Phase II study using LN-145 for Persistent Cervical Cancer
A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma
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Clinical Trial Information
Trial Contact: Frankos, Marie; Djuro, Victor
Trial Phone: 321.841.5357 ; 321.841.7477
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IRB No: 17.164.12
Protocol Abbrev: C-145-04
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase II
Age Group: Adult
Treatment: LN-145
Therapies Involved: Oncology: Neo-adjuvant
ClinicalTrials.gov ID: NCT03108495
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Objective
Primary Objective
• To evaluate the efficacy of LN-145 in patients with recurrent, metastatic, or persistent cervical carcinoma based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 -
Key Eligibility
Inclusion Criteria:
• Must be greater than 18 years of age at the time of consent.
• Must have metastatic, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.
• Must have had at least 1 prior systemic immunotherapy or chemotherapeutic treatment for cervical carcinoma. Patients must have either progressive disease or no response (i.e., no PR or CR) while receiving or after the completion of the most recent prior treatment.
• Any prior therapy directed at the malignant tumor, including radiation therapy, chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least 28 days prior to tumor resection.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must be seronegative for the HIV antibody, hepatitis B antigen, and hepatitis C antibody or antigen.
• Patients of childbearing potential must be willing to practice an approved method of birth control starting at the time of informed consent and for 1 year after the completion of the study treatment regimen
