A Phase 1/2 interventional study of Biopsy and Biospecimen Collection in Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma and Unresectable Triple-Negative Breast Carcinoma, sponsored by Roswell Park Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Roswell Park Cancer Institute · Phase 1/2, Interventional, and Treatment
This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer.
PRIMARY OBJECTIVE:
I. To evaluate the safety profile of modified CKM (celecoxib, rintatolimod and interferon alpha-2b) regimen (replacement of INTRON [registered trademark] A, using alternative source of interferon alpha-2b [IFNalpha2b]) combined with pembrolizumab therapy in metastatic triple negative breast cancer patients.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of the CKM in combination with pembrolizumab in patients with metastatic triple negative breast cancer (mTNBC) as compared to historic outcomes of pembrolizumab and other anti-PD1/PD-L1 therapies alone, as determined by secondary measures of efficacy including:
Ia. Progression-free survival (PFS); Ib. Overall survival (OS); Ic. Overall response rate (ORR) to the combination therapy using Immune Modulated Response Evaluation Criteria in Solid Tumors (iRECIST); Id. Disease control rate (DCR) using iRECIST.
EXPLORATORY OBJECTIVES:
I. Examine the immune analysis profile of CKM and pembrolizumab combination:
Ia. Examine the relationship of infiltrating CD4+ and CD8+ T cells and other immune and genetic markers, and their associated PD-1, CD45RA or CD45RO levels; Ib. Correlate PD-L1 expression within both neoplastic and nonneoplastic stromal elements of the tumor microenvironment to PFS, OS, ORR and adverse events (AEs); Ic. Correlate immune panel results with ORR, PFS, OS and AEs.
II. Comparison of response assessment criteria for a prospective analysis:
IIa. Response evaluation criteria in solid tumors (RECIST) 1.1 response assessment; IIb. iRECIST response assessment.
OUTLINE: This is a phase I dose escalation study of interferon alpha-2b followed by a phase II study. Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive rintatolimod intravenously (IV), celecoxib orally (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 computed tomography (CT) scan or magnetic resonance imaging (MRI) at screening and follow-up and undergo blood sample collection during screening and on study.
COHORT II: 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.
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Exclusion Criteria:
Cardiac risk factors including:
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.
Procedure: Biospecimen Collection · Drug: Celecoxib · Procedure: Computed Tomography · Biological: Interferon Alpha-2 · Procedure: Magnetic Resonance Imaging · Biological: Pembrolizumab · Drug: Rintatolimod
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.
Procedure: Biopsy · Procedure: Biospecimen Collection · Drug: Celecoxib · Procedure: Computed Tomography · Biological: Interferon Alpha-2 · Procedure: Magnetic Resonance Imaging · Biological: Pembrolizumab · Drug: Rintatolimod
Undergo tumor biopsy
Also known as: BIOPSY_TYPE, Bx
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given PO
Also known as: Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177
Undergo CT scan
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Given IV
Also known as: Alpha-2-Interferon, Alpha-2a Interferon, IFN-Alpha-2, IFN-AlphaA, IFNA2, IFNA2 Protein, Interferon Alpha 2, Interferon Alpha 2a, Interferon Alpha 2b, Interferon Alpha A, Interferon Alpha-A, LeIF A
Undergo MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Given IV
Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475
Given IV
Also known as: Ampligen, Atvogen
Incidence of Dose Limiting Toxicities
The dose limiting toxicities will be summarized by cohort using frequencies and relative frequencies.
Time frame: Up to 13 months
Median Progression-free Survival
Will be summarized using standard Kaplan-Meier methods, with estimates of the median survival obtained with 90% confidence intervals.
Time frame: From the start of post-chemokine modulation (CKM) therapy therapy until disease progression, death, or lst follow-up, assessed up to 13 months
Overall Response Rate
Evaluated using Immune Modulated Response Evaluation Criteria in Solid Tumors. Will be summarized using frequencies and relative frequencies, and obtained with 90% confidence intervals.
