Sargramostim for Cancer of Skin

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Kaiser Permanente-Bellflower, Bellflower, CA
Cancer of Skin+8 More
Sargramostim - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a combination of two immunotherapy drugs and a colony stimulating factor may help treat patients with advanced melanoma.

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Eligible Conditions

  • Cancer of Skin
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Stage IIIA Cutaneous Melanoma AJCC v7
  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Metastatic Cutaneous Melanoma
  • Unresectable Cutaneous Melanoma
  • Stage III Cutaneous Melanoma AJCC v7
  • Stage IIIC Cutaneous Melanoma AJCC v7

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cancer of Skin

Study Objectives

This trial is evaluating whether Sargramostim will improve 1 primary outcome and 4 secondary outcomes in patients with Cancer of Skin. Measurement will happen over the course of Up to 90 days after the last study drug administration.

Year 5
Overall survival
Year 5
Progression free survival
Up to 5 years
Clinical response
Immune response
Day 90
Incidence of toxicities

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cancer of Skin

Trial Design

2 Treatment Groups

Arm A (nivolumab, ipilimumab, sargramostim)
1 of 2
Arm B (nivolumab, ipilimumab)
1 of 2
Experimental Treatment

This trial requires 600 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sargramostim is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Arm A (nivolumab, ipilimumab, sargramostim)INDUCTION THERAPY: Patients receive nivolumab IV over 30 minutes on day 1, ipilimumab IV over 30 minutes on day 1, and sargramostim SC on days 1-14. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive nivolumab and sargramostim as in Induction therapy. Patients with PR, SC, or CR at 24 weeks may continue maintenance therapy for up to 2 years in the absence of disease progression or unacceptable toxicity.
Arm B (nivolumab, ipilimumab)INDUCTION THERAPY: Patients receive nivolumab and ipilimumab as in Arm I. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive nivolumab as in Induction therapy. Patients with PR, SD, or CR at 24 weeks may continue maintenance therapy for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved
Sargramostim
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

Kaiser Permanente-Bellflower - Bellflower, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You must be between 18 and 75 years of age. show original
You have a performance status of 0 or 1. show original
Patients must have known BRAF mutational status of tumor; wild-type (WT) or mutated, prior to randomization
Patients may have had prior systemic therapy in the adjuvant setting (e.g. interferon, BRAF, or MEK agents). Patients may have had prior anti-CTLA-4 in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment. Patients may have had any prior programmed cell death (PD)-1/PD-ligand (PD-L)1 agent in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment
Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting >= 4 weeks prior to randomization and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy >= 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be >= 4 weeks from randomization and patients must be fully recovered from post-surgical complications
ANC > 1,500/uL (obtained within 4 weeks prior to randomization). show original
You have unresectable stage III or stage IV melanoma according to American Joint Committee on Cancer (AJCC) version (v)7. show original
Patients must have measurable disease per RECIST 1. show original
You are white blood cell count > 3,000/uL (obtained within 4 weeks prior to randomization). show original
You have a platelet count of at least 100,000/uL. show original

Patient Q&A Section

What are common treatments for melanoma?

"Treatment for metastatic melanoma consists of surgery, chemotherapy, targeted therapy, or a combination of these. Chemotherapy is often used to treat skin cancer but its utility against melanoma is debatable. Radiation therapy is used to treat tumors in the brain, eye, chest, or pelvis. The exact role of surgery in melanoma remains unclear." - Anonymous Online Contributor

Unverified Answer

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

"In the United States, it is estimated that 10,960 new cases of melanoma will be diagnosed, while 4,500 cases of melanoma will die in the year 2007 (3.0% of all cases) (National Cancer Institute (NCI)). The overall annual mortality rates for melanoma will nearly double in the next 2 decades, with more than 49,300 new cases and 37,600 melanoma deaths occurring annually by 2020 (3.7% of all cases). In 2007 there was an increase in the age-standardized crude death rates for melanoma from 3.1 per 100,000 for 1975 to 8.4 per 100,000 for 2005." - Anonymous Online Contributor

Unverified Answer

What causes melanoma?

