Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Iovance Biotherapeutics, Inc.
- Study ID
- NCT03108495
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- LN-145 — BIOLOGICALA tumor sample is resected from each participant and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
- LN-145 + pembrolizumab — BIOLOGICALA tumor sample is resected from each participant and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. The first dose of anti-PD-1 immunotherapy will be administered following tumor resection.
Study Details
Prospective, multicenter, multiple cohort, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145), with or without pembrolizumab, followed by IL-2 after a non-myeloablative lymphodepletion (NMA-LD) preparative regimen for the treatment of participants with recurrent, metastatic, or persistent cervical carcinoma.
Key Dates
- First listed
- Apr 11, 2017
- Start date
- Jun 22, 2017
- Status verified
- Jul 2026
- Primary completion
- Aug 22, 2025
- Completion
- Aug 22, 2025
Study Design
- Enrollment
- 210 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1 LN-145 monotherapyLN-145 monotherapy in participants who have progressed during or following systemic therapy; this cohort is no longer open for enrollment.
- Experimental: Cohort 2 LN-145 monotherapyLN-145 monotherapy in participants who have previously received a PD-1/PD-L1 checkpoint inhibitor either as monotherapy or combination therapy.
- Experimental: Cohort 3 - Combination Arm (TIL + Pembrolizumab) - US OnlyLN-145 in combination with pembrolizumab in participants who have not received any therapies other than prior chemoradiation or surgery for loco-regional disease.
- Experimental: Cohort 4 - Previously Enrolled CohortLN-145 monotherapy in previously enrolled participants who do not meet requirements for inclusion in the other study cohorts; this cohort is not open for enrollment.
- Experimental: Cohort 5 Retreatment CohortLN-145 monotherapy as a re-treatment.
Primary Outcome Measure
Cohort 1 and 2: Objective Response Rate [ Time Frame: Up to 60 months ]
Locations (24)
Related coverage on Hipa.ai
- Pembrolizumab cervical cancer trial posts phase 2 resultsPembrolizumab · Jul 31, 2026 · ClinicalTrials.gov
Find similar trials in Phoenix, AZ
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St. Joseph's Hospital and Medical Center Center For Women's Health· Phoenix, AZUniversity of Southern California· Los Angeles, CAUniversity of California San Diego· San Diego, CASylvester Comprehensive Cancer Center· Miami, FLUniversity of Florida Health Cancer Center· Orlando, FLUniversity of South Florida H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL
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