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    Summary
    EudraCT Number:2018-001167-23
    Sponsor's Protocol Code Number:IMMU-132-06
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-09-08
    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 ConcernedGermany - PEI
    A.2EudraCT number2018-001167-23
    A.3Full title of the trial
    A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Sacituzumab Govitecan in Participants with Urothelial Cancer That Cannot Be Removed or Has Spread
    A.4.1Sponsor's protocol code numberIMMU-132-06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03547973
    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 SponsorGilead Sciences, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897476
    B.5.6E-mailclinical.trials@gilead.com
    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 Yes
    D.2.1.1.1Trade name Trodelvy
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSacituzumab govitecan
    D.3.2Product code IMMU-132
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNSACITUZUMAB GOVITECAN
    D.3.9.1CAS number 1491917-83-9
    D.3.9.2Current sponsor codeIMMU-132
    D.3.9.4EV Substance CodeSUB191213
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Bavencio
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate for 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 INNAVELUMAB
    D.3.9.3Other descriptive nameavelumab
    D.3.9.4EV Substance CodeSUB180078
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    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.IMP: 3
    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 nameDomvanalimab
    D.3.2Product code AB154
    D.3.4Pharmaceutical form Concentrate for 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 INNDomvanalimab
    D.3.9.1CAS number 2368219-35-4
    D.3.9.2Current sponsor codeAB154
    D.3.9.3Other descriptive nameWBP2117
    D.3.9.4EV Substance CodeSUB207237
    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 No
    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.IMP: 4
    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 nameZimberelimab
    D.3.2Product code AB122
    D.3.4Pharmaceutical form Concentrate for 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 INNZimberelimab
    D.3.9.2Current sponsor codeAB122
    D.3.9.4EV Substance CodeSUB207236
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 No
    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
    Histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial carcinoma of the urinary tract predominant
    E.1.1.1Medical condition in easily understood language
    Malignant urothelial cancer (UC) of renal pelvis, bladder, urethra or ureter
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10077840
    E.1.2Term Urothelial cancer of renal pelvis
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046714
    E.1.2Term Urothelial carcinoma bladder
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046723
    E.1.2Term Urothelial carcinoma ureter
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046728
    E.1.2Term Urothelial carcinoma urethra
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - The primary objective is Objective Response Rate (ORR) based on BICR by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (Cohorts 3, 4 and 6; Cohorts 1 and 2 by central review)

    - PFS based on central review by RECIST 1.1 criteria (Cohort 5 only)
    E.2.2Secondary objectives of the trial
    • Cohort 1 and 2
    - DOR based on central review by RECIST 1.1
    - PFS based on central review by RECIST 1.1
    - OS
    • Cohort 3
    - DOR, CBR, and PFS based on BICR by RECIST 1.1
    - ORR, DOR, CBR, and PFS based on investigator review by RECIST 1.1
    - OS
    - Safety and tolerability of SG in combination with pembrolizumab
    • Cohort 4
    - DOR, CBR, and PFS based on BICR by RECIST 1.1
    - ORR, DOR, CBR, and PFS based on investigator review by RECIST 1.1 and iRECIST
    - OS
    - Safety and tolerability of SG in combination with cisplatin
    • Cohort 5
    - OS
    - Safety and tolerability of SG in combination with ZIM (Cohort 5 Arm 1)
    • Cohort 6
    - DOR, CBR, and PFS based on BICR by RECIST 1.1
    - ORR, DOR, CBR, and PFS based on investigator review by RECIST 1.1 and iRECIST
    - OS
    - Safety and tolerability of SG monotherapy (Cohort 6 Arm 1)
    - Safety and tolerability of SG in combination with ZIM (Cohort 6 Arm 2)
    - Safety and tolerability of SG in combination with ZIM and DOM (Cohort 6 Arm 3)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male subjects, >=18 years of age, able to understand and give written informed consent.
    2. Subjects with histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic UC.
    Upper and lower tract tumors are permitted and mixed histologies are permitted if UC is the predominant histology.
    3. Cohorts 4, 5 and 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma must be provided for biomarker testing including PD-L1 and Trop-2.
    4. ECOG Performance status score of 0 or 1.
    5. Cohort 1: Have had progression or recurrence of UC following receipt of platinum-containing regimen (cisplatin or carboplatin):
    a) Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
    b) Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with ecurrence/progression ≤12 months following completion of therapy.
    6. Cohort 1: In addition to #5, have had progression or recurrence of UC following receipt of an anti-PD-1/PD-L1 therapy and
    have a creatinine clearance ≥60 ml/min.
    7. Cohort 2: Were ineligible for platinum-based therapy* and have had progression or recurrence of UC therapy for metastatic disease with antiPD1/PD-L1 therapy. Subject may not have received any platinum for treatment of recurrent, metastatic or advanced disease.
