Recruiting NCT06792695

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

Phase II Interventional Metastatic Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Volrustomig, FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan), Bevacizumab.
Who it may be relevant to: Registry conditions: Metastatic Colorectal Cancer. Basic parameters: 18 years — 130 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Canada, China, France +7
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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).

Detailed description

This is a Phase II, platform, open-label, multi-drug, multicenter, global study.

This is a modular study, that includes a master protocol and substudies.

Partcipants will be randomised to one of the following intervention groups:

* Volrustomig + FOLFIRI + bevacizumab group (Arm A) * FOLFIRI + bevacizumab group (Arm B)

The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.

Interventions

Drug Volrustomig
Volrustomig will be administered as intravenous (IV) infusion.
Drug FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
FOLFIRI will be administered as IV infusion.
Drug Bevacizumab
Bevacizumab will be administered as IV infusion.

Primary outcome measures

Progression Free Survival (PFS) [Time frame: Approximately 3 years]
Number of Participants with Adverse Events (AEs) [Time frame: Approximately 3 years]

Secondary outcome measures (8)

Overall Survival (OS) [Time frame: Approximately 3 years]
Objective Response Rate (ORR) [Time frame: Approximately 3 years]
Disease Control Rate (DCR) [Time frame: Approximately 3 years]
Duration of Response (DOR) [Time frame: Approximately 3 years]
Time to second progression or death (PFS2) [Time frame: Approximately 3 years]
Maximum Observed Concentration (Cmax) [Time frame: Approximately 3 years]
Observed lowest concentration before the next dose is administered (Ctrough) [Time frame: Approximately 3 years]
Number of patients with positive Antidrug Antibodies (ADAs) [Time frame: Approximately 3 years]

Eligibility criteria

Overall Inclusion Criteria:

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:

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 14 centers

Research Site — Scottsdale
Research Site — Los Angeles
Research Site — Washington D.C.
Research Site — Chicago
Research Site — Baltimore
Research Site — Boston
Research Site — Rochester
Research Site — Trenton
… and 6 more centers

Italy · 9 centers

Research Site — Bologna
Research Site — Castelfranco Veneto
Research Site — Florence
Research Site — Milan
Research Site — Milan
Research Site — Naples
Research Site — Pavia
Research Site — Pisa
… and 1 more center

Spain · 9 centers

Research Site — Barcelona
Research Site — Barcelona
Research Site — Madrid
Research Site — Madrid
Research Site — Madrid
Research Site — Málaga
Research Site — Pamplona
Research Site — Santander
… and 1 more center

China · 8 centers

Research Site — Beijing
Research Site — Chengdu
Research Site — Harbin
Research Site — Shanghai
Research Site — Shanghai
Research Site — Shanghai
Research Site — Wuhan
Research Site — Zhengzhou

France · 7 centers

Research Site — Bordeaux
Research Site — Marseille
Research Site — Montpellier
Research Site — Montpellier
Research Site — Poitiers
Research Site — Saint-Priez En Jarez
Research Site — Villejuif

Germany · 5 centers

Research Site — Berlin
Research Site — Dresden
Research Site — Essen
Research Site — Hamburg
Research Site — Marburg

South Korea · 5 centers

Research Site — Seoul
Research Site — Seoul
Research Site — Seoul
Research Site — Seoul
Research Site — Yongin-si

United Kingdom · 5 centers

Research Site — Cambridge
Research Site — London
Research Site — London
Research Site — Manchester
Research Site — Metropolitan Borough of Wirral

Canada · 4 centers

Research Site — Victoria
Research Site — Barrie
Research Site — Toronto
Research Site — Montreal

Taiwan · 4 centers

Research Site — Kaohsiung City
Research Site — Taipei
Research Site — Taoyuan
Research Site — Yung Kang City

Australia · 3 centers

Research Site — East Melbourne
Research Site — Wollongong
Research Site — Woodville South

Netherlands · 3 centers

Research Site — Amsterdam
Research Site — Maastricht
Research Site — Zwolle

Identifiers

NCT: NCT06792695 · D798VC00001 · 2024-518469-84

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