Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retrovir… (NCT02595866) | Clinical Trial Compass
CompletedPhase 1
Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer
United States58 participantsStarted 2016-04-04
Plain-language summary
This phase I trial studies the side effects of pembrolizumab in treating patients with human immunodeficiency virus (HIV) and malignant neoplasms that have come back (relapsed), do not respond to treatment (refractory), or have distributed over a large area in the body (disseminated). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically proven metastatic or locally advanced tumors for which no standard therapy exists, or where standard therapy has failed, or in patients otherwise ineligible for standard therapy, or for an indication that anti-PD-1 therapy has been shown to be effective in studies in HIV-uninfected participants; disease-specific criteria will be applied for certain common cancers and cancers strongly associated with HIV; however, enrollment will not be confined to these tumors
* Non-small cell lung cancer (NSCLC)
* Metastatic or locally advanced disease that progressed after at least one prior therapy
* Note: patients that have actionable molecular targets (e.g., epidermal growth factor receptor \[EGFR\], anaplastic lymphoma kinase \[ALK\], c-ros oncogene 1\[ROS1\] mutations) must have received (when indicated) prior appropriate targeted therapy using Food and Drug Administration (FDA)-approved agents
* AIDS-related non-Hodgkin lymphoma and other non-Hodgkin lymphoma
* Failed standard first-line therapy; and
* Failed autologous stem cell transplant if indicated for histology (i.e diffuse large B-cell lymphoma) or autologous stem cell transplant is not feasible
* Classical Hodgkin lymphoma
* Relapsed or refractory de novo classical Hodgkin lymphoma having failed standard first-line therapy; and
* May have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naive b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Observed Adverse Events (AEs)
Timeframe: Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.
2
Incidence of Immune-related Events of Clinical Interest (irECI)
Timeframe: Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.
3
Incidence of cART-related ECIs of Grade 2 or Higher AEs
Timeframe: Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.