Acasunlimab + Pembrolizumab for Melanoma

Not currently recruiting at 1 trial location

Overseen By Genmab Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Genmab

Must be taking: Anti-PD-1

Disqualifiers: Non-cutaneous melanoma, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment, acasunlimab (an experimental treatment), both alone and combined with pembrolizumab (an immunotherapy drug), for individuals with advanced melanoma of the skin. Melanoma is a serious type of skin cancer, and this study targets those whose cancer has returned or spread after previous treatments. Participants should have melanoma that has progressed after at least one prior treatment, including therapy that blocks a protein called PD-1. For those with melanoma that has returned or spread and who have already tried other treatments, this trial might be suitable. Participants will receive active treatments, with no placebos involved. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of acasunlimab and pembrolizumab has been tested in patients with certain types of cancer and appears manageable in terms of safety. In studies involving cancer patients, including those with non-small cell lung cancer, this combination was tolerated without major issues.

When used alone, acasunlimab was also well-tolerated. While some patients experienced changes in lab results or health, these were expected and closely monitored.

Since this trial is in Phase 2, earlier studies have already demonstrated some safety. Participants will receive regular monitoring to ensure their safety and to address any problems promptly. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about acasunlimab combined with pembrolizumab for melanoma because it targets the immune system differently compared to standard treatments like checkpoint inhibitors alone. Acasunlimab, a novel agent, works by potentially enhancing the immune system’s response to cancer cells, which could improve effectiveness when used with pembrolizumab. This combination aims to offer a new approach for patients whose melanoma has progressed after prior treatments, potentially providing more options and hope for better outcomes.

What evidence suggests that this trial's treatments could be effective for melanoma?

This trial will evaluate the effects of acasunlimab both alone and with pembrolizumab for treating advanced melanoma. Studies have shown that acasunlimab, when combined with pembrolizumab, can enhance the body's immune response against tumors. In individuals with a type of lung cancer, this combination was safe and showed promise in combating the cancer. Acasunlimab targets two proteins to strengthen the immune system against cancer cells. Early research on acasunlimab alone suggests it can trigger a strong immune response by activating a protein called 4-1BB, which influences immune cell activity. While more data is needed for melanoma, these early results are promising for its potential to treat advanced melanoma. ^{1 2 6 7 8}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

This trial is for adults with advanced melanoma that has come back after treatment with checkpoint inhibitor therapy. They must have had at least two cycles of anti-PD-1 therapy, shown disease progression on imaging, and if they have a BRAF V600 mutation, should've tried BRAF-directed therapy unless not suitable due to medical reasons or past side effects.

Inclusion Criteria

My cancer has worsened after treatment, including one that targets the immune system.

I have completed at least 2 cycles of treatment with an anti-PD-1 therapy.

My cancer worsened within 6 months after finishing initial treatment.

Exclusion Criteria

I do not have new or worsening brain metastases or a history of cancer spreading to the lining of my brain.

My melanoma is not on the skin or in areas like hands and feet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive acasunlimab alone or in combination with pembrolizumab, with initial weekly visits and then every 3 weeks

4 months

Weekly visits initially, then every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 months

What Are the Treatments Tested in This Trial?

Interventions

• Acasunlimab
• Pembrolizumab

Trial Overview The study tests acasunlimab alone or combined with pembrolizumab in treating skin melanoma that's locally advanced or metastatic. There are no placebos used; all participants receive active medication over an estimated 15-month period including screening, treatment, and follow-up phases.

How Is the Trial Designed?

Group I: Acasunlimab in Combination with Pembrolizumab Experimental Treatment 2 Interventions

Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab once every 6 weeks (Q6W) in combination with pembrolizumab Q6W.

Group II: Acasunlimab Experimental Treatment 1 Intervention

Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab Q6W.

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials

76

Recruited

15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06984328

NCT06984328 | Study of the Effectiveness and Safety ... This is a Phase 2, randomized, open-label, multicenter trial evaluating the efficacy and safety of acasunlimab as monotherapy and in combination with ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=GCT1046-07

Study of the Effectiveness and Safety of Acasunlimab ... 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) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11987116/

Acasunlimab, an Fc-inert PD-L1×4-1BB bispecific antibody ... Acasunlimab (DuoBody-PD-L1×4-1BB) is an investigational, bispecific antibody designed to elicit an antitumor immune response via conditional 4-1BB activation.

4. withpower.com withpower.com/trial/phase-2-melanoma-5-2025-61ae2

Acasunlimab + Pembrolizumab for Melanoma This Phase 2 medical study run by Genmab is evaluating whether Acasunlimab and Pembrolizumab will have tolerable side effects & efficacy for patients with ...

5. trial.medpath.com trial.medpath.com/news/ad4766e1e32606c9/genmab-advances-two-phase-3-and-phase-2-trials-testing-acasunlimab-combinations-in-lung-cancer-and-melanoma

Genmab Advances Two Phase 3 and Phase 2 Trials Testing ... Genmab is conducting a Phase 3 trial evaluating acasunlimab combined with pembrolizumab versus docetaxel in PD-L1 positive metastatic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06984328?term=acasunlimab&rank=2

Study of the Effectiveness and Safety of Acasunlimab ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. delta.larvol.com delta.larvol.com/products/?ProductId=adf0a7c8-61de-47bf-844e-401d41e040b4&Index=0

acasunlimab (GEN1046) / Genmab Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2533

Acasunlimab (DuoBody-PD-L1x4-1BB) alone or in ... Conclusions: In PD-L1+ pts with mNSCLC following progression on prior CPI tx, acasunlimab + pembro combo showed a manageable safety profile and ...