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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 53

Inclusion Criteria

Inclusion Criteria: 1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma (Cohort 1) or Stage III or IV NSCLC (Cohort 2). 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. 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I: Safety of IOV-4001;Phase 2: Objective Response Rate (ORR)

Secondary Outcome Measures

Name	Time	Method
CR Rate;Duration of Response (DOR);Disease Control Rate (DCR);Progression-free Survival (PFS);Overall Survival (OS);Safety and Tolerability of IOV-4001;Feasibility of IOV-4001

Related Trials

A Phase II study of induction PD-1 blockade (nivolumab) in patients with surgically complete resectable mismatch repair deficient endometrial cancer (NIVEC)

RecruitingNot Applicable

Yonsei University Health System, Severance Hospital

Updated 1/22/2024