Avelumab plus Cetuximab in patients with mCRC

Phase 1

• Conditions: Metastatic colorectal cancer; MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004392-32-IT
• Lead Sponsor: A.O.U. Università degli Studi della Campania Luigi Vanvitelli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-05
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Histologically proven diagnosis of colorectal adenocarcinoma;

Diagnosis of metastatic disease;

RAS (NRAS and KRAS exon 2,3 and 4) wild-type in tissue at initial diagnosis;

Efficacy of a first line therapy containing an anti-EGFR agent (panitumumab or cetuximab) with a major response achieved (complete or partial response);

A second line therapy;

More than 4 months from last dose of anti-EGFR agent administered in first line treatment before randomization;

Measurable disease according to RECIST criteria v1.1;

ECOG PS of 0 to 1 at trial entry;

Estimated life expectancy of more than 12 weeks.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

Participation in a clinical study or experimental drug treatment within 30 days;

Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment;

All subjects with brain metastases, except those meeting the following criteria:
-Brain metastases have been treated locally, and
-No ongoing neurological symptoms that are related to the brain localization of the disease;

Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the efficacy (OS) of avelumab and cetuximab combinedin pre-treated RAS wild type metastatic colorectal cancer patients;Secondary Objective: To demonstrate superiority with regard to the objective response rate (ORR) of avelumab and cetuximab combined in pre-treated RAS wild type metastatic colorectal cancer patients.<br>To demonstrate superiority with regard to progression free survival (PFS) of avelumab and cetuximab combined in pre-treated RAS wild type metastatic colorectal cancer patients.<br>To determine the safety and tolerability of avelumab and cetuximab combinedin pre-treated RAS wild type metastatic colorectal cancer patients.;Primary end point(s): The primary endpoint for the trial is OS time, defined as the interval from enrollment to death for every cause.;Timepoint(s) of evaluation of this end point: The survival follow-up will continue until 2 years after the last subject receives the last dose of avelumab and cetuximab.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The overall response rate (ORR) according to RECIST 1.1<br><br>Progression free survival (PFS) according to RECIST 1.1<br><br>The safety profile of the trial drugs as measured by the incidence of AEs, SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS.;Timepoint(s) of evaluation of this end point: The ORR according to RECIST 1.1<br>The PFS according to RECIST 1.1<br>The Safety profile of the trial drugs as meausured by the incidence of AEs, SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS.