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887 essais correspondent à votre recherche

Fiche détaillée de l'essai

Acronyme : " COMBO D5330C00004"
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase Ia, Phase Ib
Descriptif

Experimental: Module 1 Part A
Module 1 Part A: ascending doses of AZD6738 in combination with carboplatin AUC5 will be administered to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD).
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 1 Part B
Module 1 Part B: patients with advanced lung adenocarcinoma with low expression of ATM will receive AZD6738 and carboplatin, at the dose, frequency and schedule recommended from Module 1 Part A.
Intervention: Drug: Administration of AZD6738 in combination with carboplatin

Experimental: Module 2 Part A1
Module 2 Part A1: ascending doses of AZD6738 will be administered alone to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) to take into Module 2 Part A2.
Intervention: Drug: Administration of AZD6738

Experimental: Module 2 Part A2
Module 2 Part A2: ascending doses of AZD6738 will be administered in combination with olaparib to patients to define the dose, frequency and schedule of AZD6738 and olaparib to take into Module 2 Part B.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B1
Module 2 Part B1: Patients with second line 'ATM deficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B2
Module 2 part B2: Patients with second line 'ATM proficient' gastric adenocarcinoma including GEJ adenocarcinoma will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B3
Module 2 Part B3: Patient with second or third line breast cancer with BRCA mutations (somatic or germline), excluding HER2 positive breast cancer will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 2 Part B4
Module Part B4: Patients with second or third line triple negative breast cancer with no known BRCA mutations. This expansion will be enriched for patients with disease harbouring a HRR-related gene mutation (HRRm) will receive AZD6738 with olaparib, at dose, frequency and schedule recommended from Module 2 Part A2.
Intervention: Drug: Administration of AZD6738 in combination with olaparib

Experimental: Module 3 Part A
Module 3 Part A: cohort escalation of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients to define the dose, frequency and schedule of AZD6738 and MEDI4736 to take into Module 3 Part B.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Experimental: Module 3 Part B
Module 3 Part B: cohort expansions of AZD6738 in combination with MEDI4736 in HNSCC or NSCLC patients at dose, frequency and schedule from Module 3 Part A.
Intervention: Drug: Administation of AZD6738 in combination with MEDI4736

Informations

ATM deficient, ATM proficient, HER2 negative, Breast, Gastric, Head & Neck, Lung

cancer métastatique

ligne de traitement variable selon les organes

 

12/12/2018
B3 : cancer du sein HER2 négatif avec mutation BRCA1 ou BRCA2 somatique ou germinale, en 2ème et 3ème ligne : Fermé
B4 : cancer du sein triple négatif sans mutation BRCA1 ou BRAC2 identifiée, en 2ème ou 3ème ligne : Ouvert

 

Phase: 1,1b,

Promoteur: AstraZeneca
Autre(s) acronyme(s): D5330C00004
Contact promoteur: AstraZeneca Clinical Study Information Center
AstraZeneca Cancer Study Locator Service

-
Source: Clinical trials.gov le 02/08/2018"

Cet essai dans d'autres annuaires :

Titre :

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies

Critères d'inclusion :
  1. "Aged at least 18

  2. The presence of a solid malignant tumour that is not considered appropriate for further standard treatment

  3. Module 1 and 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan

  4. Module 1 Part B Study expansion: second line lung adenocarcinoma with ATM deficient tumours.

  5. Module 2 Part B All - No previous treatment with PARP inhibitor.

  6. Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours

  7. Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours

  8. Module2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer

  9. Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC) Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma"

Critères de non-inclusion :
  1. "A diagnosis of ataxia telangiectasia

  2. Prior exposure to an ATR inhibitor

  3. Bad reaction to AZD6738

  4. Module 1: Contra-indicated for treatment with carboplatin

  5. Module 2: Contra-indicated for treatment with olaparib

  6. Module 3: Contra-indicated for treatment with MEDI4736"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest Dr CAMPONE Mario - - / Oui 11/09/2018
Afficher les détails
Acronyme : " METRIC CDX-011 Glembatumumab"
Spécialité : Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Non

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Active Comparator: Capecitabine
Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.
Drug: Capecitabine

Experimental: Drug: CDX-011
CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.

Informations


Cancer du sein triple négatif surexprimant gpNMB 

1ère ou 2ème ligne métastatique

A progression, ayant recu des anthracyclines

"Phase: 2

Promoteur: Celldex Therapeutics
Autre(s) acronyme(s): CDX-011
Glembatumumab
Contact promoteur: Celldex Therapeutics
-
Source: Clinicaltrials.org 09/10/2017"

Cet essai dans d'autres annuaires :

Titre :

"A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study) "

Critères d'inclusion :

Among other criteria, patients must meet all of the following conditions to be eligible for the study:

  1. Diagnosed with metastatic (i.e., cancer that has spread) TNBC

    - minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by             immunohistochemistry

    - HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell

  2. Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.

  3. Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.

  4. Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.

  5. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).

  6. ECOG performance status of 0 - 1.

  7. Adequate bone marrow, liver and renal function.

Critères de non-inclusion :
  1. Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.

  2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.

  3. Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.

  4. Significant cardiovascular disease.

  5. Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.

