Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients
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|ClinicalTrials.gov Identifier: NCT05176470|
Recruitment Status : Recruiting
First Posted : January 4, 2022
Last Update Posted : April 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Melanoma Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 Pathologic Stage IIID Cutaneous Melanoma AJCC v8||Drug: Cyclophosphamide Drug: Fludarabine Biological: Lifileucel Biological: Pembrolizumab Procedure: Therapeutic Conventional Surgery||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IB Study to Assess the Safety and Efficacy of Neoadjuvant Administration of Autologous Tumor Infiltrating Lymphocytes (LN144/Lifileucel) and Pembrolizumab for Treatment of Patients With Locally Advanced (Stage IIIB-D) Melanoma|
|Estimated Study Start Date :||May 31, 2022|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Treatment (pembrolizumab, lifileucel)
Patients receive pembrolizumab IV on day -14, cyclophosphamide IV QD on days -7 to -6, fludarabine IV over 30 minutes QD on days -5 to -1, and lifileucel IV infusion on day 0. Patients also receive pembrolizumab IV on day 28 and 70, and undergo surgery on day 80.
MAINTENANCE: Patients receive pembrolizumab IV every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
Other Name: Fluradosa
Given by IV infusion
Procedure: Therapeutic Conventional Surgery
- Feasibility of neoadjuvant administration of MK-3475 and LN-144/Lifileucel in 3 stage IIIB-D melanoma patients (Phase 1) [ Time Frame: Up to 2 years ]Success rate of tumor infiltrating lymphocyte (TIL) expansion from all screened eligible patients who have had tumor-involved lymph node(s) removed; percentage of all eligible patients who have completed the screening and treated with LN-144/lifileucel.
- Incidence of grade >= 3 treatment-emergent adverse events (both immune and non-immune related) (Phase 2) [ Time Frame: Up to 2 years ]The severity of AEs will be graded according to CTCAE version 5.0, and frequencies and percentages of patients with AEs will be tabulated by severity grade.
- Overall objective response rate [ Time Frame: Up to 2 years ]Evaluated by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and immune-related RECIST (irRECIST) criteria.
- Relapse-free survival (RFS) rate [ Time Frame: At 24 months ]Kaplan-Meier method will be used to estimate the median time and the corresponding 95% CI.
- Major pathologic response (MPR) rate [ Time Frame: Up to 2 years ]MPR will be summarized by number and percentage of patients with major pathologic response, as well as the corresponding 2-sided exact 95% confidence intervals (95% CI).
- Immune correlates (as described above) with respect to response and 24-month relapse free survival, of the TIL/LN-144 + pembrolizumab neoadjuvant therapy [ Time Frame: Up to 2 years ]
- Success rate of TIL growth from tumor-involved lymph node(s) [ Time Frame: Up to 2 years ]
- Doses of the infused TIL with respect to response and 24-month relapse-free survival [ Time Frame: Up to 2 years ]
- Changes in the patients' health-related quality of life [ Time Frame: Up to 2 years ]Measured by a standardized questionnaire during and after the study protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05176470
|Contact: The Ohio State University Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Richard C. Wu, M.D. Ph.D. Richard.Wu@osumc.edu|
|Principal Investigator: Richard C. Wu, M.D. Ph.D.|
|Principal Investigator:||Richard C Wu, M.D. Ph.D.||Ohio State University Comprehensive Cancer Center|