- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05135845
Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma (METIMGAST)
February 1, 2023 updated by: Assistance Publique - Hôpitaux de Paris
Phase II Trial to Evaluate the Combination of Capmatinib + Spartalizumab in Advanced Oesogastric Adenocarcinoma
Immunotherapy with anti-PD1 antibodies provides encouraging results on a subset of patients.
Capmatinib, a MET inhibitor, has shown an imunomodulatory effect and a synergy with spartalizumab a PD-1 inhibitor.
The purpose of this phase II trial is to evaluate the efficacy and safety of the combination of capmatinib + spartalizumab in adult patients with advanced oesogastric adenocarcinoma.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Besançon, France, 25030
- Hôpital Jean Minjoz
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Dijon, France
- Centre François Leclerc
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Lyon, France, 69008
- Centre Léon Bérard
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Paris, France, 75010
- AP-HP Hôpital Saint Louis
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Pessac, France, 33604
- Hôpital Haut Lévêque
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Toulouse, France, 31059
- Institut universitaire du cancer
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Villejuif, France, 94805
- Institut Gustave Roussy
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically documented locally advanced or metastatic oesogastric adenocarcinoma.
- Unresectable tumor.
- Patients must have received at least one prior systemic chemotherapy based on platinium salt and fluoropyrimidine with documented progression during chemotherapy.
- Patients must have received trastuzumab in case of HER2 positive tumor (HER2 +++ or HER2++ and FISH or SISH+)
- Determination of tumor MET amplification by FISH available
- ECOG Performance Status ≤ 1.
- Measurable tumoral disease according to RECIST 1.1 criteria.
- Patients must be willing and able to swallow and retain oral medication.
- Age ≥18 years.
- Women of childbearing potential and males who are sexually active must agree to follow instructions for method(s) of contraception for the duration of study treatments with Capmatinib and Spartalizumab until 7 days after the last dose of Capmatinib and 150 days after the last dose of Spartalizumab
- Consent to participate in the trial after information
- Affiliated to a social security system
Exclusion Criteria:
- Previous treatment with immunotherapy or MET inhibitor
- Impossibility to take oral medication
- Persistent toxicities related to prior treatment of grade greater than 1
- Presence or history of another malignant disease that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.
- Use of any live vaccines within 4 weeks of initiation of study treatment.
- History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).
- History or current interstitial lung disease or non-infectious pneumonitis
- Active autoimmune disease or a documented history of autoimmune disease (Patients with vitiligo, controlled type I diabetes mellitus on stable insulin dose, residual autoimmune-related hypothyroidism only requiring hormone replacement or psoriasis not requiring systemic treatment are permitted).
- Allogenic bone marrow or solid organ transplant
- Uncontrolled active infection
- Human Immunodeficiency Virus (HIV) infection
- Untreated active Hepatitis B infection (HBsAg positive) (Patients with active hepatitis B (HBsAg positive) may be enrolled provided viral load (HBV DNA) at screening is <100 UI/mL. Patients may receive antiviral treatment with lamivudine, tenofovir, entecavir, or other antiviral agents before the initiation of study treatment to suppress viral replication).
- Untreated active hepatitis C (HCV RNA positive) (patients that achieved a sustained virological response after antiviral treatment and show absence of detectable HCV RNA ≥6 months after cessation of antiviral treatment are eligible)
- Untreated or symptomatic central nervous system (CNS) lesion. However, patients are eligible if: a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥4 weeks after treatment and c) patients must be off corticosteroid therapy for ≥2 weeks
- Clinically significant, uncontrolled heart diseases
- Recent acute coronary syndrome or unstable ischemic heart disease
- Congestive heart failure ≥ Class III or IV as defined by New York Heart Association
- Long QT syndrome (> 480 ms in women and 470 ms in men), family history of idiopathic sudden death or congenital long QT syndrome.
- Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥150 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening
- Surgery less than 4 weeks
- Radiotherapy less than 2 weeks
- Pregnancy or breastfeeding or women of child-bearing potential, unless they are using highly effective methods of contraception.
