Informations générales (source: ClinicalTrials.gov)

NCT06792695 En recrutement IDF
A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)
Interventional
  • Métastase tumorale
  • Tumeurs colorectales
Phase 2
AstraZeneca (Voir sur ClinicalTrials)
mars 2025
juin 2028
13 mai 2026
The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT GUSTAVE ROUSSY Michel DUCREUX En recrutement IDF 29/05/2026 18:05:05  Contacter
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Research Site - 42270 - Saint-Priez En Jarez - France Recrutement non commencé Contact (sur clinicalTrials)

Critères

Tous


- Histopathologically confirmed colorectal adenocarcinoma.

- Provision of FFPE tumor sample collected as per SoC.

- Presence of measurable disease by RECIST 1.1 criteria.

- ECOG performance status of 0 or 1.

- Life expectancy ≥ 12 weeks at the time of screening.

Substudy Inclusion Criteria:

- No radiological evidence of liver metastasis.

- No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy
where, > 6 months have elapsed between completion of therapy and documented date of
diagnosis of recurrent or metastatic disease.

- Known pMMR/MSS status (only pMMR/MSS mCRC allowed).

- Adequate organ and bone marrow function

- Body weight > 35 kg at screening and at randomization.

- Contraceptive use by participants should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.

Overall Exclusion Criteria:

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- Central nervous system metastases or spinal cord compression

- Known history of severe allergy to any monoclonal antibody or study intervention.

- Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy.

- History of another primary malignancy.

Substudy Exclusion Criteria:

- Potentially resectable disease with multidisciplinary plan for radical surgery.

- Active or prior documented autoimmune or inflammatory disorders or cardiac
conditions.

- Participants with a prior history of hypertensive crisis or hypertensive
encephalopathy or bleeding risks.

- Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic
attack or cerebrovascular accident.

- History of abdominal or tracheoesophageal fistula, GI perforation and/or fistulae,
or intraabdominal abscess within 6 months prior to randomization.

- Prior exposure to immune mediated therapy.