  6. Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.

  7. Chronic use of systemic corticosteroids.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Mercier-Blas - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com / Non 09/10/2017
Afficher les détails
Acronyme : "2102-HEM-101 FT-2102 Forma FT-2102-HEM-101"
Spécialité : Hématologie
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

Experimental: PH1 Dose Escalation & Expansion FT-2102
Intervention: Drug: FT-2102


Experimental: PH1 Esc. and Exp. FT-2102+Azacitidine
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH1 Esc. and Exp. FT-2102+Cytarabine
Interventions:
Drug: FT-2102
Drug: Cytarabine


Experimental: PH2 Cohort 1 FT-2102 Single Agent
At the completion of Phase 1, Phase 2 Cohort 1 will commence enrollment wherein patients with relapsed or refractory (R/R) AML will be treated with the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 2 FT-2102 Single Agent
In Phase 2 Cohort 2, patients with AML/ MDS in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after cytotoxic-containing induction therapy with residual IDH-R132 mutation will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 3 FT-2102 Single Agent
In Phase 2 Cohort 3, patients with R/R AML/MDS, previously treated with an IDH1 inhibitor will be treated at the RP2D of FT-2102 as a single-agent.
Intervention: Drug: FT-2102


Experimental: PH2 Cohort 4 FT-2102+Azacitidine
In Phase 2 Cohort 4, patients with R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 5 FT-2102+Azacitidine
In Phase 2 Cohort 5, patients with R/R AML/MDS that have inadequately responded or have progressed immediately proceeding hypomethylating therapy will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine


Experimental: PH2 Cohort 6 FT-2102+Azacitidine
In Phase 2 Cohort 6, patients with R/R AML/MDS that have been previously treated with single-agent IDH1 inhibitor therapy as their last therapy prior to study enrollment will be treated with the RP2D of FT-2102 in combination with azacitidine.
Interventions:
Drug: FT-2102
Drug: Azacitidine

Informations

Leucémie myéloïde aiguë ou de syndrome myélodysplasique

mutation IDH1

récidivant ou réfractaire

2ème ligne ou +

Phase: 1,2

Promoteur: NR
Acronymes: 2102-HEM-101 FT-2102
Promoteur : Forma FT-2102-HEM-101

Source: Clinical trial.gov 2018

Cet essai dans d'autres annuaires :

Titre :

A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation

Critères d'inclusion :
  1. Pathologically proven acute myeloid leukemia (AML) or intermediate, high-risk, or very high risk Myelodysplastic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) which is relapsed or refractory (R/R) to standard therapy and/or for which standard therapy is contraindicated or which has not adequately responded to standard therapy.

  2. Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site

  3. Good performance status

  4. Good kidney and liver function

Critères de non-inclusion :
  1. Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy

  2. Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias

  3. Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication

  4. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therap

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Nimubona - - 0 / 0 Oui 29/11/2018
Afficher les détails
Acronyme : "AP32788-15-101 TAKEDA TAK-788 U1111-1217-7205"
Spécialité : Pneumologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : À venir

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase I, Phase II
Descriptif

Experimental: Dose Escalation Cohort
TAK-788 treatment for participants with advanced NSCLC.

Experimental: Expansion Cohort 1
TAK-788 treatment for NSCLC participants with EGFR exon 20 activating insertions, who have either not received or not shown an objective response to an EGFR tyrosine kinase inhibitors (TKI), and who have no active, measurable central nervous system (CNS) metastases.

Experimental: Expansion Cohort 2
TAK-788 treatment for NSCLC participants with HER2 exon 20 activating insertions or point mutations and no active, measurable CNS metastases.

Experimental: Expansion Cohort 3
TAK-788 treatment for NSCLC participants with EGFR exon 20 activating insertions or HER2 exon 20 activating insertions or point mutations and active, measurable CNS metastases.

Experimental: Expansion Cohort 4
TAK-788 treatment for NSCLC participants with other targets against which TAK-788 is active (examples include EGFR exon 19 deletions or exon 21 substitutions [with or without T790M mutations] and other uncommon EGFR activating mutations), with or without active, measurable CNS metastases.

Experimental: Expansion Cohort 5
TAK-788 treatment for NSCLC participants with EGFR exon 20 activating insertions, who have previously shown an objective response to an EGFR TKI and subsequently progressed, with or without active, measurable CNS metastases.

Experimental: Expansion Cohort 6
TAK-788 treatment NSCLC participants with EGFR exon 20 activating insertions, who have not received prior systemic anticancer treatment for locally advanced or metastatic disease, with or without active, measurable CNS metastases

Experimental: Expansion Cohort 7
TAK-788 treatment for participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active, with or without active CNS metastases.

Experimental: Extension Cohort
TAK-788 treatment for participants with previously treated locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations.

