Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors

(SALIENT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Partner Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Sargramostim (Cytokine)

Participant Groups

Group I: Sargramostim daily: 5 of 7 days Experimental Treatment 2 Interventions

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.

Group II: Sargramostim daily: 14 of 21 days Experimental Treatment 2 Interventions

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.

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

🇪🇺 Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Partner Therapeutics - No Currently Active Sites Lexington, MA

Who Is Running the Clinical Trial?

Partner Therapeutics, Inc. Lead Sponsor

References