Clinical trial · Interventional
Neoadjuvant Nivolumab and Relatlimab in Merkel Cell Carcinoma
A Phase 2, Open Label, Single Arm Clinical Trial of Neoadjuvant Nivolumab and Relatlimab in Stage I To III Resectable Merkel Cell Carcinoma
NCT06151236CI-TRIAL-00103417recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to test neoadjuvant dual immunotherapy in Merkel cell carcinoma with the aim to improve recurrence-free survival
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Treatment
- description
- Nivolumab and relatlimab will be administered in a fixed dose combination (FDC). The FDC product contains nivolumab and relatlimab in a protein-mass ratio of 3:1 (nivolumab 240 mg and relatlimab 80 mg): in a 20 mL concentrate solution per single vial. The dose and dosing regimen for this study is nivolumab 480 mg and relatlimab 160 mg - 2 vials per infusion. This was primarily based on the observed benefit/risk profile observed in metastatic melanoma patients from Study CA224-020 pharmacokinetics (PK), pharmacodynamics, and extensive nivolumab monotherapy clinical experience. In addition, the Phase 2/3 Study CA224-047 established this dose as active in unresectable and metastatic melanoma. This study is open label and single arm, with all patients scheduled to receive two doses of nivolumab and relatlimab FDC prior to surgery on days 1 and 29.
- interventionNames
- Drug: Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination
Primary outcomes (1)
- measure
- Pathological complete response rate
- timeFrame
- Week 6
- description
- Proportion of patients with a pathological complete response, as determined on the week 6 surgical specimen using the guidelines published by the International Neoadjuvant Melanoma Consortium: Complete pathological response (pCR) = 0% viable tumour cells in the surgical specimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged ≥ 18 years 2. Written consent 3. Histologically confirmed, resectable Merkel cell carcinoma with AJCC (8th ed) clinical or pathological stage I (≥ 10 mm), IIA, or IIB or III disease 4. In-transit metastases are permitted if they are completely resectable 5. Measurable disease according to RECIST 1.1 criteria 6. Previous radiotherapy permitted if there is RECIST-measurable progression of disease since the completion of radiotherapy 7. At least one of either, archival tissue from a primary or nodal MCC lesion (if applicable) for the current diagnosis and/or a newly obtained core biopsy of a lesion which has not been previously irradiated. 8. ECOG 0-1 9. Adequate organ function on blood pathology 10. Life expectancy \>12 months 11. Female patients to use effective contraception during study treatment and for 5 months after last dose. Exclusion Criteria: 1. Clinical, radiographic or pathological evidence of distant metastases 2. Contraindication to nivolumab and / or relatlimab 3. Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment 4. Active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy 5. A diagnosis of immunodeficiency or chronic steroid therapy \>10 mg OD prednisone or equivalent 6. Additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study. 7. Uncontrolled cardiovascular disease or history of myocarditis 8. Has had an allogenic tissue/solid organ transplant 9. Troponin T (TnT) or I (TnI) \>2 × institutional ULN 10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis or current interstitial lung disease 11. Has an active infection requiring systemic therapy 12. Active Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. 13. Known HIV 14. Pregnant or breast feeding females 15. Concurrent medical or social conditions that may prevent the patient attending assessments or procedures per schedule
References
Publications (0)
Data not yet available
No reference posted for this study.