Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab · 1 trial · 1 indication
The proportion of patients having either a complete response (CR) or partial response (PR), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. For non-target lesions, CR is the disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
| Arm | Type | Description |
|---|---|---|
| ALX148 + Doxorubicin (PLD) + Pembrolizumab | EXPERIMENTAL | Given on Day 1 of each 21 day cycle, in the following order of administration: 200 mg IV pembrolizumab\* (maximum of 2 years (approximately 35 cycles) 45 mg/kg IV ALX148 30 mg/m\^2 IV doxorubicin (Pegylated Liposomal Doxorubicin (PLD)\* \*standard of care |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | A type of immunotherapy that stimulates the body's immune system to fight cancer cells by targeting and blocking PD-1 proteins on the surface of certain immune T-cells, thus triggering the T-cells to find and kill cancer cells. |
| ALX148 | DRUG | A fusion protein comprised of a high affinity CD47 blocker linked to an inactive immunoglobulin Fc region, enhancing innate and adaptive immune responses against cancer. |
| Doxorubicin | DRUG | An anthracycline that slows/stops the growth of cancer cells by blocking an enzyme called topo isomerase 2, used as second line non-platinum chemotherapy in patients with platinum-resistant ovarian cancer. |
Inclusion Criteria: 1. Participants must have recurrent epithelial ovarian cancer. 2. Platinum-resistant disease: Patients who recur within \< 6 months of prior platinum-based therapy excluding those with primary platinum refractory disease (see exclusion criteria). 3. Following histology types are...
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Pembrolizumab is being studied in combination with ALX148 and liposomal doxorubicin for the treatment of recurrent platinum-resistant ovarian cancer. It is currently in Phase 2 clinical development for this indication, with an active clinical trial enrolling female patients aged 18 years and older in the United States.
Pembrolizumab targets PDCD1, also known as programmed cell death protein 1, and acts as an inhibitor of this target. By inhibiting PDCD1, it is designed to modulate the immune response against cancer cells. This mechanism is being evaluated in the context of ovarian cancer treatment.
Pembrolizumab is being developed by ALX Oncology Holdings Inc., a biopharmaceutical company traded under the ticker symbol ALXO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in combination with other agents for ovarian cancer.
Pembrolizumab is in Phase 2 clinical development for ovarian cancer. The ongoing trial is active but not recruiting participants, and it is an uncontrolled, non-randomized study. The drug is investigational and has not yet been approved for this indication.
Pembrolizumab is being evaluated in clinical trial NCT05467670, titled 'Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer.' This Phase 2 trial is active in the United States and has an enrollment of 16 participants.
No, Pembrolizumab is not the same as ALX148. Pembrolizumab is the drug being studied, while ALX148 is a separate agent that is combined with Pembrolizumab and liposomal doxorubicin in the clinical trial for ovarian cancer. Both are part of the investigational combination regimen.