Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors

Part of paid clinical trials in Lexington, Massachusetts.

Sponsor
Partner Therapeutics, Inc.
Study ID
NCT05284214
Phase
PHASE2
Status
Withdrawn

Conditions

  • Solid Tumor
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 31, 2024
Status verified
Sep 2023
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sargramostim daily: 14 of 21 days
    Sargramostim administered by subcutaneous (SC) injection for 14 consecutive days every 3 weeks, for up to 12 weeks, given in combination with an ipilimumab-containing regimen.
  • Experimental: Sargramostim daily: 5 of 7 days
    Sargramostim given by SC injection for 5 consecutive days every week, for up to 12 weeks, given in combination with an ipilimumab-containing regimen for a total of 12 weeks.

Primary Outcome Measure

The number of participants with severe, life-threatening or fatal adverse events [ Time Frame: Up to 36 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Partner Therapeutics - No Currently Active SitesLexingtonMassachusetts02421-

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Partner Therapeutics - No Currently Active Sites· Lexington, MA

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