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Adjuvant Nivolumab and Ipilimumab
Nivolumab and ipilimumab together block immune checkpoints (PD-1 and CTLA-4) to enhance anti-tumor T-cell responses in adjuvant settings.
Nivolumab and ipilimumab together block immune checkpoints (PD-1 and CTLA-4) to enhance anti-tumor T-cell responses in adjuvant settings. Used for Adjuvant treatment of melanoma (resected stage III/IV), Adjuvant treatment of renal cell carcinoma (resected stage III/IV).
At a glance
| Generic name | Adjuvant Nivolumab and Ipilimumab |
|---|---|
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Drug class | PD-1 inhibitor and CTLA-4 inhibitor combination |
| Target | PD-1 and CTLA-4 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Nivolumab is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, preventing immune evasion. Ipilimumab is a CTLA-4 inhibitor that enhances T-cell priming and activation. Combined, they provide dual checkpoint inhibition to maximize anti-tumor immunity in the adjuvant (post-surgical) setting to reduce recurrence risk.
Approved indications
- Adjuvant treatment of melanoma (resected stage III/IV)
- Adjuvant treatment of renal cell carcinoma (resected stage III/IV)
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated pneumonitis
- Immune-mediated endocrinopathy
Key clinical trials
- Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma (PHASE2)
- A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC) (PHASE1)
- Neo-adjuvant Immunotherapy in Patients With Localized Melanoma (PHASE2)
- Exercise to Boost Response to Checkpoint Blockade Immunotherapy (EARLY_PHASE1)
- Adjuvant Nivolumab & Low Dose Ipilimumab for Stage III & Resected Stage IV Melanoma (PHASE2)
- Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (PHASE2)
- A Study of Carboplatin and Paclitaxel Chemotherapy With Nivolumab With or Without Ipilimumab in Patients With Ovarian Cancer (PHASE1)
- SWE-NEO: Swedish NeoAdjuvant Trial Comparing Monotherapy to Combined Immunotherapy in Resectable Stage III Melanoma (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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