Solid TumorPhase 2SALIENTNCT05284214
Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors
A Phase 2 study testing Sargramostim and Ipilimumab-containing therapy in people with Solid Tumor and Solid Tumor, Adult, run by Partner Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Solid Tumor, Adult
- What is being tested?
- Sargramostim and Ipilimumab-containing therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2024to Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Partner Therapeutics - No Currently Active Sites
Lexington, Massachusetts, 02421
About this study
Official title: 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.
- Conditions
- Solid Tumor, Solid Tumor, Adult
- Being tested
- Sargramostim, Ipilimumab-containing therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SargramostimBiological
Also called Leukine®
Sargramostim for injection
Ipilimumab-containing therapyBiological
Also called Yervoy®
Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously..
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Sargramostim; Biological: Ipilimumab-containing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with severe, life-threatening or fatal adverse events
Measured: Up to 36 weeks
Secondary outcomes (11)
Number of participants who develop colon inflammation (colitis)
Measured: Up to 36 weeks
Number of participants who develop pneumonitis (lung inflammation)
Measured: Up to 36 weeks
Number of participants who discontinue sargramostim due to a treatment related adverse event
Measured: Up to 12 weeks
Number of missed doses
Measured: Up to 12 weeks
Number of participants requiring dose modifications
Measured: Up to 12 weeks
Change from baseline in Treatment Assessment Questionnaire
Measured: Daily up to 12 weeks.
Number of participants who develop anti-drug antibodies against sargramostim
Measured: 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):
Measured: 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:
Measured: Up to Week 36
Progression-free survival
The time from randomization until disease progression or death from any cause
Measured: Up to 36 weeks
Overall survival
The time from randomization until death from any cause
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study startJan 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: Study did not commence.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Partner Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fiona Garner, Study director, Partner Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284214
- Sponsor's protocol ID
- PTX-001-004
- Acronym
- SALIENT
- Status last verified
- Sep 2023
- First submitted
- 9 Mar 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sargramostim Safety and Tolerability With Standard Of Care Ipilimumab Containing Therapy in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT05284214
- Acronym / sponsor ID
- SALIENT / PTX-001-004
- Conditions
- Solid Tumor, Solid Tumor, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not commence.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Partner Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sargramostim daily: 14 of 21 days | Experimental | Biological: Sargramostim, Biological: Ipilimumab-containing therapySargramostim 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. |
| Sargramostim daily: 5 of 7 days | Experimental | Biological: Sargramostim, Biological: Ipilimumab-containing therapySargramostim 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SargramostimAlso: Leukine®Sargramostim for injection | Biological | Sargramostim daily: 14 of 21 days, Sargramostim daily: 5 of 7 days |
| Ipilimumab-containing therapyAlso: Yervoy®Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously.. | Biological | Sargramostim daily: 14 of 21 days, Sargramostim daily: 5 of 7 days |
Primary outcome
The number of participants with severe, life-threatening or fatal adverse events
Time frame: Up to 36 weeks
11 secondary outcomes
Number of participants who develop colon inflammation (colitis)
Time frame: Up to 36 weeks
Number of participants who develop pneumonitis (lung inflammation)
Time frame: Up to 36 weeks
Number of participants who discontinue sargramostim due to a treatment related adverse event
Time frame: Up to 12 weeks
Number of missed doses
Time frame: Up to 12 weeks
Number of participants requiring dose modifications
Time frame: Up to 12 weeks
Change from baseline in Treatment Assessment Questionnaire
Time frame: Daily up to 12 weeks.
Number of participants who develop anti-drug antibodies against sargramostim
Time frame: Day 1, Week 4, Week 13, Week 17 and Week 36
Overall response rate
Time frame: Up to Week 36
Disease control rate
Time frame: Up to Week 36
Progression-free survival
Time frame: Up to 36 weeks
Overall survival
Time frame: Up to 36 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Garner study director
Partner Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sargramostim and Ipilimumab-containing therapy in people with Solid Tumor and Solid Tumor, Adult, run by Partner Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with severe, life-threatening or fatal adverse events (time frame: Up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.