Last updated on October 2018

Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer


Brief description of study

Immune chekpoints (ICI) are evaluated in many digestive cancers. Certain types of cancer appear to be rather refractory to ICI such as colorectal cancers (CRC). However, the MSI CRC representing approximately 15% of the CRCs exhibits a high mutational load which generates many potentially immunogenic neoantigens. In addition, strong expression of PD-L1 was found in the MSI CRCs relative to the CRC (MSS) stages. Localized MSI CRCs have a better prognosis than MSS CRCs, probably due to immunogenic neoantigens associated with a CD8 + T-specific immune response. On the oher hand, in metastatic CRC (mCRC) things are different because i) the MSI frequency is only 4 to 7% and ii) the good prognosis conferred by the MSI status is controversial.

Preliminary results suggest that patients with MSI mCRC are highly sensitive to ICI even chemoresistant tumors receiving several lines of chemotherapy. Recently, another anti-PD1 alone or in combination with an anti-CTLA4 (antigen associated with cytotoxic T-lymphocyte 4) was tested in the MSI CRCs and a selection of interesting results in heavily pretreated patients with a disease control rate of 56% for monotherapy and 81% for combinated therapy.

Anti-PD1s now have marketing authorization for patients with melanoma and metastatic pulmonary carcinoma , Which are known to have a high level of mutations . ICIs appear to be as promising in MSI CRCs as in other tumors and therefore face the same major challenges.

Avalumab is an anti-PD-L1 antibody recently tested in several different types of tumors with promising results and is currently being studied in phase III in gastric cancer. There is no data on the effectiveness of this ICI in the MSI mCRCs. In addition, only anti-PD1 was used in the MSI-mCRC and not the anti-PD-L1, and only in chemoresistance (3rd line or more). The main objective of the SAMCO study is to test the efficacy and tolerance of avelumab in the 2nd line of treatment in patients with a MSI mCRC progression after standard 1st line chemotherapy +/- targeted therapy.

Clinical Study Identifier: NCT03186326

Find a site near you

Start Over

CH

Charleville, France
  Connect »

Ch J Minjoz

Besançon, France
  Connect »

Ch Rene Dubos

Pontoise, France
  Connect »

CHIC

Quimper, France
  Connect »

Hopital de Bicetre

Le Kremlin-Bicêtre, France
  Connect »

Ch Du Mans

Le Mans CEDEX 9, France
  Connect »

Institut Paoli Calmettes

Marseille CEDEX 9, France
  Connect »

Centre Hospitalier

Montceau-les-Mines, France
  Connect »

Hopitaux Du Leman

Thonon-les-Bains, France
  Connect »

Hopital Prive Sainte Marie

Chalon-sur-Saône, France
  Connect »

Hopital Layne

Mont-de-Marsan, France
  Connect »

Ch D'Abbeville

Abbeville CEDEX, France
  Connect »

Ico Site Paul Papin

Angers CEDEX 2, France
  Connect »

Chu D'Angers

Angers CEDEX 9, France
  Connect »

Ch D'Auxerre

Auxerre, France
  Connect »

Ch Cote Basque

Bayonne CEDEX, France
  Connect »

Hopital Duchenne

Boulogne-sur-Mer, France
  Connect »

Ch William Morey

Chalon-sur-Saône, France
  Connect »

Centre Hospitalier General

Châlons-en-Champagne, France
  Connect »

Clinique Saint Come

Compiègne CEDEX, France
  Connect »

Hopital Henri Mondor

Créteil CEDEX, France
  Connect »

Chd Vendee

La Roche-sur-Yon, France
  Connect »

Clinique Du Cap D'Or

La Seyne-sur-Mer, France
  Connect »

Ch Longjumeau

Longjumeau, France
  Connect »

Hopital Europeen Marseille

Marseille CEDEX 03, France
  Connect »

Chu La Timone

Marseille CEDEX 5, France
  Connect »

Centre Hospitalier

Montélimar, France
  Connect »

Ch Saint Jean

Perpignan, France
  Connect »

Chu Robert Debre

Reims CEDEX, France
  Connect »

Hopital Drome Nord

Romans-sur-Isère, France
  Connect »

Chu Charles Nicolle

Rouen CEDEX 01, France
  Connect »

Clinique Trenel

Sainte-Colombe-Les-Vienne, France
  Connect »

CH

Soissons CEDEX, France
  Connect »

Chu Nancy-Brabois

Vandœuvre-lès-Nancy, France
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.