Can a drug cocktail make immunotherapy work better for Hard-to-Treat breast cancer?
NCT ID NCT05756166
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This early-phase trial tests whether adding a combination of rintatolimod, celecoxib, and interferon alpha-2b can enhance the effectiveness of pembrolizumab, an immunotherapy drug, in people with metastatic or unresectable triple-negative breast cancer. The combination aims to modify the immune response and tumor environment to help the immune system attack cancer cells more effectively. The study will evaluate safety, side effects, and the best dose of the combination, and will also look at how well the treatment controls the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of rintatolimod, celecoxib, and interferon alpha-2b, given with pembrolizumab
- What this could lead to
- If it works, this could point toward a way to make immunotherapy more effective for people with metastatic triple-negative breast cancer, potentially slowing the disease or shrinking tumors.
- What could go wrong
- This is an early, small trial with only 5 participants, so results may not apply broadly. The drug combination may cause side effects, and it is not yet known if it will improve outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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5 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>= 18 years of age * Have pathologically confirmed diagnosis of PDL-1-negative or PDL1 positive unresectable or metastatic TNBC with no curative treatment options * Have been informed of other treatment options * Patient has lesion that can be biopsied and is willing to undergo the procedure as part of the protocol. Note: For cohort 1 and cohort 2: Patient with accessible tumor will be offered optional pre-treatment and post-treatment biopsies. Biopsies are mandatory for cohort 3 * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Ability to swallow and retain oral medication * Have measurable disease per RECIST 1.1 criteria present * Any line of therapy allowed, radiologically confirmed progression * No cancer-directed therapy for at least 3 weeks prior to study treatment (bone-directed therapies are allowed) * Platelets \>= 100,000/uL * Hemoglobin \>= 9.0 g/dL * Absolute neutrophil count (ANC) \>= 1500/uL * Total bilirubin =\< institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional ULN * Creatinine \< ULN or, creatinine clearance \>= 50 mL/min per Cockcroft-Gault equation for patients with creatinine levels greater than ULN * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients currently treated with systemic immunosuppressive agents, including steroids (greater than equivalent of 10 mg daily of prednisone), are ineligible until 3 weeks after removal from immunosuppressive treatment. (Inhaled steroids are allowed.) * Patients with active autoimmune disease or history of transplantation * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Patients with known serious mood disorders. (Major depression diagnosis is an exclusion. Other stable mood disorders on stable therapy for \> 6 months or not requiring therapy may be allowed after consultation with the principal investigator.) * Cardiac risk factors including: * Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent. While our published clinical studies involving short-term CKM did not indicate increased risk of cardiac events, the CKM can induce flu-like symptoms, providing justification for its avoidance in patients with recent cardiac events * Patients with a New York Heart Association classification of III or IV * Patients with a history of stroke * History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years * Prior allergic reaction or hypersensitivity to nonsteroidal antiinflammatory drug (NSAIDs) or any drugs administered on protocol * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug * Any patients with a positive antinuclear antibodies test will be excluded from study * Has a known history of human immunodeficiency virus (HIV) infection * Concurrent active hepatitis B (defined as hepatitis B antigen \[HBsAg\] positive and/or detectable hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\]) and hepatitis C virus (defined as anti-hepatitis C virus \[HCV\] antibody \[Ab\] positive and detectable HCV ribonucleic acid \[RNA\]) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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Other studies related to the condition(s) this trial covers.
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