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Checkpoint Inhibitor

Pre- and Post-Surgery Pembrolizumab for Melanoma

Phase 2
Waitlist Available
Led By Sapna P Patel
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
Patients must have clinically detectable stage III (clinically detectable N1b, N1c, N2b, N2c, N3b and N3c) or stage IV resectable melanoma. Patients with melanoma of mucosal or acral origin are eligible. Patients with a history of brain metastases are not eligible.
Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site. Nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by hematoxylin (H) & eosin (E) stained slides.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for adults with high-risk melanoma (stage III-IV) that can be removed by surgery. They must not have had previous neoadjuvant immunotherapy or certain other treatments, no active infections, and no history of severe autoimmune disease or pneumonitis. Participants need functioning major organs, no brain metastases, and women of childbearing age must test negative for pregnancy.Check my eligibility
What is being tested?
The study tests the effectiveness of Pembrolizumab, an immune system-boosting drug given before and after surgery versus only after surgery in treating melanoma. It's a phase II trial to see if this approach better prevents cancer from returning.See study design
What are the potential side effects?
Pembrolizumab may cause side effects like fatigue, skin reactions, diarrhea, hormonal gland problems (like thyroid), liver inflammation, lung issues (pneumonitis), infusion reactions and could potentially worsen any pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma is at stage III or IV and can be surgically removed, but I don't have brain metastases.
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My melanoma was confirmed at its first appearance or when it spread.
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My cancer has spread to multiple lymph nodes but I am still eligible.
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My melanoma is confirmed to be at least stage IIIB through biopsy.
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I have melanoma and haven't had immunotherapy or neoadjuvant treatment for it.
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I am not planning to undergo any other cancer treatments while on this trial.
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I've had radiation or surgery for cancer, and any side effects are now mild.
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My cancer's status has been checked with a physical exam and specific scans within the last 42 days.
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I have had a brain scan within the last 42 days.
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My kidney function is good, with a creatinine clearance rate over 30 mL/min.
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I can take care of myself but might not be able to do heavy physical work.
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I have never needed steroids for non-infectious lung inflammation.
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I do not have an infection that needs treatment with medication.
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I haven't needed treatment for an autoimmune disease in the last 2 years.
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I have not received any live vaccines in the last 42 days.
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I am HIV positive with stable health, CD4 count >= 350, and viral load < 25,000 IU/ml.
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I have had cancer before, but it doesn't need current treatment.
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My doctors agree I am healthy enough for surgery.
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I am willing to provide tissue samples from my surgery for research.
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I agree to provide tissue samples for testing after receiving pre-surgery treatment.
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I've had the required scans within the last 42 to 49 days before my planned surgery.
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I will register for the next step of the trial at least 17 days before my surgery.
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I had surgery to completely remove my melanoma before joining Step 3.
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I do not have any visible cancer left after surgery.
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I can have surgery or radiation to remove any tiny cancer remains before starting additional treatment.
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I've had a full check-up and scans showing no signs of cancer recently.
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I registered for step 3 within 84 days after my surgery.
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I've had surgery to remove my cancer and recent scans show no signs of cancer.
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I have not had an R2 resection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of treatment and follow-up until relapse, death, or 3.5 years post randomization. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Two-Year Event-Free Survival Rate
Secondary outcome measures
Number of Participants Receiving Surgery
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Response Rate
+1 more

Side effects data

From 2021 Phase 3 trial • 453 Patients • NCT03066778
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%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (adjuvant pembrolizumab)Experimental Treatment5 Interventions
Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study.
Group II: Arm II (adjuvant and neoadjuvant pembrolizumab)Active Control5 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~1820
Computed Tomography
2017
Completed Phase 2
~2710
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Pembrolizumab
2017
Completed Phase 3
~2050
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,565 Previous Clinical Trials
41,223,487 Total Patients Enrolled
558 Trials studying Melanoma
193,071 Patients Enrolled for Melanoma
Sapna P PatelPrincipal InvestigatorSWOG Cancer Research Network
1 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Melanoma
34 Patients Enrolled for Melanoma

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03698019 — Phase 2
Melanoma Research Study Groups: Arm I (adjuvant pembrolizumab), Arm II (adjuvant and neoadjuvant pembrolizumab)
Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03698019 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03698019 — Phase 2

Frequently Asked Questions

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

Are there other examples of Pembrolizumab's efficacy?

"Pembrolizumab is being trialed in 1000 different ongoing clinical studies. 122 of those are large-scale Phase 3 trials. Although many of the Pembrolizumab trials originate out of Houston, Texas, there are 36030 locations worldwide conducting research on this treatment."

Answered by AI

Are participants still being recruited for this research?

"This study is not recruiting at this moment. The listing for the trial was first posted on December 6th, 2018 and updated most recently on September 23rd, 2022. Other melanoma trials 848 are currently looking for patients while 1000 other Pembrolizumab studies are actively enrolling participants."

Answered by AI

Has Pembrolizumab received the green light from the FDA?

"Pembrolizumab has not been proven effective yet, however, there is some evidence that it is safe. Consequently, our team at Power awarded it a 2."

Answered by AI

What are the primary indications for Pembrolizumab?

"Pembrolizumab is an immunotherapy treatment that can be used for patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

How many people are being given this experimental medication?

"No, this study concluded its search for participants on September 23rd, 2022. The trial was first posted December 6th, 2018. If you are looking for other melanoma trials, 848 are actively enrolling patients while 1,000 trials are still recruiting for Pembrolizumab treatment."

Answered by AI

At how many different hospitals is this research project being conducted?

"You can find a full list of the 100 clinical trial sites on our website. The locations are spread out across Saint George, Burnsville, Hibbing and many other places. To limit travel, make sure to choose a site that is close to your location."

Answered by AI
~52 spots leftby Feb 2025