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COX-2 Inhibitor
Combo Immunotherapy for Triple Negative Breast Cancer
Phase 1 & 2
Recruiting
Led By Shipra Gandhi
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any line of therapy allowed, radiologically confirmed progression on prior therapy
Creatinine < ULN or, creatinine clearance >= 50 mL/min per Cockcroft-Gault equation for patients with creatinine levels greater than ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests if a combo of drugs (ckm+pembrolizumab) can treat metastatic triple negative breast cancer. CKM drugs modify the immune system & tumor-related processes; celecoxib causes cell death & reduces blood vessel growth. Pembrolizumab helps the body's immune system attack cancer.
Who is the study for?
This trial is for adults with triple negative breast cancer that has spread or can't be surgically removed. They must have normal bilirubin levels, agree to use contraception, and not have had cancer treatment in the last 3 weeks. Patients should be able to take oral meds, have measurable disease, and a performance status indicating they are relatively active.Check my eligibility
What is being tested?
The trial tests chemokine modulation therapy (CKM) - rintatolimod with celecoxib and interferon alpha 2b - combined with pembrolizumab immunotherapy. CKM may modify immune responses and tumor growth while pembrolizumab could help the immune system fight cancer more effectively.See study design
What are the potential side effects?
Possible side effects include flu-like symptoms due to CKM therapy, potential gastrointestinal issues from celecoxib, fatigue, allergic reactions similar to other NSAIDs or drugs used in the protocol, as well as common immunotherapy-related side effects like inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened despite previous treatments.
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My kidney function, measured by creatinine levels, is normal or near normal.
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I haven't had cancer treatment in the last 3 weeks, except for bone treatments.
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I can swallow and keep down pills.
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My triple-negative breast cancer cannot be surgically removed or cured.
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I am fully active or can carry out light work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Disease control rate
Overall response rate
Overall survival
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort II (CMK, early pembrolizumab)Experimental Treatment8 Interventions
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Group II: Cohort I (CKM, pembrolizumab)Experimental Treatment7 Interventions
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Celecoxib
2019
Completed Phase 4
~1740
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Pembrolizumab
2017
Completed Phase 2
~2010
Rintatolimod
2019
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,429 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
31,095 Total Patients Enrolled
10 Trials studying Breast Cancer
1,638 Patients Enrolled for Breast Cancer
Shipra GandhiPrincipal InvestigatorRoswell Park Cancer Institute
4 Previous Clinical Trials
76 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has worsened despite previous treatments.My kidney function, measured by creatinine levels, is normal or near normal.I haven't had cancer treatment in the last 3 weeks, except for bone treatments.Your platelet count is at least 100,000 per microliter.I am aware of other treatment options available to me.I have had stomach ulcers, bleeding, or a hole in my stomach in the last 3 years.I can swallow and keep down pills.You have a detectable disease that meets specific measurement criteria.I am allergic to NSAIDs or any medication planned for this treatment.Your liver enzyme levels are not more than 2.5 times the normal range at the study center.My triple-negative breast cancer cannot be surgically removed or cured.You have been diagnosed with HIV in the past.I am fully active or can carry out light work.I haven't taken strong immune system suppressing drugs for the last 3 weeks.I am willing to have a biopsy of my tumor.You have an ongoing autoimmune disease or have had an organ transplant in the past.Your total bilirubin level is within the normal range for the medical facility where you are receiving treatment.Your hemoglobin level is at least 9.0 grams per deciliter.I haven't had a heart attack or severe heart issue in the last 3 months.I am 18 years old or older.I have active hepatitis B or C.You have been diagnosed with severe mood disorders like major depression. If you have a stable mood disorder and have been on the same treatment for more than 6 months, you may still be considered after talking with the main doctor in charge of the study.I have had a stroke in the past.My heart condition severely limits my daily activities.You need to have a certain number of a type of white blood cell called neutrophils in your blood.I have not tested positive for antinuclear antibodies.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (CKM, pembrolizumab)
- Group 2: Cohort II (CMK, early pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this clinical trial still available to the public?
"As per clinicaltrials.gov, this particular medical trial has ceased recruitment efforts; the original posting was on March 1st 2023 and it was last edited on February 23rd 2023. Despite this study's inactivity, there are still 4597 active trials actively searching for participants."
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