Clinical trial NCT05284214: Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors
Official title: Sargramostim Safety and Tolerability With Standard Of Care Ipilimumab Containing Therapy in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Solid Tumor
Solid Tumor, Adult
Lead sponsor: Partner Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: The number of participants with severe, life-threatening or fatal adverse events
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Number of participants who develop colon inflammation (colitis)
timeFrame: Up to 36 weeks
measure: Number of participants who develop pneumonitis (lung inflammation)
timeFrame: Up to 36 weeks
measure: Number of participants who discontinue sargramostim due to a treatment related adverse event
timeFrame: Up to 12 weeks
measure: Number of missed doses
timeFrame: Up to 12 weeks
measure: Number of participants requiring dose modifications
timeFrame: Up to 12 weeks
measure: Change from baseline in Treatment Assessment Questionnaire
timeFrame: Daily up to 12 weeks.
measure: Number of participants who develop anti-drug antibodies against sargramostim
timeFrame: Day 1, Week 4, Week 13, Week 17 and Week 36
measure: Overall response rate
timeFrame: Up to Week 36
measure: Disease control rate
timeFrame: Up to Week 36
measure: Progression-free survival
timeFrame: Up to 36 weeks
measure: Overall survival
timeFrame: Up to 36 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Partner Therapeutics - No Currently Active Sites
state: Massachusetts
Study officials:
affiliation: Partner Therapeutics, Inc.
name: Fiona Garner
role: STUDY_DIRECTOR
References: