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SWOG S1609


Clinical Trial Title

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

Trial Status

Open to Enrollment

Start Date

April 14, 2017

Trial Type

Cancer - Adult Oncology

Specific Condition

Rare Tumors


This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.

Eligibility Criteria

  • Patients are eligible under ONE of the following criteria:
  •     Patients must have histologically confirmed rare cancer
  •     FOR PATIENTS ENROLLED IN EAY131 "NCI-MATCH" PRIOR TO EAY131 ADDENDUM 10 ONLY: Patients must have histologically confirmed rare cancer identified in Section 18.1 t that did not have a match to a molecularly-guided therapy on EAY131 "NCI-MATCH" protocol or who are off protocol treatment on EAY131
  • Patients must be ≥ 18 years of age
  • Patients must have a Zubrod Performance Status of 0-2
  • No other prior malignancy is allowed except for the following:
  •     Adequately managed Stage I or II cancer from which the patient is currently in complete remission
  •     Any other cancer from which the patient has been disease free for one year
  •     Adequately managed Stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission
  • Patients may have received either prior anti-CTLA4 or other prior anti-PD-1/anti-PD-L1 therapy, not both, provided that it is completed ≥ 4 weeks prior to registration
  • Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy ≥ 28 days prior to registration and have stable disease at time of registration. Metastatic brain parenchymal disease must have been treated and patient must be off steroids for 7 days prior to registration. Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to registration
  • Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and bisphosphonates)

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Oncology Clinical Research



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Last Updated: Wednesday, January 27, 2021 12:57:01 PM