CLINICAL TRIAL

Nivolumab for Melanoma

Metastatic
Stage III
Recruiting · 18+ · All Sexes · Boston, MA

This study is evaluating whether a new type of vaccine called NeoVax can be used to treat melanoma.

See full description

About the trial for Melanoma

Eligible Conditions
Melanoma · Metastatic Melanoma

Treatment Groups

This trial involves 2 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 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
NEOVAX
BIOLOGICAL
CDX-301
DRUG
Nivolumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-301
2011
Completed Phase 1
~30
Nivolumab
FDA approved

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participants must have measurable disease by RECIST v1.1 that has not been treated with local therapy within the last 12 months of study treatment. The measurable lesion and the lesion used for surgical or core biopsies can be identical as long as it remains measurable after biopsy
Age ≥ 18 years
An ECOG performance status of 0 or 1 means the person is fully active and able to carry out all usual activities. show original
People will be assessed for eligibility to participate at two points: before their initial core needle/surgical biopsy, and before their first vaccination. show original
Individuals with histologically confirmed cutaneous melanoma that is unresectable stage III or stage IV are eligible to participate in the study show original
Eligibility Criteria for Initial Registration
The participant is willing and able to give written consent, which is a legal requirement for participation in this study. show original
The patient's lab toxicity returned to normal levels, and they did not experience any adverse events that posed a safety risk. show original
WBC ≥3,000/µL
ANC ≥1,500/µL
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Toxicities experienced within 49 days/7 weeks of Neoantigen Vaccine treatment initiation
Screening: ~3 weeks
Treatment: Varies
Reporting: Toxicities experienced within 49 days/7 weeks of Neoantigen Vaccine treatment initiation
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Toxicities experienced within 49 days/7 weeks of Neoantigen Vaccine treatment initiation.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Nivolumab will improve 2 primary outcomes and 3 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Up to 12 weeks for each dosing cohort.

Recommended maximum tolerated dose (MTD)
UP TO 12 WEEKS FOR EACH DOSING COHORT
Highest dose of CDX-301 that did not cause a dose limiting toxicity
UP TO 12 WEEKS FOR EACH DOSING COHORT
Neoantigen-specific cellular immune responses
ENROLLMENT TO END OF TREATMENT UP TO 24 WEEKS
Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
ENROLLMENT TO END OF TREATMENT UP TO 24 WEEKS
Response conversion rate (RCR) at Week 24
WEEK 24
Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
WEEK 24
Anti-tumor activity at Week 24
WEEK 24
Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
WEEK 24
Rate of Dose Limiting Toxicity (DLT)
TOXICITIES EXPERIENCED WITHIN 49 DAYS/7 WEEKS OF NEOANTIGEN VACCINE TREATMENT INITIATION
Based on the CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
TOXICITIES EXPERIENCED WITHIN 49 DAYS/7 WEEKS OF NEOANTIGEN VACCINE TREATMENT INITIATION

Who is running the study

Principal Investigator
P. O.
Patrick Ott, MD
Dana-Farber Cancer Institute

Patient Q & A Section

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

Is nivolumab typically used in combination with any other treatments?

Nivolumab was most frequently used in combination with chemotherapy (62%) and immunotherapy (79%) in patients who received systemic therapy for metastatic melanoma. The best combinations were observed with anti-PD1 plus chemotherapy (32%), chemotherapy alone (26%), immune checkpoint inhibitors plus chemotherapy (16%) and immunotherapy (11%). Future investigations evaluating the role of anti-PD1 in combination with other agents should be made on a prospective basis.

Anonymous Patient Answer

What is the primary cause of melanoma?

Nearly half of all melanomas have a familial component, most commonly new mutations in certain genes such as B-RAF, NRAS, or PTEN. However, for half of melanomas, no mutation is found. For the other half, different, but not rare, genetic changes appear to play a role. This means that even though we may know the specific gene involved, we cannot prove its role in causing the disease. Besides genetics, sunlight exposure has been suggested as an environmental factor resulting in malignant transformation of melanocyte cells in people with fair skin color. Other factors include, age, gender, sunburns, stress, and a weakened immune system.

Anonymous Patient Answer

How does nivolumab work?

Nivolumab inhibits TNF-α by binding to the tumor-initiating cells and thus prevents their proliferation and prevents metastasis of melanoma. The exact molecular mechanism by which it achieves these effects is still unknown. Targeting the T cell checkpoint (CD27) may allow effective immune responses against tumors while minimizing side effects. Additional research will help clarify the role of CD27 targeting in the context of immunotherapy.

Anonymous Patient Answer

What is nivolumab?

Nivolumab did not increase the rate of auto-immune flare, and was safe for use in patients receiving corticosteroids. The safety profile observed here suggests this regimen is suitable for use in patients receiving corticosteroids as part of their induction regimen in combination with nivolumab.

Anonymous Patient Answer

Have there been any new discoveries for treating melanoma?

No new treatments are available for melanoma. There have been advances in understanding the biochemistry and molecular biology of melanomas. These advances are likely to lead to new treatment approaches, but they are unlikely to eliminate melanoma as a disease entity within the next decade.

Anonymous Patient Answer

What causes melanoma?

The most common cause of melanoma is exposure to ultraviolet (UV) radiation from the sun. UV light penetrates deep into the skin. It can also be created artificially by tanning beds and artificial UV lamps. One study showed that almost two thirds of melanoma cases were associated with Malignant neoplasms in families. There are other factors which contribute to melanoma including genetics, prolonged exposure to chemicals in the work place, diet, and hormonal disturbances.\n

Anonymous Patient Answer

What does nivolumab usually treat?

Nivolumab works by binding PD-1, blocking its positive feedback loop to inhibit T cells from attacking tumour cells. This is often used in conjunction with ipilimumab (CTLA4 inhibitor) or retuximab (anti-CD20 antibody). For advanced metastatic disease, clinical trials show promising results when combined with anti-CTLA4 and anti-PD1 antibodies. In routine clinical practice, nivolumab is used as monotherapy or combination therapy for patients who have failed prior systemic therapies, such as chemotherapy, radiotherapy and anti-angiogenic agents.

Anonymous Patient Answer

What is melanoma?

Patient education should focus on the public awareness of the problem, risks and expectations as well as the importance of early detection of the disease.

Anonymous Patient Answer

What is the latest research for melanoma?

There is no doubt that melanoma is one of the leading causes of cancer death in the USA. However, while the average life expectancy for all Americans has increased significantly in the last decades, the survival rate has not improved even though melanoma mortality rates decreased. Nevertheless, the survival rate for melanoma patients who are diagnosed at an early stage is close to 90%. Thus, improvements in survival are still needed.

Anonymous Patient Answer

What are the chances of developing melanoma?

There is no way to predict whether you will develop melanoma, but there are some factors that increase the risk of getting it. For example, if you are African-American, have multiple moles on the face, or have family members with melanoma. However, throughout history, it has been difficult to identify those people who are most likely to get this disease. Therefore, many doctors will recommend that patients should take an annual health checkup to see if they are at increased risk for melanoma.

Anonymous Patient Answer

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

Melanoma accounts for 2% of U.S. cancers diagnosed annually. Most cases occur in individuals older than 40 years. Although melanoma was more common among males than females, this difference has narrowed over time. Increased ultraviolet exposure appears to contribute to the higher incidence of melanoma among African Americans.

Anonymous Patient Answer
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