The MAYA2 trial
Key facts
- Where
- Aalborg, Copenhagen Oe és Odense C, DániaSee the 3 sites
- Phase
- 2. fázis
Where in Dánia
- Aalborg University HospitalAalborg, DániaToborzás még nem indult
- RigshospitaletCopenhagen Oe, DániaToborzás még nem indult
- Odense University HospitalOdense C, DániaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- EU 2025-521941-25-00
- Record updated
- 2026. május 18.
- Original description
The main objective of the study is to investigate the possibility of making immunotherapy, a new and effective treatment, usually reserved for a few percent of patients with specific genomic profiles, available for a greater amount of patients with mCRC in later lines of therapy, and to investigate specific biomarkers predictive for treatment response.Read full original descriptionShow less
Ipilimumab and nivolumab plus temozolomide and capecitabine for patients with chemo-refractory pMMR, MGMT silenced metastatic colorectal cancer: The MAYA2 trial
The main objective of the study is to investigate the possibility of making immunotherapy, a new and effective treatment, usually reserved for a few percent of patients with specific genomic profiles, available for a greater amount of patients with mCRC in later lines of therapy, and to investigate specific biomarkers predictive for treatment response.
Inclusion: Signed written informed consent according to ethics committee requirements; Age ≥18 years; Metastatic or non-resectable adenocarcinoma of the colon or rectum; MSS or pMMR confirmed locally by PCR or IHC, respectively; MGMT promoter methylation confirmed by PCR and IHC in solid tumor tissue; Prior therapy with oxaliplatin, irinotecan and fluoropyrimidin based chemotherapy (or intolerance to these). Prior cetuximab, panitumumab, bevacizumab, aflibercept, regorafenib or trifluridine/tipiracil is allowed but not mandatory; ECOG performance status 0-1; Woman of childbearing potential must have been tested negative in a serum pregnancy test within 5 days prior to randomization. Fertile patients must agree to use a highly effective method of birth control (see appendix 2 – highly effective methods of contraception) during the study and for six months after the discontinuation of study medication; Adequate bone marrow function and organ function: a. Absolute neutrophil count (ANC) > 1.5 x 109/l and platelets (pl) > 100 x 109/l b. Serum bilirubin < 1.5 × upper limit of normal (ULN); and AST/ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases). c. Estimated (eGFR) or measured glomerular filtration rate (GFR) > 50 ml/min.
Exclusion: Previous treatment with temozolomide; Concurrent secondary active malignancy; Patients with either homozygosity or compound heterozygosity for multiple gene variants of dihydropyrimidine dehydrogenase (DPD), leading to a significant reduction in 5-FU metabolism do not meet eligibility criteria. However, those with decreased DPD activity who have previously tolerated 5-FU treatment can participate with capecitabine dosed according to the latest tolerated dose of capecitabine or 5FU; Any condition requiring a daily dose of more than 10 mg prednisolone (or any other corticosteroid of equivalent strength), or any other immunosupressant, e.g. but not limited to mycophenolate and anti-TNF agents; Clinically significant cardiovascular disease, such as recent cerebrovascular accidents or myocardial infarction within 6 months of study enrollment, unstable angina, New York Heart Association (NYHA) Functional Classification Grade II or higher congestive heart failure, or severe uncontrolled cardiac arrhythmia; Any other condition or therapy, which in the investigators opinion may pose a risk to the patient or interfere with the study objectives; History of autoimmune disease. Exceptions are adequately controlled autoimmune induced hypothyroidism, type 1 diabetes. Psoriasis or vitiligo are allowed as long as no systemic treatment is required; Patients with known hypersensitivity to any of the study drugs or their excipients; Malabsorption, significant bowel resection, or any other disease that would significantly inhibit bowel absorption; Symptomatic brain metastases, or radiographic evidence of progression of known brain metastases within 8 weeks of entry in the study; Pregnancy or breastfeeding; Significant co-morbidity that the investigator considers inadequately controlled, or that would make the patient unable to tolerate study treatment; Inability to swallow tablets.