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

ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Volrustomig

    Drug

    Volrustomig will be administered as intravenous (IV) infusion.

  • FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)

    Drug

    FOLFIRI will be administered as IV infusion.

  • Bevacizumab

    Drug

    Bevacizumab will be administered as IV infusion.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Volrustomig + FOLFIRI+ Bevacizumab group (Arm A)Experimental treatment 3 interventions
Group B: FOLFIRI+ BEVACIZUMAB group (Arm B)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

PFS is defined as the time from randomization until progression per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) or death due to any cause.

Time frame
Approximately 3 years
2

Number of Participants with Adverse Events (AEs)

Number of participants who received at least one dose of study treatment will be assessed.

Time frame
Approximately 3 years

Secondary outcomes

1

Overall Survival (OS)

OS is defined as the time from randomization until the date of death due to any cause.

Time frame
Approximately 3 years
2

Objective Response Rate (ORR)

ORR is defined as the proportion of participants who have a confirmed complete response or confirmed partial response as per RECIST 1.1.

Time frame
Approximately 3 years
3

Disease Control Rate (DCR)

DCR is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1 after randomization.

Time frame
Approximately 3 years
4

Duration of Response (DOR)

DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 or death due to any cause.

Time frame
Approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Parexel

Collaborator

Source ClinicalTrials.gov
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