SWOG clinical trial number
S1609

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

Open
Phase
Accrual
98%
Abbreviated Title
DART
Status Notes
Permanently Closed to Accrual: 1, 2, 3,4, 5, 6, 7, 8, 9, 10, 13, 14, 15, 16, 17, 18, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 41, 42, 43, 44, 45, 48, 51, 52, and 53.

Temporarily Closed to Accrual: 40, 46.

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.


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

2024

A Phase II Basket Trial of Dual Anti–CTLA-4 and Anti–PD-1 Blockade in Rare Tumors (DART SWOG 1609 Cohort 48) in Patients with Advanced Gallbladder Cancer

S Patel;E Guadarrama;Y Chae;M Dennis;B Powers;C-Y Liao;W Ferri;T George;E Sharon;C Ryan;M Othus;G Lopez;C Blanke;R Kurzrock Cancer Sep 1;130(17):2918-2927

PMid: PMID38358334 | PMC number: PMC11309904

A phase II basket trial of Dual Anti–CTLA-4 and Anti–PD-1 Blockade in Rare Tumors (DART SWOG 1609 Cohort 47) in patients with gestational trophoblastic neoplasia

S Patel;M Othus;Y Chae;M Dennis;S Gordon;D Mutch;W Samlowski;W Robinson;E Sharon;C Ryan;G Lopez;M Plets;C Blanke;R Kurzrock Clinical Cancer Research Jan 5;30(1):33-38

PMid: PMID37882676 | PMC number: PMC10842092

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: Sarcomatoid Lung Cohort #11

Y Chae;M Othus;S Patel;P Sandhu;L Corum;J Cetnar;S Rayani;L Il-Young Chung;M Chansky;C McLeod;H Chen;E Sharon;H Streicher;C Ryan;C Blanke;R Kurzrock AACR Annual Meeting (April 5-10, 2024, San Diego, CA), poster

Decoding biomarkers of immune activation in neuroendocrine carcinomas treated with ipilimumab and nivolumab using a multiomic approach

C Haymaker;G Kumar;Y Chae;E Gonzalez-Koslova;C Dualt;J Zhang;M Othus;L Soto;G Manyam;P Jiang;E Cuentas;C Fernandez;A Reuben;H Maecker;S Gnjatic;G al-Atrash;J Zhang;J Lee;S Patel;R Kurzrock ESMO Sarcoma and Rare Cancers Congress (March 14-16, 2024 Lugano, Switzerland), poster

Correlations Between First Cycle Toxicity and Overall Survival in Patients with Rare Cancers Treated with Immune Checkpoint Inhibitors (NCI/SWOG S1609)

M Othus;S Patel;YK Chae;E Dietrich;H Streicher;E Sharon;R Kurzrock ASCO Annual Meeting (May 31 - June 4, 2024, Chicago, IL ), poster;J Clin Oncol 42, 2024 (suppl 16; abstr 2655)

Correlation Between Tumor Size Change and Outcome in a Rare Cancer Immunotherapy Basket Trial

M Othus;S Patel;YK Chae;H Streicher;E Sharon;R Kurzrock JNCI-Journal of the National Cancer Institute May 8;116(5):673-680

PMid: PMID38243705 | PMC number: PMC11077308

Evaluation of mixed response in tumor size and survival in patients with rare cancers treated with dual checkpoint inhibitor therapy (DART SWOG S1609)

Y Chae;E Dietrich;M Othus;L Il-Young Chung;H Kim;C Ryan;CD Blanke;S Patel;R Kurzrock ASCO Annual Meeting (May 31 - June 4, 2024, Chicago, IL ), Rapid Oral Abstract Session; J Clin Oncol 42, 2024 (suppl 16; abstr 2514)

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

S Patel;M Othus;Y Chae;T Huynh;B Tan;T Kuzel;N Vogelzang;C McLeod;G Lopez;H Chen;E Sharon;H Streicher;C Ryan;C Blanke;R Kurzrock Journal for ImmunoTherapy of Cancer (JITC) Jul 27;12(7):e009074

