RecruitingPhase 2NCT06792695
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
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)
Sponsor
AstraZeneca
Enrollment
120 participants
Start Date
Mar 12, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 YearsMax Age: 130 Years
Inclusion Criteria11
- 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.
- 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.
Exclusion Criteria10
- 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.
- 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.
Interventions
DRUGVolrustomig
Volrustomig will be administered as intravenous (IV) infusion.
DRUGFOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
FOLFIRI will be administered as IV infusion.
DRUGBevacizumab
Bevacizumab will be administered as IV infusion.
Locations(76)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06792695
Related Trials
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
NCT0465706879 locations
Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy
NCT059859541 location
A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer
NCT0682046341 locations
Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)
NCT061494811 location
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer
NCT0707963113 locations