Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab · 2 trials · 4 indications
Feasibility of preoperative radiation and Pembrolizumab in newly diagnosed, non-metastatic patients with triple negative breast cancer.
An increase in the tumor-infiltrating lymphocyte score (TILs) as measured by Salgado criteria. An increase in TILs is an indicator of immune system engagement (range is 0-100 in percent), therefore increase indicates better outcome. A lead in with pembrolizumab alone followed by the combination of pembrolizumab with RT will allow for serial assessment of TILs. This will establish the contribution of RT to the immune response generated by pembrolizumab. The working group's consensus for Salgado criteria is that TILs may provide more biological relevant information when scored as a continuous variable. The percentage of stromal TILs is a semi quantitative parameter for this assessment (0%-100%). No formal recommendation for a clinically relevant TIL threshold(s) can be given at this stage. The consensus was that a valid methodology is currently more important than issues of thresholds for clinical use, which will be determined once a solid methodology is in place.
| Arm | Type | Description |
|---|---|---|
| Treatment (carboplatin, pembrolizumab) | EXPERIMENTAL | Patients receive carboplatin IV over 30 minutes on day -2 of cycle 1 only. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial. Patients also undergo blood sample collection on the trial. |
| Pembrolizumab with RT Boost | EXPERIMENTAL | Study drug plus "tumor boost" before standard of care treatment |
| Name | Type | Description |
|---|---|---|
| Carboplatin | DRUG | Given IV |
| Pembrolizumab | BIOLOGICAL | Given IV |
| Computed Tomography | PROCEDURE | Undergo CT |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| RT Boost | RADIATION | The second dose of pembrolizumab will be given in conjunction with an RT boost, consisting of 8 Gy for 3 fractions. |
Inclusion Criteria: * Have a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer who have received systemic chemotherapy including platinum-based chemotherapy * Have a cancer antigen (CA)-125 that normalized after first-line therapy * CA-125 increased to more than twice the upper lim...
Pembrolizumab is being studied in breast cancer as a preoperative treatment combined with radiation in a Phase 1 clinical trial. The study is active but not recruiting participants and is being conducted in the United States with female patients aged 18 years and older.
Pembrolizumab is an antibody, classified as a -mab, and is being investigated in oncology. It is being studied in combination with other therapies for the treatment of breast cancer and recurrent fallopian tube carcinoma.
Pembrolizumab is being developed by United Therapeutics Corporation, which is listed on the stock exchange under the ticker UTHR. The company is conducting clinical trials for this drug in oncology indications.
Pembrolizumab is in Phase 1 clinical development for breast cancer. It is also being studied in a Phase 2 trial for recurrent fallopian tube carcinoma, recurrent ovarian carcinoma, and recurrent primary peritoneal carcinoma. Both trials are active but not recruiting.
Pembrolizumab is being studied in two clinical trials. The first is NCT03366844, a Phase 1 study of preoperative pembrolizumab plus radiation in breast cancer. The second is NCT04387227, a Phase 2 study of pembrolizumab and carboplatin for recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Pembrolizumab is a distinct drug being studied for multiple cancer types. It is being evaluated alone and in combination with other agents, such as radiation and carboplatin, in clinical trials for breast cancer and recurrent gynecologic cancers.