Informations

Cancer du poumon non à petites cellules, localement avancé, métastatique

mutation - insertion HER2 ou EGRF selon les cohortes 

2ème ligne et +

Phase: 1,2

Promoteur: Millennium Pharmaceuticals, Inc/TAKEDA
Autre(s) acronyme(s): AP32788-15-101 TAKEDA
TAK-788
Contact promoteur: Takeda Study Registration Call Center

Mail promoteur: globaloncologymedinfo@takeda.co
Tel promoteur: 1-866-835-2233
Coordonnateur: NR
-
Source: Clinical trials.gov 2018

Cet essai dans d'autres annuaires :

Titre :

A Phase 1/2 Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of the Oral EGFR/HER2 Inhibitor TAK-788 (AP32788) in Non-Small Cell Lung Cancer

Critères d'inclusion :

General Inclusion Criteria (all cohorts: dose escalation and expansion):

  1. Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC (Stage IIIB or IV) or other solid tumors. For all cohorts except Expansion Cohort 7, the locally advanced or metastatic disease is NSCLC. For Expansion Cohort 7, the locally advanced or metastatic disease is any solid tumor other than NSCLC

  2. Must have sufficient tumor tissue available for analysis.

  3. Must have measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1.

  4. Male or female participants greater than or equal to (>=) 18 years old. For participants in Japan, aged >=20 years.

  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

  6. Minimum life expectancy of 3 months or more.

  7. Adequate organ function at baseline.

  8. Normal QT interval on screening electrocardiogram (ECG), defined as QT interval corrected (Fridericia) (QTcF) of less than or equal to (<=) 450 millisecond (ms) in males or <=470 ms in females.

  9. Willingness and ability to comply with scheduled visits and study procedures.

Part 1: Dose Escalation Cohort Specific Inclusion Criteria:

  1. 1. Refractory to standard available therapies.

Part 2: Expansion Cohort 1 Specific Inclusion Criteria:

  1. Have a documented EGFR in-frame exon 20 insertion by a local test.

  2. Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.

  3. Prior treatment with an EGFR TKI is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician.

Expansion Cohort 2 Specific Inclusion Criteria:

  1. Have one of the following documented by a local test:

           - A HER2 exon 20 insertion;

           - An activating point mutation in HER2.

  1. Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.

  2. Prior treatment with a pan-HER TKI (example, afatinib, neratinib, or dacomitinib) is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician.

Part 2: Expansion Cohort 3 Specific Inclusion Criteria:

  1. Have one of the following documented by a local test:

           - An EGFR exon 20 insertion;

            - A HER2 exon 20 insertion;

            - An activating point mutation in HER2.

  1. Previously treated with one or more regimen of systemic therapy for locally advanced or metastatic disease.

  2. For participants with an EGFR exon 20 insertion: prior treatment with an EGFR TKI is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.

  3. For participants with a HER2 exon 20 insertion or HER2 activating point mutation: prior treatment with a pan-HER TKI (example, afatinib, neratinib, or dacomitinib) is allowed unless the participants had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI.

  4. Have either previously untreated intracranial CNS metastases or previously treated intracranial CNS metastases with radiologically documented new or progressing CNS lesions.

  5. Have at least one target (that is, measurable) intracranial CNS lesion (>=10 millimeter [mm] in longest diameter by contrast enhanced magnetic resonance imaging [MRI]).

Part 2: Expansion Cohort 4 Specific Inclusion Criteria:

  1. Have one of the following documented by a local test: an activating mutation in EGFR including exon 19 deletions or exon 21 L858R substitution (with or without T790M), or an uncommon activating mutation other than exon 20 insertion including, but not limited to, G719X (where X is any other amino acid), S768I, L861Q, or L861R.

  2. Treatment naive for locally advanced or metastatic disease or previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.

  3. Have or do not have active (untreated or progressing) CNS metastases.

Part 2: Expansion Cohort 5 Specific Inclusion Criteria:

NSCLC participants with EGFR exon 20 activating insertions, who have previously shown an objective response to an EGFR TKI and subsequently progressed, with or without active, measurable CNS metastases.

  1. Have a documented EGFR in-frame exon 20 insertion by a local test.

  2. Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.

  3. Previously showed an objective response to an EGFR TKI and subsequently progressed as assessed by the investigator or treating physician.

  4. Have or do not have active (untreated or progressing) CNS metastases.

Part 2: Expansion Cohort 6 Specific Inclusion Criteria:

NSCLC participants with EGFR exon 20 activating insertions, who have not received prior systemic anticancer treatment for locally advanced or metastatic disease, with or without active, measurable CNS metastases.

  1. Have a documented EGFR in-frame exon 20 insertion by a local test.

  2. No prior systemic treatment for locally advanced or metastatic disease.

  3. Have or do not have active (untreated or progressing) CNS metastases.

Part 2: Expansion Cohort 7 Specific Inclusion Criteria:

Participants with solid tumors other than NSCLC with EGFR/HER2 mutations against which TAK-788 is active, with or without active, measurable CNS metastases.

  1. Have a solid tumor that is not NSCLC and that is refractory to standard therapy.

  2. Have EGFR or HER2 mutations, documented by a local test.

  3. Have or do not have active (untreated or progressing) CNS metastases.

Part 3: Extension Cohort Specific Inclusion Criteria:

  1. Have a documented EGFR in-frame exon 20 insertion by a local test and sufficient tumor tissue available for central analysis.

  2. Brain metastases are allowed if they have been treated with surgery and/or radiation and have been stable without requiring corticosteroids to control symptoms within 7 days prior to the first dose of TAK-788.

