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

Primary Purpose

Metastatic Colorectal Cancer, MSI

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLFOX regimen
FOLFIRI Protocol
Avelumab
Panitumumab
Cetuximab
Bevacizumab
Aflibercept
Sponsored by
Federation Francophone de Cancerologie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring immunotherapy, second line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven colorectal adenocarcinoma with metastasis(es) non-resectable
  • MSI-H determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) or by molecular biology
  • At least one measurable target (primary tumor or metastasis) according to RECIST v1.1
  • Mutational status RAS and BRAF
  • Age ≥ 18
  • OMS ≤ 2
  • Life expectancy < 3 months
  • Patient failure (progression or unacceptable toxicity) of chemotherapy containing fluoropyrimidine (capecitabine or 5FU) +/- irinotecan +/- oxaliplatin with or without cetuximab, bevacizumab and panitumumab (patients in progression during or within 3 months after discontinuation of adjuvant chemotherapy are eligible)
  • PNN > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dL
  • Total bilirubin < 25 µmol/L, ASAT < 5x LSN, ALAT < 5 x LSN, PT > 60%, , PAL<2.5 x LSN ( < 5 x LSN in case of hepatic metastasis)
  • Creatinine clearance > 50 ml/min according to MDRD formula (≥ 30 ml/min according to the Cockcroft-Gault formula)
  • Patient belonging to a social security scheme
  • Patient information and signature of the informed consent

Exclusion Criteria:

  • Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR
  • Patient treated with FOLFIRINOX or FOLFOXIRI in 1st line
  • Cerebral metastasis
  • Previous treatment with anti-PD1 or anti-PDL1
  • Autoimmune disease that might be aggravated during treatment with an immuno-stimulating agent (patients with type I diabetes, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible)
  • Immunosuppressive long-term treatment (patients necessitating a corticotherapy are eligible if they are administered in doses < or = to the equivalent of 10 mg of prednisone daily, administration of steroids by a route resulting in minimal systemic exposure (local, intra-anal, intraocular or inhalation) are eligible).
  • Transplant patients (including stem cell transplants), HIV positive or other immune deficiency syndromes
  • Active infection by HBV or HCV
  • Known severe hypersensitivity to monoclonal antibodies or history of anaphylactic shock, or uncontrolled asthma
  • Any known specific contraindication or allergy to the treatments used in the study
  • Persistence of toxicities related to 1st line chemotherapy grade > 2 (NCI-CTC v4.0) (except alopecia and neuropathy sequelae of oxaliplatin)
  • Vaccination during the 4 weeks preceding the start of treatment
  • Known deficit in DPD
  • QT/QTc interval > 450 msec for men and > 470 msec for women
  • K+ < LIN, Mg2+ < LIN, Ca2+ < LIN
  • Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack
  • Any progressive pathology not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure
  • Patient with interstitial pneumonitis or pulmonary fibrosis
  • History of chronic diarrhea or inflammatory disease of the colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment
  • History of malignant pathologies during the past 5 years except basocellular skin carcinoma or in situ cervical carcinoma, properly treated
  • Patient already included in another clinical trial during treatment with an experimental molecule for L2
  • Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test
  • Persons deprived of liberty or under supervision
  • Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons

