2 Participants Needed

TIL Therapy + Pembrolizumab for Skin Cancer

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Overseen ByThe Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 4 weeks before starting the trial, and you should not be on systemic corticosteroids or other immunosuppressive medications within 14 days before the study drug administration.

What data supports the effectiveness of the drug pembrolizumab for skin cancer?

Pembrolizumab has shown high durable response rates in a large study of 411 patients with melanoma, a type of skin cancer, with very little toxicity. It is approved for the treatment of unresectable/metastatic melanoma, indicating its effectiveness in treating this form of skin cancer.12345

Is TIL Therapy + Pembrolizumab safe for humans?

Pembrolizumab, also known as Keytruda, has been shown to be generally safe in humans, with common side effects including fatigue, rash, itching, and diarrhea. Less common side effects can include thyroid issues, inflammation of the colon (colitis), liver inflammation (hepatitis), and lung inflammation (pneumonitis).36789

How is the TIL Therapy + Pembrolizumab treatment for skin cancer different from other treatments?

This treatment combines lifileucel, a one-time cell therapy using a patient's own immune cells, with pembrolizumab, a drug that helps the immune system attack cancer by blocking a protein called PD-1. This combination is unique because it uses both personalized cell therapy and a checkpoint inhibitor to enhance the body's ability to fight skin cancer.1371011

What is the purpose of this trial?

This phase I/II trial tests the safety and side effects of LN-144 (Lifileucel) and pembrolizumab in treating patients with stage IIIB-D or stage IV melanoma that has spread to nearby tissue or lymph nodes. Biological therapies, such as LN-144 (Lifileucel), use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.

Research Team

RC

Richard C Wu, M.D. Ph.D.

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Adults aged 18-75 with Stage IIIB-D or IV melanoma, accessible for tumor removal and no prior treatments. Must have good performance status, life expectancy over 3 months, and adequate organ function. Women must not be pregnant/breastfeeding; participants need to use contraception.

Inclusion Criteria

I can care for myself and doctors expect me to live 3 months or more.
I have a tumor in my lymph node that can be measured and accessed for treatment.
I have another cancer type, but it won't affect this trial's treatment.
See 12 more

Exclusion Criteria

My lung function test shows less than 60% of the normal breathing capacity.
I am an adult under legal guardianship or trusteeship.
You have tested positive for HTLV1/HTLV2 or syphilis.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive pembrolizumab, cyclophosphamide, fludarabine, and lifileucel, followed by surgery

12 weeks
Multiple visits for drug administration and surgery

Maintenance

Participants receive pembrolizumab every 6 weeks for up to 1 year

1 year
Visits every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years
Every 3 months

Treatment Details

Interventions

  • Lifileucel
  • Pembrolizumab
Trial Overview The trial is testing LN-144 (Lifileucel) combined with pembrolizumab against advanced melanoma. Lifileucel uses living organism substances to target cancer cells while pembrolizumab boosts the immune system's response to cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, lifileucel)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV on day -14, cyclophosphamide IV QD on days -7 to -6, fludarabine IV over 30 minutes QD on days -5 to -1, and lifileucel IV infusion on day 0. Patients also receive pembrolizumab IV on day 28 and 70, and undergo surgery on day 80. MAINTENANCE: Patients receive pembrolizumab IV every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Lifileucel is already approved in United States for the following indications:

🇺🇸
Approved in United States as Lifileucel for:
  • Unresectable or metastatic melanoma in adults who have previously been treated with a PD-1 inhibitor and, if BRAF-positive, a BRAF inhibitor with or without a MEK inhibitor

Find a Clinic Near You

Who Is Running the Clinical Trial?

Richard Wu

Lead Sponsor

Trials
1
Recruited
2+

Iovance Biotherapeutics, Inc.

Industry Sponsor

Trials
26
Recruited
1,800+

Findings from Research

Pembrolizumab is a monoclonal antibody that effectively blocks the PD-1 receptor on T cells, enhancing their ability to attack cancer cells, particularly in melanoma patients.
In a Phase I study involving 411 patients, pembrolizumab demonstrated high durable response rates with minimal toxicity, indicating its potential as a safe and effective treatment option for melanoma.
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma.Hersey, P., Gowrishankar, K.[2017]
In a phase 1a/b trial involving 26 patients with PD-L1-positive non-small cell lung cancer (NSCLC), the combination of ramucirumab and pembrolizumab showed a manageable safety profile, with 84.6% experiencing treatment-related adverse events, primarily hypertension.
The treatment demonstrated promising efficacy, with an objective response rate of 42.3%, and particularly strong results in patients with high PD-L1 expression (TPS ≥ 50%), who had a median progression-free survival that was not reached.
Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC.Herbst, RS., Arkenau, HT., Bendell, J., et al.[2023]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]

References

Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC. [2023]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. [2023]
Ipilimumab alone or ipilimumab plus anti-PD-1 therapy in patients with metastatic melanoma resistant to anti-PD-(L)1 monotherapy: a multicentre, retrospective, cohort study. [2021]
Dermatological adverse events associated with immune checkpoint inhibitor-based combinations of anticancer therapies: a systematic review. [2022]
Pembrolizumab in the management of metastatic melanoma. [2020]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. [2023]
Pembrolizumab: first global approval. [2021]
Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. [2023]
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