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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521941-25-00

Enrollment

165

Registered

2025-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Brief summary

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

Detailed description

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

Interventions

DRUGTEMOZOLOMIDE

DRUGIPILIMUMAB

DRUGCAPECITABINE

DRUGNIVOLUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026