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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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
~1100
Aldesleukin
2012
Completed Phase 4
~1620
Pembrolizumab
2017
Completed Phase 2
~2010
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,133 Total Patients Enrolled
557 Trials studying Melanoma
193,213 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab been granted regulatory approval by the FDA?

"Our team has assessed the safety of Pembrolizumab to be a 2, as this is only in Phase 2 and there are no efficacy studies present."

Answered by AI

Is it possible to partake in this research endeavor?

"In order to be accepted, applicants must have a diagnosis of melanoma and age between 18-70 years old. Altogether this study is seeking 170 participants."

Answered by AI

Does this research protocol include geriatric individuals?

"To be eligible for this trial, participants must fall within the 18 to 70 year old age bracket. Conversely, there are 392 clinical trials available for minors and 2330 studies open to senior citizens."

Answered by AI

In what medical contexts is Pembrolizumab typically prescribed?

"Pembrolizumab is a viable treatment option for non-Hodgkin's lymphoma, melanoma of the skin, recurrent cervical cancer, and leukemia."

Answered by AI

How many participants have been recruited to this clinical trial thus far?

"Affirmative. The data published on clinicaltrials.gov reveals that this medical investigation is presently recruiting for volunteers, with the trial first posted in December 2015 and last edited in October 2022. 170 participants are being sought from two distinct centres."

Answered by AI

Are there any current opportunities to enroll in this experiment?

"Per the information presented on clinicaltrials.gov, this medical experiment is presently seeking volunteers to join it. The trial was initially announced in December 2015 while its latest edits were made in October 2022."

Answered by AI

Have researchers conducted any other experiments involving Pembrolizumab?

"At present, 1817 clinical trials are actively studying the efficacy of Pembrolizumab. Of these live studies, 281 have advanced to Phase 3. Philadelphia is one of many research centres for this medication and 63413 locations host active studies on Pembrolizumab treatment."

Answered by AI
Recent research and studies
New England Journal of MedicineJournal
Pembrolizumab Versus Ipilimumab in Advanced Melanoma
Robert, Caroline, Jacob Schachter, Georgina V. Long, Ana Arance, Jean Jacques Grob, Laurent Mortier, Adil Daud, et al.. 2015. “Pembrolizumab Versus Ipilimumab in Advanced Melanoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1503093.
Clinical Cancer ResearchJournal
Adoptive Transfer of Tumor-infiltrating Lymphocytes in Patients with Metastatic Melanoma: Intent-to-treat Analysis and Efficacy After Failure to Prior Immunotherapies
Besser, Michal J., Ronnie Shapira-Frommer, Orit Itzhaki, Avraham J. Treves, Douglas B. Zippel, Daphna Levy, Adva Kubi, et al.. 2013. “Adoptive Transfer of Tumor-infiltrating Lymphocytes in Patients with Metastatic Melanoma: Intent-to-treat Analysis and Efficacy After Failure to Prior Immunotherapies”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-13-0380.
Clinical Cancer ResearchJournal
Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T-cell Transfer Immunotherapy
Rosenberg, Steven A., James C. Yang, Richard M. Sherry, Udai S. Kammula, Marybeth S. Hughes, Giao Q. Phan, Deborah E. Citrin, et al.. 2011. “Durable Complete Responses in Heavily Pretreated Patients with Metastatic Melanoma Using T-cell Transfer Immunotherapy”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-11-0116.
clinicaltrials.govStudy
A Prospective Randomized and Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
2015. "A Prospective Randomized and Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02621021.
~2 spots leftby Jun 2025
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