Immunotherapy in Patients With Early dMMR Rectal Cancer
ConditionCancer of Rectum
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
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
Eligibility criteria
Qualifiers
Age ≥ 18 years.
Histologically verified non-metastatic rectal cancer stage 1-3.
No indication for local therapy like TEM.
Histologically verified dMMR or MSI.
Disqualifiers
Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
Concomitant use of systemic glucocorticoids more than the equivalent dose to tablet prednisolone 10 mg/day. Treatment with systemic glucocorticoids must end no later than two weeks before inclusion.
Subjects with active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol.
Known allergy or intolerance to any of the drugs used (nivolumab and ipilimumab).
Trial design
Treatments tested in this trial
- Nivolumab
- Ipilimumab
Treatment groups
39 Participants
are divided into 1 treatment groupSponsors and collaborators
Odense University Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Zealand University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Aarhus University Hospital
Collaborator
Bispebjerg Hospital
Collaborator
Herlev and Gentofte Hospital
Collaborator
Vejle Hospital
Collaborator
Source ClinicalTrials.gov