"A large proportion of melanomas are caused by UV light. In a large percentage, there may be genetic factors. The prevalence of melanoma varies with ethnicity and socioeconomic status." - Anonymous Online Contributor

Unverified Answer

What are the signs of melanoma?

"Mature and mature women are at a higher risk of naevus development, especially of uveal melanomas, whereas men older than 60 years suffer more frequently from melanomas of the scalp and neck and from naevi in the face. Moreover, in men, the risk of metastasis increases with the age. Mature and elderly women are at a higher risk for secondary melanomas, especially of nodular, infiltrating, and metastatic melanomas. These women, also, show a higher incidence of melanomas of the eyelid and nose." - Anonymous Online Contributor

Unverified Answer

Can melanoma be cured?

"Based on our data on the prognosis of melanoma, the question of whether this disease can be treated and cured may seem very improbable. Whether the development of a clinically viable approach could be more problematic can be discussed later. In the meantime, we advise physicians and patients in whom these questions should be addressed, especially those with early-stage disease, to pursue research as thoroughly as possible in this area because we find that it is of high priority in patient care." - Anonymous Online Contributor

Unverified Answer

What is melanoma?

"Melanoma is a type of cancer involving the skin or underlying tissue, not the blood or lungs, that often appears coloured slightly or totally black. It most commonly forms skin changes such as a mole, itch, pigmentation or pain. It is usually first noticed on the hands or feet, on the lower part of the eyelid, or on the trunk or lower portion of the back. When the initial lesion has spread, it commonly spreads to the lymph nodes near the skin or on the lining of the eyes, nose or mouth, the brain or blood vessels. It most commonly kills skin lesions, spreads, and spreads to the lymph nodes. About 1 in 3 individuals with skin cancer will die from the disease." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for melanoma?

"The overall survival rate varies from 1 year to 15 years. It varies according to melanoma type and also the individual patient. In terms of the age of the patient and the different clinical stages, it is very important for the melanoma patient to be monitored. They should have regular followups, get dermatology appointments and stay in contact with their doctor as often as possible. It makes a difference not just for the melanoma patient to go back and get another appointment every few months, but every few weeks. I am sending this email to remind you to go back regularly to your doctors and get regular appointments." - Anonymous Online Contributor

Unverified Answer

How does sargramostim work?

"Sargramostim showed no clinically relevant antitumor efficacy against MM xenografts or human MM cell xenografts in the EMMPRIN-deficient xenograft model. Data from a recent study suggest that the EMMPRIN-mediated sargramostim-induced activation of NF-κB is not involved in sargramostim-mediated antitumor efficacy against MM." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating melanoma?

"Our patient's age significantly influences the survival of the patients with this cancer. It’s important to perform the appropriate treatment for patients who present with stage III and IV. However, we have to acknowledge the fact that in more favorable circumstances, the survival rates are far lower than the survival rate in patients presenting stage IV disease. The role of anti-VEGF and anti-angiogenic therapy in the treatment of melanoma is still a highly debated one. It’s important to monitor patients carefully to manage the side effects of this new method of treatment and to improve the outcome for patients who use it. Although, we have to note that, it’s important to do so." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving sargramostim?

"Sargramostim treatment has improved outcomes in melanoma patients, but in a small subgroup. Further research is recommended to identify the subgroup of patients who are most likely to benefit and to explore other immunomodulatory or immunostimulatory agents (such as immune-modulating cytokines or PD-1 and PD-L1 agonists, or PD-L1 inhibitors) when combined with chemotherapy or immunotherapy to improve outcome." - Anonymous Online Contributor

Unverified Answer

Is sargramostim safe for people?

"In people with advanced melanoma on maintenance infusion of GM-CSF or G-CSF, sargramostim administered as a single intraportal infusion at a dose of 24 mg/m2 is a potentially safe procedure." - Anonymous Online Contributor

Unverified Answer

Does sargramostim improve quality of life for those with melanoma?

"Despite the lack of effectiveness, sargramostim can be safely administered to patients with melanoma because of its few side effects. Sargramostim improves quality of life in patients after surgery for melanoma and may increase cancer survival and/or prolong overall survival." - 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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