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NCT06984328
Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07)
Phase 2 trial testing Acasunlimab in Cutaneous Melanoma in 1 participant. Participants enrolled and being followed up; not accepting new ones.
15 July 2027
Quick facts
| Lead sponsor | Genmab |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 25 July 2025 |
| Primary completion | 15 July 2027 |
| Estimated completion | 15 July 2029 |
| Sites | 2 locations across Puerto Rico, United States |
Drugs / interventions tested
- Acasunlimab — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Cutaneous Melanoma — all drugs for Cutaneous Melanoma →
- Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID) — all drugs for Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID) →
- Metastatic Cutaneous Melanoma (Stage IV) — all drugs for Metastatic Cutaneous Melanoma (Stage IV) →
Sponsor
Genmab — full company profile →
Who can join
18 and older, any sex, with Cutaneous Melanoma or Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to learn about the effectiveness and safety of the bispecific antibody acasunlimab (also known as DuoBody®-PD-L1x4-1BB) when given either alone or together with the cancer drug pembrolizumab in participants with locally advanced or metastatic melanoma of the skin. All participants will receive active drugs; no one will be given a placebo. The trial duration will be approximately 15 months for each participant, including a 28-day screening period and estimated 4-month treatment and 10-month follow-up periods; however, the duration of the treatment and follow-up periods may vary for each participant. Participants will have regular check-ups while on treatment, with visits every week initially, and then every 3 weeks later in the trial.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
After a Decade of Therapy Revolution in Cutaneous Melanoma-Perspectives on Emerging Treatment Strategies.
Wohlfeil SA, Utikal JS. · · 2026 · PMID 42232604 · DOI 10.32604/or.2026.078650
Verify or expand the search:
- PubMed search for NCT06984328
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Acasunlimab
Trials testing the same drug.
- NCT06635824 — Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cel · Phase 3 · active not recruiting
- NCT06046274 — GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer · Phase 2 · withdrawn
- NCT05117242 — Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent ( · Phase 2 · active not recruiting
- NCT04937153 — GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies · Phase 1 · completed
- NCT03917381 — GEN1046 Safety Trial in Patients With Malignant Solid Tumors · Phase 1, PHASE2 · active not recruiting
Other recruiting trials for Cutaneous Melanoma
Currently open trials in the same condition.
- NCT06319196 — Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma · Phase 2 · recruiting
- NCT07148245 — Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma · recruiting
- NCT06967961 — Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers · NA · recruiting
- NCT06194929 — Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutan · Phase 1, PHASE2 · recruiting
- NCT06223659 — EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigra · Phase 2 · recruiting
Other Genmab trials
Trials by the same sponsor.
- NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
- NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
- NCT07288177 — Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · Phase 2 · recruiting
- NCT06771921 — A First-in-Human Trial of Safety and Efficacy of GEN1078 in Participants With Solid Tumors · Phase 1, PHASE2 · terminated
- NCT06635824 — Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cel · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06984328 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genmab
- Last refreshed: 8 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06984328.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing