4 Participants NeededMy employer runs this trial

Secukinumab for Melanoma

(REPLAY Trial)

AS
EB
Overseen ByEmily Bolch
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Duke University
Must be taking: PD-1 therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of secukinumab, a medication for individuals with advanced melanoma that has spread to other parts of the body. It targets those who previously received immune checkpoint inhibitors (medicines that help the immune system attack cancer) but had to stop due to side effects like serious skin rashes or liver issues. Participants will receive secukinumab before resuming their previous or new cancer treatment to determine if it helps manage these side effects. For those who experienced these issues during past cancer treatments, this trial might be suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroid therapy or other immunosuppressive treatments, you may need to stop them before starting the trial.

Is there any evidence suggesting that Secukinumab is likely to be safe for humans?

Research has shown that Secukinumab is generally safe. Studies on its long-term use indicate that most people tolerate it well for up to five years, with no new safety issues emerging during this period. One study reported a low cancer risk, with only 0.85 cases per 100 patient-treatment years. Additionally, a large safety review found a low risk of serious infections and other severe problems. Overall, extensive research over several years suggests that Secukinumab is safe for patients.12345

Why do researchers think this study treatment might be promising for melanoma?

Secukinumab is unique because it targets interleukin-17A (IL-17A), a protein involved in inflammatory responses, which is different from most melanoma treatments that focus primarily on immune checkpoints like PD-1 or CTLA-4. Researchers are excited about this treatment because it offers a new mechanism of action, potentially enhancing the effectiveness of existing immune checkpoint inhibitors. By combining secukinumab's anti-inflammatory properties with established therapies, there is hope for improved outcomes in melanoma patients who may not fully respond to current options.

What evidence suggests that Secukinumab might be an effective treatment for metastatic melanoma?

Research has shown that secukinumab effectively treats psoriasis by reducing inflammation and improving skin quality. For instance, studies found that after 12 weeks of treatment, nearly 90% of psoriasis patients experienced significant skin improvement. In this trial, participants will receive secukinumab as part of their melanoma treatment regimen. Although direct evidence for using secukinumab in melanoma is limited, it targets a protein called IL-17A, involved in inflammation, which might help manage immune-related side effects from cancer treatments. Importantly, secukinumab carries a low risk of causing new cancers, with a rate of only 0.85 cases per 100 patient-treatment years, suggesting it could be a safe option for patients with a history of cancer.35678

Who Is on the Research Team?

AS

April Salama, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults with advanced melanoma who previously had immune therapy, developed moderate or severe side effects like colitis, hepatitis, or skin rash from it, and are now restarting similar immune therapy. Participants need to have good organ function.

Inclusion Criteria

Participant or legally acceptable representative provides written informed consent for the trial
I am 18 years old or older.
I have advanced metastatic melanoma confirmed by biopsy.
See 3 more

Exclusion Criteria

Participants known to be pregnant or breastfeeding
History or current condition, therapy, or lab abnormality that might confound study results or interfere with participation, per treating physician
Known psychiatric or substance abuse disorders interfering with trial cooperation
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-treatment

Participants receive pre-treatment with secukinumab (300mg) within 1 to 7 days prior to the initial ICI dose

1 week
1 visit (in-person)

Treatment

Participants receive secukinumab weekly for the first 4 weeks, then once every 4 weeks, alongside ICI therapy

Until grade 3 side effect occurs or ICI is discontinued
Weekly visits initially, then every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with CT scans every 12 weeks and survival follow-up for up to three years

Up to 3 years
CT scans every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Secukinumab

Trial Overview

The study tests if giving secukinumab (an IL-17A blocking antibody) is safe and doable for people with metastatic melanoma who had serious side effects from earlier immune checkpoint inhibitor treatment and are starting that treatment again.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SecukinumabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

Secukinumab in Patients with Psoriasis and a Personal ... - PMC

The primary endpoint of the study was tumor recurrence or progression and new cancer diagnosis during treatment. Secondary outcome assessment of secukinumab ...

Real-World Data Suggest Long-Term Treatment With ...

The overall secukinumab survival rate was 81.9% for an average treatment exposure of 147.9 weeks; The approved posology was the most commonly ...

Effectiveness and Safety of Secukinumab in Latin American ...

Secukinumab demonstrated real-world effectiveness and improved dermatology quality-of-life in chronic plaque psoriasis patients from Latin America.

Malignancy Risk Low in Secukinumab Treatment

Over a five-year period, the EAIR malignancy rate in secukinumab-treated patients was 0.85/100 patient-treatment years (PTY; 95% CI, 0.74-0.98).

Effectiveness and Safety of Secukinumab for Psoriasis ... - PMC

Secukinumab has demonstrated sustained long-term efficacy with a favourable safety profile in various manifestations of psoriatic disease.

Long-term Safety of Secukinumab Over Five Years in Patients ...

Secukinumab demonstrated a favourable safety profile for up to 5 years of treatment across the 3 indications, and no new safety signals were identified.

Assessment of safety profile of secukinumab in real-world ...

Death was reported in 949 (2.1%) cases, 6591 (14.72%) were hospitalized, disability occurred in 586 (1.30%) cases, congenital anomaly in 14 ( ...

Safety Outcomes Vary by IL-23, IL-17 Inhibitor Use in ...

In adults with psoriasis, IL-23 inhibitors were associated with lower risks for serious infection and all-cause mortality but higher ...