- Sexually active males unless they use a condom during intercourse while taking capmatinib and for 7 days after stopping treatment and should not father a child in this period.
- Participants receiving treatment with strong inducers of CYP3A and could not be discontinued ≥ 1 week prior to the start of treatment.
- Systemic chronic steroid therapy (>10 mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment.
- Patient having out of range laboratory values defined as:
- Total bilirubin >2 mg/dL, except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 x ULN or direct bilirubin >1.5 x ULN
- Alanine aminotransferase (ALT) > 3 x ULN
- Aspartate aminotransferase (AST) > 3 x ULN
- Coagulation: Prothrombin Time (PT) >4 seconds more than the ULN or International Normalized Ratio (INR) >1.7
- Absolute neutrophil count (ANC) <1.5 x 109/L
- Platelet count <75 x 109/L
- Hemoglobin <9 g/dL
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) <45 mL/min
- Serum lipase >1 ULN
- Cardiac troponin I (cTnI) elevation >2 x ULN
- Potassium, Magnesium, Phosphorus, total Calcium (corrected for serum albumin) outside of normal limits (patients may be enrolled if corrected to within normal limits with supplements during screening)
- Patients under legal protection
- Participation to another interventional study with treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response
Time Frame: 6 months
|
Overall response rate defined as the proportion of patients with at least one objective tumour response (complete or partial) according to response evaluation criteria in solid tumours (RECIST) v1.1 within 6 months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of unacceptable toxicity of the regimen during the first and second cycles of administration
Time Frame: Day 42
|
Presence of at least one of (composite endpoint):
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Day 42
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Proportion of unacceptable toxicity of the regimen during the whole treatment course
Time Frame: 12 months or treatment discontinuation
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Presence of at least one of (composite endpoint):
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12 months or treatment discontinuation
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Proportion of patients with adverse events during the whole treatment course
Time Frame: 12 months or treatment discontinuation
|
All adverse events during the whole treatment course
|
12 months or treatment discontinuation
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Duration of overall response
Time Frame: 24 months
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Time between the first occurrence of tumor objective response, partial or complete (RECIST 1.1) and the first radiological progression, with response assessment every 9 weeks, up to 24 months
|
24 months
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Time to response
Time Frame: 24 months
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Time between inclusion and the first occurrence of tumor objective response (complete or partial, according to RECIST 1.1) or the end of the study, with response assessment every 9 weeks, up to 24 months
|
24 months
|
Progression-free survival
Time Frame: 24 months
|
Time between inclusion and the date of the first radiological progression (according to RECIST 1.1), death (any cause), or last follow-up (maximum=24 months), whichever occurs first.
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24 months
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Overall survival
Time Frame: 24 months
|
Time between inclusion and death (any cause) or last follow-up (maximum=24 months), whichever occurs first
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24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 22, 2022
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
October 1, 2025
Study Registration Dates
First Submitted
October 28, 2021
First Submitted That Met QC Criteria
November 15, 2021
First Posted (Actual)
November 26, 2021
Study Record Updates
Last Update Posted (Actual)
February 3, 2023
Last Update Submitted That Met QC Criteria
February 1, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP201152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)Not yet recruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditions
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Clinical Trials on Capmatinib
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-
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-
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-
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-
Novartis PharmaceuticalsAvailableNon-Small Cell Lung Cancer | Nonsmall Cell Lung Cancer | Carcinoma, Non-Small Cell Lung | Non-Small-Cell Lung Carcinoma
-
Novartis PharmaceuticalsActive, not recruitingNon-small Cell Lung CancerUnited States
-
Intergroupe Francophone de Cancerologie ThoraciqueNovartisCompletedNon Small Cell Lung Cancer | MET Alterations | METex14 MutationsFrance
-
Massachusetts General HospitalNovartisCompletedMalignant Non-small Cell Neoplasm of Lung Stage IVUnited States
-
Timothy BurnsNovartisRecruitingNon-small Cell Lung CancerUnited States
-
Novartis PharmaceuticalsWithdrawnCarcinoma | Non-Small-Cell Lung Cancer