SWOG clinical trial number
S1320
A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAFV600E/K Mutant Melanoma
Closed
Phase
Accrual
100%
Abbreviated Title
Melanoma - Ph II Intermittent vs Continuous Dabrafenib and Trametinib BRAF Positive Melanoma
Status Notes
Effective 7/15/2019, Step 2 registration (randomization) is permanently closed to accrual.
<b>Effective 4/19/19, Step 1 (leadâ€in continuous dosing) will be permanently closed to accrual effective April 19, 2019 at 11:59 p.m. Pacific Time.
All patients who have consented must be registered to Step 1 (leadâ€in continuous dosing) prior to 11:59 p.m. PT on April 19, 2019 in order to be eligible to participate. This closure does not apply to Step 2 randomization</b>
<b>Effective 4/19/19, Step 1 (leadâ€in continuous dosing) will be permanently closed to accrual effective April 19, 2019 at 11:59 p.m. Pacific Time.
All patients who have consented must be registered to Step 1 (leadâ€in continuous dosing) prior to 11:59 p.m. PT on April 19, 2019 in order to be eligible to participate. This closure does not apply to Step 2 randomization</b>
Activated
07/22/2014
Closed
07/15/2019
Participants
CTSU, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
Research committees
Melanoma
Treatment
Dabrafenib
Trametinib Dimethyl Sulfoxide
Eligibility Criteria Expand/Collapse
Patients must have histologically or cytologically confirmed Stage IV or unresectable Stage III BRAF V600E or BRAF V600K mutant melanoma; BRAFV600 mutant status must be documented by a CLIA-certified laboratory; Patient must have CT scan of neck, chest, abdomen and pelvis within 28 days prior to registration (a whole body PET/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the neck, chest, abdomen and pelvis within 28 days prior to registration). Tests to assess non-measurable disease must be performed with 42 days prior to registration.
Publication Information Expand/Collapse
2021
2020
Other Clinical Trials
SWOG Clinical Trial Number
S2000
A randomized phase 2 trial of encorafenib + binimetinib + nivolumab vs ipilimumab + nivolumab in BRAFV600-mutant melanoma brain metastases
Research Committee(s)
Melanoma
Activated
09/23/2020
Accrual
100%
Open
Phase
SWOG Clinical Trial Number
CTSU/EA6174
A Phase III Randomized Trial Comparing Adjuvant MK-3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma
Research Committee(s)
Melanoma
Activated
10/01/2018
Open
Phase
SWOG Clinical Trial Number
CTSU/EA6141
Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma
Research Committee(s)
Melanoma
Activated
09/10/2015
Open
Phase