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Monoclonal Antibodies

DS-8273a & Nivolumab for Melanoma

Phase 1
Waitlist Available
Led By Jeffrey Weber, MD, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

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.

Eligible Conditions
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety (adverse events) of the protocol therapy
Secondary study objectives
Anti-tumor activity of the protocol therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DS-8273a & NivolumabExperimental Treatment2 Interventions
Patient groups (cohorts) will receive a single dose level of DS 8273a \& Nivolumab; DS 8273a will be increased in subsequent cohorts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DS-8273a
2014
Completed Phase 1
~50
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor
415 Previous Clinical Trials
465,396 Total Patients Enrolled
4 Trials studying Melanoma
497 Patients Enrolled for Melanoma
NYU Langone HealthLead Sponsor
1,410 Previous Clinical Trials
855,594 Total Patients Enrolled
11 Trials studying Melanoma
338 Patients Enrolled for Melanoma
Daiichi Sankyo, Inc.Industry Sponsor
389 Previous Clinical Trials
422,858 Total Patients Enrolled
4 Trials studying Melanoma
497 Patients Enrolled for Melanoma
~1 spots leftby Nov 2025
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