Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors

NCT05284214 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: PTX-001-004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• The number of participants with severe, life-threatening or fatal adverse events

  Up to 36 weeks

Secondary Outcomes (11)

• 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

Study Arms (2)

Sargramostim daily: 14 of 21 days

EXPERIMENTAL

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; Biological: Ipilimumab-containing therapy

Sargramostim daily: 5 of 7 days

EXPERIMENTAL

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; Biological: Ipilimumab-containing therapy

Interventions

Sargramostim BIOLOGICAL

Sargramostim for injection

Also known as: Leukine®

Sargramostim daily: 14 of 21 days; Sargramostim daily: 5 of 7 days

Ipilimumab-containing therapy BIOLOGICAL

Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously..

Also known as: Yervoy®

Sargramostim daily: 14 of 21 days; Sargramostim daily: 5 of 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Partner Therapeutics, Inc.: lead

Study Sites (1)

Partner Therapeutics - No Currently Active Sites

Lexington, Massachusetts, 02421, United States

Location

MeSH Terms

Interventions

sargramostim; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Fiona Garner

  Partner Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: January 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

US (1)