Pembrolizumab (Keytruda)

Immunotherapy · Approved since 2014

US FDA Approved EU EMA Approved ES Funded by SNS approved in CRC IV 164 Clinical Trials
PD-1

Description

Pembrolizumab is a humanized monoclonal antibody and immune checkpoint inhibitor approved for treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer. It is indicated as a tumor-agnostic therapy for patients whose tumors have progressed on or after fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy. The drug has also been studied in neoadjuvant settings for locally advanced colorectal cancer and as combination therapy with other agents in microsatellite stable (MSS) metastatic disease.

Mechanism of Action

Pembrolizumab binds to the programmed cell death protein-1 (PD-1) receptor on T-cells, blocking its interaction with ligands PD-L1 and PD-L2. By inhibiting this immune checkpoint pathway, pembrolizumab prevents T-cell exhaustion and enhances the immune system's ability to recognize and eliminate cancer cells. This mechanism is particularly effective in MSI-H/dMMR tumors which have high tumor mutational burden and increased neoantigen expression.

Molecular Targets

Side Effects

Fatigue Diarrhea Nausea Pruritus Rash Decreased appetite Pyrexia Hypothyroidism Pneumonitis Colitis Hepatitis

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT07415031 Phase 2
Recruiting
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies
United States, Australia, Belgium, Canada, France, Germany, Greece, Israel, Ital
NCT07410676 Phase 1
Recruiting
EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
China
NCT07262619 Phase 1
Recruiting
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors
United States, Australia, New Zealand
NCT07223047 Phase 1
Recruiting
A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
United States, Canada, Spain
NCT07255664 Phase 1
Recruiting
A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC
Germany
NCT07227168 Phase 1
Recruiting
A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
United States
View all 164 clinical trials →