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SWOG S1609

Status:

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 patients with rare cancers with two immunotherapy drugs: nivolumab and ipilimumab . 

Interventions:

  • 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:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

The following rare cancers:

  • Undifferentiated carcinoma of the GI tract
  • Squamous cell carcinoma of the GI tract
  • Rare pancreatic tumors
  • Sarcomatoid carcinoma of the lung
  • Bronchoalveolar carcinoma of the lung
  • Trophoblastic tumor
  • Transitional cell carcinoma other than that found in kidney, pelvis, ureter or bladder
  • Cell tumor of the testes and extragonadal germ tumors
  • Epithelial tumors of the Penis
  • Squamous cell carcinoma of the genitourinary system
  • Spindle cell carcinoma of the kidney, pelvis, or ureter
  • Odontogenic malignant tumors
  • Malignant Pheochromocytoma
  • Paraganglioma
  • Cancers of the pituitary gland, thyroid gland, parathyroid gland, and adrenal cortex
  • Desmoid tumors
  • Peripheral nerve sheath tumors
  • Malignant giant cell tumors
  • Chordoma
  • Vulvar cancer
  • Metaplastic cancer of the breast
  • Gastrointestinal stromal tumor (GIST)

Eligibility:

Patients 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.

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

Patients 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!