Nivolumab for Melanoma

Phase-Based Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Melanoma+10 More
Nivolumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Melanoma

Study Summary

This study is evaluating whether a combination of drugs may be more effective than single drugs in treating melanoma.

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Eligible Conditions

  • Melanoma
  • Cancer
  • Cancer of Skin
  • Neoplasms
  • Stage III Cutaneous Melanoma AJCC v7
  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Metastatic Melanoma
  • Stage IIIA Cutaneous Melanoma AJCC v7
  • Unresectable Melanoma
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Metastatic Malignant Neoplasm in the Brain
  • Skin Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Nivolumab will improve 1 primary outcome, 6 secondary outcomes, and 1 other outcome in patients with Melanoma. Measurement will happen over the course of From treatment start date to date of disease progression or death or the last evaluation date, assessed up to 3 years.

Year 3
Circulating and tumor markers
Year 3
Incidence of stable disease
Year 3
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors version 1.1 on both arms
Year 3
Progression-free survival (PFS)
Year 3
Overall survival (OS)
Up to 3 years
Complete response
Incidence of adverse events assessed using National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0
Partial response

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

3 Treatment Groups

No Control Group
Arm A (NDT, CLOSED)

This trial requires 52 total participants across 3 different treatment groups

This trial involves 3 different treatments. Nivolumab 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 2 and have already been tested with other people.

Arm A (NDT, CLOSED)Patients receive nivolumab IV over 30 minutes on day 1, dabrafenib PO BID on days 1-28, and trametinib PO QD on days 1-28. Cycles repeats every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.
Arm C (NEB)Patients receive nivolumab IV over 30 minutes on day 1 and 15, encorafenib PO QD on days 1-28, and binimetinib PO BID on days 1-28. Cycles repeats every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.
Arm B (NT, closed to accrual)Patients receive nivolumab IV over 30 minutes on day 1 and 15, and trametinib PO QD on days 1-28. Cycles repeats every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved
Binimetinib
FDA approved
Dabrafenib
FDA approved
Encorafenib
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

M D Anderson Cancer Center - Houston, TX

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 have Stage IV melanoma or unresectable Stage III melanoma that has progressed on or after receiving prior PD-1 directed therapy show original
Prior therapies for metastatic melanoma are allowed, including chemo-, cytokine-, immuno, biological and vaccine-therapy as long as they did not include BRAFi, MEKi; patients who have progressed on or after receiving anti-PD-1therapy in the adjuvant setting are also allowed; prior ipilimumab and/or PD-1 directed therapy will be allowed with a washout period of 2 weeks and if all autoimmune adverse events have resolved to grade 1 (except endocrine abnormalities that require continuous replacement)
The disease must be evaluable.\n show original
You have a performance status of 0 or 1. show original
Metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 2 weeks after treatment is complete and within 14 days of the first dose of nivolumab administration; or If they are untreated but asymptomatic; or If they are untreated and symptomatic but symptoms are controlled on stable or decreasing doses of steroids for 14 days prior to drug administration; or If they have untreated leptomeningeal disease (LMD) as long as they fulfill all other eligibility requirements.
Note: Patients are excluded if they require high doses of systemic corticosteroids (> 8 mg equivalent of dexamethasone) to control central nervous system (CNS) symptoms.
You have white blood cells (WBC) of 2000/uL or more within one week prior to registration. show original
Neutrophils >= 1500 /uL (within one week prior to registration)
Platelets >= 100 x 10^3 /uL (within one week prior to registration)
Hemoglobin > 9.0 g/dL (within one week prior to registration)

Patient Q&A Section

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

Can melanoma be cured?

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Despite all known factors, we found no indication that melanoma can be cured. There is very little evidence that adjuvant systemic therapy can halt the dissemination of malignant melanocytes in the bloodstream and no evidence that it can cure metastatic melanoma. We do not recommend melanoma-specific adjuvant systemic therapy for patients with early melanoma stage IA in situ and melanomas < 3 mm in size with negative dermoscopy.

Unverified Answer

What is melanoma?

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Melanoma, the most deadly cancer in the world, is extremely aggressive. Signs and symptoms of this illness may not be apparent for months, even years. It is usually the result of an uncontrolled accumulation of melanin-producing cells called nevæ cells. Prevention of melanoma begins in childhood or before it. The primary prevention strategy is to discourage nevæ cell proliferation. Additional prevention strategies are sun protection and prevention of ultraviolet light radiation. It is estimated that 90% of melanomas in the UK are caused by ultraviolet light.

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What are the signs of melanoma?

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Melanomas may present with signs that reflect their infiltrative growth pattern. The most important sign is the radial growth pattern, which has a high sensitivity (80%) but a low specificity (40%), though it is the first indication of malignancy in 50% of cases.

Unverified Answer

What are common treatments for melanoma?

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Melanoma management usually differs in patients depending on their age, gender and stage of disease. These factors should be considered during the treatment process. In all, melanoma treatment affects the life expectancy and quality of life of the patients.

Unverified Answer

How quickly does melanoma spread?

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Melanomas tend to spread over time as evidenced by the increasing size and depth of infiltrations. This could be due to the size of the melanoma itself (large tumors will metastasize more in a less predictable way) or the size of the metastases as they tend to invade the tumor from below. Melanoma metastasizing early can have a drastic impact on survival\n

Unverified Answer

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

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In men and women, 1 in 20 are diagnosed with [malignant melanoma](https://www.withpower.com/clinical-trials/malignant-melanoma). The incidence rises with increasing age, being highest in the 20- to 24-year-old age group; most cases are diagnosed outside the workplace (46%), at home (30%), by visits to a dermatologist (11%), and when first presenting to a dermatologist (9%). The five-year survival rate is 79% after primary treatment for melanoma of all sites, and 70% for non-metastatic melanoma. The overall 10-year survival rate in the United States is 75% for melanoma of all sites and 59% for local-stage melanoma.

Unverified Answer

What causes melanoma?

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Melanoma development is complicated: as discussed earlier, the development may involve a sequential pathway, with different risk factors, with a different set of genes and mutations in different melanomas. Most melanomas have no known environmental triggers for development.

Unverified Answer

Is nivolumab safe for people?

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The safety and efficacy outcomes, as well as cost-benefit analysis, indicated that nivolumab should be a plausible treatment option for people with relapsed or refractory MM. A new agent was required for people younger than age 75 years or who are not amenable to nivolumab. On the basis of the data, nivolumab should be considered in this group.

Unverified Answer

Has nivolumab proven to be more effective than a placebo?

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Nivolumab has demonstrated superiority over a placebo in terms of OS. There were no significant differences between the two groups in terms of PFS, mOS or safety.

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What are the latest developments in nivolumab for therapeutic use?

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The development of therapeutic antibodies is still in a preclinical stage. It can be seen that nivolumab is a treatment option for treatment-resistant subsets of patients with metastatic melanoma or renal cell carcinoma, and a combination of ipilimumab and durvalumab showed promising results against metastatic melanoma.

Unverified Answer

What is the average age someone gets melanoma?

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In contrast to the common belief, average age of melanoma development is not 26.1 years, as reported by Melanoma Awareness Month in 2009. Average age is 31.3 years. There is a slight increased prevalence of melanoma in males.

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Is nivolumab typically used in combination with any other treatments?

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Nivolumab was commonly used as second or third line treatment in our study. Of the 47% of patients who were switched to nivolumab, 48% did so due to clinical or pathological improvement. This suggests that this particular therapy should be used even when the clinical response is inadequate after an initial treatment of a non-selective immunotherapy in some cases.

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