Status:
WITHDRAWN
Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors
Lead Sponsor:
Partner Therapeutics, Inc.
Conditions:
Solid Tumor
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05284214
Start Date
January 1 2024
End Date
September 1 2025
Last Update
September 15 2023
Active Locations (1)
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1
Partner Therapeutics - No Currently Active Sites
Lexington, Massachusetts, United States, 02421