Sargramostim (GM-CSF) + PD-1
NCT04703426 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2023-05-22
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)
Conditions
- Unresectable Melanoma
- Metastatic Melanoma
- Stage III Melanoma
- Stage IV Melanoma
Interventions
- 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
Sponsors & Collaborators
-
Partner Therapeutics (PTx)
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Elizabeth Buchbinder, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-16
- Primary Completion
- 2024-06-10
- Completion
- 2025-06-09
- FDA Drug
- Yes
More Related Trials
-
Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors
NCT05764395 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma
NCT04007588 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
NCT02967692 ·Status: TERMINATED ·Phase: PHASE3
-
Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
NCT02117362 ·Status: COMPLETED ·Phase: PHASE1
-
Immunologic Determinants of Response to Pembrolizumab (MK-3475) in Advanced Melanoma (MK-3475-161/KEYNOTE-161)
NCT03407170 ·Status: TERMINATED ·Phase: PHASE2
-
SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab
NCT03161431 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Nivolumab, BMS-936558 in Combination with Relatlimab, BMS-986016 in Patients with Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting
NCT03743766 ·Status: COMPLETED ·Phase: PHASE2
-
Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
NCT00017121 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716)
NCT03553836 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Pembrolizumab and Ibrutinib in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
NCT03021460 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
NCT02965716 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)
NCT01704287 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases
NCT02858869 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Study of Intismeran Autogene (V940) and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)
NCT06961006 ·Status: RECRUITING ·Phase: PHASE2
-
Study of the Selective PI3K-Beta Inhibitor GSK2636771 in Combination With Pembrolizumab in Patients With Metastatic Melanoma and PTEN Loss
NCT03131908 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Phase II Study of Olaparib and Pembrolizumab in Advanced Melanoma With Homologous Recombination (HR) Mutation
NCT04633902 ·Status: UNKNOWN ·Phase: PHASE2
-
Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
NCT04068181 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients
NCT02009397 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Neoadjuvant Pembrolizumab for Unresectable Stage III and Unresectable Stage IV Melanoma
NCT02306850 ·Status: COMPLETED ·Phase: PHASE2
-
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
NCT04462406 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients
NCT03126461 ·Status: WITHDRAWN ·Phase: PHASE2
-
Pilot Study of the Safety/Efficacy of Combination Checkpoint Blockade + External Beam Radiotherapy in Stage IV Melanoma
NCT02659540 ·Status: COMPLETED ·Phase: PHASE1
-
Neoadjuvant Combination Biotherapy With Ipilimumab and Nivolumab or Nivolumab Alone
NCT02736123 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
PV-10 in Combination With Pembrolizumab for Treatment of Metastatic Melanoma
NCT02557321 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
NCT03698019 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2