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Cytokine

Pembrolizumab for Melanoma

Phase 2
Waitlist Available
Led By Rodabe N Amaria
Research Sponsored by M.D. Anderson Cancer Center
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 up to 5 years
Awards & highlights

Study Summary

This trial is studying pembrolizumab in combination with standard chemotherapy, TIL, and aldesleukin for melanoma that has spread to other parts of the body.

Eligible Conditions
  • Cutaneous Melanoma
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart rate
Secondary outcome measures
Change in blood and tumor biomarkers
Overall survival
Progression-free 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: Arm II (pembrolizumab, low-dose aldesleukin)Experimental Treatment7 Interventions
Patients receive standard lymphodepleting chemotherapy comprising cyclophosphamide and fludarabine phosphate and therapeutic tumor infiltrating lymphocytes as in Arm I, followed approximately 6 hours later by low-dose aldesleukin SC for 14 days. Patients also receive pembrolizumab as in Arm I.
Group II: Arm I (pembrolizumab, high-dose aldesleukin)Experimental Treatment7 Interventions
Patients receive standard lymphodepleting chemotherapy comprising cyclophosphamide IV over 2 hours on days -7 and -6 followed by fludarabine phosphate IVPB over 15-30 minutes on days -5 to -1. Patients also receive therapeutic tumor infiltrating lymphocytes IV over 15-60 minutes on day 0 followed by high-dose aldesleukin IV over 15 minutes every 8-16 hours for up to 15 doses on days 1-5. Beginning between 21-28 days after TIL infusion, patients receive maintenance therapy comprising pembrolizumab IV over 30 minutes every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Tumor Infiltrating Lymphocytes
2015
Completed Phase 2
~30
Pembrolizumab
2017
Completed Phase 2
~2010
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Aldesleukin
2012
Completed Phase 4
~1620
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,763 Total Patients Enrolled
102 Trials studying Melanoma
25,317 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,135 Total Patients Enrolled
557 Trials studying Melanoma
193,215 Patients Enrolled for Melanoma
Rodabe N AmariaPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
140 Total Patients Enrolled
5 Trials studying Melanoma
140 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma
2015. "Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02500576.
~2 spots leftby Apr 2025
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