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Report for Clinical Trial NCT02200562

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I/II Study of Concurrent Ipilimumab and Dabrafenib in Unresectable Stage III or Stage IV Melanoma

Phase I/II study of ipilimumab concurrent ipilimumab and dabrafenib as first line treatment in Stage III or IV melanoma. Assessing safety of Ipilimumab and dabrafenib in combination. Also, assessing disease control rates.

NCT02200562 Stage III or IV Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

1 Interventions

Name: ipilimumab and dabrafenib

Type: Drug
Group Labels: 1

Ipilimumab and Dabrafenib


Primary Outcomes

Description: All patients who receive any study treatment will be included in the final summaries and listings of safety data. Detailed information collected for each AE will include a description of the event, duration, severity, relatedness to study drugs, action taken, and clinical outcome. Severity of the AEs will be graded according to the CTCAE version 4.0.

Measure: Safety of ipilimumab and dabrafenib in combination

Time: Safety analysis will be measured based on frequency and severity of adverse events experienced by patients during the study treatment period which is expected to last about 24 weeks.

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

Severity of the AEs will be graded according to the CTCAE version 4.0.. Inclusion Criteria: - For Phase I: Locally advanced or metastatic BRAF V600E/K/R positive melanoma that is either treatment-naïve or treatment-experienced. --- V600E ---

- For phase II: Histological diagnosis of BRAF V600E/K melanoma, unresectable stage III or stage IV, according to the AJCC Staging Manual, 7th Edition, 2011. --- V600E ---

- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications - Pregnancy or breast feeding - A history of a severe hypersensitivity reaction to ipilimumab or dabrafenib - Any reason why, in the opinion of the investigator, the patient should not participate Inclusion Criteria: - For Phase I: Locally advanced or metastatic BRAF V600E/K/R positive melanoma that is either treatment-naïve or treatment-experienced. --- V600E ---



HPO Nodes


HPO: