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Clinical Trials/2024-515788-73-00
2024-515788-73-00
Not yet recruiting
Phase 2

FFCD - 1703 - POCHI : PEMBROLIZUMAB in combination with XELOX or FOLFOX-BEVACIZUMAB in patients with Microsatellite Stable (MSS) metastatic colorectal cancer and a high immune infiltrate: a proof-of-concept study. Phase II – non-randomised- multicentre.

Fondation Franc.Cancerologie Digestive86 sites in 1 country55 target enrollmentStarted: July 30, 2024Last updated:
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Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Fondation Franc.Cancerologie Digestive
Enrollment
55
Locations
86
Primary Endpoint
The primary endpoint is the percentage of patients alive and without progression at 10 months. Progression is defined by: - radiological progression evaluated by the investigator according to RECIST v1.1 criteria. - death, whatever the cause
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the efficacy of pembrolizumab in combination with XELOX or FOLFOX and bevacizumab as 1st line treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC) with a high immune infiltrate. Efficacy will be determined by analysis of the number of patients alive and without radiological and/or clinical progression at 10 months (based on RECIST 1.1 criteria evaluated by the investigator).

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adequate liver function: AST/ALT ≤ 5xULN, total bilirubin ≤ 2xULN, Alkaline phosphatase ≤ 5xULN
  • •Creatinine clearance > 50 mL/min according to the CKD-EPI formula
  • •Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour
  • •Patient who is a beneficiary of the social security system
  • •Information provided to patient and signature of the informed consent form
  • •Both MSS and pMMR metastatic colorectal adenocarcinoma (metachronous or synchronous metastases), histologically proven
  • •Patients who have had adjuvant/post-operative chemotherapy and/or post-operative radiotherapy for the treatment of their primary tumor or R0 resected metastatic lesions can be included if they have a recurrence more than 6 months after the end of this treatment
  • •High immune response defined as the immune infiltration score obtained on the primary tumour (resection of primary tumour containing at least 2 mm of tumour-free margin between the tumour and nontumour area)
  • •Unresectable cancer with at least one measurable metastatic target according to RECIST v1.1 criteria
  • •Absence severe neuropathy (≥ grade 2) (chemo-induced or not)

Exclusion Criteria

  • •Active infection requiring intravenous antibiotics at day 1 of cycle 1
  • •Another concomitant cancer or history of cancer during the last 5 years, except for carcinoma in situ of the uterine cervix or a basal cell or squamous cell skin carcinoma or any other carcinoma in situ considered as cured
  • •Previous bone marrow allogenic stem cell transplantation or previous organ transplantation
  • •Previous treatment with anti-PD1 or anti-PDL1 or another immunotherapy
  • •History of idiopathic pulmonary fibrosis, medicinal product-related pneumonia or proof of active pneumonia or pneumonitis on a chest CTscan prior to therapy
  • •HIV infection, active hepatitis B or C infection, active tuberculosis
  • •Colorectal cancer with microsatellite instability (dMMR and/or MSI)
  • •Patient eligible for curative treatment (resection and/or thermal ablation according to the opinion of the local multidisciplinary tumour meeting board) and patient with RAS wild-type tumour for whom a tumour shrinkage with an anti-EGFR is necessary to perhaps obtain a XML File Identifier: IjpoCuOJiXEw1TRpi8rHlb0n7yE= Page 27/63 downstaging for a secondary surgery (according to the opinion of the local multidisciplinary tumour meeting board and/or at investigator's discretion)
  • •Patient with only primary tumour biopsies available or only a sample of a metastasis (no surgical resection of the primary tumour)
  • •An auto-immune disease which may worsen during treatment with an immune-stimulating agent (patients with type I diabetes, vitiligo, psoriasis, hypo or hyperthyroidism not requiring immunosuppressant therapy are eligible)

Outcomes

Primary Outcomes

The primary endpoint is the percentage of patients alive and without progression at 10 months. Progression is defined by: - radiological progression evaluated by the investigator according to RECIST v1.1 criteria. - death, whatever the cause

The primary endpoint is the percentage of patients alive and without progression at 10 months. Progression is defined by: - radiological progression evaluated by the investigator according to RECIST v1.1 criteria. - death, whatever the cause

Secondary Outcomes

  • Overall survival: is defined as time between date of inclusion and date of death of patient (whatever the cause) or date of last news if patient is XML File Identifier: IjpoCuOJiXEw1TRpi8rHlb0n7yE= Page 28/63 alive
  • Grades 3 – 4 adverse events: will be evaluated according to NCI-CTC v4.0 criteria and described by maximum grade based on total duration of treatment and 30 days after treatment
  • Secondary resection rate (R0 and R1): is defined as the percentage of patients who underwent surgery on their metastatic lesions after the protocol treatment.
  • Histological response in case of secondary resection: is evaluated according to the TRG (Rubbia-Brandt L et al. Annals Oncol 2007), in patients who underwent a secondary resection. This response is evaluated according to the various categories: TRG1/TRG 2/TRG 3/TRG 4/TRG 5.
  • Outcome of tumour markers (CEA and CA19.9): the evolution of the markers will be analyzed by a graphic representation of the percentage change from baseline rate.
  • Progression-free survival, according to the investigator (RECIST criteria): defined as time between date of inclusion and date of a first radiological progression or date of death (whatever the cause). Patients alive without progression will be censured at date of last news. According to iRECIST criteria, progression will be considered as an event if it is confirmed. If the patient dies before confirmation, the event will be considered as unconfirmed progression.
  • The percentage of patients alive and without progression at 10 months (according to centralised review, RECIST and iRECIST criteria): progression is defined as radiological progression or death, whatever the cause. According to iRECIST criteria, the patient will be considered as in progression if progression is confirmed in the next 2 months.
  • Time to progression, according to the investigator (RECIST criteria) and in centralised review (RECIST and iRECIST criteria): is defined as the time between date of inclusion and date of first progression (RECIST v1.1 criteria) or date of suspected progression if confirmed (iRECIST criteria).
  • Time to an objective response (according to the investigator and in centralised review, RECIST criteria): is defined as the time between the date of inclusion and the date of a first objective response (complete response or partial response) during treatment. Patients with no imaging study (or if best response is not evaluable, or patients not treated) will not be taken into account in the analysis.
  • Best response during treatment (according to the investigator and in centralised review, RECIST criteria): the best response is described by a percentage according to different categories: complete response (CR), partial response (PR), stability (S), progression (P) and not evaluable (NE). The best objective response is evaluated during treatment based on different imaging studies and according to RECIST v1.1 criteria.
  • Depth of response (according to the investigator and in centralised review, RECIST criteria): is defined as the relative difference between the sum total of the largest diameters of target lesions in NADIR (RECIST v1.1: in the absence of new lesions or progression of non-target lesions) and the sum total of the largest diameters of target lesions at inclusion.
  • Early tumour shrinkage at 9 weeks, according to the investigator (RECIST criteria) and in centralised review (RECIST and iRECIST criteria): is defined as the relative difference between the sum of the largest diameters of the target lesions at 9 weeks and the sum of different targets at inclusion. Tumour shrinkage corresponds to a relative difference > 20% with RECIST v1.1 criteria and > 30% with iRECIST.

Investigators

Sponsor
Fondation Franc.Cancerologie Digestive
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

David TOUGERON

Scientific

Fondation Franc.Cancerologie Digestive

Study Sites (86)

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