Infusion of IOV-4001 for advanced melanoma and lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of IOV-4001, a genetically modified autologous tumor-infiltrating lymphocyte (TIL) product, in adult patients with unresectable or metastatic melanoma and advanced non-small-cell lung cancer (NSCLC). The study aims to assess how well IOV-4001 can target and kill tumor cells, potentially offering enhanced antitumor activity by disrupting the PDCD1 gene associated with programmed cell death protein-1 (PD-1). Participants will receive the infusion and be monitored for safety and effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
2. Participants who have received the following previous therapy:

   1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.
   2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:

      * those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
      * those with oncogene-driven tumors: Have progressed during/after ≥1 targeted therapy AND either:

        * platinum doublet chemotherapy
        * Or within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Participants who is assessed as having at least one resectable lesion.
5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
6. Participants who have adequate organ function.
7. Cardiac function test required.
8. Pulmonary function test may be required.
9. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months.
10. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

Exclusion Criteria:

1. Participants who have melanoma of uveal/ocular origin.
2. Participants who have symptomatic untreated brain metastases.
3. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
4. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
5. Participants who have any form of primary immunodeficiency.
6. Participants who have another primary malignancy within the previous 3 years.
7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.

Where it's running

• The Angeles Clinic and Research Institute
  Los Angeles, California, United States Recruiting
• Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Orlando Health Cancer Institute
  Orlando, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• The University of Kansas Cancer Center
  Westwood, Kansas, United States Recruiting
• University of Louisville
  Louisville, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Iovance Biotherapeutics Study Team
• Email: Clinical.Inquiries@iovance.com
• Phone: 1-844-845-4682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating IOV-3001 for Advanced Melanoma Treatment

  This study is testing a new treatment called IOV-3001 to see if it can help adults with advanced melanoma who haven't been able to have surgery.

  Recruiting at 5 sites Phase 1/2 Iovance Biotherapeutics, Inc. · Denver, Colorado and 4 other locations · NCT06940739

• Cemiplimab guided by ctDNA levels (PALACE)

  This study will see if starting adults with advanced (stage IIIB/C or IV) non-small cell lung cancer and PD-L1 ≥50% on cemiplimab, then using ctDNA and early scans to decide whether to add chemotherapy, can improve overall survival.

  Recruiting at 19 sites Phase 2 Fundación GECP · Alicante, Alicante and 19 other locations · NCT06917573

• Combining immunotherapy with prednisone and sirolimus for kidney transplant recipients with advanced skin cancer

  This study is testing a new treatment that combines two immunotherapy drugs with prednisone and sirolimus to see if it helps kidney transplant recipients with advanced skin cancer while keeping their transplanted kidney safe.

  Recruiting at 25 sites Phase 1/2 National Cancer Institute (NCI) · La Jolla, California and 25 other locations · NCT05896839

• Combining lifileucel with pembrolizumab for advanced melanoma treatment

  This study is testing if combining a new treatment called lifileucel with pembrolizumab can help people with advanced melanoma feel better compared to just using pembrolizumab alone.

  Recruiting at 71 sites Phase 3 Iovance Biotherapeutics, Inc. · Birmingham, Alabama and 81 other locations · NCT05727904

• Personalized vaccine combined with pembrolizumab for advanced solid tumors

  This study is testing a new personalized cancer vaccine combined with pembrolizumab to see if it helps people with advanced solid tumors fight their cancer better.

  Recruiting Phase 1/2 Mayo Clinic · Jacksonville, Florida · NCT05269381

• Combining cabozantinib and nivolumab to treat advanced melanoma and head and neck cancer

  This study is testing a combination of two cancer drugs, cabozantinib and nivolumab, to see if they can help people with advanced melanoma or head and neck cancer while also looking at how to better match treatments to patients based on their tumor characteristics.

  Recruiting at 211 sites Phase 2 National Cancer Institute (NCI) · Phoenix, Arizona and 231 other locations · NCT05136196

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.