Pembrolizumab for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
MelanomaPembrolizumab - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
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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

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

2 of 3
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
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

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: Drug
2/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

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