Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors

Phase 2

Withdrawn

• Conditions: Solid Tumor, Adult; Solid Tumor

• Registration Number: NCT05284214
• Lead Sponsor: Partner Therapeutics, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15
• Study Start: 2024-01
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The number of participants with severe, life-threatening or fatal adverse events	Up to 36 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants requiring dose modifications	Up to 12 weeks
Number of participants who develop pneumonitis (lung inflammation)	Up to 36 weeks
Number of participants who develop anti-drug antibodies against sargramostim	Day 1, Week 4, Week 13, Week 17 and Week 36
Overall survival	Up to 36 weeks	The time from randomization until death from any cause
Number of missed doses	Up to 12 weeks
Change from baseline in Treatment Assessment Questionnaire	Daily up to 12 weeks.
Disease control rate	Up to Week 36	The number of participants who have a complete response, partial response, or stable disease response to treatment using Investigator-assessed efficacy evaluation by iRECIST:
Progression-free survival	Up to 36 weeks	The time from randomization until disease progression or death from any cause
Number of participants who discontinue sargramostim due to a treatment related adverse event	Up to 12 weeks
Number of participants who develop colon inflammation (colitis)	Up to 36 weeks
Overall response rate	Up to Week 36	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):

Trial Locations

Locations (1)

Partner Therapeutics - No Currently Active Sites; 🇺🇸 Lexington, Massachusetts, United States