NCT05361174 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
| NCT ID | NCT05361174 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Iovance Biotherapeutics, Inc. |
| Condition | Unresectable Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2022-07-20 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 53 participants in total. It began in 2022-07-20 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
Iovance Biotherapeutics Study Team
STUDY DIRECTOR
Iovance Biotherapeutics
Frequently Asked Questions
Who can join the NCT05361174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Unresectable Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05361174 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05361174 currently recruiting?
Yes, NCT05361174 is actively recruiting participants. Contact the research team at Clinical.Inquiries@iovance.com for enrollment information.
Where is the NCT05361174 trial being conducted?
This trial is being conducted at Los Angeles, United States, Miami, United States, Orlando, United States, Tampa, United States and 7 additional locations.
Who is sponsoring the NCT05361174 clinical trial?
NCT05361174 is sponsored by Iovance Biotherapeutics, Inc.. The principal investigator is Iovance Biotherapeutics Study Team at Iovance Biotherapeutics. The trial plans to enroll 53 participants.
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