Sites / Locations

  • Ch - Centre Hospitalier D'Abbeville
  • Ch - Centre Hospitalier Du Pays D'Aix
  • Chu - Hôpital Sud - Service D'Hge
  • Privé - Clinique de L'Europe
  • Cac - Ico Site Paul Papin
  • CHU - Hôtel Dieu
  • Privé - Hopital Privé D'Antony
  • Ch - Hôpital Victor Dupouy
  • Ch - Centre Hospitalier Ardeche Meridionale
  • Ch - Ght Unyon Auxerre
  • Privé - Institut Sainte Catherine
  • Ch - Hôpital Henri Duffaut
  • Ch - Centre Hôspitalier Côte Basque
  • Ch - Centre Hospitalier de Beauvais
  • Chu - Jean Minjoz
  • Privé - Centre de Radiotherapie Pierre Curie
  • Privé - Polyclinique Bordeaux Nord
  • Privé - Cac Institut Bergionié
  • Privé - Polyclinique Saint-Privat
  • Ch - Hôpital Duchenne
  • Privé - Clinique Pasteur Lanroze Cfro
  • Privé - Centre Maurice Tubiana
  • Privé - Cac Centre Francois Baclesse
  • Privé - Infirmerie Protestante de Lyon
  • Ch - Centre Hospitalier de Carcassonne
  • Chi - Centre Hospitalier de Castres Mazamet
  • Ch - Centre Hospitalier William Morey
  • Privé - Hopital Prive Sainte Marie
  • Ch - Centre Hospitalier Metropole Savoie
  • Ch - Centre Hospitalier de Charleville Mezieres
  • Ch - Centre Hospitalier de Cholet
  • Ch - Centre Hospitalier General
  • Ch - Centre Hospitalier de Châteauroux
  • Ch - Hopitaux Civils de Colmar
  • Privé - Clinique Saint Come
  • Ch - Centre Hospitalier Sud Francilien
  • Privé - Clinique Des Cèdres
  • Privé - Clinique de Flandre
  • Ch - Ghpso Site de Creil
  • Chu - Aphp - Hopital Henri Mondor
  • Ch - Chic de Créteil
  • Chu - Hopital Francois Mitterrand
  • Privé - Institut de Cancerologie de Bourgogne Grrecc
  • Privé - Cac- Centre Georges-Francois Leclerc
  • Privé - Ghm Institut Daniel Hollard
  • Chu - Grenoble Alpes
  • Privé - Clinique Sainte Marguerite
  • Ch - Centre Hospitalier Marne La Vallee-Jossigny
  • Chd - Centre Hospitalier Vendee
  • Privé - Clinique Du Cap D'Or
  • Ch - Hopital Andre Mignot
  • Ch - Hopital Louis Pasteur - Oncologie Hematologie
  • Privé - Cmc Les Ormeaux
  • Chu - Aphp - Hôpital de Bicêtre
  • Ch - Centre Hospitalier Du Mans
  • Ch - Centre Hospitalier Docteur Schaffner
  • Ch - Hôpital Franco Britannique
  • Privé - Cac - Centre Oscar Lambret
  • Chu - Dupuytren
  • Ch - Gh Nord Essone
  • Chu - Hôpital de La Croix Rousse
  • Privé - Cac Centre Léon Berard
  • Chu - Hôpital Edouard Herriot
  • Privé - Hôpital Européen Marseille
  • Chu - La Timone
  • Privé - Cac Institut Paoli Calmettes
  • Ch - Hôpital Saint Joseph
  • Ch - Ghi de L'Est Francilien Site de Meaux
  • Ch - Hôpital Belle Isle
  • Privé - Clinique Claude Bernard
  • Ch - Hôpital Layné
  • Ch - Centre Hospitalier de Montceau Les Mines
  • Ch - Groupe Hospitalier Intercommunal Le Raincy
  • Privé - Centre de Cancérologie Du Grand Montpellier
  • Ch - Centre Hospitalier de Montélimar
  • Privé - Hôpital Prive Du Confluent Sas
  • Privé - Cac - Centre Antoine Lacassagne
  • Chu - Hôpital Caremeau
  • Chr - Centre Hospitalier Régional de La Source
  • Privé - Cac - Institut Curie
  • Chu - Hôpital Cochin
  • Chu - Hôpital Europeen Georges Pompidou
  • Chu - Aphp - Hôpital Saint Louis
  • Chu - Hôpital Saint Antoine
  • Chu - Aphp - Gh La Pitié Salpêtrière
  • Ch - Centre Hospitalier de Pau
  • Ch - Hôpital Saint Jean
  • Chu - Hôpital Haut Lévêque
  • Ch - Hôpital Lyon Sud
  • Privé - Centre Cario - Hcpa
  • Chu - Hôpital de La Miletrie
  • Ch - Hôpital Rene Dubos
  • Ch - Hôpital Annecy Genevois
  • Privé - Polyclinique Francheville
  • Ch - Chic - Centre Hospitalier de Cornouaille
  • Chu - Hôpital Robert Debre
  • Chu - Centre Hospitalier Universitaire Pontchaillou
  • Privé - Centre de Radiotherapie Et D'Oncologie Médicale de L'Essone
  • Privé - Clinique Pasteur
  • Ch - Hôpitaux Drome Nord
  • Chu - Hôpital Charles Nicolle
  • Privé - Clinique Mutualiste de L'Estuaire - Cite Sanitaire
  • Privé - Hôpital Privé Saint Gregoire
  • Privé - Clinique de L'Union
  • Ch - Centre Hospitalier de Saint-Malo
  • Privé - Cmco Côte D'Opale
  • Chu - Hôpital Nord - Saint-Étienne
  • Privé - Clinique Trenel
  • Ch - Centre Hospitalier de Soisson
  • Privé - Cac - Institut de Cancérologie de Strasbourg Europe
  • Privé - Clinique Sainte Anne
  • Ch - Hopitaux Du Leman
  • Ch - Hôpital Sainte Musse
  • Chu - Hôpital Rangueil
  • Chu - Hôpital Trousseau
  • Chu - Hôpital Nancy-Brabois
  • Privé - Institut de Cancerologie de Lorraine
  • Chu - Aphp - Hôpital Paul Brousse
  • Privé - Cac - Gustave Roussy
  • Ch - Centre Hospitalier Intercommunal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A Chemotherapy (standard treatment)

