Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab · 1 trial · 3 indications
AE: any untoward medical occurrence in participants administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. Severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1: Mild (asymptomatic/mild symptoms; clinical/diagnostic observations only; intervention not indicated); Grade 2: Moderate (minimal, local/noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3: Severe (severe/medically significant but not immediately life-threatening hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death related to AE.
A DLT was defined as any TEAE that occurred during Cycle 1 and was considered by investigator to be at least possibly related to TAK-676 in combination with pembrolizumab. TEAEs meeting DLT definitions occurring in later cycles were considered in the determination of recommended phase 2 dose (RP2D) of TAK-676. DLTs were assessed based on NCI CTCAE version 5.0.
TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. An SAE is defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) may require intervention to prevent items 1 through 5 above. b) may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization
TEAE: Any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent.
TEAE: Any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent.
| Arm | Type | Description |
|---|---|---|
| Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676 | EXPERIMENTAL | Participants will receive image-guided radiation therapy between Day -8 and Day -2. Participants will then receive pembrolizumab 200 milligram (mg), infusion, intravenously (IV), once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by TAK-676 infusion with escalating doses (0.2 mg and above), IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | IV infusion. |
| TAK-676 | DRUG | IV infusion. |
| Image-guided radiation therapy | RADIATION | Radiation therapy. |
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 2. Participants must have at least 2 measurable lesions (i.e. ≥10 mm longest diameter for extranodal lesions, ≥15 mm short axis for lymph nodes), with at least one inside and at least one other outside of...
Pembrolizumab is being studied for use in non-small-cell lung carcinoma, among other cancers. In a Phase 1 clinical trial, it was evaluated in combination with TAK-676 after radiation therapy for the treatment of non-small-cell lung cancer, triple-negative breast cancer, and squamous cell carcinoma of the head and neck. The trial has been completed.
Pembrolizumab is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 1 clinical development for oncology indications, including non-small-cell lung carcinoma.
Pembrolizumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing.
Pembrolizumab has been studied in one clinical trial, identified as NCT04879849. This Phase 1 trial, titled 'A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers,' enrolled 34 participants in the United States. The trial has been completed.
No, Pembrolizumab is not the same as TAK-676. In the clinical trial NCT04879849, Pembrolizumab was studied in combination with TAK-676 after radiation therapy. Pembrolizumab is the drug of interest, while TAK-676 is a separate investigational agent being tested alongside it.