OncoMatch/Clinical Trials/NCT05318469
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
Is NCT05318469 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Ivermectin and Balstilmab for anatomic stage iv breast cancer ajcc v8.
Treatment: Ivermectin · Balstilmab · Pembrolizumab — This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab or pembrolizumab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as balstilimab or pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivermectin may help block the formation of growths that may become cancer. Giving ivermectin with balstilimab or pembrolizumab may increase the effect of balstilimab or pembrolizumab in shrinking tumors in patients with triple negative breast cancer. The secondary objectives of the study include evaluating the following efficacy outcomes: objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), and patients' quality of life (QOL) by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression ≤ 10% (≤ 10%)
Triple negative status will be defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%
Required: PR (PGR) expression ≤ 10% (≤ 10%)
Triple negative status will be defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%
Required: HER2 (ERBB2) negative (negative)
HER2 negative (by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH])
Required: PD-L1 (CD274) negative (negative)
For Phase 2 expansion only, must be PD-L1 negative. Note: For Phase 1 safety cohort, any PD-L1 status will be allowed to enroll.
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — metastatic
Patients must have progressed on 1-2 prior lines of systemic therapy (chemotherapy and/or drug-antibody conjugate) in the metastatic setting
Cannot have received: immune checkpoint inhibitor
Exception: Prior use of immune checkpoint inhibitor in neoadjuvant or adjuvant setting only permitted if last dose is at least 1 year from start of study intervention
Prior immune checkpoint inhibitor therapy in metastatic setting (Note: Prior use of immune checkpoint inhibitor in neoadjuvant or adjuvant setting only permitted if last dose is at least 1 year from start of study intervention)
Cannot have received: chemotherapy
Exception: within 28 days prior to day 1 of protocol therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 28 days prior to day 1 of protocol therapy
Cannot have received: radiation therapy
Exception: within 2 weeks of start of study intervention; 1-week washout permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
Cannot have received: biological therapy
Exception: within 28 days prior to day 1 of protocol therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 28 days prior to day 1 of protocol therapy
Cannot have received: immunotherapy
Exception: within 28 days prior to day 1 of protocol therapy
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 28 days prior to day 1 of protocol therapy
Lab requirements
Blood counts
ANC ≥ 1,500/mm^3; Platelets ≥ 100,000/mm^3; Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (without erythropoietin dependency and without pRBC transfusion within last 2 weeks)
Kidney function
Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min for participant with creatinine levels >1.5 x institutional ULN
Liver function
Total serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN; AST ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases; ALT ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram
Patients must have adequate organ function as defined in the following: ... (see above for full details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cedars-Sinai Medical Center · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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