Arm B - Immunotherapy (experimental arm)

Arm Description

FOLFOX or FOLFIRI +/- targeted therapy

Avelumab

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) according to the investigator
Progression is defined as RECIST v1.1 criteria. Death is also considered as an event

Secondary Outcome Measures

Overall Survival
Defined as death due to all causes

Full Information

First Posted
May 17, 2017
Last Updated
August 18, 2022
Sponsor
Federation Francophone de Cancerologie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT03186326
Brief Title
Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer
Acronym
SAMCO
Official Title
Multicenter Randomized Phase II Study Comparing the Effectiveness and Tolerance of Avelumab Versus Standard 2nd Line Treatment Chemotherapy in Patients With Colorectal Metastatic Cancer With Microsatellite Instability (MSI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer, MSI
Keywords
immunotherapy, second line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A Chemotherapy (standard treatment)
Arm Type
Active Comparator
Arm Description
FOLFOX or FOLFIRI +/- targeted therapy
Arm Title
Arm B - Immunotherapy (experimental arm)
Arm Type
Experimental
Arm Description
Avelumab
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Description
A course of treatment every 14 days Oxaliplatin: 85 mg/m² IV over 2 hours Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine) IV over 2 hours 5FU bolus: 400 mg/m² IV bolus over 10 minutes in 100 ml 0.9% NaCl 5FU continuous: 2,400 mg/m² in NaCl 0.9% in IV over 46 hours
Intervention Type
Drug
Intervention Name(s)
FOLFIRI Protocol
Intervention Description
A course of treatment every 14 days Irinotecan: 180 mg/m² IV over 1H30 Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine) IV over 2 hours 5FU bolus: 400 mg/m² IV bolus over 10 minutes in 100 ml 0.9% NaCl 5FU continuous: 2,400 mg/m² in NaCl 0.9% in IV over 46 hours
Intervention Type
Drug
Intervention Name(s)
Avelumab
Intervention Description
A course of treatment every 14 days. Premedication obligatory with antihistamines and paracetamol (example: 25-50 mg diphenhydramine and 500-650 mg paracetamol) IV, approximately 30 to 60 minutes before each dose of avelumab. Then: Avelumab: 10 mg/kg IV in 1 hour diluted with 0.9% saline solution; alternatively a 0.45% saline solution can be used if needed
Intervention Type
Drug
Intervention Name(s)
Panitumumab
Intervention Description
Administered at 6 mg/Kg
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Administered at 500 mg/m²
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Administered at 5 mg/Kg
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Intervention Description
Administered at 4 mg/Kg
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) according to the investigator
Description
Progression is defined as RECIST v1.1 criteria. Death is also considered as an event
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Defined as death due to all causes
Time Frame
up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven colorectal adenocarcinoma with metastasis(es) non-resectable MSI-H determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) or by molecular biology At least one measurable target (primary tumor or metastasis) according to RECIST v1.1 Mutational status RAS and BRAF Age ≥ 18 OMS ≤ 2 Life expectancy < 3 months Patient failure (progression or unacceptable toxicity) of chemotherapy containing fluoropyrimidine (capecitabine or 5FU) +/- irinotecan +/- oxaliplatin with or without cetuximab, bevacizumab and panitumumab (patients in progression during or within 3 months after discontinuation of adjuvant chemotherapy are eligible) PNN > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dL Total bilirubin < 25 µmol/L, ASAT < 5x LSN, ALAT < 5 x LSN, PT > 60%, , PAL<2.5 x LSN ( < 5 x LSN in case of hepatic metastasis) Creatinine clearance > 50 ml/min according to MDRD formula (≥ 30 ml/min according to the Cockcroft-Gault formula) Patient belonging to a social security scheme Patient information and signature of the informed consent Exclusion Criteria: Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR Patient treated with FOLFIRINOX or FOLFOXIRI in 1st line Cerebral metastasis Previous treatment with anti-PD1 or anti-PDL1 Autoimmune disease that might be aggravated during treatment with an immuno-stimulating agent (patients with type I