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SWOG S1609


Recruiting | Phase: NA

Official Title:

Treatment with Ipilimumab and Nivolumab for Rare Cancers (DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in Rare Tumors)

Study Purpose:

To evaluate the effectiveness of treating rare cancers with two immunotherapy drugs: nivolumab and ipilimumab


  • Study agents: nivolumab, ipilimumab
  • All patients will be treated with ipilumumab every six weeks and nivolumab every two weeks.
  • Patients will stay on study therapy until their cancer gets worse or decide to stop therapy. 

After completion of study therapy, patients are followed for up to 10 years after study enrollment.   

Key Participation Requirements:


Male or Female


19 years and older


The following rare cancers:

  • Undifferentiated carcinoma of the GI tract
  • Rare pancreatic tumors
  • Sarcomatoid carcinoma of the lung
  • Bronchoalveolar carcinoma of the lung
  • Epithelial tumors of the Penis
  • Squamous cell carcinoma variants of the genitourinary system
  • Spindle cell carcinoma of kidney, pelvis or ureter
  • Odontogenic malignant tumors
  • Pancreatic neuroendocrine tumor (PNET)
  • Malignant Pheochromocytoma
  • Carcinomas of the pituitary gland, thyroid gland, parathyroid gland, and adrenal cortex (This will close PERMANENTLY on 8/15/2019)
  • Desmoid tumors
  • Malignant giant cell tumors
  • Metaplastic carcinoma of the breast
  • Perivascular epithelioid cell tumor (PEComa)
  • Peritoneal mesothelioma
  • Basal Cell Carcinoma
  • Clear cell cervical cancer
  • Esthenioneuroblastoma
  • Endometrial carcinosarcoma (malignant mixed mullerian tumors)
  • Clear cell endometrial cancer
  • Clear cell ovarian cancer
  • Gestational trophoblastic disease (GTD)
  • Gallbladder cancer
  • Small cell carcinoma of the ovary, hypercalcemic type
  • PD-L1 amplified tumors
  • Angiosacroma
  • High-Grade Neuroendocrine carcinoma
  • Treatment-emergent small-cell neuroendocrine prostate cancer


Must have cancer that has gotten worse on previous therapy and there are no other approved or standard therapy options available that have been shown to improve the chances of survival, or have cancer for which there is no standard treatment that exists.

May have had any number of treatments for disease including one of the drugs used in this trial but cannot have had both.

Must not have an autoimmune disease that has required treatment during the past 2 years.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

SWOG S1609

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!