SWOG clinical trial number
S1609

DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors

Open
Phase
II
Accrual
90%
Abbreviated Title
DART
Status Notes
Effective February 4, 2020 at 2:00 p.m. Pacific Time, Cohort #35: Vulvar cancer will be temporarily closed to accrual.

Protocol Revision #9 (Version Date: 10/21/19), distributed on 11/27/19 - reactivated S1609 to accrual.

Protocol Revision #6 (Version Date: 4/15/2019), distributed on 6/11/2019 - activated, re-activated, and temp closed many cohorts. Please see Revision #6 for additional detail.

For the PD-L1 amplified cohort, patients do NOT need to qualify under one of the applicable histologies listed in Section 18.1.

Patients may now be registered directly to S1609 without having to be enrolled on EAY131 ("NCI-MATCH"). See Revision #3 for details.

Currently OPEN Cohorts:
4, 11, 12, 18, 19, 21, 27, 29, 38, 41, 42, 47, 48, 49, 50, 53

PERMANENTLY Closed Cohorts:
1, 2, 3, 5, 6, 7, 8, 9, 10, 13, 14, 15, 17, 20, 22, 23, 24, 25, 26, 28, 30, 31, 32, 33, 34, 36, 37, 39, 43, 44, 45 ,52

TEMPORARILY Closed Cohorts:
16, 26, 35, 40, 41, 46, 51, 52

Activation - Effective 1/13/2017, 2pm CT
Activated
01/13/2017
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Research committees

Early Therapeutics & Rare Cancers
Breast Cancer
Gastrointestinal Cancer
Genitourinary Cancer
Lung Cancer
Melanoma

Treatment

Ipilimumab Nivolumab

Eligibility Criteria Expand/Collapse

Please see Section 5.0 of the S1609 protocol.

S1609 cohorts are opened and closed at irregular intervals. Consult the SWOG S1609 Accrual report at: http://www.swogstat.org/accrual/dart.pdf for Cohort status and planned Cohort Closures PRIOR TO CONSENTING PATIENTS to S1609.

Publication Information Expand/Collapse

2020

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: The Neuroendocrine Cohort

S Patel;M Othus;Y Chae;F Giles;D Hansel;P Singh;A Fontaine;M Shah;A Kasi;T Al Baghdadi;S Vasireddy;E Mayerson;CW Ryan;Melissa Plets;CD Blanke;R Kurzrock Clinical Cancer Research May 15;26(10):2290-2296

PMid: PMID31969335 | PMC number: PMC7231627

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: The Small Bowel Cancer Cohort

YK Chae;M Othus;SP Patel;M Zalupski;A Kasi;M Khalil;A Kalyan;B Polite;S Fenton;S Gurung;C McLeod;F Giles;HX Chen;E Sharon;E Mayerson;M Plets;C Ryan;CD Blanke;R Kurzrock American Association for Cancer Research Annual Meeting (April 24-29, 2020, San Diego, CA)

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: The Salivary Gland Tumor Cohort

YK Chae;M Othus;SP Patel;J Ohr;F Worden;J Suga;A Naing;S Fenton;H Kang;S Gurung;C Mcleod;F Giles;HX Chen;E Sharon;E Mayerson;M Plets;C Ryan;CD Blanke;R Kurzrock American Association for Cancer Research Annual Meeting (April 24-29, 2020, San Diego, CA)

Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Metaplastic Carcinoma of the Breast: DART (SWOG S1609, Cohort 36)

S Adams;M Othus;S Patel;Y Chae;K Miller;R Chugh;S Schuetze;E Sharon;L Korde;R Gray;E Mayerson;M Plets;R Kurzrock J Clin Oncol 38: 2020 (suppl; abstr 1073); American Society of Clinical Oncology 2020 Annual Meeting, poster session

2019

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) S1609: The Neuroendocrine Cohort

SP Patel;M Othus;YK Chae;FJ Giles;DE Hansel;PP Singh;AC Fontaine;M Shah;AK Kasi;T Al Baghdadi;M Matrana;Z Gatalica;WM Korn;J Hayward;CM McLeod;H Chen;E Sharon;E Mayerson;CW Ryan;M Plets;CD Blanke;R Kurzrock American Association for Cancer Research (March 29-April 3, 2019, Atlanta, GA), accepted 2/8/19, oral presentation

SWOG S1609: A phase II basket trial of Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors (DART)

S Patel;M Othus;Y Chae;F Giles;J Hayward;C McLeod;H Chen;E Sharon;E Mayerson;C Ryan;M Plets;CD Blanke;R Kurzrock J Clin Oncol 37(suppl; abstr TPS2658); ASCO (5/31-6/4/2019, Chicago IL), TIPS, poster session

Trials, Tribulations, and Triumphs in Coordinating a “Not Otherwise Categorized” Cohort in an Umbrella Trial for Rare Cancers

E Mayerson;M Plets;R Kurzrock;YK Chae;S Patel;M Othus Society for Clinical Trials (May 19-22, 2019, New Orleans, LA), oral

Rethinking the Traditions of Trial Design: A Rare Cancer Basket Trial as a Motivating Example

M Plets;E Mayerson;R Kurzrock;YK Chae;S Patel;M Othus Society for Clinical Trials (May 19-22, 2019, New Orleans, LA), oral

2016

Rare cancer research in the National Clinical Trials Network:The SWOG Experience

A Schott European Society for Medical Oncology (October 7-11, 2016, Copenhagen, Denmark), invited oral presentation

Reports & Approvals

Trial Locations

Other Clinical Trials

SWOG Clinical Trial Number
CTSU/EA1151

Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Research Committee(s)
Breast Cancer
Activated
07/24/2019
Open
Phase