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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03449108 | LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas | PHASE2 | ACTIVE NOT_RECRUITING | 30 | — | — | Apr 27, 2018 | Apr 30, 2027 | May 22, 2026 | 1 | United States |
Assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Estimation will use 80% confidence intervals by the Wilson score method.
| Arm | Type | Description |
|---|---|---|
| ICI Ovarian Cancer, Sarcomas, Triple Negative Breast Cancer (LN-145-S1, nivolumab) | EXPERIMENTAL | Ipilimumab will be administered as a single dose prior to tumor resection. Nivolumab will be administered once prior to tumor resection. Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine IV over 15-30 minutes daily on days -5 to -1, LN-145-S1 IV over 45 minutes on day 0 and aldesleukin IV over 30 minutes on days 1-4 for up to 6 doses. Within 12 weeks after receiving LN-145-S1, patients receive nivolumab IV over 30 minutes every 4 weeks in the absence of disease progression or unacceptable toxicity. The second dose will be administered prior to TIL administration and dosing will continue every 4 weeks and continued until unacceptable toxicity, progression, or start of another cancer therapy. |
| Thyroid Cohort (LN-145) | EXPERIMENTAL | Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine IV over 15-30 minutes daily on days -5 to -1, autologous tumor infiltrating lymphocytes LN-145 IV over 45 minutes on day 0 and aldesleukin IV over 30 minutes on days 1-4 for up to 6 doses. |
| Name | Type | Description |
|---|---|---|
| Aldesleukin | BIOLOGICAL | Given IV |
| Autologous Tumor Infiltrating Lymphocytes LN-145 | BIOLOGICAL | Given IV |
| Autologous Tumor Infiltrating Lymphocytes LN-145-S1 | BIOLOGICAL | Given IV |
| Cyclophosphamide | DRUG | Given IV |
| Fludarabine | DRUG | Given IV |
| Ipilimumab | BIOLOGICAL | Given IV |
| Nivolumab | BIOLOGICAL | Given IV |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
| Questionnaire Administration | OTHER | Ancillary studies |
Inclusion Criteria: * Age between 18 and 70 (Subjects aged 16-70 may be enrolled into the osteosarcoma cohort). * Subjects must be willing and able to provide informed consent. For patients \< 18 years of age, their parents or legal guardians must sign a written informed consent. Assent, when appro...