diabetes, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) Immunosuppressive long-term treatment (patients necessitating a corticotherapy are eligible if they are administered in doses < or = to the equivalent of 10 mg of prednisone daily, administration of steroids by a route resulting in minimal systemic exposure (local, intra-anal, intraocular or inhalation) are eligible). Transplant patients (including stem cell transplants), HIV positive or other immune deficiency syndromes Active infection by HBV or HCV Known severe hypersensitivity to monoclonal antibodies or history of anaphylactic shock, or uncontrolled asthma Any known specific contraindication or allergy to the treatments used in the study Persistence of toxicities related to 1st line chemotherapy grade > 2 (NCI-CTC v4.0) (except alopecia and neuropathy sequelae of oxaliplatin) Vaccination during the 4 weeks preceding the start of treatment Known deficit in DPD QT/QTc interval > 450 msec for men and > 470 msec for women K+ < LIN, Mg2+ < LIN, Ca2+ < LIN Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack Any progressive pathology not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure Patient with interstitial pneumonitis or pulmonary fibrosis History of chronic diarrhea or inflammatory disease of the colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment History of malignant pathologies during the past 5 years except basocellular skin carcinoma or in situ cervical carcinoma, properly treated Patient already included in another clinical trial during treatment with an experimental molecule for L2 Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test Persons deprived of liberty or under supervision Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Taieb, Pr
Organizational Affiliation
HOPITAL EUROPEEN G. POMPIDOU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch - Centre Hospitalier D'Abbeville
City
Abbeville CEDEX
ZIP/Postal Code
80142
Country
France
Facility Name
Ch - Centre Hospitalier Du Pays D'Aix
City
Aix-en-Provence
ZIP/Postal Code
13616
Country
France
Facility Name
Chu - Hôpital Sud - Service D'Hge
City
Amiens CEDEX 1
ZIP/Postal Code
80054
Country
France
Facility Name
Privé - Clinique de L'Europe
City
Amiens
ZIP/Postal Code
80090
Country
France
Facility Name
Cac - Ico Site Paul Papin
City
Angers CEDEX 2
ZIP/Postal Code
49055
Country
France
Facility Name
CHU - Hôtel Dieu
City
Angers CEDEX 9
ZIP/Postal Code
49933
Country
France
Facility Name
Privé - Hopital Privé D'Antony
City
Antony
ZIP/Postal Code
92166
Country
France
Facility Name
Ch - Hôpital Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Ch - Centre Hospitalier Ardeche Meridionale
City
Aubenas CEDEX
ZIP/Postal Code
07205
Country
France
Facility Name
Ch - Ght Unyon Auxerre
City
Auxerre
ZIP/Postal Code
89000
Country
France
Facility Name
Privé - Institut Sainte Catherine
City
Avignon CEDEX
ZIP/Postal Code
84918
Country
France
Facility Name
Ch - Hôpital Henri Duffaut
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Ch - Centre Hôspitalier Côte Basque
City
Bayonne CEDEX
ZIP/Postal Code
64109
Country
France
Facility Name
Ch - Centre Hospitalier de Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Chu - Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Privé - Centre de Radiotherapie Pierre Curie
City
Beuvry
ZIP/Postal Code
62660
Country
France
Facility Name
Privé - Polyclinique Bordeaux Nord
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Privé - Cac Institut Bergionié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Privé - Polyclinique Saint-Privat
City
Boujan-sur-Libron
ZIP/Postal Code
34760
Country
France
Facility Name
Ch - Hôpital Duchenne
City
Boulogne-sur-Mer
ZIP/Postal Code
62321
Country
France
Facility Name
Privé - Clinique Pasteur Lanroze Cfro
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Privé - Centre Maurice Tubiana
City
Caen
ZIP/Postal Code
14052
Country
France
Facility Name
Privé - Cac Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Privé - Infirmerie Protestante de Lyon
City
Caluire-et-Cuire
ZIP/Postal Code
69300
Country
France
Facility Name
Ch - Centre Hospitalier de Carcassonne
City
Carcassonne
ZIP/Postal Code
11000
Country
France
Facility Name
Chi - Centre Hospitalier de Castres Mazamet
City
Castres
ZIP/Postal Code
81090
Country
France
Facility Name
Ch - Centre Hospitalier William Morey
City
Chalon-sur-Saône
ZIP/Postal Code
7100
Country
France
Facility Name
Privé - Hopital Prive Sainte Marie
City
Chalon-sur-Saône
