Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
165
Countries
1
Sites
3
Colorectal cancer
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 …
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-09-19
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
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.
Conditions and MedDRA coding
Colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- 1. Signed written informed consent according to ethics committee requirements
- 2. Age ≥18 years
- 3. Metastatic or non-resectable adenocarcinoma of the colon or rectum
- 4. MSS or pMMR confirmed locally by PCR or IHC, respectively
- 5. MGMT promoter methylation confirmed by PCR and IHC in solid tumor tissue
- 6. 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.
- 7. ECOG performance status 0-1
- 8. 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.
- 9. 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 criteria 13
- 1. 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.
- 2. 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.
- 3. Significant co-morbidity that the investigator considers inadequately controlled, or that would make the patient unable to tolerate study treatment.
- 4. Patients with known hypersensitivity to any of the study drugs or their excipients.
- 5. Inability to swallow tablets.
- 6. Malabsorption, significant bowel resection, or any other disease that would significantly inhibit bowel absorption.
- 7. Previous treatment with temozolomide.
- 8. Concurrent secondary active malignancy.
- 9. 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.
- 10. 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.
- 11. Symptomatic brain metastases, or radiographic evidence of progression of known brain metastases within 8 weeks of entry in the study.
- 12. Pregnancy or breastfeeding
- 13. Any other condition or therapy, which in the investigators opinion may pose a risk to the patient or interfere with the study objectives.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Disease control rate (DCR) (complete response (CR), PR, or SD) evaluated by a CT scan 16 weeks after initiation of TemCap.
Secondary endpoints 5
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
SUB122750 · Substance
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 mg/Kg milligram(s)/kilogram
- Max total dose
- 6 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 150 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 150 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 150 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 150 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 150 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 150 mg/m2 milligram(s)/sq. meter
- Max total dose
- 150 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB29397 · Substance
- Active substance
- Ipilimumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1 mg/Kg milligram(s)/kilogram
- Max total dose
- 1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J. B. Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Kristian Krejberg
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Kristian Krejberg
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, Code 10, E-data capture, Code 8 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 165 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Aalborg University Hospital
Oncology, Hobrovej 18-22, 9000, Aalborg
Rigshospitalet
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Oncology, J. B. Winsloews Vej 4, 5000, Odense C
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | EORTC_QLQ_C30_Danish | 1 |
| Protocol (for publication) | Protocol Maya2 trial | 3 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin _ De Videnskabsetiske Komiteer | 2.0 |
| Subject information and informed consent form (for publication) | Informed consent form | 1 |
| Subject information and informed consent form (for publication) | Informed consent form Pr-studie | 1 |
| Subject information and informed consent form (for publication) | Subject information main study | 3 |
| Subject information and informed consent form (for publication) | Subject information pre-study | 3 |
| Subject information and informed consent form (for publication) | Tillg til samtykkeblanket | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Opdivo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Temodal | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xeloda | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Yervoy | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis | 2.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-17 | Denmark | Acceptable 2025-08-29
|
2025-09-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-24 | Denmark | Acceptable 2025-08-29
|
2025-09-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-30 | Denmark | Acceptable 2026-05-08
|
2026-05-18 |