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Tests treatment safety and results for Unresectable Melanoma
Official title A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
ClinicalTrials.gov ID: NCT05361174
What this study is testing
What is IOV-4001?
IOV-4001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for unresectable melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
- Participants who have received the following previous therapy:
- Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK...
- Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:
- those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
You likely can't join if
- Participants who have melanoma of uveal/ocular origin.
- Participants who have symptomatic untreated brain metastases.
- Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the...
- Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
- Participants who have any form of primary immunodeficiency.
- Participants who have another primary malignancy within the previous 3 years.
See the full eligibility criteria
- Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
- Participants who have received the following previous therapy:
- Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.
- Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:
- those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
- those with oncogene-driven tumors: Have progressed during/after ≥1 targeted therapy AND either:
- platinum doublet chemotherapy
- Or within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
- Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants who is assessed as having at least one resectable lesion.
- Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
- Participants who have adequate organ function.
- Cardiac function test required.
- Pulmonary function test may be required.
- Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months.
- Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
- Participants who have melanoma of uveal/ocular origin.
- Participants who have symptomatic untreated brain metastases.
- Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
- Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
- Participants who have any form of primary immunodeficiency.
- Participants who have another primary malignancy within the previous 3 years.
- Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Westwood, Kansas, United States
- Louisville, Kentucky, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Miami, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States; Westwood, Kansas, United States; Louisville, Kentucky, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.