Study of the Effectiveness and Safety of Acasunlimab Alone or With Pembrolizumab in treating Advanced Melanoma of the Skin That Has Returned After or did not respond to Cancer Immunotherapy (ABBIL1TY MELANOMA-07)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Genmab A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

completed 5 May 2026

Decision date (initial)

2025-10-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Genmab A/S

External identifiers

EU CT number

2025-520468-16-00

ClinicalTrials.gov

NCT06984328

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

Evaluate the antitumor activity of acasunlimab as monotherapy and in combination with pembrolizumab.

Conditions and MedDRA coding

Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID), Metastatic Cutaneous Melanoma (Stage IV)

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Subjects ≥ 18 years of age with histologically or cytologically confirmed diagnosis of relapsed/refractory, locally advanced unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma.
2. Subject must have radiographic progression on or following ≥ 1 prior systemic therapy according to local and international guidelines, including a programmed cell death protein 1 blocking antibody (anti-PD-1) treatment or combination treatment containing an anti-PD-1.
3. Subject must have received a minimum of 2 cycles of an approved anti PD-1 as monotherapy or combination therapy, containing an anti-PD-1.
4. Neoadjuvant and/or adjuvant systemic therapy count as the first line of prior systemic therapy if there is documented disease progression ≤ 6 months after completion of therapy.
5. Subjects with a BRAF V600 mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to enrollment in the study, unless deemed not clinically indicated by the Investigator due to concurrent medical condition or prior toxicity.
6. Subject has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 7 days prior to Cycle 1 Day 1.

Exclusion criteria 2

1. Subjects with non-cutaneous or acral melanoma.
2. Subjects with newly identified or known unstable or symptomatic central nervous system metastases or history of carcinomatous meningitis.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genmab A/S

Sponsor organisation

Genmab A/S

Address

Carl Jacobsens Vej 30

City

Valby

Postcode

2500

Country

Denmark

Scientific contact point

Organisation

Genmab A/S

Contact name

Jacob Vemb Hansen - Genmab A/S

Public contact point

Organisation

Genmab A/S

Contact name

Genmab Trial Information - Genmab A/S

Third parties 7

Locations

4 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 37 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications