Informations générales (source: ClinicalTrials.gov)
A Phase II/III Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma
Interventional
Phase 2/Phase 3
Canadian Cancer Trials Group (Voir sur ClinicalTrials)
novembre 2016
juin 2024
19 octobre 2024
Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests
show that this drug works by helping improve the body's immune response to help fight
cancer. Pembrolizumab may help the immune system to recognize cancer cells and slow down
the growth and/or spreading of cancer.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Isabelle MONNET | 29/03/2024 01:28:44 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 22/02/2024 17:11:05 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Ambroise Paré | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Bichat | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Caen - CHU - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Alexis Vautrin - 54500 - Vandoeuvre les Nancy - Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Mulhouse - 68070 - Mulhouse - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier du Mans - 72037 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Centre Rene Gauducheau - 44805 - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHITS Toulon Sainte Musse - 83056 - Toulon - France | Contact (sur clinicalTrials) | ||||
| CHRU de Tours - Hopital Bretonneau - 37044 - Tours Cedex - Tours Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| CHU - Angers - 49033 - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU Dupuytren - 87042 - Limoges - FR - France | Contact (sur clinicalTrials) | ||||
| CHU Rennes - Hopital Pontchaillou - 35033 - Rennes - FR - France | Contact (sur clinicalTrials) | ||||
| Clermont-Ferrand - CHU - 63003 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Hopital du Scorff - 56100 - Lorient - FR - France | Contact (sur clinicalTrials) | ||||
| Hopital Jean Minjoz - 25030 - Besancon Cedex - France | Contact (sur clinicalTrials) | ||||
| Hopital Larrey - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Lille - Hopital Calmette - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Lyon URCOT - 69310 - Pierre-benite - FR - France | Contact (sur clinicalTrials) | ||||
| Marseille - Hopital Nord - 13915 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Nouvel Hopital Civil Hopitaux - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Patients must have histologically confirmed malignant pleural mesothelioma. Patients
must be eligible to receive standard chemotherapy with pemetrexed and cisplatin and
have no contraindications to standard chemotherapy.
- Patients must have unresectable advanced and/or metastatic disease, incurable by
standard therapies.
- All patients must have a cellular tumour block from their primary or metastatic
tumour available and consent to release the block/recently cut slides for
correlative analyses (See Section 11.0) and the centre/pathologist must have agreed
to the submission of the specimen(s).
- Presence of radiologically documented disease. At least one site of disease must be
unidimensionally measurable as follows:
- CT scan (with slice thickness of ≤ 5 mm): ≥ 10 mm --> longest diameter
- Physical exam (using calipers): ≥ 10 mm
- Lymph nodes by CT scan ≥ 15 mm --> measured in short axis
- All radiology studies must be performed within 21 days prior to registration
(exception: within 28 days if negative).
- Age ≥ 18 years.
- ECOG performance status 0 or 1.
Previous Therapy
Cytotoxic Chemotherapy:
- Patients must not have received prior chemotherapy for any stage of
advanced/metastatic disease.
- Patients who received previous (neo)adjuvant cisplatin-based systemic chemotherapy
must have received the last dose of chemotherapy at least 12 months before
registration. Please contact CCTG PRIOR to randomization for such patients.
Other Anti-Cancer Therapy:
- Patients may not have received targeted small molecule therapy, immunotherapies and
viral therapies, biologic therapies and angiogenesis inhibitors for
advanced/metastatic disease, or any prior immunotherapy for any stage of disease.
Radiation:
- Patients may have had prior radiation therapy, but NOT to the thorax unless clear
disease progression has been demonstrated and confirmed with CCTG. A minimum of 28
days must have elapsed between the end of radiotherapy and registration onto the
study. Radiation must have involved < 30% of functioning bone marrow and there must
be measurable disease outside the previously irradiated area (patients whose sole
site of disease (for example pleural rind) is in a previously irradiated area are
ineligible UNLESS there is evidence of progression, or new lesions have been
documented, in the irradiated field). Please contact CCTG PRIOR to randomization if
the patient has received prior thoracic radiation. Patients must have recovered from
any acute toxic effects from radiation prior to registration.
Previous Surgery:
- Previous major surgery is permitted provided that it has been at least 28 days prior
to patient registration and that wound healing has occurred.
- Lab Requirements:
- Absolute neutrophils ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 90 g/L
- Bilirubin ≤ 1.5 x ULN (upper limit of normal)
- AST and ALT ≤ 2.5 x ULN
- Serum creatinine < 1.25 x ULN or Creatinine clearance ≥ 50 mL/min
- Patient consent must be appropriately obtained in accordance with applicable local
and regulatory requirements.
- Patients must be accessible for treatment, response assessment and follow-up.
Patients registered on this trial must be treated and followed at the participating
centre.
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days
of patient randomization.
- Women/men of childbearing potential must have agreed to use two highly effective
contraceptive methods during the study and for six months after discontinuation.
- Patient must be able (i.e. sufficiently fluent) and willing to complete the quality
of life questionnaires.
- Patients must have histologically confirmed malignant pleural mesothelioma. Patients
must be eligible to receive standard chemotherapy with pemetrexed and cisplatin and
have no contraindications to standard chemotherapy.
- Patients must have unresectable advanced and/or metastatic disease, incurable by
standard therapies.
- All patients must have a cellular tumour block from their primary or metastatic
tumour available and consent to release the block/recently cut slides for
correlative analyses (See Section 11.0) and the centre/pathologist must have agreed
to the submission of the specimen(s).
- Presence of radiologically documented disease. At least one site of disease must be
unidimensionally measurable as follows:
- CT scan (with slice thickness of ≤ 5 mm): ≥ 10 mm --> longest diameter
- Physical exam (using calipers): ≥ 10 mm
- Lymph nodes by CT scan ≥ 15 mm --> measured in short axis
- All radiology studies must be performed within 21 days prior to registration
(exception: within 28 days if negative).
- Age ≥ 18 years.
- ECOG performance status 0 or 1.
Previous Therapy
Cytotoxic Chemotherapy:
- Patients must not have received prior chemotherapy for any stage of
advanced/metastatic disease.
- Patients who received previous (neo)adjuvant cisplatin-based systemic chemotherapy
must have received the last dose of chemotherapy at least 12 months before
registration. Please contact CCTG PRIOR to randomization for such patients.
Other Anti-Cancer Therapy:
- Patients may not have received targeted small molecule therapy, immunotherapies and
viral therapies, biologic therapies and angiogenesis inhibitors for
advanced/metastatic disease, or any prior immunotherapy for any stage of disease.
Radiation:
- Patients may have had prior radiation therapy, but NOT to the thorax unless clear
disease progression has been demonstrated and confirmed with CCTG. A minimum of 28
days must have elapsed between the end of radiotherapy and registration onto the
study. Radiation must have involved < 30% of functioning bone marrow and there must
be measurable disease outside the previously irradiated area (patients whose sole
site of disease (for example pleural rind) is in a previously irradiated area are
ineligible UNLESS there is evidence of progression, or new lesions have been
documented, in the irradiated field). Please contact CCTG PRIOR to randomization if
the patient has received prior thoracic radiation. Patients must have recovered from
any acute toxic effects from radiation prior to registration.
Previous Surgery:
- Previous major surgery is permitted provided that it has been at least 28 days prior
to patient registration and that wound healing has occurred.
- Lab Requirements:
- Absolute neutrophils ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 90 g/L
- Bilirubin ≤ 1.5 x ULN (upper limit of normal)
- AST and ALT ≤ 2.5 x ULN
- Serum creatinine < 1.25 x ULN or Creatinine clearance ≥ 50 mL/min
- Patient consent must be appropriately obtained in accordance with applicable local
and regulatory requirements.
- Patients must be accessible for treatment, response assessment and follow-up.
Patients registered on this trial must be treated and followed at the participating
centre.
- In accordance with CCTG policy, protocol treatment is to begin within 2 working days
of patient randomization.
- Women/men of childbearing potential must have agreed to use two highly effective
contraceptive methods during the study and for six months after discontinuation.
- Patient must be able (i.e. sufficiently fluent) and willing to complete the quality
of life questionnaires.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at
doses more than 10 mg prednisone or equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first and any dose of trial
treatment.
- Has active autoimmune disease that has required systemic treatment in the past 3
years (i.e. with use of disease modifying agents, corticosteroids or
immunosuppressive drugs) or history of allogeneic transplantation. Replacement
therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy
for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic
treatment.
- Must not have received a live vaccine within 30 days of planned start of study
therapy.
- Patients with known active central nervous system (CNS) metastases and/or
carcinomatous meningitis. Subjects with previously treated brain metastases may
participate provided they are stable (without evidence of progression by imaging for
at least four weeks prior to the first dose of trial treatment and any neurologic
symptoms have returned to baseline), have no evidence of new or enlarging brain
metastases, and are not using steroids for at least 7 days prior to trial treatment.
This exception does not include carcinomatous meningitis which is excluded
regardless of clinical stability.
- Patients who have experienced untreated and/or uncontrolled cardiovascular
conditions and/or have symptomatic cardiac dysfunction including cardiac ventricular
arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular
conduction defects) or who have had unstable angina congestive heart failure or
myocardial infarction within the previous year. Patients with a significant cardiac
history, this includes hypertension, even if controlled, should have a LVEF ≥ 50%.
- Patients with a history of other malignancies unless having undergone curative
therapy (i.e. resection, radiation, etc) and do not require concurrent anticancer
therapy.
- History of allergic reactions attributed to compounds of similar chemical or
biologic composition to pembrolizumab or any of the other chemotherapy agents.
- Concurrent treatment with other investigational drugs or anti0cancer therapy.
- Patients with serious illness or medical condition that would not permit the patient
to be managed according to the protocol including, but not limited to:
- History of significant neurologic or psychiatric disorder which would impair
the ability to obtain consent or limit compliance with study requirements.
- Active infection requiring systemic therapy; (including any patient known to
have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
[note: testing in asymptomatic patients is not required] or tuberculosis).
- Known history of, or any evidence of active, non-infectious pneumonitis.
- Any other medical conditions that might be aggravated by treatment.
- Serious or non-healing wound, ulcer, or bone fracture.
- Patients with evidence of interstitial lung disease.
- Patients with severe/uncontrollable tumor pain that requires radiation prior to
starting on systemic therapy.
- Pregnant or lactating women. (N.B.: All women of childbearing potential must have a
negative pregnancy test within 72 hours prior to registration).