Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab · 1 trial · 1 indication
The objective response rate will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per RECIST v1.1, tumor response was assessed using MRI or CT imaging. Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) as a ≥30% decrease in the sum of diameters of target lesions from baseline; Stable Disease (SD) as neither sufficient tumor shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD); and PD as a ≥20% increase in the sum of diameters of target lesions or the appearance of new lesions. Disease Control Rate (DCR) was defined as the proportion of participants who achieved CR, PR, or SD as their best overall response during the assessment period, reflecting the ability of treatment to prevent disease progression. The RECIST median duration of response is the time, measured from the first date of CR or PR to PD or death.
The duration of response and disease control will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per RECIST v1.1, tumor response was assessed using MRI or CT imaging. Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) as a ≥30% decrease in the sum of diameters of target lesions from baseline; Stable Disease (SD) as neither sufficient tumor shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease; and Progressive Disease (PD) as a ≥20% increase in the sum of diameters of target lesions (with an absolute increase of at least 5 mm) or the appearance of new lesions. Disease Control Rate (DCR) was defined as the proportion of participants who achieved CR, PR, or SD as their best overall response during the assessment period, reflecting the ability of treatment to prevent disease progression. The Duration of Response is the time, measured from the first date of CR or PR to PD or death.
Treatment related adverse events will be assessed using CTCAE v4.0.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - Pembrolizumab | EXPERIMENTAL | Arm 1 - Pembrolizumab injection dosed at 200 mg given Q3 weeks by IV infusion on Day 1 of each 3 week cycle. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab Injection | DRUG | Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W. |
Inclusion Criteria: 1. Have histologically (or cytologically) documented, metastatic carcinoma with no primary site identified. The following tests are required to exclude a primary site of disease: complete history and physical examination, blood chemistry (including serum tumor marker for prostat...
Pembrolizumab is being studied for the treatment of Carcinoma of Unknown Primary, a cancer where the original site of the tumor cannot be identified. It is an investigational small molecule in Phase 2 clinical development for this indication, evaluated in a completed trial in Canada.
Pembrolizumab targets the PD-1 receptor, a protein on immune cells that helps regulate immune responses. By blocking PD-1, it aims to enhance the body's immune system to attack cancer cells. This mechanism is relevant for treating Carcinoma of Unknown Primary, though the specific biomarker selection in the trial is not detailed.
Pembrolizumab is being developed by Avalon GloboCare Corp., a biopharmaceutical company listed on the stock exchange under the ticker ALBT. The company is conducting clinical research on this drug for the treatment of Carcinoma of Unknown Primary.
Pembrolizumab is in Phase 2 clinical development for Carcinoma of Unknown Primary. It is an investigational drug, meaning it has not been approved by regulatory authorities for this use. A Phase 2 trial has been completed, but the drug remains under clinical investigation.
Pembrolizumab has one completed clinical trial, identified as NCT03391973, titled 'Pembrolizumab in Patients With Poor-Prognosis Carcinoma of Unknown Primary Site (CUP)'. This Phase 2 study enrolled 33 participants in Canada, was uncontrolled, and included adults aged 18 years and older.
Pembrolizumab is the generic name for the drug also known as Keytruda. However, in the context of this development program, it is being studied by Avalon GloboCare Corp. for Carcinoma of Unknown Primary. The drug is an investigational small molecule in Phase 2 trials for this indication.