C-145-04 (CLINICAL TRIAL IN RECURRENT, METASTATIC OR PERSISTENT CERVICAL CARCINOMA)

Immunotherapy for Recurrent, Metastatic or Persistent Cervical Carcinoma

TUMOR INFILTRATING LYMPHOCYTE (TIL) therapy is derived from a patient’s own immune cells called lymphocytes that have come to the site of tumor to kill the tumor.

The TIL therapy under investigation in this clinical trial, lifileucel (formerly LN-145), is expanded and rejuvenated TIL that was extracted from the patient’s own tumor.

 

ADDITIONAL INFORMATION ABOUT TIL:

CLINICAL TRIAL OVERVIEW

C-145-04 is a Phase 2 clinical trial enrolling patients with recurrent, metastatic or persistent cervical cancer.

The clinical trial is designed to determine if Iovance investigational TIL therapy lifileucel is safe and effective for the treatment of recurrent, metastatic or persistent cervical carcinoma.

The following cohorts are currently enrolling to position lifileucel for potential future use in broad lines of therapy in cervical cancer:

  • Cohort 1 (pivotal cohort) is active and not currently recruiting to support registration of lifileucel in advanced cervical cancer. Cohort 1 patients have progressed following initial systemic therapy for recurrent or metastatic cervical cancer.
  • Cohort 2 is active and not currently recruiting to support registration of lifileucel in patients who have progressed following treatment with anti-PD-1/PD-L1 therapy (pembrolizumab);
  • Cohort 3 is investigating lifileucel in combination with pembrolizumab in patients who have not received any therapies, other than prior chemoradiation or surgery;
  • Cohort 4 is intended for previously enrolled patients who do not meet the criteria defined for registration, e.g. patients dosed with Gen 1 TIL product; and
  • Cohort 5 will enroll patients for retreatment with lifileucel for patients who have progressed after initial treatment with lifileucel.

There are several objectives to the trial, some of which aim to determine:

  • Whether lifileucel helps reduce the size of a patient’s tumor(s).
  • Whether lifileucel reduces or slows the progression of the cervical carcinoma.
  • Whether lifileucel eliminates all detectable cervical carcinoma.
  • Whether treatment with lifileucel extends the life of a patient without their cancer worsening.

Lifileucel is an investigational therapy that is being tested in clinical studies and has not been approved by the FDA or any other agency for any indication. A clinical trial is designed to explore efficacy and safety of experimental therapies. You should talk to your doctor about the benefits and risks of participating in this trial.

 

YOU MAY QUALIFY FOR THE TRIAL IF:

  • You have been diagnosed with recurrent, metastatic or persistent cervical carcinoma
  • You have not received prior systemic treatment with the exception of chemoradiation or surgery for loco-regional disease, or
  • Your cancer progressed during or following prior systemic therapy, including therapy with or without pembrolizumab
  • You are at least 18 years old

 

If you satisfy these key eligibility criteria, you may be eligible to participate in this clinical trial.  There are other additional eligibility criteria that can only be assessed by a trial physician.

To learn more about the trial, please call: 1-866-565-4410

Further details for healthcare providers can be accessed below:
https://clinicaltrials.gov/ct2/show/NCT03108495

To view a list of active trial sites, please visit https://clinicaltrials.gov/ct2/show/NCT03108495.