ZIP/Postal Code
71100
Country
France
Facility Name
Ch - Centre Hospitalier Metropole Savoie
City
Chambéry CEDEX
ZIP/Postal Code
73011
Country
France
Facility Name
Ch - Centre Hospitalier de Charleville Mezieres
City
Charleville
ZIP/Postal Code
08000
Country
France
Facility Name
Ch - Centre Hospitalier de Cholet
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Ch - Centre Hospitalier General
City
Châlons-en-Champagne
ZIP/Postal Code
51005
Country
France
Facility Name
Ch - Centre Hospitalier de Châteauroux
City
Châteauroux
ZIP/Postal Code
36000
Country
France
Facility Name
Ch - Hopitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Privé - Clinique Saint Come
City
Compiègne CEDEX
ZIP/Postal Code
60204
Country
France
Facility Name
Ch - Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
Privé - Clinique Des Cèdres
City
Cornebarrieu
ZIP/Postal Code
31700
Country
France
Facility Name
Privé - Clinique de Flandre
City
Coudekerque-Branche
ZIP/Postal Code
59210
Country
France
Facility Name
Ch - Ghpso Site de Creil
City
Creil
ZIP/Postal Code
60100
Country
France
Facility Name
Chu - Aphp - Hopital Henri Mondor
City
Créteil CEDEX
ZIP/Postal Code
94000
Country
France
Facility Name
Ch - Chic de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Chu - Hopital Francois Mitterrand
City
Dijon CEDEX
ZIP/Postal Code
21079
Country
France
Facility Name
Privé - Institut de Cancerologie de Bourgogne Grrecc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Privé - Cac- Centre Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Privé - Ghm Institut Daniel Hollard
City
Grenoble
ZIP/Postal Code
38028
Country
France
Facility Name
Chu - Grenoble Alpes
City
Grenoble
Country
France
Facility Name
Privé - Clinique Sainte Marguerite
City
Hyères
ZIP/Postal Code
83400
Country
France
Facility Name
Ch - Centre Hospitalier Marne La Vallee-Jossigny
City
Jossigny
ZIP/Postal Code
77600
Country
France
Facility Name
Chd - Centre Hospitalier Vendee
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Privé - Clinique Du Cap D'Or
City
La Seyne-sur-Mer
ZIP/Postal Code
83500
Country
France
Facility Name
Ch - Hopital Andre Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Ch - Hopital Louis Pasteur - Oncologie Hematologie
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Privé - Cmc Les Ormeaux
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Chu - Aphp - Hôpital de Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
Ch - Centre Hospitalier Du Mans
City
Le Mans CEDEX 9
ZIP/Postal Code
72037
Country
France
Facility Name
Ch - Centre Hospitalier Docteur Schaffner
City
Lens
Country
France
Facility Name
Ch - Hôpital Franco Britannique
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
Privé - Cac - Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Chu - Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Ch - Gh Nord Essone
City
Longjumeau
ZIP/Postal Code
91160
Country
France
Facility Name
Chu - Hôpital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Privé - Cac Centre Léon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Chu - Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Privé - Hôpital Européen Marseille
City
Marseille CEDEX 03
ZIP/Postal Code
13331
Country
France
Facility Name
Chu - La Timone
City
Marseille CEDEX 5
ZIP/Postal Code
13385
Country
France
Facility Name
Privé - Cac Institut Paoli Calmettes
City
Marseille CEDEX 9
ZIP/Postal Code
13273
Country
France
Facility Name
Ch - Hôpital Saint Joseph
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
Ch - Ghi de L'Est Francilien Site de Meaux
City
Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
Ch - Hôpital Belle Isle
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Privé - Clinique Claude Bernard
City
Metz
ZIP/Postal Code
57070
Country
France
Facility Name
Ch - Hôpital Layné
City
Mont-de-Marsan
ZIP/Postal Code
40024
Country
France
Facility Name
Ch - Centre Hospitalier de Montceau Les Mines
City
Montceau-les-Mines
ZIP/Postal Code
71300
Country
France
Facility Name
Ch - Groupe Hospitalier Intercommunal Le Raincy
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Privé - Centre de Cancérologie Du Grand Montpellier
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Ch - Centre Hospitalier de Montélimar
City
Montélimar
ZIP/Postal Code
26216
Country
France
Facility Name
Privé - Hôpital Prive Du Confluent Sas
City
Nantes
ZIP/Postal Code
44577
Country
France
Facility Name
Privé - Cac - Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Chu - Hôpital Caremeau
