Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT04013854
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • nivolumab — DRUG
    All arms will receive a pre-surgery dose of nivolumab (480 mg IV). Post-surgery nivolumab doses will be determined by pathologic response and randomization.
  • Ipilimumab — DRUG
    Only subjects who fail to achieve a complete, or near complete, pathological response, and are then randomized to Arm C will receive Ipilimumab (1 mg/kg) )

Study Details

Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.

Key Dates

Start date
Jan 1, 2020
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
67 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: Adjuvant Nivolumab (Complete Pathological Response)
    480 mg IV for up to one year
  • Active Comparator: Arm B: Adjuvant Nivolumab (Less than Complete Response)
    480 mg IV for up to one year
  • Experimental: Arm C: Adjuvant Combination (Less than Complete Response)
    ipilimumab (1mg/kg) plus nivolumab (3mg/kg) for 4 doses and then nivolumab (480 mg) alone for a total of one year

Primary Outcome Measure

Recurrence-Free Survival [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
Duke Cancer InstituteDurhamNorth Carolina27710-
Lancaster General HospitalLancasterPennsylvania17601-
Abramson Cancer Center, University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Durham, NC

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Duke Cancer Institute· Durham, NCLancaster General Hospital· Lancaster, PAAbramson Cancer Center, University of Pennsylvania· Philadelphia, PA

Related Studies