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

Launched by IOVANCE BIOTHERAPEUTICS, INC. · Apr 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IOV-4001, which is given as an infusion to adults with advanced skin cancer (melanoma) that cannot be removed by surgery or has spread to other parts of the body, as well as those with advanced non-small-cell lung cancer (NSCLC). The researchers want to find out if this treatment is effective and safe for these patients. The trial is currently recruiting participants aged between 18 and 75 who have been diagnosed with specific stages of melanoma or NSCLC and have already tried certain other treatments without success.

To be eligible for the trial, participants must have a confirmed diagnosis of either advanced melanoma or NSCLC and must have experienced disease progression after previous treatments. Participants will undergo tests to ensure they have adequate organ function and a manageable level of physical ability. Those who join the study will receive the infusion treatment and will be monitored closely for any side effects and how well the treatment works. It’s important for potential participants to discuss any concerns with their doctor, especially regarding past treatments and overall health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
• 2. Participants who have received the following previous therapy:
• • 1. 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.
• 2. 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
• • 3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • 4. Participants who is assessed as having at least one resectable lesion.
• • 5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
• • 6. Participants who have adequate organ function.
• • 7. Cardiac function test required.
• • 8. Pulmonary function test may be required.
• • 9. 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.
• • 10. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
• Exclusion Criteria:
• • 1. Participants who have melanoma of uveal/ocular origin.
• • 2. Participants who have symptomatic untreated brain metastases.
• • 3. 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.
• • 4. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
• • 5. Participants who have any form of primary immunodeficiency.
• • 6. Participants who have another primary malignancy within the previous 3 years.
• • 7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.