NCI Expands Clinical Trial Access for Patients With HIV in CITN-12 Trial

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The National Cancer Institute (NCI) is sponsoring an ongoing clinical trial that evaluates pembrolizumab in people with HIV who have relapsed or refractory cancer and are also taking antiretroviral therapy. People with HIV are often excluded from participating in clinical trials of new cancer treatments because of concerns that treatments may be unsafe for them.

An ongoing clinical trial is evaluating pembrolizumab in people with HIV who have relapsed or refractory cancer and are also taking antiretroviral therapy, announced the National Cancer Institute (NCI).

The CITN-12 trial, sponsored by NCI, is expanding clinical trial access for people with HIV, who have long been excluded from trials of new cancer treatments. Their exclusion has been a result of concerns that the treatments may be unsafe for them, according to the NCI report. Consequently, there are no data available on the impact of these drugs among people with HIV.

With the availability of existing antiretroviral therapies, most HIV-positive people are able to live as long as people without the infection. With longer life expectancy and higher susceptibility to some types of cancer, more people with HIV are developing cancers common in older age groups, wrote the authors of the report.


“For many years, NCI has recommended that people with HIV should not be arbitrarily excluded from cancer clinical trials and has enrolled people with HIV in immunotherapy trials,” wrote the authors. “Early results from one such NCI-sponsored trial appear to validate the inclusion of appropriately selected HIV-positive people in immunotherapy clinical trials.”

The CITN-12 trial is conducted by NCI’s HIV and AIDS Malignancy Branch and the Cancer Immunotherapy Trials Network (CITN). The trial measured the functionality of each participant’s immune system by the number of immune cells in the blood before treatment with pembrolizumab. Based on analysis, participants were categorized by immune function: moderate dysfunction, mild dysfunction, or relatively normal. Trial enrollment is still active.

Inclusion criteria include:

  • Histologically or cytologically proven metastatic or locally advanced tumors for which no standard therapy exists, or where standard therapy has failed
  • Non—small cell lung cancer: metastatic or locally advanced that progressed after at least 1 prior therapy
  • AIDS-related non-Hodgkin lymphoma and other non-Hodgkin lymphoma
  • Classical Hodgkin lymphoma
  • Hepatocellular carcinoma
  • Kaposi sarcoma
  • Melanoma

Patients receive pembrolizumab intravenously for 30 minutes on day 1 and continue receiving their recommended combination antiretroviral therapy orally daily. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Following the study treatment, patients are followed up for 1 year.

Preliminary results have shown no negative association between pembrolizumab and antiretroviral therapy, and most of the side-effects were not considered severe; they were similar to those observed in HIV-negative patients.

“Although our results are very preliminary, they are encouraging,” wrote the authors. “This trial, along with many other NCI-sponsored studies, has demonstrated that people with HIV can safely participate in clinical trials. Importantly, these trials have helped to define appropriate trial eligibility criteria for people with HIV that may inform the design of future clinical trials.”