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Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors

Studies

Study First Submitted Date 2022-03-09
Study First Posted Date 2022-03-17
Last Update Posted Date 2022-12-02
Start Month Year January 2024
Primary Completion Month Year September 2025
Verification Month Year November 2022
Verification Date 2022-11-30
Last Update Posted Date 2022-12-02

Facilities

Sequence: 200614097
Name Partner Therapeutics – No Currently Active Sites
City Lexington
State Massachusetts
Zip 02421
Country United States

Browse Interventions

Sequence: 96296005 Sequence: 96296006 Sequence: 96296007 Sequence: 96296008 Sequence: 96296009 Sequence: 96296010 Sequence: 96296011 Sequence: 96296012
Mesh Term Ipilimumab Mesh Term Sargramostim Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents Mesh Term Immune Checkpoint Inhibitors Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Immunologic Factors Mesh Term Physiological Effects of Drugs
Downcase Mesh Term ipilimumab Downcase Mesh Term sargramostim Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents Downcase Mesh Term immune checkpoint inhibitors Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term immunologic factors Downcase Mesh Term physiological effects of drugs
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52327133 Sequence: 52327134
Name Solid Tumor Name Solid Tumor, Adult
Downcase Name solid tumor Downcase Name solid tumor, adult

Id Information

Sequence: 40270179
Id Source org_study_id
Id Value PTX-001-004

Countries

Sequence: 42690158
Name United States
Removed False

Design Groups

Sequence: 55766809 Sequence: 55766810
Group Type Experimental Group Type Experimental
Title Sargramostim daily: 14 of 21 days Title Sargramostim daily: 5 of 7 days
Description 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. Description 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.

Interventions

Sequence: 52638126 Sequence: 52638127
Intervention Type Biological Intervention Type Biological
Name Sargramostim Name Ipilimumab-containing therapy
Description Sargramostim for injection Description Treatment for cancer containing ipilimumab at either 1 mg/kg or 3 mg/kg, intravenously..

Design Outcomes

Sequence: 177955478 Sequence: 177955479 Sequence: 177955480 Sequence: 177955481 Sequence: 177955482 Sequence: 177955483 Sequence: 177955484 Sequence: 177955485 Sequence: 177955486 Sequence: 177955487 Sequence: 177955488 Sequence: 177955489
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure The number of participants with severe, life-threatening or fatal adverse events Measure Number of participants who develop colon inflammation (colitis) Measure Number of participants who develop pneumonitis (lung inflammation) Measure Number of participants who discontinue sargramostim due to a treatment related adverse event Measure Number of missed doses Measure Number of participants requiring dose modifications Measure Change from baseline in Treatment Assessment Questionnaire Measure Number of participants who develop anti-drug antibodies against sargramostim Measure Overall response rate Measure Disease control rate Measure Progression-free survival Measure Overall survival
Time Frame Up to 36 weeks Time Frame Up to 36 weeks Time Frame Up to 36 weeks Time Frame Up to 12 weeks Time Frame Up to 12 weeks Time Frame Up to 12 weeks Time Frame Daily up to 12 weeks. Time Frame Day 1, Week 4, Week 13, Week 17 and Week 36 Time Frame Up to Week 36 Time Frame Up to Week 36 Time Frame Up to 36 weeks Time Frame Up to 36 weeks
Description 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): Description The number of participants who have a complete response, partial response, or stable disease response to treatment using Investigator-assessed efficacy evaluation by iRECIST: Description The time from randomization until disease progression or death from any cause Description The time from randomization until death from any cause

Browse Conditions

Sequence: 194080349
Mesh Term Neoplasms
Downcase Mesh Term neoplasms
Mesh Type mesh-list

Sponsors

Sequence: 48465307
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Partner Therapeutics, Inc.

Overall Officials

Sequence: 29368178
Role Study Director
Name Fiona Garner
Affiliation Partner Therapeutics, Inc.

Design Group Interventions

Sequence: 68360092 Sequence: 68360093 Sequence: 68360094 Sequence: 68360095
Design Group Id 55766809 Design Group Id 55766810 Design Group Id 55766809 Design Group Id 55766810
Intervention Id 52638126 Intervention Id 52638126 Intervention Id 52638127 Intervention Id 52638127

Eligibilities

Sequence: 30855629
Gender All
Minimum Age 18 Years
Maximum Age N/A
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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254312144
Number Of Facilities 1
Registered In Calendar Year 2022
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 11

Designs

Sequence: 30601470
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26747386 Sequence: 26747387
Intervention Id 52638126 Intervention Id 52638127
Name Leukine® Name Yervoy®

Responsible Parties

Sequence: 28967983
Responsible Party Type Sponsor