PMid: PMID39067873 | PMC number: PMC11284838

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

Y Chae;M Othus;S Patel;B Powers;C Hsueh;R Govindarajan;S Bucur;H Kim;L Il-Young Chung;C McLeod;H Chen;E Sharon;H Streicher;C Ryan;CD Blanke;R Kurzrock Journal for ImmunoTherapy of Cancer (JITC) Sep 28;12(9):e009128

PMid: PMID39343510 | PMC number: PMC11440191

2023

Change in RECIST Tumor Size Correlates Linearly with Survival in Patients Treated with Checkpoint Inhibitor Therapy (SWOG S1609)

M Othus;S Patel;Y Chae;E Dietrich;H Streicher;E Sharon;R Kurzrock J Clin Oncol 41, 2023 (suppl 16; abstr 2504); ASCO Annual Meeting (June 2-6, 2023, Chicago, IL), oral

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: The Bronchoalveolar Carcinoma of the Lung (Cohort 12)

Y Chae;M Othus;S Patel;D Gerber;T Tanvetyanon;L Il-Young Chung;C McLeod;H Chen;E Sharon;H Streicher;C Ryan;C Blanke;R Kurzrock WCLC Annual Meeting (September 9-12, 2023, Singapore), poster

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: The Desmoid Tumors (Cohort 27)

YK Chae;M Othus;S Patel;B Powers;C-T Hsueh;R Govindarajan;S Bucur;L Il-Young Chung;C McLeod;H Chen;E Sharon;H Streicher;C Ryan;C Blanke;R Kurzrock J Clin Oncol 41, 2023 (suppl 16; abstr 11516); ASCO Annual Meeting (June 2-6, 2023, Chicago, IL), poster session

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

Y Chae;M Othus;S Patel;R Edwards;J Scalici;L Il-Young Chung;C McLeod;H Chen;E Sharon;H Streicher;C Ryan;C Blanke;R Kurzrock J Clin Oncol 41, 2023 (suppl 16; abstr 5517); ASCO Annual Meeting (June 2-6, 2023, Chicago, IL), poster session

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: The non-epithelial ovarian tumor cohort #13

Y Chae;M Othus;S Patel;K Wilkinson;E Whitman-Purves;J Lea;J Schallenkamp;N Adra;L Appleman;M Alden;J Thomes Pepin;J Ellerton;A Poklepovic;A Walter;M Rampurwala;L Il-Young Chung;C McLeod;H Chen;E Sharon;H Streicher;C Ryan;CD Blanke;R Kurzrock AACR Annual Meeting (April 14-19, 2023, Orlando, FL, poster

A phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) SWOG S1609: the clear cell ovarian, endometrial, cervical cancer cohorts

Y Chae;M Othus;S Patel;F Backes;D O'Malley;M Cristea;A Naing;K Kurnit;R Eskander;S Goodrich;L Il-Young Chung;C McLeod;H Chen;E Sharon;H Streicher;C Ryan;CD Blanke;R Kurzrock AACR Annual Meeting (April 14-19, 2023, Orlando, FL, poster

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: The small cell carcinoma of the ovary, hypercalcemic type cohort #49

Y Chae;M Othus;S Patel;R Aljumaily;K Win;T Pejovic;S Thomas;L Il-Young Chung;C McLeod;H Chen;E Sharon;H Streicher;C Ryan;CD Blanke;R Kurzrock AACR Annual Meeting (April 14-19, 2023, Orlando, FL, poster

Clinical outcomes and translational analysis of DART S1609: the thyroid cancer cohort; PD-1+ PD-L1+ TIL correlated with favorable survival

YK Chae;Y Lu;S Patel;C Rodriguez;A Onitilo;A Mattour;I Rybkin;S Fenton;L Il-Young Chung;H Kim;M Othus;E Parra;J Zhang;L Gomez;C Fernandez;L Soto;H Chen;G Manyam;D Duose;R Luthra;J Zhang;G Al-Atrash;I Wistuba;J Lee;J Zhang;C Haymaker;C McLeod;H Chen;E Sharon;C Ryan;G Lopez;M Plets;CD Blanke;R Kurzrock SITC Annual Meeting (Nov. 1-5, 2023, San Diego, CA), poster

2022

A Multicenter Phase II Trial of Ipilimumab and Nivolumab in Unresectable or Metastatic Metaplastic Breast Cancer: Cohort 36 of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART, SWOG S1609)

