Clinical Trial Is Enrolling Patients With Cervical Cancer for Investigational Immunotherapy

An investigational immunotherapy is currently under review in a phase 2 clinical trial to see if patients with recurrent, metastatic or persistent cervical cancer benefit from it.

The trial is enrolling participants across 35 sites in the United States, France, Germany, Netherlands, Spain, Switzerland and the United Kingdom.

Researchers plan to examine the safety and efficacy of using autologous tumor infiltrating lymphocytes (TILs). The TIL immunotherapy LN-145, which was developed by Iovance Biotherapeutics, will be studied in patients who have received at least one prior immunotherapy or chemotherapy treatment for cervical cancer. LN-145 has not been approved by the Food and Drug Administration or any other agency outside of the U.S.

TIL therapy started in 1988 — the first trial studied it in patients with metastatic melanoma, according to a report from the American Association for Cancer Research (AACR). In cases of melanoma and virally-associated tumors, such as HPV-mediated cervical cancer, the therapy showed efficacy, explained the researchers of this trial.

The therapy works by surgically removing a patient’s T lymphocytes from the cancerous tumor, then the TILs are sent to a lab where they are multiplied to create billions of TILs over a course of three weeks. The patient will then undergo a week of preconditioning therapy. Finally, the TILs are infused into the body through IV with the hope that they will target and attack the cancer.

“As outcomes for patients with recurrent, metastatic or persistent cervical cancer remain extremely poor, there is an enormous need for the development of novel immunotherapeutic approaches with curative potential,” wrote the researchers.

Using LN-145, the researchers want to see if the therapy reduces or slows the progression of cervical cancer, eliminates all detectable disease and helps patients live longer without disease worsening.

Who is Eligible?

Patients who want to be considered for the trial, must have recurrent, metastatic or persistent cervical cancer; have received at least one prior line of therapy; and be at least 18 years old. Their cancer must also have progressed during or following previous therapy.

In addition, patients must also have adequate bone marrow, liver, pulmonary, cardiac and renal function. They must be fully active or, if physically restricted, must be active enough to carry out light activities, such as house or office work, according to the ECOG Scale of Performance Status.

Researchers estimate to have a total of 75 participants in the study. The trial completion date is estimated to be September 2024.

To learn more about the C-145-04 clinical trial, call 1-866-565-4410 or visit clinicaltrials.gov.