COSENSE-1: A feasibility study for using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens for patients with metastatic colorectal cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

St. Olavs Hospital HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

7 May 2025 → ongoing

Decision date (initial)

2024-12-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

The primary objective of this study is to test the feasibility of incorporating patient-derived tumouroids as clinical decision support in clinical practice.

Secondary objectives 1

1. Secondary objectives are to describe the tumour response to treatment using efficacy measures and assess the progression-free survival and the overall survival, as well as assess the toxicity experienced by the participants.

Conditions and MedDRA coding

MSS/pMMR metastatic colorectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age 18 or older
2. Obtained written informed consent
3. ECOG performance status 0 or 1
4. Documented pMMR/MSS colorectal cancer adenocarcinoma by histology or cytology, or, when biopsy is contraindicated/not feasible within required timeframes, unequivocal clinical–radiological-biomedical evidence of colorectal cancer confirmed by MDT review
5. The oxaliplatin-based regimen FOLFOX (+/- antibody) versus the irinotecan-based regimen FOLFIRI (+/- antibody), are evaluated by an experienced physician, independent of inclusion in the trial, to be equally recommended for the participant as standard of care first-line therapy in the treatment of mCRC, following the Norwegian national guideline on the treatment of colorectal cancer
6. Unresectable metastatic disease (not amenable to radical surgery of the cancer disease at the time of study inclusion)
7. Patient has measurable or evaluable disease per RECIST (version 1.1)

Exclusion criteria 7

1. Pregnancy or planned pregnancy during the study period, due to the risks of drug treatment to a developing foetus
2. Unresolved toxicities of a previous systemic treatment that, in the opinion of the physician, make the patient unfit for inclusion
3. Inability to understand study procedures and comply with them, or disorder that compromises the patient’s ability to provide informed consent and/or comply with study procedures
4. Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
5. Patient has metastatic MMR deficient/MSI adenocarcinoma
6. ECOG performance status 2 or worse
7. Patient is not equally eligible for FOLFOX (+/- antibody) and FOLFIRI (+/- antibody) chemotherapy regimens, according to the Norwegian national guideline on the treatment of colorectal cancer

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The rate of generating valid tumouroid response reports (valid is defined as a fper patienold-change growth in untreated controls of > 1, registered on day 5, 6, 7 or 8 and normalised with resepect to day 0 or 1): a) t included in the trial and b) per patient with obtained tumour samples, and 2) the time from referral to start of allocated treatment.
2. What is the time from referral to start of allocated treatment

Secondary endpoints 7

1. Response Rates (RR) including ORR, according to RECIST v1.1. criteria
2. Overall Survival (OS)
3. Progression Free Survival (PFS), defined as the time from starting first-line treatment to the time of documentation of PD according to RECIST on active therapy, determined failure of treatment strategy or death
4. Progression Free Survival Rate at 6 months
5. Disease Control Rate (DCR) assessed with RECIST v1.1
6. Clinical Benefit Rate (CBR), defined as the percentage of patients who had a complete response, partial response, or had stable disease for 6 months or more
7. Toxicity graded with the CTCAE v.5.0: incidence of grade 3-5 adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

St. Olavs Hospital HF

Sponsor organisation

St. Olavs Hospital HF

Address

Prinsesse Kristinas G. 3

City

Trondheim

Postcode

7030

Country

Norway

Scientific contact point

Organisation

St. Olavs Hospital HF

Contact name

Cancer clinic

Public contact point

Organisation

St. Olavs Hospital HF

Contact name

Cancer clinic

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

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.

Application history

7 submissions — initial application plus substantial / non-substantial modifications