Pembrolizumab for Melanoma

Phase-Based Progress Estimates
Ohio State University Comprehensive Cancer Center, Columbus, OHMelanoma+4 MorePembrolizumab - Biological
18 - 75
All Sexes
What conditions do you have?

Study Summary

This trial is testing the safety and side effects of two different treatments for melanoma that has spread to nearby tissue or lymph nodes.

Eligible Conditions
  • Locally Advanced Melanoma
  • Metastatic Melanoma
  • Pathologic Stage III Cutaneous Melanoma
  • Stage IIIB Cutaneous Melanoma

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Up to 2 years

At 24 months
Relapse-free survival (RFS) rate
Up to 2 years
Changes in the patients' health-related quality of life
Doses of the infused TIL with respect to response and 24-month relapse-free survival
Feasibility (Phase 1)
Feasibility of neoadjuvant administration of MK-3475 and LN-144/Lifileucel in 3 stage IIIB-D melanoma patients (Phase 1)
Immune correlates (as described above) with respect to response and 24-month relapse free survival, of the TIL/LN-144 + pembrolizumab neoadjuvant therapy
Incidence of grade >= 3 treatment-emergent adverse events (both immune and non-immune related) (Phase 2)
Major pathologic response (MPR) rate
Major pathologic response rate
Overall objective response rate
Success rate of TIL growth from tumor-involved lymph node(s)

Trial Safety

Side Effects for

Pembrolizumab Second Course
100%Inappropriate antidiuretic hormone secretion
100%Urinary tract infection
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%, Urinary tract infection with 100%.

Trial Design

1 Treatment Group

Treatment (pembrolizumab, lifileucel)
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 1

Treatment (pembrolizumab, lifileucel)Experimental Group · 5 Interventions: Fludarabine, Cyclophosphamide, Lifileucel, Therapeutic Conventional Surgery, Pembrolizumab · Intervention Types: Drug, Drug, Biological, Procedure, Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved
Therapeutic Conventional Surgery
Completed Phase 3
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Richard WuLead Sponsor
Iovance Biotherapeutics, Inc.Industry Sponsor
19 Previous Clinical Trials
1,720 Total Patients Enrolled
8 Trials studying Melanoma
945 Patients Enrolled for Melanoma
Richard C Wu, M.D. Ph.D.Principal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between 18 and 75 years old.
You have not received any treatment for your condition before.
If you have had herpes simplex virus (HSV) infection before, you must have received treatment. If you have had Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection before, you must not have any symptoms and have low levels of the virus.
You have Stage IIIB-D locally advanced or Stage IV melanoma (based on specific guidelines), and the disease can be confirmed through imaging or physical examination.
You should be able to perform daily activities with little assistance (ECOG performance status of 0 or 1) and have a life expectancy of at least 3 months according to the investigator. Additionally, you must have at least one measurable lymph node with cancer that can be easily accessed for TIL harvest.
You need to have a recent ultrasound exam to confirm that your melanoma has spread to your lymph nodes. This can be done by taking a small sample (fine needle aspiration or FNA) from the lymph node. This must have been done within the 28 days prior to starting the treatment.
People with or without a specific gene mutation called BRAF V600E/K can participate.
You have a history of heart problems or currently experience symptoms related to heart disease. Before participating in the trial, you will undergo a medical evaluation to determine your heart function. You must have a score of 2B or better on the New York Heart Association Functional Classification to be eligible.
You can participate in the trial if you have had cancer before, but it must not interfere with the safety or effectiveness of the study treatment.
If you have had cancer before or currently have another type of cancer, you can still participate in the trial if it will not affect the safety or evaluation of the treatment being studied.

Frequently Asked Questions

Has Pembrolizumab obtained clearance from the FDA?

"The safety of Pembrolizumab is estimated to be a 1, as this Phase 1 trial contains limited information on its efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Are there any previous data sets that have evaluated the efficacy of Pembrolizumab?

"At present, 1817 clinical trials are researching Pembrolizumab. Of those active investigations, 281 have entered Phase 3 testing. While the majority of these studies take place in Philadelphia, Pennsylvania, globally 63417 sites are running research with this medication." - Anonymous Online Contributor

Unverified Answer

What is the current cohort size for this medical experiment?

"Affirmative. attests to the fact that this clinical trial is actively seeking participants, having been initially posted on July 1st 2022 and most recently updated on October 24th 2022. The study requires 15 patients from one centre." - Anonymous Online Contributor

Unverified Answer

Is the age restriction of this trial under 55 years old?

"To participate in this trial, applicants must be over the age of consent and below 75. There are 395 studies available to individuals under 18 years old and 2389 trials for those above 65." - Anonymous Online Contributor

Unverified Answer

In what ways has Pembrolizumab been found to be beneficial for patients?

"Pembrolizumab is typically prescribed for lymphoma and non-Hodgkin's disease. Additionally, this medication may be beneficial in the treatment of malignant melanomas, recurrent cervical cancer, and leukemia." - Anonymous Online Contributor

Unverified Answer

Would it be feasible to partake in this research study at present?

"Right, the information available on attests that this trial is actively recruiting candidates. The research was initially made public on July 1st 2022 and has been edited as recently as October 24th 2022. A total of 15 participants need to be enrolled at a single site for the study's completion." - Anonymous Online Contributor

Unverified Answer

Are there any criteria for participating in this medical experiment?

"This medical trial is enrolling 15 participants aged 18-75 with cutaneous melanoma. In order to be eligible, no prior therapies are permitted and all applicants must have received pathology confirmation of their condition in the 28 days before commencing treatment. Additionally, those with BRAF V600E/K mutations and past or concurrent malignancies that don't interfere the safety evaluations can qualify for entry. Furthermore, it's important that patients possess an ECOG performance score of 0-1 as well as estimated life expectancy greater than three months; they must also demonstrate measurable disease across primary sites (20mm CXR scan minimum) plus a" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.