Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors (SALIENT)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Solid Tumor; Solid Tumor, Adult
• Intervention / Treatment: Biological: Sargramostim; Biological: Ipilimumab-containing therapy

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Lexington, Massachusetts, United States, 02421
      • Partner Therapeutics - No Currently Active Sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: Sargramostim; Sargramostim for injection; Other Names: Leukine®; Biological: Ipilimumab-containing therapy; Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously..; Other Names: Yervoy®
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.	Biological: Sargramostim; Sargramostim for injection; Other Names: Leukine®; Biological: Ipilimumab-containing therapy; Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously..; Other Names: Yervoy®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who develop colon inflammation (colitis)		Up to 36 weeks
Number of participants who develop pneumonitis (lung inflammation)		Up to 36 weeks
Number of participants who discontinue sargramostim due to a treatment related adverse event		Up to 12 weeks
Number of missed doses		Up to 12 weeks
Number of participants requiring dose modifications		Up to 12 weeks
Change from baseline in Treatment Assessment Questionnaire		Daily up to 12 weeks.
Number of participants who develop anti-drug antibodies against sargramostim		Day 1, Week 4, Week 13, Week 17 and Week 36
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
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
Progression-free survival	The time from randomization until disease progression or death from any cause	Up to 36 weeks
Overall survival	The time from randomization until death from any cause	Up to 36 weeks

Collaborators and Investigators

• Sponsor: Partner Therapeutics, Inc.
• Investigators: Study Director: Fiona Garner, Partner Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab; Sargramostim
• Other Study ID Numbers: PTX-001-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No