Phase II study evaluating ipilimumab as a single agent in the first-line treatment of adult patients (Pts) with metastatic uveal melanoma (MUM): The GEM-1 trial.

Rodriguez, J.M. Piulats; Olza, María Ochoa de; Codes, M.; López-Martín, José A.; Berrocal, A.; García, Margarita; Gúrpide, Alfonso; Homet, Blanca; Martín‐Algarra, Salvador

doi:10.1200/jco.2014.32.15_suppl.9033

Cited by 34 publications

(18 citation statements)

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“…Ipilimumab, an anti-CTLA4 agent, is an immune checkpoint inhibitor that has shown response rates of 5–10% with ipilimumab in patients with MUM, with a median OS time of 6.0–9.7 months [35–37]. Preliminary data from a phase II trial conducted by the Spanish Melanoma Group (GEM), using front line ipilimumab 10 mg/kg IV every 3 weeks for four doses followed by maintenance doses every 12 weeks until disease progression or acceptable toxicity in treatment-naïve MUM patients, showed promising response rates at a median follow-up time of 5.5 months [38]. However, the Dermatologic Cooperative Oncology Group (DeCOG) conducted an open-label multicenter phase II trial in treatment-naïve or pretreated MUM patients which reported a median progression-free survival (PFS) and OS of only 2.8 and 6.8 months, respectively.…”

Section: Discussionmentioning

confidence: 99%

Nivolumab and Ipilimumab in the Treatment of Metastatic Uveal Melanoma: A Single-Center Experience

Karivedu

Eldessouki

Taftaf

et al. 2019

Case Reports in Oncological Medicine

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Background. Metastatic uveal melanoma (MUM) is associated with a poor prognosis, with a median overall survival (OS) of 4–15 months. Despite new insights into the genetic and molecular background of MUM, satisfactory systemic treatment approaches are currently lacking. The study results of innovative treatment strategies are urgently needed. Patients and Methods. This was a retrospective case series of 8 patients with MUM managed at the University of Cincinnati between January 2015 and January 2018. The immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 1.1 criteria were used for patient evaluation, and magnetic resonance imaging was used for evaluation at treatment checkpoints. Objective. To assess the clinical outcome of patients with MUM treated with a combination of checkpoint inhibitors. Results. The series included eight patients, six men and two women, with MUM. Their median age at MUM diagnosis was 69 (range, 55–77) years. All patients were treated with ipilimumab and nivolumab combination along with transarterial chemoembolization (TACE), followed by nivolumab maintenance and monthly TACE procedures. The majority of patients had a partial response or stable disease. Two of the patients had partial response, while four others had stable disease. Two other patients experienced disease progression. Conclusion. We report the outcomes of eight patients with MUM treated with the combination of ipilimumab and nivolumab. We report the clinical outcome and toxicity associated with this treatment approach. Further studies are warranted to explore immunotherapy in MUM. These findings support the consideration of immunotherapy in MUM.

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Section: Discussionmentioning

confidence: 99%

Nivolumab and Ipilimumab in the Treatment of Metastatic Uveal Melanoma: A Single-Center Experience

Karivedu

Eldessouki

Taftaf

et al. 2019

Case Reports in Oncological Medicine

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“…Interim findings presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2014 included 13 evaluable patients. 82 After a median follow up of 5.5 months, one patient (7.7%) achieved a partial response and six patients (46.2%) had stable disease. The median OS was 9.8 months.…”

Section: Treatment Of Metastatic Uveal Melanomamentioning

confidence: 92%

Treatment of uveal melanoma: where are we now?

et al. 2018

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Uveal melanoma, a rare subset of melanoma, is the most common primary intraocular malignancy in adults. Despite effective primary therapy, nearly 50% of patients will develop metastatic disease. Outcomes for those with metastatic disease remain dismal due to a lack of effective therapies. The unique biology and immunology of uveal melanoma necessitates the development of dedicated management and treatment approaches. Ongoing efforts seek to optimize the efficacy of targeted therapy and immunotherapy in both the adjuvant and metastatic setting. This review provides a comprehensive, updated overview of disease biology and risk stratification, the management of primary disease, options for adjuvant therapy, and the current status of treatment strategies for metastatic disease.

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“…However, other multiple phase II trials have shown low RRs ranging from 0% to 5%, a PFS of ~3 months, and an OS of less than one year [149,150,151,152,153]. The GEM-1 study [154] an open label, single arm phase II trial evaluated first line ipilimumab in 32 adult patients newly diagnosed with MUM and was conducted in five centres in Spain belonging to the Spanish Melanoma Group (GEM). Patients received four high doses of ipilimumab (10 mg/kg) every three weeks and a maintenance dose every 12 weeks.…”

Section: Current Innovative Therapeutic Options For Metastatic Tumentioning

confidence: 99%

New Insights into Molecular Oncogenesis and Therapy of Uveal Melanoma

Violanti

Bononi

Gallenga

et al. 2019

Cancers

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Uveal melanoma (UM), which is the most common cancer of the eye, was investigated in recent years by many teams in the field of biomedical sciences and eye clinicians. New knowledge was acquired on molecular pathways found to be dysregulated during the multistep process of oncogenesis, whereas novel therapeutic approaches gave significant results in the clinical applications. Uveal melanoma-affected patients greatly benefited from recent advances of the research in this eye cancer. Tumour biology, genetics, epigenetics and immunology contributed significantly in elucidating the role of different genes and related pathways during uveal melanoma onset/progression and UM treatments. Indeed, these investigations allowed identification of new target genes and to develop new therapeutic strategies/compounds to cure this aggressive melanoma of the eye. Unfortunately, the advances reported in the treatment of cutaneous melanoma have not produced analogous benefits in metastatic uveal melanoma. Nowadays, no systemic adjuvant therapy has been shown to improve overall survival or reduce the risk of metastasis. However, the increasing knowledge of this disease, and the encouraging results seen in clinical trials, offer promise for future effective therapies. Herein, different pathways/genes involved in uveal melanoma onset/progression were taken into consideration, together with novel therapeutic approaches.

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Phase II study evaluating ipilimumab as a single agent in the first-line treatment of adult patients (Pts) with metastatic uveal melanoma (MUM): The GEM-1 trial.

Cited by 34 publications

References 0 publications

Nivolumab and Ipilimumab in the Treatment of Metastatic Uveal Melanoma: A Single-Center Experience

Nivolumab and Ipilimumab in the Treatment of Metastatic Uveal Melanoma: A Single-Center Experience

Treatment of uveal melanoma: where are we now?

New Insights into Molecular Oncogenesis and Therapy of Uveal Melanoma

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