Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anti-OX40 Antibody PF-04518600 · 1 trial · 9 indications
BORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and will be reported for each arm along with 95% two-sided confidence intervals.
| Arm | Type | Description |
|---|---|---|
| CLOSED TO ENROLLMENT: Arm I (binimetinib, avelumab) | EXPERIMENTAL | Patients will receive a 15-day lead-in of binimetinib, followed by binimetinib PO BID and avelumab IV over 60 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| CLOSED TO ENROLLMENT: Arm II (anti-OX40 antibody PF-04518600, avelumab) | EXPERIMENTAL | Patients will receive a 15-day lead-in of anti-OX40 antibody PF-04518600, followed by anti-OX40 antibody PF-04518600 IV over 60 minutes and avelumab IV over 60 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| CLOSED TO ENROLLMENT: Arm III (utomilumab, avelumab) | EXPERIMENTAL | Patients will receive a 15-day lead-in of utomilumab, followed by utomilumab IV over 60 minutes every 4 weeks and avelumab IV over 60 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm A (avelumab, binimetinib, liposomal doxorubicin) | EXPERIMENTAL | Patients receive a 15 day lead-in of binimetinib orally (PO) twice daily (BID) in the absence of disease progression or unacceptable toxicity. Patients then receive binimetinib PO BID on days 1-28, avelumab intravenously (IV) over 60 minutes on days 1 and 15, and liposomal doxorubicin IV over 60 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm B (avelumab, sacituzumab govitecan) | EXPERIMENTAL | Patients will receive a 15-day lead-in of sacituzumab govitecan given on day -15, followed by sacituzumab govitecan day 8 and day 15 of Cycle (C) 1; day 1,8, and 21 of C2; day 1, 15 and 21 of C3; day 8 and 15 of C4, and schedule continues with two weeks on, one week off for 21-day cycles. Patients also receive 10mg/kg avelumab over 60 minutes on day 1 and day 15 of each 28 day cycle. Cycles repeat in the absence of disease progression or unacceptable toxicity. |
| Arm C (avelumab, liposomal doxorubicin) | EXPERIMENTAL | Patients will receive a 15-day lead-in of liposomal doxorubicin, followed by liposomal doxorubicin on Day 1 and 10mg/kg avelumab over 60 minutes on Day 1 and Day 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Anti-OX40 Antibody PF-04518600 | BIOLOGICAL | Given IV |
| Avelumab | DRUG | Given IV |
| Binimetinib | DRUG | Given PO |
| Utomilumab | BIOLOGICAL | Given IV |
| Liposomal Doxorubicin | DRUG | Given IV |
| Sacituzumab Govitecan | DRUG | Given IV |
Inclusion Criteria: 1. Signed and dated written informed consent 2. Subjects \>= 18 years of age 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Clinical stage IV invasive breast cancer or unresectable locoregional recurrence of invasive breast cancer meeting the following...
Anti-OX40 Antibody PF-04518600 is an investigational monoclonal antibody being studied for the treatment of Stage III breast cancer, including Stage IIIA, IIIB, and IIIC breast cancer. It is also being evaluated in patients with Stage IV, recurrent, invasive, or unresectable breast cancer, specifically triple-negative breast carcinoma.
Anti-OX40 Antibody PF-04518600 targets the OX40 receptor, a costimulatory molecule on T cells. By engaging OX40, the antibody is designed to enhance T-cell activation and promote an anti-tumor immune response, which may help the immune system recognize and attack cancer cells.
Anti-OX40 Antibody PF-04518600 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is currently in Phase 2 clinical development for oncology indications.
Anti-OX40 Antibody PF-04518600 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is active but not recruiting participants, and it is evaluating the drug in combination with other agents for breast cancer.
Anti-OX40 Antibody PF-04518600 is being studied in clinical trial NCT03971409, a Phase 2 study titled 'Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer.' The trial is active but not recruiting, with an estimated enrollment of 145 participants in the United States.
Yes, Anti-OX40 Antibody PF-04518600 is the same drug as PF-04518600. The name PF-04518600 refers to the specific anti-OX40 monoclonal antibody being developed by Gilead Sciences. It is also referred to as an anti-OX40 antibody in clinical trial documentation.