CLINICAL TRIAL

VV1 for Melanoma

Recruiting · 18+ · All Sexes · New Orleans, LA

This study is evaluating whether a combination of two drugs may help treat cancer.

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About the trial for Melanoma

Eligible Conditions
Melanoma · Endometrial Neoplasms · Carcinoma, Hepatocellular · Carcinoma · Non-Small Cell Lung Carcinoma (NSCLC) · Lung Neoplasms · Carcinoma, Non-Small-Cell Lung

Treatment Groups

This trial involves 8 different treatments. VV1 is the primary treatment being studied. Participants will be divided into 8 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
VV1
BIOLOGICAL
+
Cemiplimab
BIOLOGICAL
Experimental Group 2
VV1
BIOLOGICAL
+
Cemiplimab
BIOLOGICAL
Experimental Group 3
VV1
BIOLOGICAL
+
Cemiplimab
BIOLOGICAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
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:
Age ≥18 years on day of signing informed consent.
a. For the NSCLC cohort, histologically confirmed diagnosis of advanced and/or metastatic NSCLC suitable for first line immunotherapy. NSCLC harboring an activating EGFR mutation or anaplastic lymphoma kinase (ALK) rearrangement must have progressed following available EGFR or ALK targeted therapy in addition to treatment with platinum-based chemotherapy (unless ineligible for platinum therapy). i. Able to supply archival (or fresh) formalin-fixed, paraffin- embedded tumor tissue collected within 6 months prior to enrollment for determination of programmed death ligand 1 (PD- L1) status.
ii. PD-L1 status of ≥50% per local standardized testing. Samples should be provided to the central lab for post-hoc centralized testing.
b. For the melanoma cohorts, histologically confirmed diagnosis of advanced and/or metastatic cutaneous melanoma in which radiological progression has been demonstrated during therapy with a PD-(L)1 immune checkpoint inhibitor and for which no existing options are considered to provide clinical benefit (only one line of PD-(L)1 therapy is permitted). Progression on ipilumumab is not required. BRAF V600 mutation patients must have progressed on, or are intolerant to, BRAF +/- MEK inhibitor therapy.
i. At least one tumor lesion amenable to IT injection via palpation or ultrasound. Injection of deep visceral lesions is not permitted. ii. Agrees to provide a newly obtained biopsy of injected lesions prior to start of study treatment, and to repeat biopsies twice during study treatment, and to providing the acquired tissue for biomarker analysis. Tissue obtained for the biopsy must not be previously irradiated, but a new or progressing lesion in the radiation field is acceptable.
Patients must have received at least one dose of anti-PD-(L)1 therapy within 16 weeks of initiating study treatment. show original
You have measurable disease based on RECIST 1.1. show original
Performance status of 0 or 1 on the ECOG Performance Scale
You have a life expectancy of at least 3 months.\n show original
Patients meeting any of the following
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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: within 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: within 24 months.
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 VV1 will improve 1 primary outcome and 3 secondary outcomes in patients with Melanoma. Measurement will happen over the course of within 24 months.

To investigate the pharmacodynamics (PD) of VV1 by measuring serum IFNβ
WITHIN 24 MONTHS
To investigate the pharmacodynamics (PD) of VV1 by measuring serum IFNβ expression
Serum concentration time
WITHIN 24 MONTHS
Serum concentration time data using RT-PCR of VSV-IFNβ-NIS and systemic cemiplimab levels
Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0
WITHIN 24 MONTHS
Safety and tolerability
Objective response rate (ORR) per imaging assessment
WITHIN 24 MONTHS
Percentage of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through disease progression, by investigator review based on RECIST version 1.1

Patient Q & A Section

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

What causes melanoma?

Melanoma has numerous inherited and noninherited risk factors. Most melanomas are suspected to be a manifestation of ultraviolet radiation via UVA, UVB, or both. It is extremely difficult to distinguish between sun exposure and melanoma. The first definitive identification of an inherited melanoma susceptibility gene was in 1996.\n

Anonymous Patient Answer

What are the signs of melanoma?

