Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors

Solid Tumor Clinical Trial

— SALIENT  

Official title:

Sargramostim Safety and Tolerability With Standard Of Care Ipilimumab Containing Therapy in Patients With Solid Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05284214
• Other study ID #: PTX-001-004
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2024
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: Partner Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This open label, randomized study will evaluate safety and tolerability of sargramostim when combined with an ipilimumab-containing regimen received as part of standard of care therapy. The study will evaluate 2 sargramostim administration schedules. Patients will be randomized 1:1 to the sargramostim administration schedules and stratified based on planned dose of ipilimumab (1 mg/kg, 3 mg/kg). Sargramostim will be administered for the first 12 weeks following the assigned treatment schedule or until disease progression, intolerable toxicity, consent withdrawal, pregnancy, or death, whichever comes first. Checkpoint inhibitor therapy will be administered in accordance with institutional standard of care guidelines, at the Investigator's discretion. Patients will be followed up for to 24 weeks following end of sargramostim treatment for safety, efficacy, and survival.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with solid tumors that will start an ipilimumab-containing therapy (with or without anti-PD-1, such as nivolumab) as part of standard of care in approved ipilimumab indication
• Recovery from any toxicities related to prior therapies
• Ability and willingness to self-administer or have a caregiver administer a SC injection of sargramostim
• Women of child-bearing potential willing to use birth control

Exclusion Criteria:

• Recent radiation therapy for cancer that has spread to bones or to the brain
• History of a severe reaction to prior immune checkpoint inhibitors
• Pleural or pericardial effusion, or history of recurrent pleural or pericardial effusion.
• Heart rhythm with symptoms within the last 12 months
• Known or suspected intolerance or hypersensitivity to sargramostim or any product component or diluent
• Use drugs that can suppress the immune system
• Women who are pregnant or breastfeeding
• Live virus vaccine within 28 days prior to study treatment and for 4 weeks after study treatment.
• Have other active cancers
• Participation in another clinical trial
• Any other medical condition or laboratory abnormality that would put patient at risk or confound interpretation of trial results

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor
• Solid Tumor, Adult

Intervention

Biological:
• Sargramostim
Sargramostim for injection
• Ipilimumab-containing therapy
Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously..

Locations

Country	Name	City	State
United States	Partner Therapeutics - No Currently Active Sites	Lexington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Partner Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with severe, life-threatening or fatal adverse events		Up to 36 weeks
Secondary	Number of participants who develop colon inflammation (colitis)		Up to 36 weeks
Secondary	Number of participants who develop pneumonitis (lung inflammation)		Up to 36 weeks
Secondary	Number of participants who discontinue sargramostim due to a treatment related adverse event		Up to 12 weeks
Secondary	Number of missed doses		Up to 12 weeks
Secondary	Number of participants requiring dose modifications		Up to 12 weeks
Secondary	Change from baseline in Treatment Assessment Questionnaire		Daily up to 12 weeks.
Secondary	Number of participants who develop anti-drug antibodies against sargramostim		Day 1, Week 4, Week 13, Week 17 and Week 36
Secondary	Overall response rate	The number of participants who have a complete response or partial response to treatment using Investigator-assessed efficacy evaluation by immune-related (i)Response Evaluation Criteria in Solid Tumors (iRECIST):	Up to Week 36
Secondary	Disease control rate	The number of participants who have a complete response, partial response, or stable disease response to treatment using Investigator-assessed efficacy evaluation by iRECIST:	Up to Week 36
Secondary	Progression-free survival	The time from randomization until disease progression or death from any cause	Up to 36 weeks
Secondary	Overall survival	The time from randomization until death from any cause	Up to 36 weeks