Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT02983006
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • DS-8273a — BIOLOGICAL
    * Starting Dose: 4 mg/ kg IVQ 3 weeks (Cohort 1) * Dose Escalation: 8 mg/kg IV Q 3 weeks (Cohort 2), 16 mg/kg IV Q 3 weeks (Cohort 3), 24 mg/kg IV Q 3 weeks (Cohort 4), 2 mg/kg IV Q 3 weeks (Cohort -1), 4 mg/kg IV Q 3 weeks (Cohort -2)
  • Nivolumab — BIOLOGICAL
    5 mg/kg IV Q 3 weeks

Study Details

The purpose of this study is to evaluate the safety profile, tolerability, and immunoregulatory (pharmacodynamic; PD) activity of DS-8273a administered in combination with nivolumab (anti-PD-1 antibody) to subjects with unresectable Stage III or Stage IV melanoma.

Key Dates

Start date
Oct 31, 2016
Status verified
Oct 2021
Primary completion
Dec 23, 2019
Completion
Jan 1, 2021

Study Design

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

Arms

  • Experimental: DS-8273a & Nivolumab
    Patient groups (cohorts) will receive a single dose level of DS 8273a \& Nivolumab; DS 8273a will be increased in subsequent cohorts.

Primary Outcome Measure

Safety (adverse events) of the protocol therapy [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Laura and Isaac Perlmutter Cancer CenterNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Laura and Isaac Perlmutter Cancer Center· New York, NY

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