Sargramostim (GM-CSF) + PD-1
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04703426|
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : July 7, 2022
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:
- Sargramostim (GM-CSF)
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Melanoma Metastatic Melanoma Stage III Melanoma Stage IV Melanoma||Drug: Sargramostim (GM-CSF) Drug: Pembrolizumab (anti-PD-1)||Phase 2|
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 have not 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 who have not received prior immunotherapy in the metastatic setting.
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 not 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Copy of A Phase II Trial of Pembrolizumab (Anti PD-1) Therapy Combined With Sargramostim (GM-CSF) in Unresectable or Metastatic Melanoma|
|Actual Study Start Date :||April 16, 2021|
|Estimated Primary Completion Date :||June 10, 2024|
|Estimated Study Completion Date :||June 9, 2025|
Experimental: Sargramostim (GM-CSF) + Pembrolizumab (anti-PD-1)
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:
Participants will be assessed at 12 weeks for disease response/progression and further study treatment.
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.
Other Name: Leukine
Drug: Pembrolizumab (anti-PD-1)
Drug that stimulates blood cells that may help support the immune system during cancer treatment, given as intravenous infusion
Other Name: Keytruda
- Overall Response Rate (ORR) [ Time Frame: 12 weeks ]The primary study endpoint is response rate per RECIST criteria.
- Number of Participants With Treatment-Related Adverse Events [ Time Frame: 12 weeks ]Number and proportion of adverse events, graded as defined by CTCAE version 5.0
- Overall Survival Rate [ Time Frame: 12 weeks ]Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) will be used.
- Progression Free Survival Rate [ Time Frame: 12 weeks ]Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) will be used.
- Overall Response Rate (ORR)-irRC [ Time Frame: 12 weeks ]To evaluate the overall response rate in advanced melanoma to combination anti- PD-1 therapy and sargramostim by irRC criteria.
- CD4+ ICOS T cell changes [ Time Frame: 12 weeks ]Evaluate changes in CD4+ ICOS T cells from biopsies (pre-treatment, on-treatment, post-treatment) and correlate using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04703426
|Contact: Elizabeth Buchbinder, MD||617-632-5055||Elizabeth_Buchbinder@dfci.harvard.edu|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Donald Lawrence, MD 617-724-4000 firstname.lastname@example.org|
|Principal Investigator: Donald Lawrence, MD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Elizabeth Buchcinder, MD 617-632-5055|
|Principal Investigator: Elizabeth Buchbinder, MD|
|Principal Investigator:||Elizabeth Buchbinder, MD||Dana-Farber Cancer Institute|