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The Combination of Anti-PD-1 With Radiotherapy in Previously Untreated Metastatic Melanoma

2019-07-16 10:38:28 | BioPortfolio

Summary

Currently, the first line treatment options for surgically unresectable metastatic melanoma includes anti-PD1 agents such as nivolumab and pembrolizumab. In western countries, UV associated cutaneous melanoma has 30-40% response rates to immune checkpoint inhibitors (ICIs). However, response rates are lower in Asians. The reason for this discrepancy is attributed to the difference in subtypes since most of the Asian patients are mostly subgrouped as acral lentiginous or mucosal types that are unrelated to UV exposures. Thus, there is an unmet need to bolster the effect of ICIs in these patients.

The combination of radiotherapy with ICIs have been demonstrated by several pre-clinical studies. High dose radiation has shown to promote STING pathway which activates dendritic cells needed in priming phase. In addition, low dose radiation may activate macrophage differentiation. These mechanisms in turn may enhance responses to immunotherapy.

In this study, the investigators aim to evaluate the efficacy and tolerability of anti-PD-1 blockade in combination with radiotherapy in surgically unresectable, treatment naive metastatic melanoma.

Study Design

Conditions

Melanoma

Intervention

The combination of radiotherapy with anti-PD1 (pembrolizumab or nivolumab)

Location

Department of Surgery, Yonsei University College of Medicine
Seoul
Korea, Republic of
120-752

Status

Recruiting

Source

Yonsei University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-16T10:38:28-0400

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A Phase 2/3 Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab in Subjects With Unresectable or Metastatic Melanoma

This is an adaptive clinical trial that includes a dose escalation phase followed by a randomized controlled Phase 3 trial. The purpose of the dose escalation phase is to establish the Pha...

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A Phase II Study of High Dose Bolus IL2 in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy: Efficacy and Biomarker Study

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A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Anti-CTLA-4 Treatment-Naïve Subjects With Unresectable or Metastatic Melanoma (CheckMate 218)

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PubMed Articles [8001 Associated PubMed Articles listed on BioPortfolio]

Pembrolizumab as first-line treatment for metastatic uveal melanoma.

No standard treatment has been defined for metastatic uveal melanoma (mUM). Although clinical trials testing Nivolumab/Pembrolizumab for cutaneous melanoma did not include mUM, anti PD-1 agents are co...

Phase 2 trial of nivolumab combined with stereotactic body radiotherapy in patients with metastatic or locally advanced inoperable melanoma.

Nivolumab improves survival in metastatic melanoma patients. Unfortunately, most patients do not respond to this treatment. Preclinical data indicates that radiotherapy could work synergistically with...

Hypophysitis secondary to nivolumab and pembrolizumab is a clinical entity distinct from ipilimumab-associated hypophysitis.

Little has been published describing hypophysitis after nivolumab or pembrolizumab treatment. We aimed to (i) assess the risk of hypophysitis following nivolumab or pembrolizumab treatment, (ii) chara...

Three cases of nivolumab therapy-failed advanced melanoma successfully controlled by ipilimumab with intensity-modulated radiotherapy.

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Pembrolizumab for Unresectable or Metastatic Melanoma in Patients Older than 85 Years of Age.

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Medical and Biotech [MESH] Definitions

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

The total amount of radiation absorbed by tissues as a result of radiotherapy.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

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