Symptoms of melanoma usually are described by the patient, or diagnosed by a physician only if the patient is aware of a melanoma. The general public needs a list of symptoms, if it sees them.

Anonymous Patient Answer

Can melanoma be cured?

If melanoma is diagnosed early, the cure rate is close to 90 percent, but once the cancer is large or has metastasized, cure rates are much lower.

Anonymous Patient Answer

What are common treatments for melanoma?

People with melanoma should be informed of the many options for treating metastatic disease and possible side effects, and to discuss each option with their health care team before committing to a treatment choice.

Anonymous Patient Answer

What is melanoma?

The melanoma is a deadly malignant tumor of the skin (skin cancer and melanoma). It is a disease that is unique in its pathogenesis, clinical features, and histological appearance, and is the leading cause of cancer death in young people, especially those who are fair or red-haired. Melanoma is sometimes called the "dreadful mole". There is a large group of patients affected by the illness who are not aware that they have it until it is too late. Thus, those who are in need of such information are recommended to get in touch with a melanoma awareness program or go to a hospital specializing in oncology so that they will recognise the signs and symptoms in a timely manner.

Anonymous Patient Answer

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

Almost 90 million men and women over age 50 in the United States are diagnosed annually with melanoma, making it the second most common cancer for women and the fourth most common cancer for men after colon, lung, and prostate. Melanoma has the largest projected increase among all cancers. In the early 21st century, the mortality rate is projected to fall due to advances in early detection and improved treatments.

Anonymous Patient Answer

Have there been other clinical trials involving ipilumumab?

ipilimumab was FDA-approved in 2011 for treatment of early stage melanoma in conjunction with either DTIC or ipembrolizumab for the treatment of metastatic melanoma. In December 2011, ipilumumab started a phase I trial in patients with advanced melanoma. In July 2012, an open label phase II trial reported that treatment with ipilumumab could induce complete and durable response, with a 10% rate of complete responses and a 20% rate of durable responses, in a cohort of 9 metastatic melanoma patients. The same study reported a median median response time of more than 12 weeks, with a duration of response up to 6.

Anonymous Patient Answer

What are the latest developments in ipilumumab for therapeutic use?

Over the last 5 years, ipilumumab has expanded from immunosuppression to a therapeutic agent, and has the potential to become a therapeutic option for the treatment of metastatic disease and as an immunotherapy in metastatic uveal melanoma. Although many ongoing trials have been reported, the clinical activity of ipilumumab has not been well characterized.

Anonymous Patient Answer

Is ipilumumab safe for people?

The safety profile of ipilumumab supports ongoing development for melanoma in refractory and metastatic melanoma or in combination with other agents for unresectable or metastatic melanoma, and supports continued use for first line treatment of patients with unresectable and/or metastatic melanoma with wild-type BRAF.

Anonymous Patient Answer

Has ipilumumab proven to be more effective than a placebo?

The superiority of ipilumumab over a placebo in terms of PFS and OS for metastatic melanoma adds to the evidence supporting the efficacy of anti-PD-1/PD-L1 inhibitors.

Anonymous Patient Answer

Does melanoma run in families?

There are no strong familial links to the disease and a genetic basis, as suggested by recent evidence, remains elusive. We recommend genetic testing in families with multiple cases of melanoma. Although not necessarily hereditary, there may be rare, inherited, sporadic non-familial cases of early-onset familial melanoma. These cases suggest that both polygenic and gene-environment factors may contribute to disease susceptibility.

Anonymous Patient Answer

How does ipilumumab work?

Ipilumumab is a monoclonal antibody that blocks PD-L1, a receptor that helps inhibit the activity of immune cells, thus, stopping the cancer from being killed. Its activity was especially seen on B16 tumors in mice that express the P53 protein, which is often lost in human melanomas\n

Anonymous Patient Answer
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