Pembrolizumab for Stage IIIB Cutaneous Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Stage IIIB Cutaneous Melanoma+7 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether giving the immunotherapy drug pembrolizumab before and after surgery is better than giving it just after surgery for treating patients with high-risk melanoma.

Eligible Conditions
  • Stage IIIB Cutaneous Melanoma
  • Pathologic Stage III Cutaneous Melanoma
  • Stage IV Cutaneous Melanoma
  • Mucosal Melanoma
  • Clinical Stage III Cutaneous Melanoma
  • Acral Lentiginous Melanoma

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 10 years

At 24 weeks
Disease control
Year 10
Event-free survival (EFS) in patients with high-risk resectable melanoma randomized to neoadjuvant pembrolizumab with patients randomized to adjuvant pembrolizumab
Year 10
Overall survival
Up to 10 years
Immune-related RECIST response rate
Local/regional control in the surgical site(s)
Pathologic response rate
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response rate
Total number of pembrolizumab doses

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

2 Treatment Groups

Arm II (adjuvant and neoadjuvant pembrolizumab)
1 of 2
Arm I (adjuvant pembrolizumab)
1 of 2

Active Control

Experimental Treatment

336 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Arm I (adjuvant pembrolizumab)Experimental Group · 5 Interventions: Computed Tomography, Therapeutic Conventional Surgery, Biospecimen Collection, Magnetic Resonance Imaging, Pembrolizumab · Intervention Types: Procedure, Procedure, Procedure, Procedure, Biological
Arm II (adjuvant and neoadjuvant pembrolizumab)ActiveComparator Group · 5 Interventions: Computed Tomography, Therapeutic Conventional Surgery, Biospecimen Collection, Magnetic Resonance Imaging, Pembrolizumab · Intervention Types: Procedure, Procedure, Procedure, Procedure, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Biospecimen Collection
2004
Completed Phase 1
~670
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,071 Previous Clinical Trials
41,128,519 Total Patients Enrolled
Sapna P PatelPrincipal InvestigatorSouthwest Oncology Group
1 Previous Clinical Trials
35 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must have clinically detectable stage III (clinically detectable N1b, N1c, N2b, N2c, N3b and N3c) or stage IV resectable melanoma.
Patients are eligible for this trial if they have a histologically confirmed melanoma or melanoma in situ, or a melanoma in situ with positive sentinel lymph nodes
Patients must have a CT or MRI of the brain within 42 days prior to randomization
Patients with multiple regional nodal basin involvement are eligible
Patients may have received prior radiation therapy, including after prior surgical resection