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SWOG S1616

Status:

Recruiting | Phase II

Official Title:

Testing treatment with Ipilimumab and Nivolumab compared to treatment with Ipilimumab alone in advanced melanoma.  

Study Purpose:

The purpose of this study is to compare any good and bad effects of using Ipilimumab in combination with Nivolumab to the usual approach of treating with Ipilimumab alone.

Interventions:

  • Arm 1 will receive Ipilimumab alone for up to four times.   
  • Arm 2 will receive the combination of Nivolumab and Ipilimumab up to four times.
  • Arm 2 patients will also receive Nivolumab alone after completing the combination treatment.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Stage IV or unresectable stage III melanoma.

Eligibility:

No prior treatment with Ipilimumab.

Must have had prior treatment with anti-PD1 or anti-PD-L1 agents and had disease progression.

No other malignancy is allowed except for the following: basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage 0, 1, or 2 cancer from which the patient is currently in complete remission for two years.  

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

Methodist Health System Trial Code:

SWOG S1616

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!