← Back to Search

Checkpoint Inhibitor

Pembrolizumab for Melanoma

Phase 2
Waitlist Available
Research Sponsored by NewLink Genetics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing whether adding an experimental immunotherapy drug to existing checkpoint inhibitor drugs will better treat melanoma.

Eligible Conditions
  • Metastatic Melanoma
  • Melanoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Response Rate
Safety and Tolerability Assessed by Development of AEs and Laboratory Parameters
Secondary outcome measures
Anti-Tumor Mechanism
Anti-tumor Immune Response
Clinical Activity
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1C HyperAcute®-Melanoma (HAM) + pembrolizumabExperimental Treatment2 Interventions
Arm 1C will receive pembrolizumab at 2 mg/kg given every 3 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
Group II: Arm 1B HyperAcute®-Melanoma (HAM) + nivolumabExperimental Treatment2 Interventions
Arm 1B will receive nivolumab alone at 3 mg/kg given every 2 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
Group III: Arm 1A HyperAcute®-Melanoma (HAM) + IpilimumabExperimental Treatment2 Interventions
Arm 1A will receive ipilimumab at 3 mg/kg given every 3 weeks for 4 weeks and 300 Million HyperAcute®-Melanoma (HAM) Immunotherapy cells per each immunization, given every week for 4 weeks, every 2 weeks for 5 months, every month for 6 months, and every 3 months for one year.
Group IV: Arm 2A Ipilimumab AloneActive Control1 Intervention
Arm 2A will receive ipilimumab alone at 3 mg/kg every 3 weeks for a total of four doses.
Group V: Arm 2B Nivolumab aloneActive Control1 Intervention
Arm 2B will receive nivolumab alone at 3 mg/kg given every 2 weeks
Group VI: Arm 2C Pembrolizumab aloneActive Control1 Intervention
Arm 2C will receive pembrolizumab at 2 mg/kg given every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Pembrolizumab
FDA approved
Ipilimumab
FDA approved

Find a Location

Who is running the clinical trial?

NewLink Genetics CorporationLead Sponsor
35 Previous Clinical Trials
2,836 Total Patients Enrolled
5 Trials studying Melanoma
206 Patients Enrolled for Melanoma
Eugene Kennedy, MDStudy DirectorNewLink Genetics Corporation
3 Previous Clinical Trials
143 Total Patients Enrolled

Frequently Asked Questions

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

In how many different settings is this research being undertaken?

"To limit participant burden, the 5 enrolling sites for this trial are geographically distributed. There are centres in Niles, Westwood and Knoxville as well as other cities. You can pick the location nearest you when deciding whether to join the trial."

Answered by AI

How many participants will this research project be able to accommodate?

"This particular clinical trial is no longer admitting patients. The posting for this study went up on 6/1/2014 and the most recent edit was on 5/26/2020. If you are looking for other trials, there are 796 active studies involving melanoma and 1741 HAM Immunotherapy studies currently recruiting participants."

Answered by AI

Are there previous cases of HAM Immunotherapy being used in a clinical setting?

"587 clinical trials have completed since 2009 testing HAM Immunotherapy, with many more ongoing. There are currently 1741 live clinical trials being conducted worldwide, a significant number of which are based in Niles, Illinois."

Answered by AI

Are we still looking for people to participate in this research?

"This study is not recruiting at the moment. The most recent update was on May 26th, 2020 and it was initially posted on June 1st, 2014. If you are looking for other studies, there are 796 clinical trials actively searching for patients with melanoma and 1741 studies for HyperAcute®-Melanoma (HAM) Immunotherapy that are enrolling participants."

Answered by AI

What are the possible side effects of HAM Immunotherapy?

"Although there is some data suggesting that HyperAcute®-Melanoma (HAM) Immunotherapy is safe, it only received a score of 2 because there is no clinical evidence yet confirming its efficacy."

Answered by AI

What are the goals of this experiment?

"The aim of this two-year trial is to observe the Clinical Response Rate. Additionally, investigators will analyze secondary outcomes including but not limited to: Clinical Activity (measured by disease-free survival, progression-free survival, overall survival, and duration of response), Anti-tumor Immune Response, and Immune Activation."

Answered by AI

What is HAM Immunotherapy typically used to treat?

"The HyperAcute®-Melanoma (HAM) Immunotherapy can be used to target and treat patients with unresectable melanoma, microsatellite instability high, or squamous cell carcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Immunotherapy Study for Patients With Stage IV Melanoma
2014. "Immunotherapy Study for Patients With Stage IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02054520.
~4 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top