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CAR T-cell Therapy

Pembrolizumab for Melanoma

Phase 2
Waitlist Available
Led By Stephanie L Goff, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after end of treatment
Awards & highlights

Study Summary

This trial is testing if adding the drug pembrolizumab to cell therapy, which takes young tumor infiltrating lymphocytes (TIL) cells from a person's tumors and grows them in a lab, is safe and effective to shrink melanoma tumors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate
Secondary outcome measures
Frequency and severity of treatment-related adverse events
Overall survival

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/ACT TIL + PembroExperimental Treatment5 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +young TIL + highdose aldesleukin (IL-2) + pembrolizumab
Group II: 1/ACT TILExperimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +young TIL + highdose aldesleukin (IL-2)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1080
Aldesleukin
2012
Completed Phase 4
~1620
Pembrolizumab
2017
Completed Phase 2
~2010
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,721 Previous Clinical Trials
40,965,034 Total Patients Enrolled
559 Trials studying Melanoma
195,422 Patients Enrolled for Melanoma
Stephanie L Goff, M.D.Principal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
111 Total Patients Enrolled
2 Trials studying Melanoma
111 Patients Enrolled for Melanoma

Media Library

Young TIL (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02621021 — Phase 2
Melanoma Research Study Groups: 2/ACT TIL + Pembro, 1/ACT TIL
Melanoma Clinical Trial 2023: Young TIL Highlights & Side Effects. Trial Name: NCT02621021 — Phase 2
Young TIL (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02621021 — Phase 2
~2 spots leftby Jun 2025
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