  3. Must have received at least 1 prior line of therapy for locally advanced or metastatic disease and no more than 2 regimens of systemic anticancer chemotherapies for locally advanced or metastatic disease.

Prior treatment with an EGFR TKI is allowed unless the participant had an objective response and subsequent progression as assessed by the investigator or treating physician during treatment with that prior TKI

Critères de non-inclusion :
  1. Previously received TAK-788.

  2. Received small-molecule anticancer therapy (including cytotoxic chemotherapy, and investigational agents, <=14 days prior to first dose of TAK-788 (except for reversible EGFR TKIs [that is, erlotinib or gefitinib], which are allowed in the dose escalation and expansion cohorts up to 7 days prior to the first dose of TAK-788).

  3. Received antineoplastic monoclonal antibodies including immunotherapy within 28 days of the first dose of TAK-788.

  4. Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or participants with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.

    Note: This exclusion criteria does not apply to Expansion Cohort 7.

  5. Received radiotherapy <=14 days prior to the first dose of TAK-788. SRS and stereotactic body radiosurgery are allowed up to 7 days prior to the first dose.

  6. Received a strong CYP4503A inhibitor or strong CYP3A inducer within 2 weeks prior to first dose of TAK-788.

  7. Have undergone major surgery within 28 days prior to first dose of TAK-788. Minor surgical procedures, such as catheter placement or minimally invasive biopsy, are allowed.

  8. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring corticosteroids to control symptoms within 7 days prior to the first dose of TAK-788.

  9. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).

  10. Have significant, uncontrolled, or active cardiovascular disease.

  11. Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.

  12. Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes.

  13. Have an ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics, or a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of history.

  14. Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.

  15. Female participants who are lactating and breastfeeding or have a positive urine or serum pregnancy test during the screening period.

    Note: Female participants who are lactating will be eligible if they discontinue breastfeeding.

  16. Have gastrointestinal illness or disorder that could affect oral absorption of TAK-788.

  17. Have any condition or illness that, in the opinion of the investigator, might compromise participant safety or interfere with the evaluation of the safety of the drug.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - CHU de Rennes - Site Hôpital Pontchaillou Dr Hervé Lena - herve.lena@chu-rennes.fr ARCs/IRCs Pneumologie - ide-pneumo-arc@chu-rennes.fr nc / nc À venir 20/12/2018
Afficher les détails
Acronyme : "ARRAY-818-302  2015-005805-35 BEACON CRC
Spécialité : Digestif
Traitement : Récidive
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

Experimental: Safety Lead-in, Triplet Arm
Encorafenib + binimetinib + cetuximab.

Experimental: Doublet Arm
Encorafenib + cetuximab.

Active Comparator: Control Arm
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.
Interventions:
Drug: Cetuximab
Drug: Irinotecan
Drug: Folinic Acid
Drug: 5-Fluorouracil

Informations

Cancer Colorectal Métastatique

BRAF V600E-mutant

2ème ligne et +

Phase 3

Promoteur: Array BioPharma
Acronymes: 2015-005805-35
BEACON CRC
Contact promoteur:
Array BioPharma
Mail promoteur: clinicaltrials@arraybiopharma.com

Tel promoteur:
303-381-6604

-
Source: Clinical trial.gov du 25/06/2018"

Cet essai dans d'autres annuaires :

Détails complémentaires sur l'essai :

Titre :

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

Critères d'inclusion :
  1. Age ≥ 18 years at time of informed consent

  2. Histologically- or cytologically-confirmed CRC that is metastatic

  3. Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory

  4. Progression of disease after 1 or 2 prior regimens in the metastatic setting

  5. Evidence of measurable or evaluable non-measurable disease per RECIST, v1.1

  6. Adequate bone marrow, cardiac, kidney and liver function

  7. Able to take oral medications

  8. Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of childbearing potential

  9. Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-u

Critères de non-inclusion :
  1. Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab, panitumumab or other EGFR inhibitors

  2. Prior irinotecan hypersensitivity or toxicity that would suggest an inability to tolerate irinotecan 180 mg/m2 every 2 weeks

  3. Symptomatic brain metastasis or leptomeningeal disease

  4. History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)

  5. Known history of acute or chronic pancreatitis

  6. History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization

  7. Uncontrolled blood pressure despite medical treatment

  8. Impaired GI function or disease that may significantly alter the absorption of encorafenib or binimetinib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)

  9. Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy

  10. History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli

  11. Concurrent neuromuscular disorder that is associated with the potential of elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)

  12. Residual CTCAE ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy

  13. Known history of HIV infection

  14. Active hepatitis B or hepatitis C infection

  15. Known history of Gilbert's syndrome

  16. Known contraindication to receive cetuximab or irinotecan at the planned doses

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - CHU Hépato-Digestif Dr Touchefeu Yann - DZIUKALA Catherine - / À venir 12/07/2018
Brest - CHU de Brest - Site Morvan Dr J. P. Metges - Abdelssam Chajara - abdesslam.chajara@chu-brest.fr NC / NC Oui 12/07/2018
Afficher les détails
Acronyme : "ASCENT ASCENT-Sein IMMU-132-05"
Spécialité : Sénologie
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Non

