BMS-936558 for Malignant Melanoma of Skin

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Malignant Melanoma of Skin+1 More
BMS-936558 - Biological
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine can be safely given with a drug that boosts the immune system.

See full description

Eligible Conditions

  • Malignant Melanoma of Skin

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Melanoma of Skin

Study Objectives

This trial is evaluating whether BMS-936558 will improve 1 primary outcome and 2 secondary outcomes in patients with Malignant Melanoma of Skin. Measurement will happen over the course of 2 years, 6 months.

2 years, 6 months
Best Overall Response Rate (BORR)
Duration of Response
Time to Response

Trial Safety

Safety Progress

1 of 3

Other trials for Malignant Melanoma of Skin

Trial Design

2 Treatment Groups

A2 - BMS-936558 Without Peptide Vaccine
1 of 2
A1 - Phase I Dose Escalation
1 of 2
Active Control
Experimental Treatment

This trial requires 127 total participants across 2 different treatment groups

This trial involves 2 different treatments. BMS-936558 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

A1 - Phase I Dose EscalationCohorts 1 through 5. Each treatment cycle is comprised of 6 doses of BMS-936558 and 6 peptide vaccines administered every 2 weeks for 12 weeks (cohort 6 has no peptides) (Cycle 1: Weeks 1, 3, 5, 7, 9, and 11; Cycle 2: Weeks 13, 15, 17, 19, 21, and 23) with tumor response assessments at the end of each cycle (during Weeks 12 and 24).
A2 - BMS-936558 Without Peptide Vaccine
Biological
Cohort 6. Each treatment cycle is comprised of 6 doses of BMS-936558 administered every 2 weeks for 12 weeks (cohort 6 has no peptides) (Cycle 1: Weeks 1, 3, 5, 7, 9, and 11; Cycle 2: Weeks 13, 15, 17, 19, 21, and 23) with tumor response assessments at the end of each cycle (during Weeks 12 and 24).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Montanide ISA 51 VG
2008
Completed Phase 3
~490
gp100:209-217(210M)
1999
Completed Phase 2
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years, 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years, 6 months for reporting.

Closest Location

H. Lee Moffitt Cancer Center and Research Institute - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
HLA-A*0201 was identified as a positive marker using an allele-specific polymerase chain reaction assay; this marker is present in cohorts 5 and 6, but not in cohorts after amendment 9. show original
is a predictor of a poor prognosis The presence of positive staining of tumor tissue with antibodies to human melanoma black 45, NY-ESO-1 and/or MART-1 suggests a poorer prognosis. show original
The text states that if a person has melanoma that is not possible to be surgically removed, and the melanoma meets certain response criteria, then it is considered to be "measurable. show original
to be eligible Individuals who have had brain metastases or meningeal metastases in the past must not have any evidence of progression on MRI scans for at least 8 weeks prior to the start of the study, and must have been off immunosuppressive doses of systemic steroids for at least 2 weeks. show original
Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent), must be discontinued at least 2 weeks before starting treatment with the study drug. show original
into the trial This trial will allow people with Stage III or IV melanomas, regardless of where the cancer started, to participate. show original
for metastatic disease The person has had cancer for longer than a year and has failed at least one chemotherapy treatment show original
The patient is not allowed to have received any systemic radiation therapy within the last 4 weeks show original
A person with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 is considered to have a good prognosis. show original
Patients must have had prior chemotherapy or immunotherapy and all adverse events must have stabilized before starting the study drug. show original

Patient Q&A Section

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

"Melanoma is the second most common form of [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer) after basal cell carcinoma. It is one of the deadliest cancers, causing death in the United States each year. In a survey of melanoma among patients with cancer, approximately 12.5 million Americans are estimated to have had a melanoma diagnosis. Every year in the US, 3,100 people die from melanoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for melanoma?

"Treatment options for melanoma are extremely large in number, but still very limited in number, as shown here. As a rule, treatment of Stage I or II cutaneous melanoma is based on surgery, regional radiotherapy and topical agents. However, for stages III or IV of disease new approaches are required. These include systematic treatment with ipilimumab or anti-PD-1’s, or a combination of both. If, for unknown reasons, ipilimumab did not prove to be a very useful therapeutic option for treatment of advanced melanomas, PD-L1 seemed to be a possible therapeutic target. A trial with an adaptive combinatorial adaptive therapy approach has proved very valuable." - Anonymous Online Contributor

Unverified Answer

Can melanoma be cured?

