Topics

Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab

2019-07-16 10:39:02 | BioPortfolio

Summary

Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.

Description

Subjects with Stage III resectable melanoma will receive one dose of nivolumab 480 mg IV, then undergo standard definitive surgery approximately 4 weeks after the initial dose of nivolumab. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab 480 mg IV every 4 weeks or ipilimumab plus nivolumab, as determined by pathologic response at the time of resection. Subjects with pathologic complete response or near pathologic complete response (PathCR/nearCR) (Arm A) receive adjuvant nivolumab for up to one year. Subjects with

Study Design

Conditions

Melanoma Stage III

Intervention

nivolumab, Ipilimumab

Location

Abramson Cancer Center, University of Pennsylvania
Philadelphia
Pennsylvania
United States
19104

Status

Not yet recruiting

Source

Abramson Cancer Center of the University of Pennsylvania

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-16T10:39:02-0400

Clinical Trials [2247 Associated Clinical Trials listed on BioPortfolio]

A Study of Nivolumab in Combination With Ipilimumab Compared to Nivolumab or Ipilimumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab is more effective than nivolumab or ipilimumab alone in treatmen...

A Trial Evaluating the Safety & Efficacy of Intra-Tumoral Ipilimumab in Combination With Intra-venous Nivolumab in Patients With Metastatic Melanoma

The study is a randomized Phase I/II trial aiming to evaluate the 6 month treatment tolerance defined as the related grade 3-4 toxicity event-free survival and clinical activity of the com...

Neoadjuvant and Adjuvant Checkpoint Blockade in Patients With Clinical Stage III or Oligometastatic Stage IV Melanoma

The goal of this clinical research study is to learn if giving nivolumab alone before and after surgery or nivolumab in combination with ipilimumab before and after surgery, can help to co...

Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabra...

VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Melanoma

This pilot phase I trial studies how well VX15/2503 (pepinemab) with or without ipilimumab and/or nivolumab work in treating participants with stage IIIB-D melanoma that can be removed by ...

PubMed Articles [4977 Associated PubMed Articles listed on BioPortfolio]

Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial.

Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (NIVO1+IPI3) is approved for first-line treatment of patients with advanced melanoma in several countries. We conducted a phase IIIb/IV study (CheckMate 511) ...

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

Anti-programmed death 1 antibody monotherapy is a first-line and widely used immunotherapy for the treatment of advanced melanoma. However, its efficacy rate is lower in the Japanese population compar...

CHOROIDAL NEOVASCULARIZATION AND CHORIORETINAL ATROPHY IN A PATIENT WITH MELANOMA-ASSOCIATED RETINOPATHY AFTER IPILIMUMAB/NIVOLUMAB COMBINATION THERAPY.

To describe a case of choroidal neovascularization (CNV) and chorioretinal scarring in a patient with melanoma-associated retinopathy after ipilimumab/nivolumab combination immune therapy for malignan...

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...

Eye immune privilege? Nivolumab plus ipilimumab: successful treatment in a patient with cutaneous melanoma and ocular metastases.

Medical and Biotech [MESH] Definitions

An anti-CTLA-4 ANTIGEN monoclonal antibody initially indicated for the treatment of certain types of metastatic MELANOMA. Its mode of actions may include blocking of CTLA-4 mediated inhibition of CYTOTOXIC T LYMPHOCYTES, allowing for more efficient destruction of target tumor cells.

A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

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.

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.

More From BioPortfolio on "Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab"

Quick Search

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Monoclonal antibodies MAbs
Monoclonal antibodies recognise and attach to specific proteins produced by cells.  Types of monoclonal antibodies used to treat cancer cells: Block cell dividing dividing signals Transport cancer drugs or radiation to cancer cells Tr...


Searches Linking to this Trial