Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE1 | RECRUITING | 53 | — | — | Jul 20, 2022 | Jun 1, 2027 | Dec 5, 2024 | 10 | United States |
The safety of IOV-4001 will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the investigator
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants with unresectable or metastatic melanoma |
| Cohort 2 | EXPERIMENTAL | Participants with Stage III or IV non-small-cell lung cancer |
| Name | Type | Description |
|---|---|---|
| IOV-4001 | BIOLOGICAL | A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2. |
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...