City
Nîmes
ZIP/Postal Code
30000
Country
France
Facility Name
Chr - Centre Hospitalier Régional de La Source
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
Privé - Cac - Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Chu - Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Chu - Hôpital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Chu - Aphp - Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Chu - Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Chu - Aphp - Gh La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Ch - Centre Hospitalier de Pau
City
Pau CEDEX
ZIP/Postal Code
64046
Country
France
Facility Name
Ch - Hôpital Saint Jean
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Chu - Hôpital Haut Lévêque
City
Pessac CEDEX
ZIP/Postal Code
33604
Country
France
Facility Name
Ch - Hôpital Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Privé - Centre Cario - Hcpa
City
Plérin
ZIP/Postal Code
22190
Country
France
Facility Name
Chu - Hôpital de La Miletrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Ch - Hôpital Rene Dubos
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Ch - Hôpital Annecy Genevois
City
Pringy
ZIP/Postal Code
74374
Country
France
Facility Name
Privé - Polyclinique Francheville
City
Périgueux
ZIP/Postal Code
24000
Country
France
Facility Name
Ch - Chic - Centre Hospitalier de Cornouaille
City
Quimper
ZIP/Postal Code
29000
Country
France
Facility Name
Chu - Hôpital Robert Debre
City
Reims CEDEX
ZIP/Postal Code
51092
Country
France
Facility Name
Chu - Centre Hospitalier Universitaire Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Privé - Centre de Radiotherapie Et D'Oncologie Médicale de L'Essone
City
Ris-Orangis
ZIP/Postal Code
91130
Country
France
Facility Name
Privé - Clinique Pasteur
City
Ris-Orangis
ZIP/Postal Code
91130
Country
France
Facility Name
Ch - Hôpitaux Drome Nord
City
Romans-sur-Isère
ZIP/Postal Code
26100
Country
France
Facility Name
Chu - Hôpital Charles Nicolle
City
Rouen CEDEX 01
ZIP/Postal Code
76031
Country
France
Facility Name
Privé - Clinique Mutualiste de L'Estuaire - Cite Sanitaire
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Privé - Hôpital Privé Saint Gregoire
City
Saint-Grégoire
ZIP/Postal Code
35768
Country
France
Facility Name
Privé - Clinique de L'Union
City
Saint-Jean
ZIP/Postal Code
31240
Country
France
Facility Name
Ch - Centre Hospitalier de Saint-Malo
City
Saint-Malo
ZIP/Postal Code
35400
Country
France
Facility Name
Privé - Cmco Côte D'Opale
City
Saint-Martin-Boulogne
ZIP/Postal Code
62280
Country
France
Facility Name
Chu - Hôpital Nord - Saint-Étienne
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Privé - Clinique Trenel
City
Sainte-Colombe
Country
France
Facility Name
Ch - Centre Hospitalier de Soisson
City
Soissons CEDEX
ZIP/Postal Code
02209
Country
France
Facility Name
Privé - Cac - Institut de Cancérologie de Strasbourg Europe
City
Strasbourg
Country
France
Facility Name
Privé - Clinique Sainte Anne
City
Strasbourg
Country
France
Facility Name
Ch - Hopitaux Du Leman
City
Thonon-les-Bains
ZIP/Postal Code
74203
Country
France
Facility Name
Ch - Hôpital Sainte Musse
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Chu - Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Chu - Hôpital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Chu - Hôpital Nancy-Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Privé - Institut de Cancerologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Chu - Aphp - Hôpital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Privé - Cac - Gustave Roussy
City
Villejuif
Country
France
Facility Name
Ch - Centre Hospitalier Intercommunal
City
Villeneuve-Saint-Georges
ZIP/Postal Code
94190
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33359404
Citation
Taieb J, Andre T, El Hajbi F, Barbier E, Toullec C, Kim S, Bouche O, Di Fiore F, Chauvenet M, Perrier H, Evesque L, Laurent-Puig P, Emile JF, Bez J, Lepage C, Tougeron D. Avelumab versus standard second line treatment chemotherapy in metastatic colorectal cancer patients with microsatellite instability: The SAMCO-PRODIGE 54 randomised phase II trial. Dig Liver Dis. 2021 Mar;53(3):318-323. doi: 10.1016/j.dld.2020.11.031. Epub 2020 Dec 25.
Results Reference
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Learn more about this trial

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

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