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

• ClinicalTrials.gov Identifier: NCT05284214
• Recruitment Status: Suspended
• First Posted: March 17, 2022
• Last Update Posted: December 2, 2022
• Sponsor: Partner Therapeutics, Inc.
• Information provided by (Responsible Party): Partner Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Solid Tumor; Solid Tumor, Adult	Biological: Sargramostim; Biological: Ipilimumab-containing therapy	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sargramostim Safety and Tolerability With Standard Of Care Ipilimumab Containing Therapy in Patients With Solid Tumors
• Estimated Study Start Date: January 2024
• Estimated Primary Completion Date: September 2025
• Estimated Study Completion Date: September 2025

Arms and Interventions

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 Name: Leukine®; Biological: Ipilimumab-containing therapy; Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously..; Other Name: 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 Name: Leukine®; Biological: Ipilimumab-containing therapy; Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously..; Other Name: Yervoy®

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Number of participants who develop colon inflammation (colitis) [ Time Frame: Up to 36 weeks ]
2. Number of participants who develop pneumonitis (lung inflammation) [ Time Frame: Up to 36 weeks ]
3. Number of participants who discontinue sargramostim due to a treatment related adverse event [ Time Frame: Up to 12 weeks ]
4. Number of missed doses [ Time Frame: Up to 12 weeks ]
5. Number of participants requiring dose modifications [ Time Frame: Up to 12 weeks ]
6. Change from baseline in Treatment Assessment Questionnaire [ Time Frame: Daily up to 12 weeks. ]
7. Number of participants who develop anti-drug antibodies against sargramostim [ Time Frame: Day 1, Week 4, Week 13, Week 17 and Week 36 ]
8. Overall response rate [ Time Frame: 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):
9. Disease control rate [ Time Frame: 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:
10. Progression-free survival [ Time Frame: Up to 36 weeks ]
    The time from randomization until disease progression or death from any cause
11. Overall survival [ Time Frame: Up to 36 weeks ]
    The time from randomization until death from any cause

Eligibility Criteria

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

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
• 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

Contacts and Locations

Locations

United States, Massachusetts

Partner Therapeutics - No Currently Active Sites

Lexington, Massachusetts, United States, 02421

Sponsors and Collaborators

Partner Therapeutics, Inc.

Investigators

• Study Director: Fiona Garner; Partner Therapeutics, Inc.

More Information

• Responsible Party: Partner Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05284214
• Other Study ID Numbers: PTX-001-004
• First Posted: March 17, 2022
• Last Update Posted: December 2, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms; Ipilimumab; Sargramostim; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Physiological Effects of Drugs