120 Participants Needed

Novel Interventions for Colorectal Cancer

(CANTOR Trial)

Recruiting at 72 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AstraZeneca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments for colorectal cancer to evaluate their efficacy and safety. Participants are divided into two groups: one receives a combination of three drugs—Volrustomig (experimental treatment), FOLFIRI (chemotherapy regimen), and Bevacizumab (anti-angiogenesis drug)—while the other receives only FOLFIRI and Bevacizumab. The study seeks individuals with colorectal cancer without liver metastasis who have not recently undergone chemotherapy for metastatic cancer. Candidates should feel generally well enough to manage daily activities and have a life expectancy of at least 12 weeks. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining Bevacizumab with FOLFIRI (a mix of cancer-fighting drugs) is generally well-tolerated by patients with colorectal cancer. These treatments have been used together before and have improved treatment outcomes.

For the new addition, Volrustomig, studies are ongoing to assess its safety. Since this trial is in the middle phase of testing, Volrustomig has shown promise but is still under careful evaluation to ensure safety.

The goal of combining these treatments is to maximize effectiveness while maintaining safety for participants. Serious side effects have not been specifically reported, but some side effects may occur. Participants should discuss any concerns with the research team.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for colorectal cancer, which typically includes chemotherapy regimens like FOLFIRI combined with bevacizumab, the investigational drug Volrustomig adds a new twist by potentially enhancing the effectiveness of these traditional therapies. Researchers are excited about Volrustomig because it introduces a novel mechanism of action that targets specific pathways involved in tumor growth and survival. This innovative approach could lead to improved outcomes by not only slowing down the progression of the cancer but also increasing the overall efficacy of the existing treatment regimen.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research has shown that combining bevacizumab with FOLFIRI (a mix of cancer-fighting drugs) can improve outcomes for people with advanced colorectal cancer. Bevacizumab blocks a protein that tumors need to grow blood vessels, starving the tumors of nutrients. FOLFIRI, which includes irinotecan, 5-FU, and leucovorin, kills cancer cells or stops them from multiplying. In this trial, participants in Arm A will receive volrustomig in addition to this treatment. Volrustomig is still under study but is expected to enhance the treatment's effectiveness. Early results suggest that this combination could outperform the use of just FOLFIRI and bevacizumab, which participants in Arm B will receive.23456

Are You a Good Fit for This Trial?

This trial is for adults with confirmed colorectal cancer, good performance status (able to carry out daily activities), expected to live at least 12 weeks, no liver metastasis, and haven't had systemic therapy for metastatic CRC. They must have a specific tumor type (pMMR/MSS), be over 35 kg in weight, and have measurable disease.

Inclusion Criteria

My doctor expects me to live for at least 12 more weeks.
My diagnosis is colorectal adenocarcinoma confirmed by tissue analysis.
I can provide a tumor sample that was collected according to standard procedures.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Volrustomig + FOLFIRI + bevacizumab or FOLFIRI + bevacizumab

Approximately 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • FOLFIRI
  • Volrustomig
Trial Overview The study tests the safety and effectiveness of new treatments and combinations in colorectal cancer patients. It includes Bevacizumab, Volrustomig, and FOLFIRI regimen which consists of Fluorouracil (5-FU), leucovorin, and irinotecan.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Volrustomig + FOLFIRI+ Bevacizumab group (Arm A)Experimental Treatment3 Interventions
Group II: FOLFIRI+ BEVACIZUMAB group (Arm B)Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials
322
Recruited
137,000+
Peyton Howell profile image

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

In a study involving 84 patients with advanced colorectal cancer, the FOLFOX4 regimen showed a significantly higher overall response rate (ORR) of 40.5% compared to 9.5% for the FFG regimen, indicating greater efficacy for FOLFOX4.
While both treatment regimens were generally well tolerated, FOLFOX4 was associated with a higher incidence of peripheral neuropathy (42.9%) compared to FFG (2.4%), highlighting a safety concern with the FOLFOX4 regimen.
Multicenter, randomized phase II trial of bevacizumab plus folinic acid, fluorouracil, gemcitabine (FFG) versus bevacizumab plus folinic acid, fluorouracil, oxaliplatin (FOLFOX4) as first-line therapy for patients with advanced colorectal cancer.Madajewicz, S., Waterhouse, DM., Ritch, PS., et al.[2021]
In a study of 60 metastatic colorectal cancer patients treated with bevacizumab and chemotherapy, the most common side effects were mild bleeding (28%) and hypertension (17%), indicating that while there are some toxicities, they are generally manageable.
Serious complications were rare, with only 5% of patients experiencing severe venous thromboembolic events and gastrointestinal perforation, suggesting that bevacizumab is well tolerated in combination with various chemotherapy regimens.
Safety and tolerability of first-line bevacizumab in metastatic colorectal cancer.Akun, E., Okutur, K., Seber, S., et al.[2015]
The combination of FOLFOXIRI and bevacizumab demonstrated a promising progression-free survival (PFS) rate of 74% at 10 months in patients with unresectable metastatic colorectal cancer, based on a phase 2 study involving 57 patients.
The treatment was found to be safe, with no unexpected adverse events reported, although common serious side effects included neutropenia and hypertension, indicating that while effective, careful monitoring for these side effects is necessary.
Bevacizumab with FOLFOXIRI (irinotecan, oxaliplatin, fluorouracil, and folinate) as first-line treatment for metastatic colorectal cancer: a phase 2 trial.Masi, G., Loupakis, F., Salvatore, L., et al.[2022]

Citations

A Study of Novel Study Interventions and Combinations in ...The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and ...
Study on the Safety and Effectiveness of Volrustomig with ...The study will compare the effects of the combination of volrustomig, FOLFIRI, and bevacizumab to the effects of FOLFIRI and bevacizumab alone. The goal is to ...
Novel Interventions for Colorectal Cancer (CANTOR Trial)Research shows that combining Bevacizumab with chemotherapy regimens like FOLFIRI (a mix of cancer-fighting drugs) can improve treatment outcomes for advanced ...
NCT06792695 | A Study of Novel Study Interventions and ...The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and ...
A Study of Novel Study Interventions and Combinations in ...The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and ...
A Study of Novel Study Interventions and Combinations in ...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) ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security