
- 2024-07-16
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Observed Adverse Events (AEs) | Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles 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, 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. |
| Primary | Incidence of Immune-related Events of Clinical Interest (irECI) | Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. | 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. |
| Primary | Incidence of cART-related ECIs of Grade 2 or Higher AEs | Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles 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. |
| Secondary | Objective Response Rate (Cohorts 1-3) | Up to 2 years | 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. |
| Secondary | Progression-free Survival (Cohorts 1-3) | From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 25 months | Assessed using RECIST 1.1, "Lugano Criteria" for Malignant Lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method. |
| Secondary | Duration of Response (Cohorts 1-3) | Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years | 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. |
| Secondary | Overall Survival (Cohorts 1-3) | From the first dose of study drug to death due to any cause, assessed up to 3 years | Summarized statistically using Kaplan-Meier method. |
| Secondary | Objective Response Rate (Partial Response + Completion Response)(Kaposi Sarcoma Cohort) | Up to 2 years | Defined as the proportion of participants who achieved the best objective response rate (complete response (CR) + partial response (PR)) as determined by modified Acquired Immunodeficiency Syndrome Clinical Trials Group (ACTG) criteria Analyzed using Clopper-Pearson 95% confidence intervals. |
| Secondary | Progression-free Survival (Kaposi Sarcoma Cohort) | From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 3 years | Assessed using ACTG criteria. Summarized statistically using Kaplan-Meier method. |
| Secondary | Duration of Response (Kaposi Sarcoma Cohort) | Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years | Assessed using ACTG criteria. Summarized statistically using Kaplan-Meier method. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Observed Adverse Events (AEs) | Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. | Participants who received at least 1 dose of the study drug. | percentage of participants | NUMBER |
| PRIMARY | Incidence of Immune-related Events of Clinical Interest (irECI) | Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. | Participants who received at least 1 dose of the study drug | percentage of participants | NUMBER |
| PRIMARY | Incidence of cART-related ECIs of Grade 2 or Higher AEs | Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. | Participants who received at least 1 dose of the study drug. | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (Cohorts 1-3) | Up to 2 years | 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. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (Cohorts 1-3) | From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 25 months | 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. | months | MEDIAN |
| SECONDARY | Duration of Response (Cohorts 1-3) | Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years | 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. | months | MEDIAN |
| SECONDARY | Overall Survival (Cohorts 1-3) | From the first dose of study drug to death due to any cause, assessed up to 3 years | Participants who receive at least one dose of study drug. Participants without documented death at the time of analysis were censored at the date last known to be alive.~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. | months | MEDIAN |
| SECONDARY | Objective Response Rate (Partial Response + Completion Response)(Kaposi Sarcoma Cohort) | Up to 2 years | 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. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (Kaposi Sarcoma Cohort) | From the first dose of study drug to progressive disease or death, whichever occurs earlier, assessed up to 3 years | 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. | months | MEDIAN |
| SECONDARY | Duration of Response (Kaposi Sarcoma Cohort) | Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years | 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. | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Observed Adverse Events (AEs) | Cohort 1 (Pembrolizumab and cART) | 100 | percentage of participants | ||
| Frequency of Observed Adverse Events (AEs) | Cohort 2 (Pembrolizumab and cART) | 100 | percentage of participants | ||
| Frequency of Observed Adverse Events (AEs) | Cohort 3 (Pembrolizumab and cART) | 100 | percentage of participants | ||
| Frequency of Observed Adverse Events (AEs) | Cohort 4 (Pembrolizumab and cART) | 100 | percentage of participants | ||
| Frequency of Observed Adverse Events (AEs) | Total | 100 | percentage of participants | ||
| Incidence of Immune-related Events of Clinical Interest (irECI) | Cohort 1 (Pembrolizumab and cART) | 20.0 | percentage of participants | ||
| Incidence of Immune-related Events of Clinical Interest (irECI) | Cohort 2 (Pembrolizumab and cART) | 50.0 | percentage of participants | ||
| Incidence of Immune-related Events of Clinical Interest (irECI) | Cohort 3 (Pembrolizumab and cART) | 25.0 | percentage of participants | ||
| Incidence of Immune-related Events of Clinical Interest (irECI) | Cohort 4 (Pembrolizumab and cART) | 20.8 | percentage of participants | ||
| Incidence of Immune-related Events of Clinical Interest (irECI) | Total | 27.6 | percentage of participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohorts 1-3 (Pembrolizumab and cART) | 34 | |
| Overall Study | STARTED | Cohort 4 (Pembrolizumab and cART) | 24 | |
| Overall Study | COMPLETED | Cohorts 1-3 (Pembrolizumab and cART) | 2 | |
| Overall Study | COMPLETED | Cohort 4 (Pembrolizumab and cART) | 2 | |
| Overall Study | NOT COMPLETED | Cohorts 1-3 (Pembrolizumab and cART) | 32 | |
| Overall Study | NOT COMPLETED | Cohort 4 (Pembrolizumab and cART) | 22 |
Source ClinicalTrials.gov
Adverse events645
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Cohort 1 (Pembrolizumab and cART) | 5 | 10 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 2 (Pembrolizumab and cART) | 10 | 12 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 3 (Pembrolizumab and cART) | 7 | 12 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort 4 (Pembrolizumab and cART) | 11 | 24 | |
| other | Anemia | Blood and lymphatic system disorders | Total | 33 | 58 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 1 (Pembrolizumab and cART) | 2 | 10 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 2 (Pembrolizumab and cART) | 0 | 12 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 3 (Pembrolizumab and cART) | 0 | 12 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 4 (Pembrolizumab and cART) | 1 | 24 | |
| other | Sinus tachycardia | Cardiac disorders | Total | 3 | 58 |
1 to 10 of 645Source ClinicalTrials.gov
See all 645 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (Pembrolizumab and cART) | 5 | 10 |
| Total, all-cause mortality | Cohort 2 (Pembrolizumab and cART) | 5 | 12 |
| Total, all-cause mortality | Cohort 3 (Pembrolizumab and cART) | 5 | 12 |
| Total, all-cause mortality | Cohort 4 (Pembrolizumab and cART) | 2 | 24 |
| Total, all-cause mortality | Total | 17 | 58 |
| Total, other adverse events | Cohort 1 (Pembrolizumab and cART) | 10 | 10 |
| Total, other adverse events | Cohort 2 (Pembrolizumab and cART) | 12 | 12 |
| Total, other adverse events | Cohort 3 (Pembrolizumab and cART) | 12 | 12 |
| Total, other adverse events | Cohort 4 (Pembrolizumab and cART) | 24 | 24 |
| Total, other adverse events | Total | 58 | 58 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| U01CA154967 | Cancer Immunotherapy Trials Network Central Operations and Statistical Center | CHEEVER, MARTIN ALEXANDER | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL CANCER INSTITUTE | 2010 to 2017 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02595866
GET https://conductscience.org/api/trials/v1/NCT02595866/results?page=2