What side effects are associated with this type of intervention?

The most common treatments for melanoma using immunotherapy, such as nivolumab, ipilimumab, and pembrolizumab, are associated with several side effects. These include immune-related adverse events like skin reactions, endocrine events, and gastrointestinal issues such as diarrhea and colitis. Other common side effects are fatigue, fever, and joint pain. Serious adverse events can include pneumonitis, hepatitis, and endocrinopathies. While these treatments can be effective, they require careful monitoring due to the potential for severe immune-mediated reactions.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of melanoma, particularly those targeting immune checkpoints. Notable approvals include nivolumab (Opdivo) and pembrolizumab (Keytruda), both of which are PD-1 inhibitors that help the immune system recognize and attack cancer cells. Additionally, the combination of nivolumab and ipilimumab (Yervoy), a CTLA-4 inhibitor, has been approved for enhanced efficacy in treating advanced melanoma. These treatments have shown significant improvements in progression-free survival and overall survival in clinical trials. Cellular therapies, such as T-cell receptor (TCR) therapies and chimeric antigen receptor (CAR) T-cell therapies, are also being explored, though they are still largely in the investigational stages for melanoma.

What other types of research exist?

Promising novel alternatives to IOV-4001 for melanoma patients include: 1) Pembrolizumab (Keytruda) and Nivolumab (Opdivo), which are immune checkpoint inhibitors targeting PD-1. 2) Combination therapies such as Nivolumab with Ipilimumab (Yervoy), which target both PD-1 and CTLA-4 pathways. 3) Adoptive cell transfer therapies like TIL (tumor-infiltrating lymphocytes) therapy. 4) CAR-T cell therapies targeting specific melanoma antigens. These therapies have shown significant efficacy in clinical trials and are considered promising options for melanoma treatment in 2024.

← Back to Search

Monoclonal Antibodies

IOV-4001 for Melanoma and Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Iovance Biotherapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be assessed as having at least one resectable lesion.

Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Must not have

Participants who have symptomatic untreated brain metastases.

Participants who have another primary malignancy within the previous 3 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year or depending on when the recommended phase 2 dose is determined

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing IOV-4001, a modified immune cell treatment, in adults with advanced melanoma or lung cancer. The treatment aims to improve the ability of the patient's own immune cells to attack cancer by disabling a gene that helps cancer hide.

Who is the study for?

Adults with advanced melanoma or non-small-cell lung cancer (NSCLC) that can't be surgically removed. They must have had certain prior treatments, good organ function, and no untreated brain metastases or recent live vaccines. Participants need a measurable lesion for the study and agree to use effective birth control.

What is being tested?

The trial is testing IOV-4001 infusion's effectiveness and safety in treating unresectable/metastatic melanoma or advanced NSCLC. It will involve adults who meet specific health criteria and have received previous therapies relevant to their cancer stage.

What are the potential side effects?

While not explicitly listed here, side effects may include typical reactions to infusions such as pain at the injection site, fever, chills, nausea, fatigue, allergic reactions; organ inflammation due to immune response; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have at least one tumor that can be surgically removed.

Select...

I am fully active or can carry out light work.

Select...

I have been diagnosed with advanced melanoma or non-small cell lung cancer.

Select...

I have received platinum-based chemotherapy.

Select...

I have at least one tumor that can be measured and was removed for a specific treatment.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have brain metastases that haven't been treated and are causing symptoms.

Select...

I have had another type of cancer in the last 3 years.

Select...

My melanoma originates from the eye.

Select...

I need more than 10 mg/day of prednisone or an equivalent steroid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year or depending on when the recommended phase 2 dose is determined

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year or depending on when the recommended phase 2 dose is determined

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year or depending on when the recommended phase 2 dose is determined for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 2: Objective Response Rate (ORR)

Phase I: Safety of IOV-4001

Secondary study objectives

CR Rate

Disease Control Rate (DCR)

Duration of Response (DOR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

Participants with Stage III or IV non-small-cell lung cancer

Group II: Cohort 1Experimental Treatment1 Intervention

Participants with unresectable or metastatic melanoma

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for melanoma, particularly cellular therapies and immunotherapies, work by harnessing the body's immune system to target and destroy cancer cells. Cellular therapies, such as tumor-infiltrating lymphocytes (TILs), involve extracting immune cells from the patient, expanding them in the lab, and reinfusing them to attack the melanoma. Immunotherapies, like checkpoint inhibitors (e.g., nivolumab and ipilimumab), block proteins that prevent immune cells from attacking cancer, thereby enhancing the immune response against melanoma cells. These treatments are significant for melanoma patients as they offer targeted approaches that can lead to durable responses and potentially long-term remission, especially in cases where traditional therapies have failed.