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

"Experimental: IMMU-132
Sacituzumab govitecan (10 mg/kg on Days 1 and 8 of 21-day cycles)
Intervention: Drug: Sacituzumab govitecan

Active Comparator: Control Arm
Treatment of Physician's Choice determined before randomization from only one of the following treatments (see Appendix 2 for more details on administration and dosing management):
Eribulin (1.4 mg/m2 IV on Days 1 and 8 of a 21-day cycle). See section 6.5.1 Capecitabine (1000-1250 mg/m2 orally twice daily on Days1-14 of a 21-day cycle). See section 6.5.2 Gemcitabine (800-1200 mg/m2 IV on Days 1, 8 and 15 of a 28-day cycle). See section 6.5.3 Vinorelbine (25 mg/m2 weekly IV on Day 1 weekly) See section 6.5.4 (Note: eligible patients with Grade 2 neuropathy should not be prescribed vinorelbine as TPC)"

Informations

Cancer du sein triple négatif

Refractaire/récidive

3eme ligne et + (Doit avoir recu du taxane)

Phase: 3

Promoteur: IMMUNOMEDICS, Inc.
Acronymes: ASCENT NCT02574455
Contact promoteur: Heather Horne
Mail promoteur: hhorne@immunomedics.com
Tel promoteur: 973-605-8200
Coordonnateur: William Wegener, MD,PhD

-
Source: clinicaltrials.org
30/08/2019"

Cet essai dans d'autres annuaires :

Titre :

Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer

Critères d'inclusion :
  1. "Female or male patients, >18 years of age, able to understand and give written informed consent.

  2. Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. TNBC determination as per local institution as per standard guidelines.

  3. Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC.

  4. Prior exposure to a taxane (paclitaxel or docetaxel)-based regimen in localized or advanced/metastatic setting.

  5. Eligible for one of the chemotherapy options listed as TPC (Eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.

  6. ECOG performance score of 0 or 1 .

  7. Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.

  8. At least 2 weeks beyond prior treatment (chemotherapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy and/or radiation therapy) or major surgery, and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).

  9. At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).

  10. Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).

  11. Adequate renal and hepatic function (creatinine ≤ 2.0 x IULN, bilirubin ≤ 1.5 IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if known liver metastases).

  12. Otherwise, all toxicity at study entry < Grade 1 by NCI CTCAE v4.00 (Patients with ≤ Grade 2 neuropathy are eligible).

  13. Patients with treated, non-progressive brain metastases, off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial."

Critères de non-inclusion :
  1. "Women who are pregnant or lactating.

  2. Women of childbearing potential or fertile men unwilling to use effective contraception during study until conclusion of 4-week post-treatment evaluation period.

  3. Patients with Gilbert's disease.

  4. Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.

  5. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.

  6. Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.

  7. Infection requiring intravenous antibiotic use within one week of enrollment.

  8. Patients with a history of an anaphylactic reaction to irinotecan.

  9. Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations."

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Rennes - Centre Eugène Marquis Dr Véronique DIERAS - v.dieras@rennes.unicancer.fr - 4 / 3 Non 07/01/2019
Afficher les détails
Acronyme : "BGB-290-303 2017-003493-13"
Spécialité : Digestif
Traitement : Traitement néoadjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase III
Descriptif

"Experimental: Arm A
Approximately 270 subjects to receive BGB-290 orally.
Intervention: Drug: BGB-290

Placebo Comparator: Arm B
Approximately 270 subjects to receive placebo orally.
Intervention: Drug: Placebo"

Informations

Cancer de l'estomac locallement avancé inopérable ou métastatique

Ayant répondu à une première ligne de platine

maintenance

Phase: 3

Promoteur: BeiGene
Acronymes: BGB-290-303
2017-003493-13
Contact promoteur: Heinrich Farin, MD

Mail promoteur: Clinicaltrials@beigene.com
Tel promoteur: 781-801-1800
Coordonnateur: NR
-
Source: Clinicaltrials.gov du 02/05/2018"

Cet essai dans d'autres annuaires :

Titre :

A Phase 3, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

Critères d'inclusion :
  1. "Age ≥ 18 years.

  2. Signed informed consent.

  3. Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.

  4. Received platinum based first line chemotherapy for ≤ 28 weeks.

  5. Confirmed partial response (PR) maintained for ≥ 4 weeks or complete response (CR).

  6. Able to be randomized to study ≤ 8 weeks after last platinum dose.

  7. ECOG performance status ≤ 1.

  8. Adequate hematologic, renal and hepatic function.

  9. Must be able to provide archival tumor tissue for central biomarker assessment.

  10. Females of childbearing potential and non-sterile males must agree to use highly effective methods of birth control throughout the course of study and at least up to 6 months after last "

Critères de non-inclusion :
  1. "Unresolved acute effects of prior therapy ≥ Grade 2.

