Adjuvant Nivolumab & Low Dose Ipilimumab for Stage III & Resected Stage IV Melanoma

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT02656706
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Effective adjuvant treatment can increase cure in patients with high-risk resected melanoma. High dose interferon is a standard of care in the adjuvant setting but is highly toxic and marginally effective. The combination of ipilimumab and nivolumab is the most active regimen in patients with advanced melanoma so there is clear rationale to test this regimen in the adjuvant setting. Investigators are testing if nivolumab 3mg/kg every 2 weeks with 1mg/kg ipilimumab every 6 weeks in the high risk adjuvant setting. The duration of therapy will be six months.

Key Dates

Start date
Jul 31, 2016
Status verified
Mar 2026
Primary completion
Mar 31, 2019
Completion
Jun 30, 2026

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adjuvant treatment
    Ipilumumab:1mg/kg q6weeks (1 dose per cycle, 4 planned treatments over 6 months total) Nivolumab:3mg/kg q2weeks (3 doses per cycle, 12 planned treatments over 6 months total)

Primary Outcome Measure

Number of Participants With Treatment Related Toxicities [ Time Frame: From day 1 of treatment through 30 days post the last dose of drug, for a total of about 7 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island Hospital and The Miriam HospitalProvidenceRhode Island02903/02906-

Find similar trials in Providence, RI

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Rhode Island Hospital and The Miriam Hospital· Providence, RI

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