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Monoclonal Antibodies

Denosumab for Melanoma

Phase 2
Waitlist Available
Led By Stergios Moschos, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
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 1 year from start of study treatment
Awards & highlights

Study Summary

This trial is testing the effects of denosumab, either alone or combined with an anti-PD1 agent, on patients with metastatic melanoma who have not responded to other treatments.

Eligible Conditions
  • Melanoma
  • Skin Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year from start of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year from start of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The antitumor effect of denosumab alone as represented by the change in density of tumor-infiltrating cluster of differentiation (CD8+) cells (TILs) in tumor tissue.
The antitumor effect of denosumab alone as represented by the change in recent thymic emigrant cells in peripheral blood
The antitumor effect of denosumab combined with anti-PD-1 inhibitor as represented by the change in density of tumor-infiltrating cluster of differentiation (CD8+) cells (TILs) in tumor tissue.
+1 more
Secondary outcome measures
Overall response rate
Overall survival rate
Progression free survival rate
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm: Denosumab+ PD-1 InhibitorExperimental Treatment3 Interventions
Subjects in this trial will be given denosumab every 4 weeks, starting on day 1 of study treatment. An additional loading dose of denosumab will be administered on day 8. Subjects who started Pembrolizumab (initiated 21 days after the first dose of denosumab is given) will continue to have it administered intravenously (IV) every 3 weeks. New subjects will receive Nivolumab administered intravenously (IV) every 4 weeks (initiated 21 days after the first dose of denosumab is given). Combination therapy will continue as long as subjects benefit from therapy for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
2017
Completed Phase 4
~12500
Pembrolizumab
2017
Completed Phase 2
~2010
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,307 Total Patients Enrolled
4 Trials studying Melanoma
100 Patients Enrolled for Melanoma
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,663 Total Patients Enrolled
23 Trials studying Melanoma
19,481 Patients Enrolled for Melanoma
Stergios Moschos, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
4 Previous Clinical Trials
56 Total Patients Enrolled
4 Trials studying Melanoma
56 Patients Enrolled for Melanoma

Frequently Asked Questions

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

What are the projected end results of this experiment?

"The main objective of this medical trial, which is evaluated within a 3-week period post-denosumab treatment, will be to gauge the anti-tumor effects of denosumab combined with an anti-PD1 inhibitor. This shall be assessed by looking at changes in density and cluster differentiation (CD8+) cells present in tumor tissue. Secondary outcomes include progression free survival rate calculated from day 1 until 6 months after initiating study treatment, overall response rate measured using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and overall survival rate estimated over one year following commencement of study treatments."

Answered by AI

Has the Food and Drug Administration authorized Pembrolizumab?

"Our assessment of Pembrolizumab's safety was a 2, as the medication has been through some clinical trials and there is evidence it does not cause harm but no gaurantee that it will be effective."

Answered by AI

Is the eligibility criteria for this research trial limited to individuals above a certain age?

"The minimum age of admittance is 18 years, while the cut-off for enrollment is 99 years."

Answered by AI

Have there been any other experiments involving Pembrolizumab?

"Presently, there are 1676 clinical trials investigating the use of Pembrolizumab. Of those active studies, 212 have reached Phase 3. Though a large concentration is based in Houston, Texas, there are an additional 73 410 sites conducting research for this drug therapy."

Answered by AI

How many participants have been recruited for this clinical experiment?

"Currently, this clinical trial is not accepting participants. Although initially posted on the 25th of September 2018 and last updated on the 21st of September 2022; other melanoma studies (765) or trials involving Pembrolizumab (1676) are actively searching for patients."

Answered by AI

Who has been approved to participate in this clinical exploration?

"To be considered for this trial, individuals must have a diagnosis of melanoma and fit within the 18 to 99 year old age bracket. The research team is aiming to enrol up to 25 participants in total."

Answered by AI

In what ways is Pembrolizumab commonly administered?

"Pembrolizumab is typically prescribed to treat malignant tumors. It can also be used for a variety of other conditions, such as unresectable melanoma, microsatellite instability high tumours, and squamous cell carcinomas."

Answered by AI

Is enrollment still available for this experiment?

"At the moment, this trial is not currently enrolling. It was initially posted on September 25th 2018 and has since been edited as recently as September 21st 2022. For those looking for other clinical trials, there are 765 studies related to melanoma presently recruiting patients and 1676 trials seeking participants that involve pembrolizumab treatment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
2018. "Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03620019.
~4 spots leftby Apr 2025
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