Ipilimumab and nivolumab plus temozolomide and capecitabine for patients with chemo-refractory pMMR, MGMT silenced metastatic colorectal cancer: The MAYA2 trial

2025-521941-25-00 · tracked via the Priya Life Science EU tracker

Sponsor

Odense University Hospital

Sponsor type

Hospital/Clinic/Other health care facility

Therapeutic area

Neoplasms

Decision date

19/09/2025

Enrollment target

165

Sites

Denmark

Condition studied

Colorectal cancer

Investigational medicinal product(s)

TEMOZOLOMIDETEMOZOLOMIDETEMOZOLOMIDEIPILIMUMABTEMOZOLOMIDECAPECITABINETEMOZOLOMIDENIVOLUMABTEMOZOLOMIDECAPECITABINE

Eligibility

Age group

18-64 years, 65+ years

Sex

Female, Male

Primary endpoint

Disease control rate (DCR) (complete response (CR), PR, or SD) evaluated by a CT scan 16 weeks after initiation of TemCap.

Endpoint detail

1. PFS for patients initiating TemCap and for patients initiating TemCap with ipi-nivo, 2. OS for patients initiating TemCap and for patients initiating TemCap with ipi-nivo, 3. ORR according to RECIST 1.1 criteria, 4. Safety and tolerability of the combination of ipi-nivo and TemCap, 5. Quality of life measured by the EORCT QLQ-C30 questionnaire

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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