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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: 30 days after end of treatment
Day 30
Frequency and severity of treatment-related adverse events
Year 5
Response rate
Year 5
Response Rate
Time of death
Overall survival
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
Trial Design
4 Treatment Groups
2/ACT TIL + Pembro
1 of 4
3/Retreatment
1 of 4
2/ACT TIL+Pembro
1 of 4
1/ACT TIL
1 of 4
Experimental Treatment
170 Total Participants · 4 Treatment Groups
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
2/ACT TIL + PembroExperimental Group · 5 Interventions: Pembrolizumab, Fludarabine, Aldesleukin, Cyclophosphamide, young TIL · Intervention Types: Drug, Drug, Drug, Drug, Biological
3/Retreatment
Drug
Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: Drug2/ACT TIL+PembroExperimental Group · 5 Interventions: Pembrolizumab, Fludarabine, Aldeslaukin, Cyclophosphamide, young TIL · Intervention Types: Drug, Drug, Drug, Drug, Biological
1/ACT TILExperimental Group · 5 Interventions: Fludarabine, Aldesleukin, Aldeslaukin, Cyclophosphamide, young TIL · Intervention Types: Drug, Drug, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Fludarabine
FDA approved
Aldesleukin
2012
Completed Phase 4
~1620
Cyclophosphamide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days after end of treatment
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,073 Previous Clinical Trials
41,138,738 Total Patients Enrolled
543 Trials studying Melanoma
156,871 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
Eligibility Criteria
Age 18 - 70 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- 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.
- 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.
- 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.
- 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.
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Conditions
Cancer Related
Treatments