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    Summary
    EudraCT Number:2015-005464-42
    Sponsor's Protocol Code Number:2335/2015
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2016-06-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2015-005464-42
    A.3Full title of the trial
    A phase II study to assess the efficacy of the anti-PD-L1 antibody atezolizumab (MPDL3280A) administered with stereotactic ablative radiotherapy (SABR) in patients with metastatic tumours
    Etude de phase II visant à évaluer l’efficacité de l’anti PD-L1 atezolizumab (MDPL3280A) administré en combinaison avec la radiothérapie stéréotaxique chez des patients présentant des tumeurs métastatiques
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etude de phase II, visant à évaluer l’efficacité de la radiothérapie stéréotaxique associée à l'administration de l'anticorps atezolizumab, chez des patients présentant un cancer métastatiques
    A.3.2Name or abbreviated title of the trial where available
    SABR-PDL1
    A.4.1Sponsor's protocol code number2335/2015
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGustave Roussy
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportROCHE
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGustave Roussy
    B.5.2Functional name of contact pointRegulatory affairs officer
    B.5.3 Address:
    B.5.3.1Street Address114, rue Edouard Vaillant
    B.5.3.2Town/ cityVillejuif
    B.5.3.3Post code94805
    B.5.3.4CountryFrance
    B.5.4Telephone number+33142116198
    B.5.5Fax number+33142116290
    B.5.6E-mailSPEC.Affaires.reglementaires@gustaveroussy.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameatezolizumab
    D.3.2Product code MPDL3280A
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATEZOLIZUMAB
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB126162
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with one of following metastatic tumours:
    - Metastatic colorectal cancer
    - Metastatic non-small lung cancer
    - Metastatic renal cell carcinoma
    Patients avec l'une des tumeurs métastatiques suivantes:
    - cancer colorectal métastatique
    - cancer pulmonaire non à petites cellules métastatique
    - cancer rénal métastatique
    E.1.1.1Medical condition in easily understood language
    - Metastatic colorectal cancer
    - Metastatic non-small lung cancer
    - Metastatic renal cell carcinoma
    - cancer colorectal métastatique
    - cancer pulmonaire non à petites cellules métastatique
    - cancer rénal métastatique
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine, in each cohort, the 1 year PFS rate (based on RECIST v1.1.) under combined SABR and anti-PDL1 atezolizumab therapy
    E.2.2Secondary objectives of the trial
    1. Determine the PFS rate under combined SABR and anti-PDL1 atezolizumab therapy

    2. Further describe, the efficacy of combination (SABR and atezolizumab) both on the irradiated lesions and the non-irradiated lesions based on tumour response indicators and clinical endpoints

    3. Determine the Treatment failure rate

    4. Evaluate the toxicity of atezolizumab in combination with SABR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be 18 years of age or older.
    2. Histologically or cytologically proven metastatic solid tumours including: colorectal (CRC, Microsatellite instability negative and positive), non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC).
    3. Patients with at most 5 measurables metastases by RECIST 1.1.
    At least one of them eligible for SABR in terms of dose constraints at organ at risk and ≤ 4 cm.
    At least one of them not treated but evaluable by RECIST 1.1.
    4.Evaluation by a radiation oncologist within 45 days prior to study registration, including imaging workup to document metastases
    5. The irradiated and unirradiated tumour sites must be accessible to tumour biopsy (additional written consent required)
    6. Patients may not have used any systemic anticancer treatment (approved or investigational agent) within 4 weeks prior to being enrolled into this study.
    7. Life expectancy of more than 3 months
    8. Patients must have adequate organ function
    9. Patients must be affiliated to a social security system
    E.4Principal exclusion criteria
    1. Metastases located to the brain and with clinical signs and/or leptomingeal carcinomatosis, or with indistinct borders making targeting not feasible
    2. Metastasis localized to the central part of the chest and requiring irradiation
    3. Irradiation by SABR should not include metastases located within 3 cm of the previously irradiated structures:
    * Spinal cord previously irradiated to > 40 Gy
    * Brachial plexus previously irradiated to > 50 Gy
    * Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
    * Brainstem previously irradiated to > 50 Gy
    * Lung previously irradiated with prior V20Gy > 30%
    4. Irradiation required for cord compression and for superior veina cava syndrome.
    5. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti−PD1, or anti−PDL1 therapeutic antibodies
    Patients who have received prior treatment with anti−CTLA-4 may be enrolled, provided at least 5 half-lives (approximately 75 days) have elapsed from the last dose of anti-CTLA-4 to the first dose of atezolizumab and there was no history of severe immune-mediated adverse effects from anti−CTLA-4 (NCI CTCAE Grade 3 and 4)
    6. Treatment with systemic immunostimulatory agents (including but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1
    7. Active or History of autoimmune or inflammatory disease
    Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
    Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
    Patients with vitiligo or psoriasis or grave’s disease, not requiring systemic treatment within the last 2 years, are eligible
    8. Any malignancy other than the disease under study in the past 5 years excepting skin cancers such as BCC or SCC
    9. Uncontrolled tumour-related pain.
    Patients requiring pain medication must be on a stable regimen at study entry.
    Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
    10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.
    11. Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or Ca > 12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
    Patients who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible. However, patients who are receiving denosumab prior to enrollment must be eligible to receive bisphosphonate instead and willing to switch to bisphosphonate therapy while on the study.
    12. Severe active co-morbidity as defined in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients alive and free of progression at 1 year. Progression is defined using RECIST 1.1. criteria, or death, whatever the cause of death, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor evaluation performed at baseline, week 4, week 7, week 13 and then every 12 weeks up to 1 year from treatment initiation or to disease progression, whichever occurs first.
    E.5.2Secondary end point(s)
    1. Delay from treatment initiation to date of progression. Progression is defined using RECIST 1.1. criteria, or death, whatever the cause of death, whichever occurs first.

    2. Tumour response indicators and clinical endpoints, assessed according to RECIST v 1.1, modified RECIST (mRECIST) and immune-related response criteria (irRC), are:
    - Disease Control Rate (DCR)
    - Objective Response Rate (ORR)R
    - Duration of response (DOR)
    - Progression-free survival (PFS)
    - Time to progression of non-irradiated lesions is computed as the delay from enrollment to the first occurrence of progression outside of the irradiated field
    - Time to progression of irradiated lesions is computed as the delay from enrollment to the first occurrence of progression of irradiated lesions;
    - Evaluation of the local control, distant control.

    3. Proportion of patients who cannot receive the planned irradiation dose or relative atezolizumab dose intensity below 75% of the initially targeted dose (i.e below 900 mg).

    4. AE according to NCI- CTCAE V4.03 scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Tumor evaluation performed at baseline, week 4, week 7, week 13 and then every 12 weeks up to 1 year after treatment discontinuation or disease progression, whichever occurs first.

    2. Tumor evaluation performed at baseline, week 4, week 7, week 13 and then every 12 weeks up to 1 year after treatment discontinuation or disease progression, whichever occurs first.

    3. At each treatment administration (every 3 weeks for atezolizumab and on week 4 for SABR)

    4. All along the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as being the last protocol-specified visit of the last patient, i.e the last visit of the last patient during the follow-up period (up to 12 months after atezolizumab discontinuation) or the last attempt by the investigator to schedull this visit for the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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