"The overall cure rate for melanoma is about 30%. The high cure rate achieved in localized tumors may be attributed to complete surgical resection of the tumor site and to effective chemotherapy and surveillance in a subset of patients." - Anonymous Online Contributor

Unverified Answer

What is melanoma?

"Melanoma is the seventh most common cancer in Australia. About 3 in 100 people will be diagnosed with it in their lifetimes. Its name derives from the Greek words ""melas"", meaning black, and ""auto" "self" '. On clinical examination, a person with melanoma will often have a pigmented spot or lesion that often seems darker than those on the skin surrounding it. More than 75% of melanoma cases are in situ at the time of presentation. It is an extremely important sign of an impending melanoma that a person has no history of the disease. Melanoma has a wide geographical distribution, being found in all states and territories." - Anonymous Online Contributor

Unverified Answer

What are the signs of melanoma?

"The following can be used as signs of malignancy. A palpable lump, a new mole or abnormally thick, scaly skin. A change in your usual weight or length, and you are not passing the lump to your mum or dad." - Anonymous Online Contributor

Unverified Answer

What causes melanoma?

"Melanoma is a tumour that mainly arises from the skin. Causes can include both genetically inherited and environmental factors. The most common type of melanoma is sunburn associated with exposure to UV radiation. Other environmental factors include lifestyle, such as smoking. Skin tumours from other causes may be less likely to appear on the sun-exposed surfaces of the body where the risk of melanoma is higher." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets melanoma?

"This data should be useful to health authorities in setting the level of screening that people are required to have. The projected yearly incidence of [malignant melanoma](https://www.withpower.com/clinical-trials/malignant-melanoma) is relatively low, as most melanomas are benign, so why have we set such a high target rate? The current trend may be a consequence of the increased use of sunblock to prevent sunburn from solar radiation, which then has a higher threshold of UV exposure to the skin necessary to cause skin cancer. In a country to avoid excessive skin exposure to UV radiation, it would be reasonable to screen those below the age of 45 for the first time at 7 years, and for the first time every five years after that." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for melanoma?

"The survival rate of melanoma is low for early diagnosed melanoma with an average of three months and for late diagnosed malignant melanoma survival rate is approximately 9 months. The five-year survival rate is only about 20%-30% for metastatic disease. The five-year survival rate improves if patients are treated early with surgery and sent to a specialist unit from the beginning. If the disease remains localized to the skin, patients are able to continue their normal life and only take a few drugs, with a five-year survival rate of nearly 50%." - Anonymous Online Contributor

Unverified Answer

What is the latest research for melanoma?

"What isn’t in the new research includes what the problem is and how it can be overcome. We are in a bit of a ‘waiting for the next breakthrough’ mentality. What is new are treatments that help people already with melanoma. What is new is how to make people choose the best treatment, even if many treatments are available. What is new is new technologies that help determine if a tumor is behaving differently or how it can be treated if that happens. These are the kinds of things that need to be done – I hope that they will lead to better outcomes for all people who may or may not have melanoma." - Anonymous Online Contributor

Unverified Answer

Is bms-936558 safe for people?

"In this short trial of Bms-936558, there was a high rate (37%) of AEs compared with our expectation. All AEs were reversible. Overall, the only safety concern is a dose-dependent increase in liver enzymes. The study was stopped early as a result of safety concerns due to the high frequency of hepatotoxicity. (https://clinicaltrials.gov/ct/show/NCT00549512)." - Anonymous Online Contributor

Unverified Answer

Does melanoma run in families?

"Findings from a recent study demonstrated no significant associations between familial disposition for cancer and melanoma. However, a limitation is the small sample size, thus, further studies on this topic are required to confirm these findings." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating melanoma?

"There were many major discoveries for treating melanoma, both chemically and via radiation therapy. They can be added to the current list of treatments and be further discussed in the future. The research on melanoma, especially in recent years, is almost ongoing. The research in this area is vital, so we will continue to observe any progress made. In regards to the current state of the research, many melanoma survivors are willing to continue to fight for more improved cancer treatments because they know the benefit this research could provide. The future of cancer treatment has already shown the way in this area, and we must keep up the pace of that research, and hope that the research will translate into improvements in current cancer therapies." - 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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