Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYuan Yuan
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 1
Life expectancy > 3 months
Histologically confirmed metastatic triple negative breast cancer. Triple negative status will be defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10% and HER2 negative (by immunohistochemistry [IHC] or fluorescence in situ hybridization [FISH]), per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Disqualifiers
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 28 days prior to day 1 of protocol therapy
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)
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
Trial design
Design model
Single group
Treatments tested in this trial
Ivermectin
DrugIvermectin at the assigned dose administered PO on Days 1-3, 8-10, 15-17 of each 21 day cycle (Days1-3 of each week).
Balstilmab
DrugBalstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle.
Pembrolizumab
DrugPembrolizumab 200 mg IV on Day 1 of each 21 day cycle
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: Treatment (ivermectin, balstilimab)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Incidence of adverse events
Phase 1: To determine the recommended phase 2 dose of ivermectin in combination with balstilimab or pembrolizumab using NCI-CTCAE v5.0
Time frame
From start of study treatment until 90 days after treatment completion2
Objective response rate
Phase 2: To determine the efficacy of ivermectin in combination with balstilimab or pembrolizumab in mTNBC using the objective response rate (ORR)
Time frame
From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 2 years.Secondary outcomes
1
Objective response rate
Evaluate the efficacy of ivermectin in combination with balstilimab or pembrolizumab in mTNBC using objective response rate (ORR) using RECIST 1.1
Time frame
From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 2 years.2
Progression free survival
From start of therapy until first documentation of disease progression per RECIST 1.1 or death due to any cause.
Time frame
From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 6 years.3
Overall survival
From start of study treatment to date of death due to any cause. Patient's last known to be alive are censored at date of last contact.
Time frame
From start of study treatment to death or last contact. Assessed up to 6 years4
Duration of response
Measured from the date of first objective response recorded (CR or PR) until progression per RECIST 1.1, death or last contact (censored). Patient's last known to be alive are censored at date of last contact.
Time frame
From the date of first objective response recorded until disease progression, death or last contact. Assessed up to 6 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yuan Yuan
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Agenus Inc.
Collaborator
Gateway for Cancer Research
Collaborator
Source ClinicalTrials.gov