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Cytokine
Pembrolizumab for Melanoma
Phase 2
Waitlist Available
Led By Ann (Annie) Silk
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of follow-up, up to 3 years
Awards & highlights
Study Summary
This trialwill evaluate the safety and effectiveness of combining two treatments (IL-2 and pembrolizumab) to fight advanced melanoma.
Eligible Conditions
- Melanoma
- Melanoma of the Head and Neck
- Skin Melanoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four to six weeks later, up to three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four to six weeks later, up to three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best Overall Response Rate as Assessed by Response (BORR) Evaluation Criteria in Solid Tumors Version 1.1, With the Modification That Progressive Disease Must be Confirmed on a Subsequent Scan
Secondary outcome measures
Complete Response Rate
Number of Adverse Effects (AE) as Evaluated by National Cancer Institute Common Terminology Criteria for AE's, Version 4.0
Overall Survival Estimated Using Kaplan-Meier Curves
+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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, aldesleukin)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks and aldesleukin IV every 8 hours for up to 14 doses at weeks 4, 7, 16, 19, 28, and 31 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,222 Total Patients Enrolled
11 Trials studying Melanoma
2,278 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,657 Total Patients Enrolled
557 Trials studying Melanoma
193,223 Patients Enrolled for Melanoma
Ann (Annie) SilkPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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