Relatlimab for Melanoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Local Institution - 0011, Lund, Sweden
Melanoma
Relatlimab - Biological
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a fixed dose of two drugs can be better than one drug alone.

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Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Melanoma

Study Objectives

This trial is evaluating whether Relatlimab will improve 1 primary outcome and 17 secondary outcomes in patients with Melanoma. Measurement will happen over the course of 30 days from participant's last dose.

Day 135
Incidence of immune-mediated AEs (IMAEs)
Severity of IMAEs
Day 30
Incidence of AEs leading to discontinuation (DC)
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Incidence of deaths
Incidence of drug related AEs
Severity of AEs
Severity of AEs leading to DC
Severity of SAEs
Severity of drug related AEs
Month 96
Overall Survival (OS)
Month 96
Distant Metastasis-Free Survival (DMFS) time per Investigator assessment
Year 5
Duration of Treatment on next line therapies
Month 59
Recurrence-Free Survival (RFS) time per Investigator assessment
Year 5
Progression-Free Survival 2 (PFS2)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Melanoma

Trial Design

3 Treatment Groups

Arm A: Nivolumab Plus Relatlimab
1 of 3
Arm A: Relatlimab + Nivolumab
1 of 3
Arm B: Nivolumab
1 of 3
Experimental Treatment

This trial requires 1050 total participants across 3 different treatment groups

This trial involves 3 different treatments. Relatlimab is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Arm A: Nivolumab Plus Relatlimab
Biological
Combination
Arm A: Relatlimab + NivolumabCombination
Arm B: Nivolumab
Biological
Monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until second recurrence, up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly until second recurrence, up to 5 years for reporting.

Closest Location

Local Institution - Vancouver, Canada

Eligibility Criteria

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and 17 years of age must have a Lansky/Karnofsky performance score ≥ 80%
You are eligible for the study if you have complete resection of your tumor within 90 days prior to randomization. show original
Tumor tissue must be provided for biomarker analyses
You must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization. show original

Patient Q&A Section

What is the survival rate for melanoma?

"In a recent study, even with early-stage melanoma, 5-year disease-free survival and overall survival were only 50% and 35%, respectively. Survival rates are directly related to histologic type of tumor; patients with lentigo maligna melanoma had a significantly better outcome than patients who received wide local excision for metastatic lesions or those treated with chemotherapy." - Anonymous Online Contributor

Unverified Answer

What causes melanoma?

"As we said before, there are many theories about the cause of melanoma. Some of them are: “The exposure to ultraviolet light (UVR) causes changes in DNA and other cellular components affecting the development of melanomas". Another theory is that it is caused by genetic mutations. The most plausible hypothesis is that both UVR and genetics are involved in the development of melanoma. Unfortunately, we still don't know which one of these factors plays more important role." - Anonymous Online Contributor

Unverified Answer

What is the latest research for melanoma?

"A recent review published in 2014 identified four new drugs in development for the treatment of advanced melanoma, including three checkpoint inhibitors (pembrolizumab, nivolumab, and ipilimumab) and one immunotherapy (daclizumab). More studies using these drugs are needed to determine their efficacy in treating advanced melanoma. These newer therapies could also provide insights into mechanisms of resistance to existing treatments." - Anonymous Online Contributor

Unverified Answer

Does melanoma run in families?

"Genetic predisposition for melanoma seems to exist in families, but this risk appears unrelated to the known genetic factors associated with familial nevi. We hypothesize that environmental factors may play a role in this interaction. The mechanism(s) of such interactions remain elusive and require further investigation." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of melanoma?

"There is no single overriding factor in the causation of melanoma; rather, a complex interplay between multiple genetic, environmental, and epigenetic events that occur simultaneously in the malignant process. Genetic mutations only play a minor role in determining whether a patient develops melanoma. Overall, however, genetic changes appear to act as a sort of'molecular switch' that triggers the onset and progression from normal tissue into cancer\n" - Anonymous Online Contributor

Unverified Answer

Can melanoma be cured?

"Melanoma remains curable. Findings from a recent study of the research studies suggest that patients with early stage melanoma may benefit from surgical excision. Patients with advanced stage melanoma should consider a combination of surgery or chemotherapy with biological agents such as immunotherapy and targeted therapy." - Anonymous Online Contributor

Unverified Answer

How quickly does melanoma spread?

"Melanoma can spread very rapidly. There are many factors that determine how fast melanoma spreads. These include the thickness of the tumor, the place where it starts, and whether or not the patient has any family history of melanoma.\n" - Anonymous Online Contributor

Unverified Answer

How serious can melanoma be?

"Although some cases of melanoma may be fatal, overall mortality due to melanoma is much lower than one would expect. The risk of death is higher among men than women. Among patients who die from melanomas, the prognosis is worse among those younger than 60 years old, with a recent diagnosis, or with multiple lesions. It is possible to achieve survival even if the disease progresses rapidly." - Anonymous Online Contributor

Unverified Answer

Is relatlimab typically used in combination with any other treatments?

"Rellimab was more commonly used when used in combination with other therapies than as monotherapy. However, no significant difference was observed in relapse rate or progression-free survival. These data suggest that rellimab may provide an additional benefit in combination regimens." - Anonymous Online Contributor

Unverified Answer

How many people get melanoma a year in the United States?

"Results from a recent clinical trial shows that 1 in 50 persons may develop melanoma during their lifetime. In addition, there appears to be a significant increase in incidence during adulthood in the US population. The significance of these differences must be weighed against the cost of screening and treatment modalities." - Anonymous Online Contributor

Unverified Answer

Is relatlimab safe for people?

"Rellimab is generally well tolerated; however there were no clinically significant adverse events reported by any study participant in the trials of rellimab compared with placebo. Findings from a recent study confirm the safety profile of rellimab observed during clinical trial in patients with advanced renal cell carcinoma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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