IOV-COM-202 (IMMUNOTHERAPY FOR SOLID TUMORS)

Immunotherapy for Solid Tumors

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.

Several TIL therapies are under investigation in this clinical trial. The TIL therapies lifileucel, LN-144 and LN-145 are expanded and rejuvenated TIL that was extracted from the patient’s own tumor. For LN-145-S1, specific TIL are selected for PD-1 expression.

ADDITIONAL INFORMATION ABOUT TIL:

CLINICAL TRIAL OVERVIEW

IOV-COM-202 is a Phase 2 clinical trial of Iovance TIL therapy (lifileucel, LN-145, LN-144 and LN-145-S1), in patients that have been diagnosed with histologically confirmed unresectable or metastatic melanoma, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), recurrent or metastatic non-small cell lung cancer (NSCLC), or relapsed or refractory NSCLC.

The cohorts in the study are investigating the following treatment regimens:

  • Lifileucel in combination with anti-PD-1/PD-L1 therapy (pembrolizumab) in patients with unresectable or metastatic melanoma (Stage IIIC or Stage IV) who have not received prior immunotherapy, including checkpoint inhibitors. If BRAF mutation-positive, patients may have received a BRAF inhibitor. This cohort is active and not currently recruiting patients.
  • LN-145-S1 alone in patients with unresectable or metastatic melanoma who have received at least one prior line of systemic therapy. If BRAF mutation-positive, patients may have received a BRAF inhibitor. This cohort is active and currently recruiting patients.
  • LN-144 alone, manufactured using a 16-day, third generation process (Gen 3), in patients with unresectable or metastatic melanoma who have received at least one prior line of systemic therapy. If BRAF mutation-positive, patients may have received a BRAF inhibitor. This cohort is active and currently recruiting patients.
  • LN-145 in combination with pembrolizumab in patients with unresectable or metastatic HNSCC who have not received prior immunotherapy, including checkpoint inhibitors. This cohort is active and not currently recruiting patients.
  • LN-145 in combination with pembrolizumab in patients with recurrent or metastatic NSCLC who have not received prior immunotherapy, including checkpoint inhibitors. This cohort is active and currently recruiting patients.
    LN-145 alone in NSCLC patients who have previously received systemic therapy, which could include checkpoint inhibitors and tyrosine kinase inhibitors. This cohort is active and not currently recruiting patients.
    LN-145 therapy in combination with ipilimumab and nivolumab in patients with recurrent or metastatic NSCLC who have previously received one line of approved checkpoint inhibitor monotherapy as the only prior line of systemic therapy. This cohort is active and currently recruiting patients.

The clinical trial is designed to determine if Iovance investigational TIL therapy is safe and effective for the treatment of various solid tumors and patient populations. There are several objectives to the trial, some of which aim to determine:

  • Whether TIL therapy alone or in combination with pembrolizumab or in combination with ipilimumab and nivolumabis safe.
  • Whether TIL therapy alone or in combination with pembrolizumab or in combination with ipilimumab and nivolumab helps reduce the size of a patient’s tumor(s).
  • Whether TIL therapy alone or in combination with pembrolizumab or in combination with ipilimumab and nivolumab reduces or slows the progression of NSCLC and metastatic melanoma.
  • Whether TIL therapy alone or in combination with pembrolizumab or in combination with ipilimumab and nivolumab eliminates all detectable NSCLC and metastatic melanoma.
  • Whether TIL therapy in combination with pembrolizumab or in combination with ipilimumab and nivolumab reduces or slows the progression of HNSCC.
  • Whether TIL therapy in combination with pembrolizumab or in combination with ipilimumab and nivolumab eliminates all detectable HNSCC.
  • Whether treatment with TIL alone or in combination with pembrolizumab or in combination with ipilimumab and nivolumab extends the life of a patient without their cancer worsening.

Iovance TIL are investigational therapies that are 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 histologically with:
    • locally advanced or metastatic NSCLC
    • unresectable or metastatic melanoma
    • recurrent or metastatic HNSCC (checkpoint naïve, up to 3 prior therapies)
  • You are at least 12 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/NCT03645928

To view a list of active trial sites, please visit https://clinicaltrials.gov/ct2/show/NCT03645928.