NCT04703426

Sargramostim (GM-CSF) + PD-1

Copy of A Phase II Trial of Pembrolizumab (Anti PD-1) Therapy Combined With Sargramostim (GM-CSF) in Unresectable or Metastatic Melanoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is testing the combination of two drugs, sargramostim and pembrolizumab. The study is designed to see if the combination of these study drugs would improve the control of unresectable or metastatic melanoma cancer when compared to use of these drugs alone. The names of the study drugs involved in this study are: * Pembrolizumab * Sargramostim (GM-CSF)

Detailed description

This is an open-label phase II study looking at safety and efficacy of the combination of pembrolizumab (PD-1 inhibition and sargramostim (GMCSF) in people with unresectable stage III or IV melanoma who may have received prior immunotherapy in the metastatic setting. The U.S. Food and Drug Administration (FDA) has not approved sargramostim as a treatment option for people with stage III or IV melanoma The U.S. Food and Drug Administration (FDA) has approved pembrolizumab as a treatment option for people with stage III or IV melanoma who have received prior immunotherapy in the metastatic setting. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive the study drug(s) for as long as they do not have serious side effects and their disease does not get worse and will be followed for safety 30 days after the last dose of study drug(s). Participants may also be followed for long term follow-up every 12 weeks from the last dose of study drug(s). It is expected that about 30 people will take part in this research study.

Conditions

• Unresectable Melanoma
• Metastatic Melanoma
• Stage III Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	Sargramostim (GM-CSF)	Drug that binds to the protein PD-1 to help immune cells kill cancer cells better, it is given as an intravenous injection through a vein.
DRUG	Pembrolizumab (anti-PD-1)	Drug that stimulates blood cells that may help support the immune system during cancer treatment, given as intravenous infusion

Timeline

• Start date: 2021-04-16
• Primary completion: 2024-06-10
• Completion: 2025-06-09
• First posted: 2021-01-11
• Last updated: 2023-05-22

Regulatory

• FDA-regulated drug study