Moffitt will be re-opening a phase 2 study to evaluate the safety, tolerability and efficacy of cell transfer therapy using the autologous tumor infiltrating lymphocytes (TIL) LN-145 followed by IL-2 in patients with recurrent and/or metastatic cervical carcinoma.
TILs are generated by processing the patient’s own tumor in a lab to extract and grow specialized white cells called lymphocytes. These cells are then grown and multiplied in a laboratory before being infused back into the patient to attack the cancer.
The purpose of this study is to find out if LN-145 is safe to give to participants with recurrent and/or metastatic cervical cancer. The study also explores persistence of TILs and immune correlates of response, survival, and toxicity of the treatment.
“This is an exciting trial because we have seen complete responses in some patients with widely metastatic cervical patients who have progressed after standard therapies,” said Robert Wenham, MD, MS, FACOG, FACS, Department Chair and Program Leader, Department of Gynecologic Oncology. “It’s more proof that immunotherapy has a role in treating cervical cancer.”
To qualify for this study, patients must meet the following criteria:
- Must be 18 years of age or older.
- Must have recurrent, metastatic or persistent SSC, ASC, or AC of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.
- Must have at least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimum morbidity (defined as any procedure for which expected hospitalization is > At least one measurable target lesion, as defined by RECIST v1.1.
- Must have had progression during or following at least one and no more than three prior systemic chemotherapeutic treatments for recurrent, metastatic or persistent cervical carcinoma.
- A line of systemic therapy is defined as any chemotherapy or multiple-agent chemotherapy regimen that was administered for recurrent, metastatic or persistent SCC, ASC, or AC of the cervix.
- A bevacizumab and chemotherapy combination are encouraged as a prior line of treatment
- Neither chemoradiation, nor chemotherapy in the neoadjuvant or adjuvant settings are considered as a prior line of systemic therapy.
- Any prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents and immunologic agents must be discontinued at least 28 days prior to tumor resection. Radiation therapy must have been completed at least 3 months prior to resection of TIL-generating lesion or at least 3 months prior to Baseline for target lesions. Radiation therapy may have been up to 28 days prior to tumor resection for other lesions.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participants must be seronegative for the HIV antibody, hepatitis B antigen, and hepatitis C antibody or antigen.
- Must meet laboratory criteria per protocol.
- Participants of childbearing potential must be willing to practice an approved method of birth control starting at the time of informed consent and for one year after the completion of the study treatment regimen.
- Additional criteria may apply.
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.