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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 must not have an active infection requiring systemic therapy.
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
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 belowSelect...
My melanoma is at stage III or IV and can be surgically removed, but I don't have brain metastases.
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I do not have an infection that needs treatment with medication.
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I've had a full check-up and scans showing no signs of cancer recently.
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I agree to provide tissue samples for testing after receiving pre-surgery treatment.
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I can take care of myself but might not be able to do heavy physical work.
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My melanoma was confirmed at its first appearance or when it spread.
Select...
My melanoma is confirmed to be at least stage IIIB through biopsy.
Select...
I will register for the next step of the trial at least 17 days before my surgery.
Select...
I had surgery to completely remove my melanoma before joining Step 3.
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I've had surgery to remove my cancer and recent scans show no signs of cancer.
Select...
I have not had an R2 resection.
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I do not have any visible cancer left after surgery.
Select...
I am willing to provide tissue samples from my surgery for research.
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I have never needed steroids for non-infectious lung inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
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 2
~1720
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Pembrolizumab
2017
Completed Phase 2
~2010
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,088 Total Patients Enrolled
559 Trials studying Melanoma
195,129 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can have surgery or radiation to remove any tiny cancer remains before starting additional treatment.I've had radiation or surgery for cancer, and any side effects are now mild.I have had a brain scan within the last 42 days.I have had cancer before, but it doesn't need current treatment.I am HIV positive with stable health, CD4 count >= 350, and viral load < 25,000 IU/ml.I will register for the next step of the trial at least 17 days before my surgery.My melanoma is at stage III or IV and can be surgically removed, but I don't have brain metastases.I do not have an infection that needs treatment with medication.I have melanoma and haven't had immunotherapy or neoadjuvant treatment for it.Your white blood cell count is at least 1,500 cells per microliter.Your alkaline phosphatase level must be within a certain range before you can join the study.I've had a full check-up and scans showing no signs of cancer recently.I agree to provide tissue samples for testing after receiving pre-surgery treatment.My cancer's status has been checked with a physical exam and specific scans within the last 42 days.I can take care of myself but might not be able to do heavy physical work.My melanoma was confirmed at its first appearance or when it spread.My melanoma is confirmed to be at least stage IIIB through biopsy.My kidney function is good, with a creatinine clearance rate over 30 mL/min.My doctors agree I am healthy enough for surgery.I registered for step 3 within 84 days after my surgery.I've had surgery to remove my cancer and recent scans show no signs of cancer.I have not had an R2 resection.I had surgery to completely remove my melanoma before joining Step 3.Your hemoglobin level is at least 10 grams per deciliter within 42 days before starting the study.Your platelet count is at least 100,000 per microliter within the 42 days before starting the study.You should not have an active infection of hepatitis B or hepatitis C before starting the study.Your liver enzymes (AST and ALT) should not be more than two times the upper limit of normal.I haven't needed treatment for an autoimmune disease in the last 2 years.You need to have had a test for lactate dehydrogenase (LDH) within 42 days before starting the trial.My cancer has spread to multiple lymph nodes but I am still eligible.I've had the required scans within the last 42 to 49 days before my planned surgery.I do not have any visible cancer left after surgery.I am willing to provide tissue samples from my surgery for research.I have never needed steroids for non-infectious lung inflammation.Your bilirubin level should be below a certain number, unless you have Gilbert's syndrome, in which case it can be slightly higher.I have not received any live vaccines in the last 42 days.I am not planning to undergo any other cancer treatments while on this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (adjuvant pembrolizumab)
- Group 2: Arm II (adjuvant and neoadjuvant pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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