Genmab GCT-1046-07 (Advanced or Metastatic Cutaneous Melanoma)

Purpose of this Study

We are doing this study to find out if an experimental drug called acasunlimab (the study drug) is a safe and effective option for adults with relapsed/refractory, unresectable, locally advanced, or metastatic cutaneous melanoma that has progressed despite treatment with a checkpoint inhibitor. We want to know how well the study drug works on its own and in combination with pembrolizimab.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with cutaneous melanoma
  • Have disease that is relapsed/refractory (does not improve with treatment or comes back afterward), locally advanced unresectable (Stage IIIB, IIIC, or IIID), or metastatic (Stage IV - has spread)
  • Have received previous, unsuccessful treatment that included a PD-1 blocking antibody
For more information, contact the study team at emily.bolch@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will go through a 28-day screening period to find out it if you are eligible to take part. If you are eligible, you will get a random assignment (like a coin flip) to 1 of 2 groups. You will either:
  • Take the study drug on its own; OR
  • Take the study drug in combination with pembrolizumab
Both the study drug and pembrolizumab are given as intravenous (IV) infusions into a vein in your arm.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

Efficacy and Safety Study of Acasunlimab as Monotherapy and in Combination
With Pembrolizumab in Subjects With Relapsed/Refractory, Unresectable Locally
Advanced or Metastatic Cutaneous Melanoma That Progressed On or After
Treatment With a Checkpoint Inhibitor

Principal Investigator

April
Salama

Protocol Number

PRO00118084

NCT ID

NCT06984328

Phase

II

Enrollment Status

Pending Open to Enrollment