Case Report: Response to Ipilimumab in a Patient With HIV With Metastatic Melanoma

Burke, Matthew M.; Kluger, Harriet M.; Golden, Marjorie; Heller, Kevin N.; Hoos, Axel; Sznol, Mario

doi:10.1200/jco.2011.36.9199

Cited by 33 publications

(16 citation statements)

References 16 publications

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“…The 39 enrolled patients included two patients with HIV and no unexpected AEs were observed in these patients. Several case series report acceptable tolerability with ipilimumab in HIV and viral hepatitis patients (8–10) and ongoing studies with ipilimumab and nivolumab (NCT02408861), and with pembrolizumab alone (NCT02595866) in patients with HIV with advanced malignancy will provide additional safety data.…”

Section: Introductionmentioning

confidence: 99%

Immuno-oncology Clinical Trial Design: Limitations, Challenges, and Opportunities

Baik

Rubin²,

Forde

et al. 2017

Clinical Cancer Research

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Recent advances in immuno-oncology and regulatory approvals have been rapid and paradigm shifting in many difficult-to-treat malignancies. Despite immune checkpoint inhibitor therapy becoming the standard of care across multiple tumor types, there are many unanswered questions that need to be addressed before this therapeutic modality can be fully harnessed. Areas of limitations include treatment of patients not sufficiently represented in clinical trials, uncertainty of the optimal treatment dosing and duration, and lack of understanding regarding long-term immune related toxicities and atypical tumor responses. Patients such as those with autoimmune disease, chronic viral infections, limited performance status, and brain metastases were often excluded from initial trials due to concerns of safety. However, limited data suggest that some of these patients can benefit from therapy with manageable toxicities; thus, future studies should incorporate these patients to clearly define safety and efficacy. There are still controversies regarding the optimal dosing strategy that can vary from weight-based to flat dosing, with undefined treatment duration. Further elucidation of the optimal dosing approach and evaluation of predictive biomarkers should be incorporated in the design of future trials. Finally, there are long-term immune-mediated toxicities, atypical tumor responses such as pseudoprogression and endpoints unique to immuno-oncology that are not adequately captured by traditional trial designs; thus, novel study designs are needed. In this article, we discuss in detail the above challenges and propose needed areas of research for exploration and incorporation in the next generation of immuno-oncology clinical trials.

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Section: Introductionmentioning

confidence: 99%

Immuno-oncology Clinical Trial Design: Limitations, Challenges, and Opportunities

Baik

Rubin²,

Forde

et al. 2017

Clinical Cancer Research

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show abstract

“…Nevertheless, in cancer patients carrying a chronic viral infection such as HIV, the anti-tumor activity of these molecules has not been extensively evaluated and clinical trials are still warranted. Some clinical cases showed clinical and immunological response to checkpoint inhibitors in melanoma patients with HIV, HBV or Hepatitis C Virus (HCV) infections [ 33 , 34 , 56 - 60 ]. Moreover, in a retrospective analysis of 44 patients affected by metastatic tumors (including 29 melanoma patients) and concurrent solid organ transplant, HIV, HBV or HCV infections, the administration of anti-PD-1/PD-L1 mAbs appeared to have clinical activity in the absence of adverse effect on the viral control [ 61 ].…”

Section: Discussionmentioning

confidence: 99%

Immune Checkpoint Inhibitors in Melanoma and HIV Infection

Marra¹,

Scognamiglio²,

Peluso³

et al. 2017

TOAIDJ

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Introduction:Immunotherapy with immune checkpoint inhibitors increases the overall survival of patients with metastatic melanoma regardless of their oncogene addicted mutations. However, no data is available from clinical trials of effective therapies in subgroups of melanoma patients that carry chronic infective diseases such as HIV. Evidences suggest a key role of the immune checkpoint molecules as a mechanism of immune escape not only from melanoma but also from HIV host immune response.Conclusion:In this article, firstly, we will describe the role of the immune checkpoint molecules in HIV chronic infection. Secondly, we will summarize the most relevant clinical evidences utilizing immune checkpoint inhibitors for the treatment of melanoma patients. Lastly, we will discuss the potential implications as well as the potential applications of immune checkpoint molecule-based immunotherapy in patients with melanoma and HIV infection.

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“…Interleukin-2 was tested as an adjuvant to HAART therapy in an attempt to stimulate antitumor activity but did not show a survival benefit in a single patient [11]. Burke and colleagues reported on a single patient with HIV and stage IV melanoma who was treated with ipilimumab and experienced disease regression without dose-limiting toxicities [12]. …”

Section: Discussionmentioning

confidence: 99%

A Patient with HIV Treated with Ipilimumab and Stereotactic Radiosurgery for Melanoma Metastases to the Brain

Ruzevick

Nicholas

Redmond

et al. 2013

Case Reports in Oncological Medicine

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Cancers, such as melanoma, that are associated with immune deficiencies are a major cause of morbidity and mortality in HIV-infected patients. Once patients develop melanoma metastases to the brain, treatment is often limited to palliative surgery and/or radiation. Ipilimumab, a CTLA-4 antagonist, has been shown to improve the median survival of patients with metastatic melanoma. However, available data regarding the safety and efficacy of ipilimumab in HIV-infected patients who develop intracranial melanoma metastases is limited. Here we report our experience administering ipilimumab to a patient with HIV-AIDS who developed multiple intracranial melanoma metastases. Following treatment, our patient showed improvement in systemic tumor control without any apparent interference with antiretroviral treatment.

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Case Report: Response to Ipilimumab in a Patient With HIV With Metastatic Melanoma

Cited by 33 publications

References 16 publications

Immuno-oncology Clinical Trial Design: Limitations, Challenges, and Opportunities

Immuno-oncology Clinical Trial Design: Limitations, Challenges, and Opportunities

Immune Checkpoint Inhibitors in Melanoma and HIV Infection

A Patient with HIV Treated with Ipilimumab and Stereotactic Radiosurgery for Melanoma Metastases to the Brain

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