  2. Prior treatment with PARP inhibitor.

  3. Chemotherapy, biologic therapy, immunotherapy or other anticancer therapy ≤ 14 days prior to randomization.

  4. Major surgery or significant injury ≤ 2 weeks prior to start of study treatment.

  5. Diagnosis of myelodysplastic syndrome (MDS) or active bleeding disorder.

  6. Other diagnoses of significant malignancy

  7. Leptomeningeal disease or brain metastasis

  8. Inability to swallow capsules or disease affecting gastrointestinal function.

  9. Active infections requiring systemic treatment.

  10. Clinically significant cardiovascular disease

  11. Pregnant or nursing females."

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Brest - CHU de Brest - Site Morvan Dr J. P. Metges - RASSOUL HAYAT AGATHE - hayat.guezi@chu-brest.fr / Oui 02/05/2018
Rennes - Centre Eugène Marquis Dr Le Sourd Samuel - Enora Lejeune - nc / nc Oui 17/09/2018
Afficher les détails
Acronyme : "Bladder-ART GETUG-AFU 30 UC-01610/1617"
Spécialité : Urologie
Traitement : Traitement adjuvant
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Sans phase
Descriptif

Experimental: Experimental Arm
adjuvant pelvic radiotherapy consisting of 28 x 1.8 Gy fractions (total dose of 50.4 Gy), 5 days per week, 1 fraction /day (duration of RT is 38 days).
Intervention: Radiation: pelvic radiotherapy


No Intervention: Standard Arm
Surveillance

Informations

Carcinome urothélial pur ou dominant supérieur ou égale à 50 % associé à des variants histologiques micropapillaire, épidermoïde ou adénocarcinome

Vessie

 

Radiothérapie adjuvante

Sans Phase

Promoteur: UNICANCER
Acronymes: Bladder-ART GETUG-AFU 30
UC-01610/1617
Contact promoteur: Sandra PELISSIER

Mail promoteur: s-pelissier@unicancer.fr
Tel promoteur: 33 1 44 23 55 68
Coordonnateur:
Paul SARGOS,
Stéphane LARRE, Prof
Mail coordonnateur: MD Institut Bergonié
CHU Robert Debré
-
Source: Clinical trial octobre 2018"

Cet essai dans d'autres annuaires :

Titre :

Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer: A Randomized Multicentre Phase II Study

Critères d'inclusion :

To be eligible, the patients must fulfil all of the following inclusion criteria:

  1. Patients with histologically-confirmed muscle-invasive bladder cancer, either with pure urothelial carcinomas, or dominant urothelial carcinomas (>50%) combined with other histological variants including: micropapillary, epidermoid, or adenocarcinomas, are eligible. Patients with small cell variants, pure adenocarcinomas, or pure epidermoid carcinomas are not eligible.

  2. Patients with radical cystectomy and pelvic lymph nodes dissection with no macroscopic residual disease (R0 and R1).

    Note that only R1 patients without urinary diversion as orthotropic neo-bladder replacement are eligible for the study, to limit cystectomy bed radiation induced toxicities

  3. Patients with tumours of TNM staging: pN0-2, M0 by imagery, and pT3a, pT3b, pT4a, and pT4b, as well as, pTX-pN1-2 are eligible.

  4. Patients having received neo-adjuvant or adjuvant chemotherapy treatment are eligible. Randomisation is allowed only if AE due to chemotherapy are ≤grade 2

  5. Patients ≥18 years old.

  6. ECOG performance status ≤2.

  7. Absolute neutrophil count (ANC) ≥1500 cells/mm3

  8. Platelets ≥100000 cells/mm3

  9. Haemoglobin ≥8 g/dL (Note: following a blood transfusion or another intervention if required).

  10. Adequate hepatic function: AST (SGOT) and ALT (SGPT) ≤2.5 x ULN; or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible.

  11. Adequate renal function: clearance >30 mL/min (MDRD).

  12. Patients of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 6 months after the adjuvant radiotherapy. Acceptable method of contraception includes: hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal associated with inhibition of ovulation (oral, intravaginal, transdermal), intrauterine devices, sexual abstinence, bilateral tubal ligation, vasectomy, for female: partner who have had a vasectomy, for male: partner who is not of childbearing potential. Women must have a negative urine or serum pregnancy test within 14 days prior to randomization.

  13. Patients having provided written informed consent prior to any study-related procedures.

  14. Patients affiliated to the social security scheme.

  15. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.

Critères de non-inclusion :

Patient must not be enrolled if he/she fulfils any of the following non-inclusion criteria:

  1. Patients with R1 resection and with orthotropic neo-bladder reconstruction as urinary diversion are not eligible.

  2. Patients with clinical or radiological evidence of metastases or N3 staged bladder cancer are not eligible.

  3. Prior invasive solid tumours or haematological malignancies (except skin basal cell carcinoma, in situ epithelioma of the cervix, or prostate cancer [incidentally discovered during cystoprostatetectomy and pelvic lymph node dissection)] and with a good prognosis [T stage <pT3b and/or Gleason <8 and pN- and/or post-operative PSA <0.1 nanogramm/mL]), unless disease free for a minimum of three years prior to inclusion.

  4. Prior pelvic radiotherapy.

  5. Patients with active inflammatory bowel disease.

  6. Patients who required surgical treatment for bowel obstruction before bladder cancer diagnosis or after cystectomy.

  7. Prior chemotherapy for other malignant diseases, except for neoadjuvant pre-cystectomy chemotherapy which is permitted.