Time frame: From the start of study treatment until end of treatment or disease progression/recurrence, assessed up to 13 months
Overall Survival
Will be summarized using standard Kaplan-Meier methods, with estimates of the median survival obtained with 90% confidence intervals.
Time frame: From the start of post-CKM therapy until death due to any cause or last follow up, assessed up to 13 months
Disease Control Rate
Will be summarized using frequencies and relative frequencies and obtained with 90% confidence intervals.
Time frame: Up to 13 months
| Milestone | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
The dose limiting toxicities will be summarized by cohort using frequencies and relative frequencies.
| Participants | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) |
|---|---|---|
| Incidence of Dose Limiting Toxicities | 0 | 1 |
Will be summarized using standard Kaplan-Meier methods, with estimates of the median survival obtained with 90% confidence intervals.
| months | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) |
|---|---|---|
| Median Progression-free Survival | 2.3 (1.2 to 2.5) | 1.3 (0.5 to 2.1) |
Evaluated using Immune Modulated Response Evaluation Criteria in Solid Tumors. Will be summarized using frequencies and relative frequencies, and obtained with 90% confidence intervals.
| percentage of participants with response | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) |
|---|---|---|
| Overall Response Rate | 0 (00 to 0.44) | 0 (0 to 0.57) |
Will be summarized using standard Kaplan-Meier methods, with estimates of the median survival obtained with 90% confidence intervals.
| months | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) |
|---|---|---|
| Overall Survival | 10.2 (6.6 to 17.2) | 8.7 (1.0 to 16.4) |
Will be summarized using frequencies and relative frequencies and obtained with 90% confidence intervals.
| percentage of participants | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) |
|---|---|---|
| Disease Control Rate | 0 (0 to 0.44) | 0 (0 to 0.57) |
Collected over Baseline, monthly up to 13 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort I (CKM, Pembrolizumab) | 3/3 (100%) | 2/3 (66.7%) | 3/3 (100%) |
| Cohort II (CMK, Early Pembrolizumab) | 2/2 (100%) | 1/2 (50%) | 2/2 (100%) |
| Event | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) |
|---|---|---|
| Cardiac arrestCardiac disorders | 0/3 | 1/2 |
| Spinal cord compressionNervous system disorders | 0/3 | 1/2 |
| HypothyroidismEndocrine disorders | 1/3 | 0/2 |
| Gastrointestinal disorders - Other, specifyGastrointestinal disorders | 1/3 | 0/2 |
| Lung infectionInfections and infestations | 1/3 | 0/2 |
| Back painMusculoskeletal and connective tissue disorders | 1/3 | 0/2 |
| Event | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) |
|---|---|---|
| NauseaGastrointestinal disorders | 3/3 | 0/2 |
| FeverGeneral disorders | 1/3 | 2/2 |
| Lymphocyte count decreasedInvestigations | 0/3 | 2/2 |
| ParesthesiaNervous system disorders | 1/3 | 2/2 |
| DiarrheaGastrointestinal disorders | 2/3 | 1/2 |
| FatigueGeneral disorders | 2/3 | 1/2 |
| Non-cardiac chest painGeneral disorders | 2/3 | 0/2 |
| PainGeneral disorders | 2/3 | 1/2 |
| HeadacheNervous system disorders | 2/3 | 0/2 |
| Peripheral sensory neuropathyNervous system disorders | 2/3 | 0/2 |
All treated and eligible patients
| Age, Categorical(Participants) | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 4 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) | Total |
|---|---|---|---|
| Mean | 56.5 ± 11.5 | 48.8 ± 7.6 | 53.4 ± 9.9 |
| Sex: Female, Male(Participants) | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 3 | 1 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort I (CKM, Pembrolizumab) | Cohort II (CMK, Early Pembrolizumab) | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
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