Ipilimumab and Dabrafenib in the 1st Line Tx of Unresectable Stage III/IV Melanoma
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|ClinicalTrials.gov Identifier: NCT02200562|
Recruitment Status : Terminated (BMS withdrew support and required this trial to stop enrolling; Phase II portion never began, only a Phase I trial.)
First Posted : July 25, 2014
Last Update Posted : March 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Stage III or IV Melanoma||Drug: ipilimumab and dabrafenib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Concurrent Ipilimumab and Dabrafenib in Unresectable Stage III or Stage IV Melanoma|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||January 20, 2017|
|Actual Study Completion Date :||January 20, 2017|
|Experimental: Ipilimumab and Dabrafenib||
Drug: ipilimumab and dabrafenib
- Safety of ipilimumab and dabrafenib in combination [ Time Frame: 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200562
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|