  8. Patients with the following severe acute co-morbidity are not eligible:

    Unstable angina or congestive heart failure that required hospitalization in the 6 months before randomisation.

    Transmural myocardial infarction in the 6 months prior to randomisation.

    Acute bacterial or fungal infection requiring intravenous antibiotics at randomization.

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of inclusion.

    Severe hepatic disease: Child-Pugh Class B or C hepatic disease.

    Known acquired immune deficiency syndrome (AIDS); the study treatment could impact blood count.

  9. Patients with any other disease or illness which requires hospitalization or is incompatible with the study treatment are not eligible.

  10. Patients unable to comply with study obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the study.

  11. Patients enrolled in another therapeutic study within 30 days prior of randomisation.

  12. Pregnant or breast feeding mothers.

  13. Person deprived of their liberty or under protective custody or guardianship.

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
Saint-Grégoire - Centre Hospitalier Privé St Gregoire Dr Artignan - Stéphanie DUREL-PINSON - sdurelpinson@vivalto-sante.com / Oui 26/11/2018
Afficher les détails
Acronyme : "CHEMOIMMUNE ET16-073 2016-002736-33 "
Spécialité : Sénologie
Traitement : Thérapie ciblée néoadjuvante (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

"Cyclophosphamide et pembrolizumab
The treatments received are:

  • cyclophosphamide (50 mg/day, daily, per os)
  • pembrolizumab (200 mg every 3 weeks, intravenously [IV]). On days 1, cyclophosphamide should be taken first and pembrolizumab infusion initiated within 1 hour after cyclophosphamide intake.

Interventions:
Drug: Cyclophosphamide 50mg
Drug: Pembrolizumab 100 MG in 4 ML Injection"

Informations

Cancer du sein métastatique - HER2- 

> ou = 2ieme ligne de traitement 

1iere ligne si prétraitée en néoadjuvant ou adjuvant par une thérapie à base de taxane ou anthracycline

Phase: 2

Promoteur: Centre Léon Berard
Autre(s) acronyme(s): ET16-073
2016-002736-33
Contact promoteur:
Contact: Olivier TREDAN, MD

Mail promoteur: olivier.tredan@lyon.unicancer.fr
Tel promoteur: 33478782828
-
Source: clinicaltrials.gov 18/06/2018"

Cet essai dans d'autres annuaires :

Titre :

CHEMOIMMUNE - A Phase II Study Evaluating an Anti-PD1 Monoclonal Antibody (Pembrolizumab) in Lymphopenic Metastatic Breast Cancer Patients Treated With Metronomic Cyclophosphamide

Critères d'inclusion :
  • Female patient>=18 years of age on day of signing informed consent.

  • Histologically proven HER2-negative metastatic breast cancer. HER2-negativity is defined as immunohistochemistry (IHC) score 0, 1+ or 2+ and fluorescent in situ hybridization (FISH) negative or just FISH negative, whichever was performed.

  • Patient previously treated with at least one prior line of standard chemotherapy either in the adjuvant setting or in the metastatic setting. Patients may be included in the first line metastatic setting if they have received anthracycline and/or taxane-based therapy in the neoadjuvant/adjuvant setting.

Note: Patients with ER-positive tumors must have received at least one prior endocrine therapy, either in the adjuvant setting or in the metastatic setting.
Documented lymphopenia defined by at least one value of lymphocyte count < 1.5 G/L within 15 days before treatment start (C1D1) and following at least 15 days since the last administration of chemotherapy.
Biopsiable disease i.e. at least one lesion with a diameter ≥ 10 mm, visible by medical imaging and accessible to percutaneous sampling.
Patient willing to undergo 2 tumor biopsies (at inclusion and at C3D1).
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 and minimum life expectancy of 24 weeks.

  • Documented radiological disease progression at time of study entry.

  • At least one measurable lesion according to RECIST 1.1.

  • Adequate end organ and marrow function as defined below: all screening labs should be performed within 3 days before treatment start (C1D1).

Hematological Laboratory Values Absolute neutrophil count (ANC) ≥ 1.5G/L Platelets ≥ 100G/L Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (without transfusion within 7 days of assessment) Renal Laboratory Values Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or Calculated creatinine clearance as per MDRD or CKD-EPI formula ≥ 60 mL/min /1.73m2 Hepatic Laboratory Values Serum total bilirubin ≤ 1.5 X ULN or Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN LDH ≤ 1.5 ULN Albumin ≥ 25 g/L Coagulation Laboratory Values International Normalized Ratio (INR) ≤ 1.5 ULN Ratio of activated Partial Thromboplastin Time (aPTT) ≤ 1.5 ULN

  • Absence of prior significant treatment-related toxicity i.e. treatment-related toxicity > Grade 1 as per CTCAE v4.03 (Appendix 2), except grade 2 alopecia, grade 2 neuropathy and biological values as described in I10.

  • Women of child-bearing potential must have a negative serum pregnancy test within 3 days before C1D1.

  • Women of child-bearing potential must agree to use 2 effective forms of contraception from the time of the negative pregnancy test up to 120 days after the last dose of study drugs. Effective forms are detailed in Appendix 5.

  • Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.

  • Patients must be covered by a medical insurance.

Critères de non-inclusion :
  • Previously treated with more than 3 prior lines of chemotherapy in the metastatic setting

  • Has previously received therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand 1(PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.

  • Presenting any contraindication to cyclophosphamide treatment including known hypersensitivity to cyclophosphamide, inflammation of the bladder (cystitis), urinary outflow obstruction or active infection.

  • Requiring the use of concomitant medications defined as forbidden in the SPC of cyclophosphamide.

  • Hypersensitivity to pembrolizumab or any of its excipients.

  • Has a known history of active Bacillus Tuberculosis.

Prior treatment with:

  1. any investigational agent within 4 weeks before C1D1 (or 5 half-lives whichever is shorter with a minimum of 2 weeks);
  2. any systemic corticosteroids at doses higher than 10 mg/d of prednisolone or equivalent or immunosuppressive agent within 4 weeks before C1D1;
  3. any monoclonal antibody within 4 weeks before C1D1;
  4. any chemotherapy, targeted small molecule therapy, radiation therapy, or surgery within 2 weeks prior to C1D1.

Note: If a patient underwent a major surgical procedure, they must have adequately recovered from the toxicity (i.e. wound healing) and/or complications from the intervention prior to starting therapy.
* any live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.

  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to C1D1 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 28 days prior to C1D1. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.

  • Has active autoimmune disease that has required systemic treatment in the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d of methylprednisolone or equivalent or immunosuppressive agents.

Note: Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.

  • Has an history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active non-infectious pneumonitis.

  • Has an active infection requiring systemic therapy.

  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

  • Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.

  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) or active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest FRENEL Jean Sébbastien - - / Oui 19/06/2018
ANGERS - Institut de Cancérologie de l'Ouest Dr FRENEL Jean Sebastien - - / Oui 19/06/2018
Afficher les détails
Acronyme : "CLAG525X210C CPDR001XUS01 "
Spécialité : Digestif
Traitement : Thérapie ciblée (concomitante ou exclusive)
Ouvert aux inclusions : Oui

(Cliquer sur détails pour connaitre les centres)

Phase(s) : Phase II
Descriptif

Experimental: PDR001 and LAG525

PDR001 will be supplied as powder for solution for infusion. LAG525 will be supplied as a liquid formulation. PDR001 and LAG525 will be administered via i.v. infusion over 30 minutes once every 3 weeks. LAG525 will be given first followed by PDR001.
Biological: PDR001
PDR001 is a high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1.

Biological: LAG525

Informations

Toutes tumeurs solides 

Récidives, rechute, métastatiques

2ieme ligne et plus

  • "Poumon petites cellules
  • ADK estomac
  • ADK Oesophage
  • ADK prostate résitant
  • Sarcome tissus mous
  • ADK Ovaire
  • Tumeur Neuroendocrine avancée, bien différenciées
  • Diffuse Large B Cell Lymphoma"

Phase: 2

Promoteur: Novartis Pharmaceuticals
Autre(s) acronyme(s): NR
Contact promoteur: Study director
Mail promoteur: Novartis.email@novartis.com

Tel promoteur: 1-888-669-6682
Coordonnateur: NR
-
Source: 01/08/2018 Clinical Trials.com"

Cet essai dans d'autres annuaires :

Titre :

This is a phase II, open-label, parallel-cohort study to determine the efficacy and safety of treatment with the combination of PDR001+LAG525 across multiple tumor types that are relapsed and/or refractory to available standard of care therapies. Patients will receive study treatment for a maximum of 2 years, All disease assessments will be performed locally by the investigator.

Critères d'inclusion :
  1. Patients eligible for inclusion in this study have to meet all of the following criteria:

  2. Patient must have had at least one prior line of therapy for their disease and must not be beyond 4th progression/relapse of disease (5 maximum prior lines).

  3. Patient has a pathology confirmed diagnosis of a solid tumor or lymphoma listed in the section "condition". Patients must have measurable disease as per appropriate guidelines (Solid Tumors by RECIST 1.1 and Diffuse Large B-cell Lymphoma by Revised Response Criteria for Malignant Lymphoma - Cheson et al 2007).

  4. Expansion Cohorts only: Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Exceptions may be considered after discussion with the sponsor.

Critères de non-inclusion :
  1. "History of severe hypersensitivity reactions to other mAbs.

  2. Impaired cardiac function or clinically significant cardiac disease.

  3. Active, known or suspected autoimmune disease or a documented history of autoimmune disease within three years prior to screening with a few exceptions as per protocol.

  4. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.

  5. Patient with second primary malignancy within < 3 years of first dose of study treatment.

  6. Prior immunotherapy treatment with PD-1, PD-L1, CTLA-4, or LAG-3 antibodies"

Centres investigateurs

Centres participants à l'essai Contact investigateur Contact TEC/IRC Patients inclus/à inclure Ouverts aux inclusions Maj
NANTES - Institut de Cancérologie de l' Ouest WIAZZANE Nadia - - / Oui 27/08/2018
Afficher les détails

Fiche détaillée de l'essai