RO7198457 for Melanoma

1
Effectiveness
2
Safety
Washington University; Wash Uni. Sch. Of Med, Saint Louis, MO
Melanoma+1 More
RO7198457 - Biological
Eligibility
18+
All Sexes
Eligible conditions
Melanoma

Study Summary

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

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Eligible Conditions

  • Melanoma
  • Advanced Melanoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether RO7198457 will improve 1 primary outcome and 9 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Baseline up to 90 days after the final dose of study drug (up to approximately 27 months).

Month 27
Percentage of Participants With Adverse Events (AEs)
Month 24
Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization
Mean Change in Physical Function (PF) Score After Randomization
Mean Change in Role Function (RF) Score After Randomization
Number of Participants With Adverse Events Reported Through the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Month 24
Overall Survival (OS) After Randomization
Month 24
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization
Month 24
Duration of Response (DOR) According to RECISTv.1.1 After Randomization
Month 12
Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over
Month 24
Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization

Trial Safety

Safety Estimate

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

Compared to trials

Trial Design

3 Treatment Groups

Randomized Period: Arm A: Pembrolizumab
Safety Run-in Period: RO7198457 + Pembrolizumab

This trial requires 131 total participants across 3 different treatment groups

This trial involves 3 different treatments. RO7198457 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 and have already been tested with other people.

Safety Run-in Period: RO7198457 + PembrolizumabParticipants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of RO7198457.
Randomized Period: Arm B: RO7198457 + PembrolizumabParticipants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of RO7198457.
Randomized Period: Arm A: Pembrolizumab
Drug
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with RO7198457 plus pembrolizumab (Arm B) after confirmed disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 24 months for reporting.

Closest Location

Washington University; Wash Uni. Sch. Of Med - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Melanoma or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 is a measure of a patient's ability to carry out normal activities show original
The patient has adequate hematologic and end-organ function. show original
those who have had prior systemic therapy for advanced melanoma, with a few exceptions, are considered naive to further systemic therapy. show original
any histology except for mucosal A person with histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma; any histology except for mucosal, is eligible for this study. show original
Information on tumor specimen availability is requested from pathology laboratories show original
Disease that can be measured using the RECIST v1.1 guidelines. show original
If a fetus has a life expectancy of more than 12 weeks, then the abortion is illegal. show original

Patient Q&A Section

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

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

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The number of people diagnosed with melanoma per year is about 10/100,000. The US incidence rate of melanoma is similar to, but much higher than, the incidence rate reported for Europe. There is no clear evidence that incidence of melanoma in the United States is increasing at a faster rate than in Europe.

Unverified Answer

What causes melanoma?

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Melanoma cannot be related to any factor of the external environment such as UV radiation. Rather, it is a disease of aging with a probability of occurrence around the 70 year mark in the UK.

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What are common treatments for melanoma?

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The most common treatment for melanoma is the surgical removal of the tumour. Most other cancers are typically treated through chemotherapy, surgery, and radiotherapy. These therapies are often effective and can extend survival. However, in recent years they have been shown to increase the risk of dying from cancer and are often contraindicated in patients with poor prognosis. The use of targeted therapy has shown promise in treating advanced-stage melanoma, particularly when used in combination with surgery. This trial is evaluating the effectiveness of this approach as a first line treatment against metastatic melanoma.

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What are the signs of melanoma?

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Melanoma is an extremely treatable disease. It is the most curable form of skin cancer, and early detection can prevent it. When melanoma is detected in its early stages, it can be treated with surgery with minimal chance of recurrence. In more advanced stages, many treatments are used, with varying success rates. Early detection of melanoma is a key component in saving a patient's life.

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Can melanoma be cured?

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The most popular melanoma is a form of [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer), known as a melanoma, and it has been known to be a form of cancer for more than 1,000 years. The first treatment for skin cancer included the use of cauterization which was practiced many centuries ago. The goal was to clear/cure the skin cancer and prevent it from returning. In modern times, the goal is more focused on treating symptoms and decreasing the number of new patients. Despite advancements in diagnosis, treatment, and prognosis, the cure rate for melanoma is limited, and this disease is the cause of much pain and fear due to its high death rate, especially among young patients.

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What is melanoma?

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Melanoma is the only cancer, apart from lung, breast and skin types, that occurs in people with non-Jewish European origins. Melanoma occurs more often in men. It occurs in most countries, but presents in the elderly. Its occurrence is associated with high solar exposure. Melanomas have been found in all races, but their occurrence depends on genetic factors. Melanoma is a heterogeneous disease. The vast majority of cases occur in dark-skinned populations of the Americas. Melanoma can be prevented by physical avoidance of high-brightness sun exposure.

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What are the common side effects of ro7198457?

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Common side effects included itchiness, itchiness or burning sensation at the injection site, and itching or burning sensations in the ears, mouth, or throat. Side effects are usually mild and only occur at dose levels greater than or equal to 0.5 mg in a single injection. Side effects are transient and disappear when treatment ends. There are no dose-related side effects.

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Is ro7198457 safe for people?

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The drug has a high level of safety even if administered to people up to the age of 75 years. The dose used in the safety studies was not related to the level of exposure expected in clinical use. There are currently no restrictions on the use of ro7198457 in people, however as the trial was only a phase IIb study, no recommendation on the use of ro7198457 for the treatment of melanoma has been made.

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How does ro7198457 work?

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Overall, ro7198457 reduced cell viability by inhibiting STAT3 phosphorylation, down regulation of PI3K and P-Akt and upregulation of p21 expression. These effects were observed only in melanoma cells but not in healthy control cells.

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What does ro7198457 usually treat?

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There are several forms of melanoma that have been found to be insensitive or resistant to ro7198457 so the right candidate might not be out there but the right combination might be.

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Is ro7198457 typically used in combination with any other treatments?

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The data available so far suggests that ro07198457 has activity as a single agent against TIG-3 tumors, and that ro07198457, when combined with chemotherapy, shows promise in combating a previously resistant TIG-3 model.

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What is ro7198457?

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Ro7198457 is a novel small molecule which can block the VEGF receptor and inhibit blood vessel formation. It can inhibit vascular endothelial growth factor receptor signaling and tumour growth and reduces intraocular neovascularisation in diabetic rats. It has been granted orphan drug status by the European Medicines Agency, is in Phase 1 clinical trials with a start date of 15 January 2015, and is being developed by Aridis Therapeutics.

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