Solid Tumor, Solid Tumor, Adult
Conditions
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.
Interventions
BIOLOGICALSargramostim
Sargramostim for injection
BIOLOGICALIpilimumab-containing therapy
Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously..
Sponsors
Partner Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants with severe, life-threatening or fatal adverse events | Up to 36 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 colon inflammation (colitis) | Up to 36 weeks | — |
| Overall response rate | 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): |
| Disease control rate | 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: |
| Progression-free survival | Up to 36 weeks | The time from randomization until disease progression or death from any cause |
| Overall survival | Up to 36 weeks | The time from randomization until death from any cause |
| Number of participants who develop anti-drug antibodies against sargramostim | Day 1, Week 4, Week 13, Week 17 and Week 36 | — |
Countries
United States
Outcome results
None listed