nivolumab for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Duke Cancer Institute, Durham, NC
Melanoma+1 More
nivolumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help prevent melanoma from returning after surgery.

See full description

Eligible Conditions

  • Melanoma
  • Melanoma Stage III

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether nivolumab will improve 1 primary outcome and 3 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Approximately 4 weeks.

1 year
Recurrence-Free Survival
Approximately 4 weeks
Pathological Response Rate
Up to 13 months
Frequency and Incidence of Adverse Events
Up to 7 Years
Overall Survival

Trial Safety

Safety Estimate

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

Compared to trials

Trial Design

3 Treatment Groups

Arm B: Adjuvant Nivolumab (Less than Complete Response)
1 of 3
Arm A: Adjuvant Nivolumab (Complete Pathological Response)
1 of 3
Arm C: Adjuvant Combination (Less than Complete Response)
1 of 3
Active Control
Experimental Treatment

This trial requires 60 total participants across 3 different treatment groups

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

Arm C: Adjuvant Combination (Less than Complete Response)ipilimumab (1mg/kg) plus nivolumab (3mg/kg) for 4 doses and then nivolumab (480 mg) alone for a total of one year
Arm B: Adjuvant Nivolumab (Less than Complete Response)
Drug
480 mg IV for up to one year
Arm A: Adjuvant Nivolumab (Complete Pathological Response)
Drug
480 mg IV for up to one year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Ipilimumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 7 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 7 years for reporting.

Closest Location

Duke Cancer Institute - Durham, NC

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:
The subject must have clinical stage III resectable melanoma per investigator. Subjects may not have a diagnosis of uveal or mucosal melanoma.
Either the subject or the subject's legally authorized representative must be willing and able to provide written informed consent before the performance of any protocol-related procedures.
The subject must be ≥18 years of age on day of signing informed consent.
The subject must have a performance status of 0 or 1 on the ECOG Performance Scale.
The subject must demonstrate adequate organ function as defined in Table 1; all screening labs must be performed within 28 days of treatment initiation.
Hematologic System: Absolute neutrophil count (ANC) ≥1500/mcL; Platelets ≥100,000/mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Renal System: Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR ≥50 mL/min for subject with creatinine levels >1.5 X institutional ULN
Hepatic System: Serum total bilirubin ≤1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels >1.5 ULN; AST (SGOT) and ALT (SPGT) ≤2.5 X ULN OR ≤5 X ULN for subjects with liver metastases
A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies: A.) Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR B.) A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and is willing to use a highly effective method of contraception or abstain from heterosexual intercourse for at least 2 weeks prior to the time of first dose of study medication through 5 months after the last dose of study medication.
Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.

Patient Q&A Section

What are the signs of melanoma?

"Melanoma is a skin cancer, but it has many signs that may be detected. Common signs include: changes in colour, feeling of itchiness or irritation, mole changing shape, lump changing shape or skin getting ulcerated. Pain with manipulation may occur." - Anonymous Online Contributor

Unverified Answer

What is melanoma?

"Melanoma is a relatively rare but aggressive cancer of the skin. It is the major type of skin cancer and a leading cause of cancer related deaths in the United States. The overall 5 year survival rate is about 86% or higher. It usually presents itself as an asymptomatic, pigmented lesion and is found mostly on the trunk. Rarely, the melanoma will spread to the lymph nodes, or to other body organs. As with other types of cancer, it can be detected and managed at any stage because it is not an incurable disease. Prostate cancer is a type of cancer that forms in the prostate gland. It can be very difficult to diagnose because the initial symptoms could be similar to those of prostate cancer." - Anonymous Online Contributor

Unverified Answer

Can melanoma be cured?

"The use of topical preparations of topical agents may benefit some patients; however, there is no evidence that it can cure all forms of melanoma." - Anonymous Online Contributor

Unverified Answer

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

"Approximately 55,000 new cases are diagnosed each year in the United States. This makes up about 0.7% of the population of the United States. The majority of melanomas diagnosed are acquired nevi. Many of them also develop into melanoma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for melanoma?

"The treatment of melanoma is multidisciplinary and involves surgical resection and nodal staging as well as [immunotherapy](https://www.withpower.com/clinical-trials/immunotherapy) targeting the B(3) natriuretic peptide, anti-CTLA4 antibody, anti-IL-2 receptor, anti-PDL1 antibody and BRAF inhibitor (BORFs of VEGF/IL-6, BORFs of PDGF/CCR2 and others). Radiation therapy for the tumor bed and chemotherapy may be used with a curative intention for a limited proportion of patients." - Anonymous Online Contributor

Unverified Answer

What causes melanoma?

"UV light causes melanoma. The risk is highest in areas of the sun that are most often in sunlight. People who have a dark skin tone may be more prone to develop melanoma with UV radiation than people with lighter skin. People who wear hats, sunscreens, or long-sleeved shirts are also at increased risk of melanoma. The increased likelihood of melanoma after certain kinds of dermatologic surgery can be reduced by wearing protective sunscreen and a hat, or the use of a new technique called the Ablage operation." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for melanoma?

"The survival rate for melanoma is excellent, even in remote rural and remote regional settings. Better survival is seen in Caucasians than in other races. Younger age predicts better survival in melanoma patients." - Anonymous Online Contributor

Unverified Answer

What is nivolumab?

"Patients with unresectable stage III melanoma should be considered for treatment with Nivolumab. PFS and OS are comparable to those reported for other anti-PD-1/PD-L1 inhibitors. Further studies are needed to determine the most appropriate therapeutic dose and appropriate schedule." - Anonymous Online Contributor

Unverified Answer

How serious can melanoma be?

"Melanoma is a highly lethal cancer that is seldom detected until it has metastasised to distant sites. The average time between onset and the diagnosis of melanoma is 5-7 years. The high case fatality rate indicates that melanoma has a high biological aggressiveness. Patients with melanoma can be treated with a wide variety of modalities to control their tumour, including topical medications, surgery, radiation therapy, chemotherapy and, most recently, biological therapies." - Anonymous Online Contributor

Unverified Answer

What is the latest research for melanoma?

"The melanoma research community continues to innovate, and continue to work together to help improve the treatment and outcomes for melanoma. There are still hundreds of clinical samples available for treatment and research studies, and new therapies or treatments are continuing to be explored. As of 2016, an improved survival rate was the only improvement in melanoma treatment. The first line of treatment depends on whether your melanoma has metastasized to the lymph nodes or to other parts of the body as well as the extent of the melanoma. In Stage III melanoma, the only definitive treatment is cutaneous malignant melanoma surgery (CMS), which is surgical removal of most of the tumor and its corresponding skin." - Anonymous Online Contributor

Unverified Answer

What does nivolumab usually treat?

"A broad spectrum of cancers can benefit from the treatment with nivolumab. In a very limited number of patients, even in all cases can make a difference, such as: relapsed or refractory solid tumors, including melanoma. For some patients, particularly women with certain types of breast cancer, nivolumab may be considered as a second-line drug. The use of nivolumab is therefore limited in these cases. But even in these cases, the use of nivolumab is associated with severe and sometimes life-threatening side effects of the drug such as: rash, diarrhea, and thyroid and blood disease." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving nivolumab?

"It is difficult for nivolumab to be considered a therapeutic substance for the first time due to its low effectiveness, but this is expected to improve. The safety and use of first-line therapy, and the role of other substances should also be reconsidered, as they are still unknown." - 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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