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PD-1 Inhibitor

Sargramostim (GM-CSF) for Melanoma

Phase 2

Waitlist Available

Led By Elizabeth Buchbinder, MD

Research Sponsored by Dana-Farber Cancer Institute

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 12 weeks

Awards & highlights

Study Summary

This trial is testing whether combining these drugs leads to better control of melanoma cancer compared to using them individually.

Eligible Conditions

Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR)

Secondary outcome measures

CD4 Count determination procedure

Number of Participants With Treatment-Related Adverse Events

Overall Response Rate (ORR)-irRC

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sargramostim (GM-CSF) + Pembrolizumab (anti-PD-1)Experimental Treatment2 Interventions

Participants will receive 12 weeks of sargramostim (GM-CSF) and pembrolizumab (anti-PD-1). Participants may be pre-medicated with drugs to reduce the chance of having a sensitivity reaction to the study treatment of pembrolizumab (anti-PD-1) and sargramostim (GM-CSF). Study cycles are 21 days in length: Pembrolizumab (anti-PD-1) will be given by intravenous infusion once on day 1 of every 21 day cycle Sargramostim (GM-CSF) will be self-administered by participants via a subcutaneous (below the skin) injection daily for days 1 - 14 of each 21- day cycle. Participants will be assessed at 12 weeks for disease response/progression and further study treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sargramostim (GM-CSF)

2008

Completed Phase 3

~240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Partner Therapeutics (PTx)UNKNOWN

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,948 Total Patients Enrolled

32 Trials studying Melanoma

2,910 Patients Enrolled for Melanoma

Elizabeth Buchbinder, MDPrincipal InvestigatorDana-Farber Cancer Institute

3 Previous Clinical Trials

48 Total Patients Enrolled

3 Trials studying Melanoma

48 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 is the current sample size of this scientific research?

"Affirmative. Clinicaltrials.gov has registered that this clinical trial, with an initial posting date of April 16th 2021, is recruiting patients at present. The research team hopes to enrol 30 participants from 2 sites."

Answered by AI

Has Sargramostim (GM-CSF) been used in other clinical trials prior to this one?

"Presently, 998 clinical trials for Sargramostim (GM-CSF) are ongoing. Out of those live investigations, 127 have reached Phase 3. This particular treatment is being tested in various sites around the world totaling 37,601 locations with Chapel Hill, North carolina hosting a majority of them."

Answered by AI

Has the FDA sanctioned Sargramostim (GM-CSF) for therapeutic use?

"After evaluating Sargramostim (GM-CSF)'s safety, our team has determined the drug's risk to be a 2. This is due to its Phase 2 status, meaning while there is some evidence of safety no efficacy data exists yet."

Answered by AI

Are there any opportunities for participants to join the current clinical trial?

"Affirmative. Clinicaltrials.gov data indicates that this research is actively enrolling participants, having first been posted on April 16th 2021 and last updated on October 11th 2022. 30 patients are sought from 2 different sites for the trial's completion."

Answered by AI

What afflictions is Sargramostim (GM-CSF) generally prescribed to alleviate?

"Sargramostim (GM-CSF) is primarily employed to treat cancerous neoplasms, yet it also can be beneficial for individuals undergoing allogeneic bone marrow transplantation therapy, those with unresectable melanoma and microsatellite instability high."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sargramostim (GM-CSF) + PD-1

Elizabeth Buchbinder, MD 2021. "Sargramostim (GM-CSF) + PD-1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04703426.