S Adams;M Othus;S Patel;K Miller;R Chugh;S Schuetze;M Chamberlin;B Haley;A Storniolo;K Cawley;M Reddy;S Anderson;C Zimmerman;A O'Dea;M Mirshahidi;J Ahnert;F Brescia;O Hahn;J Raymond;D Biggs;M Thompson;R Connolly;E Sharon;L Korde;R Gray;E Mayerson;M Plets;CD Blanke;YK Chae;R Kurzrock Clinical Cancer Research, Jan 15;28(2):271-278

PMid: PMID34716198 | PMC number: PMC8776596

A Phase II Basket Trial of Dual Anti–CTLA-4 and Anti–PD-1 Blockade in Rare Tumors (DART SWOG 1609 Cohort 47) in Patients with Gestational Trophoblastic Disease

S Patel;M Othus;YK Chae;M Dennis;S Gordon;B Tan;W Samlowski;E Sharon;C Ryan;M Plets;CD Blanke;R Kurzrock Society for Immunotherapy of Cancer (SITC) (Nov 8-12,2022, Boston, MA), poster

2021

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

S Patel;M Othus;YK Chae;J Strosberg;J Wang;B Konda;J Hayward;C McLeod;H Chen;E Sharon;E Mayerson;C Ryan;M Plets;CD Blanke;R Kurzrock Cancer Sep 1;127(17):3194-3201; Apr 21. doi: 10.1002/cncr.33591. Online ahead of print

PMid: PMID33882143 | PMC number: PMC8606104

A Multicenter Phase II Trial (SWOG S1609, Cohort 51) of Ipilimumab and Nivolumab in Metastatic or Unresectable Angiosarcoma: a Sub-Study of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART)

M Wagner;M Othus;S Patel;C Ryan;A Sangal;B Powers;G Budd;A Victor;C-T Hsueh;R Chugh;S Nair;K Leu;M Agulnik;E Sharon;E Mayerson;M Plets;C Blanke;H Streicher;YK Chae;R Kurzrock Journal for Immunotherapy of Cancer, Aug;9(8):e002990. doi: 10.1136/jitc-2021-002990

PMid: PMID34380663 | PMC number: PMC8330584

2020

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART SWOG 1609) in Patients with Nonpancreatic Neuroendocrine Tumors

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), oral

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

Dual Checkpoint Blockade in a Neuroendocrine Carcinoma with Dual PD-L1/PD-L2 Amplification and High Tumor Mutational Burden [case report]

J Gong;D Adashek;D Frishberg;M Guan;V Placencio-Hickock;A Gangi;G Gresham;R Tuli;M Othus;YK Chae;R Kurzrock;A Hendifar JCO Precision Oncology May 15;4:PO.18.00391

PMid: PMID33215052 | PMC number: PMC7670562

A multicenter phase II trial (SWOG S1609, Cohort 51) of Ipilimumab and Nivolumab in metastatic or unresectable angiosarcoma: a sub-study of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART)

M Wagner;M Othus;S Patel;C Ryan;A Sangal;B Powers;GT Budd;A Victor;C-T Hsueh;R Chugh;E Mayerson;M Plets;CD Blanke;H Streicher;YK Chae;R Kurzrock Journal for ImmunoTherapy of Cancer Nov, 8 (Suppl 3) A843; Society for Immunotherapy of Cancer (SITC) Annual Meeting (November 10-15, 2020, virtual), oral presentation

Ipilimumab and Nivolumab in Rare Tumors S1609: Neuroendocrine-Response [Response to Letter to Editor]

S Patel;M Othus;YK Chae;R Kurzrock Clinical Cancer Research May 15;26(10):2434

PMid: PMID32414761

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

YK Chae;M Othus;SP Patel;S Fenton;D Wang;C Rodriguez;A Onitilo;A Mattour;I Rybkin;J Hayward;C McLeod;H Chen;E Sharon;E Mayerson;CW Ryan;M Plets;CD Blanke;R Kurzrock Journal for ImmunoTherapy of Cancer Nov, 8 (Suppl 3) A288; Society for Immunotherapy of Cancer (SITC) Annual Meeting (November 10-15, 2020, virtual), poster

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

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