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
II
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 (lead‐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 (lead‐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

2020

SWOG S1320: Improved progression-free survival with continuous compared to intermittent dosing with dabrafenib and trametinib in patients with BRAF mutated melanoma

A Algazi;M Othus;A Daud;R Lo;J Mehnert;T-G Truong;R Conry;K Kendra;G Doolittle;J Clark;M Messino;D Moore;C Lao;B Faller;R Govindarajan;A Harker-Murray;L Dreisbach;J Moon;K Grossmann;A Ribas American Association for Cancer Research Annual Meeting (April 24-29, 2020, San Diego, CA), oral

Association of Prior immune anti-PD-1 antibody therapy with longer progression free survival in patients treated with intermittent versus continuous dabrafenib and trametinib: a post-hoc analysis of S1320

A Algazi;M Othus;A Daud;J Mehnert;T-G Truong;R Conry;K Kendra;GC Doolittle;JI Clark;M Messino;DF Moore;C Lao;B Faller;R Govindarajan;A Harker-Murray;L Dreisbach;J Moon;K Grossmann;R Lo;A Ribas J Clin Oncol 38: 2020 (suppl; abstr 10039); American Society of Clinical Oncology Annual Meeting (5/29/2020 - 6/2/2020, Chicago, IL), poster

Improved clinical outcomes in patients with BRAFV600 mutant melanoma and undetectable circulating tumor DNA treated with dabrafenib and trametinib

A Algazi;M Othus;B Voorhies;K Kendra;S Dakhil;A Harker-Murray;C Lao;B Chmielowski;R Lo;K Grossmann;A Ribas J Clin Oncol 38: 2020 (suppl; abstr 10059); American Society of Clinical Oncology 2020 Annual Meeting, poster

Continuous versus intermittent BRAF and MEK inhibition in patients with BRAF-mutated melanoma: a randomized phase 2 trial

A Algazi;M Othus;A Daud;R Lo;J Mehnert;T-G Truong;R Conry;K Kendra;G Doolittle;J Clark;M Messino;D Moore;C Lao;B Faller;R Govindarajan;A Harker-Murray;L Dreisbach;J Moon;K Grossmann;A Ribas Nature Medicine Oct;26(10):1564-1568. doi: 10.1038/s41591-020-1060-8. Epub 2020 Oct 5.

PMid: PMID33020646

2015

SWOG S1320: A randomized phase II trial of intermittent versus continuous dosing of dabrafenib and trametinib in BRAFV600E/K mutant melanoma

A Algazi;M Othus;A Daud;J Mehnert;C Lao;R Kudchadkar;K Grossmann;R Lo;J Moon;J Kirkwood;A Ribas Journal of Clinical Oncology 33:5s (suppl; abstr TPS9093); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), poster session;

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