drugset / Trial / NCT05732389
Immunotherapy in Patients With Early dMMR Rectal Cancer
Phase 2
Recruiting
39 enrolled
Odense University Hospital
Aalborg University Hospital · collabAarhus University Hospital · collabBispebjerg Hospital · collabHerlev and Gentofte Hospital · collabRigshospitalet, Denmark · collabVejle Hospital · collabZealand University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this investigator-initiated, multicenter phase II trial is to evaluate the efficacy and tolerability of nivolumab and ipilimumab in patients with stage 1-3 MSI/dMMR rectal cancer. The primary objective is: Number of patients with complete clinical response after one or two cycles of immunotherapy. Patients will be treated with 1 or 2 cycles of combination immunotherapy: Cycle 1: Nivolumab 3 mg/kg days 1 and 15 \& ipilimumab 1 mg/kg day 1 Cycle 2: Nivolumab 3 mg/kg days 50 and 65 \& ipilimumab 1 mg/kg day 50
Timeline
- Start
- 2023-02-01
- Primary completion
- 2027-07
- Completion
- 2052-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | — |