Nivolumab (Opdivo)

Immunotherapy · Approved since 2014

US FDA Approved EU EMA Approved ES Hospital use approved in CRC IV 106 Clinical Trials
PD-1

Description

Nivolumab is a fully human monoclonal antibody that blocks the PD-1 immune checkpoint receptor, approved for treating microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed after fluoropyrimidine, oxaliplatin, and irinotecan. It is specifically indicated for CRC tumors with high microsatellite instability, as these tumors have increased neoantigen burden making them more responsive to immune checkpoint blockade. The drug is also being combined with ipilimumab in patients with anti-PD-1 resistant dMMR/MSI-H metastatic colorectal cancer and evaluated in neoadjuvant settings for early-stage colon cancer.

Mechanism of Action

Nivolumab binds to the programmed death-1 (PD-1) receptor on activated T cells, blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2. This prevents the PD-1 pathway-mediated inhibition of T-cell activation and proliferation, allowing the immune system to mount an effective anti-tumor response. By removing this immune checkpoint brake, cytotoxic T lymphocytes can recognize and eliminate cancer cells more effectively.

Molecular Targets

Side Effects

Fatigue Decreased appetite Nausea Diarrhea Skin rash Pruritus Cough Dyspnea

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

Clinical Trials

NCT07527858 Phase 2
Recruiting
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer
United States, Australia
NCT07328087 Early Phase 1
Recruiting
COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer
Greece
NCT06948448 Phase 2
Recruiting
A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
United States, Canada, France, Italy, Japan, Spain
NCT07223424 Phase 2
Recruiting
Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
United States
NCT06764771 Phase 1
Recruiting
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
United States, Australia, Canada
NCT06245356 Phase 2
Recruiting
Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer
France
View all 106 clinical trials →