    8. *Cisplatin-ineligible
    9. Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy
    10. Cohort 4: Cisplatin-eligible subject who has not received any therapy, specifically platinum-based chemotherapy in the metastatic or unresectable locally advanced setting.
    11. Cohort 1, 2, 3: Adequate hematology without transfusion support or growth factor support within 2 weeks of study drug initiation (hemoglobin >9 g/dL, absolute neutrophil count (ANC) >1,500 per mm3, and Platelets >100,000 per μL).
    12. Cohort 6: Subject with no prior therapy for metastatic disease or for unresectable locally advanced disease with the following exceptions:
    a) Subjects who received neoadjuvant chemotherapy with curative intent with recurrence >12 months from completion of therapy are permitted.
    b) Subjects who received adjuvant chemotherapy following cystectomy with curative intent with recurrence >12 months from completion of therapy are permitted.
    13. Cohort 6: Cisplatin-ineligible
    14. Cohort 6: Checkpoint inhibitor therapy naïve or >12 months from completion of for adjuvant therapy are permitted.
    15. Cohorts 4, 5 and 6: Adequate hematology without transfusion support or growth factor support within 2 weeks of study drug initiation (ANC ≥1500 per mm3, platelets ≥100,000 per μL, and hemoglobin ≥9 g/dL).
    16. Adequate hepatic function (Bilirubin ≤1.5 ULN, AST and ALT ≤2.5 xULN or ≤5 x ULN if known liver metastases and serum albumin >/=3 g/dl)).
    17. Cohorts 1, 2, 3 and 5: Creatinine clearance >/= 30mL/min as calculated by the Cockroft-Gault formula unless otherwise specified.
    18. Cohort 4: Creatinine clearance of at least 50 mL/min calculated by Cockcroft–Gault formula or another validated tool. For subjects receiving cisplatin at 70 mg/m2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL/min calculated by Cockcroft–Gault formula or another validated tool is required. Subjects with creatinine clearance
    between 50 to 59 mL/min are to receive a split dose of cisplatin.
    19. Cohort 5: Subjects received at least 4 cycles and no more than 6 cycles of GEM+CIS. No other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after >12 months from completion of therapy.
    a) No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator)
    b) Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.
    20. Subjects must have a 3-month life expectancy.
    21. Adequate coagulation (Prothrombin Time (PT) or INR and Activated Partial Thromboplastin Time (aPTT) ≤1.5xULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of
    intended use of anticoagulants.
    22. Cohorts 4 & 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
    23. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 16.7.
    24. Subject must be willing and able to comply with all protocol requirements.
    E.4Principal exclusion criteria
    1. Women who are pregnant or lactating.
    2. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of trial treatment.
    3. Has a diagnosis of immunodeficiency.
    4. Has had a prior anti-cancer mAb within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1) from adverse events due to agents administered more than 4 weeks earlier.
    5. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 from adverse events due to a previously administered agent.
    Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.
    Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
    6. Cohorts 4 and 5: Refractory to platinum ( in the neoadjuvant/adjuvant setting.
    7. Requires concomitant medications that significantly interfere with
    UGT1A1 with no alternate option available.
    8. Subjects with Gilbert’s disease.
    9. Subjects who previously received irinotecan.
    10. Has an active second malignancy.
    11. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids greater than 20 mg of prednisone daily for brain metastases for at least 7 days prior to trial treatment. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.
    12. Has active cardiac disease, defined as:
    a. Myocardial infarction or unstable angina pectoris within 6 months of the first date of study therapy.
    b. History of serious ventricular arrhythmia , high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
    c. New York Heart Association Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%.
    13. Has active chronic inflammatory bowel disease and subjects with a history of bowel obstruction.
    14. Has prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of enrollment.
    15. Must be at least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids ≤ 20 mg prednisone or equivalent daily are permitted for reasons outside of CNS disease provided the dose is stable for 4 weeks).
    16. Has an active infection requiring systemic therapy.
    17. Have known history of HIV-1 or 2 with uncontrolled viral load (ie, ≥ 200 copies/mL or CD4+ T-cell count < 350 cells/μL) or taking medications that may interfere with metabolism
    of study drugs. No HIV testing is required unless mandated by local health authority.
    18. Has active hepatitis B virus or hepatitis C virus defined as those with a detectable viral load.
    19. Has 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.
    20. Use of live attenuated vaccine(s) 30 days before start of study drug.
    21. Cohorts 3 to 5: Has an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive
    drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
    22. Cohorts 3, 4, 5, and 6: Has received a live vaccine including COVID-19 vaccines within 30 days prior to the first dose of study drug(s). Seasonal flu and COVID-19 vaccines that do not
    contain live virus are permitted.
    23. Cohorts 3, 4, 5, and 6: Has received immunosuppressive therapy within 3 years prior to C1D1.
    24. Cohorts 3, 4, 5, and 6: Has history or evidence of interstitial lung disease or non-infectious pneumonitis.
    25. Cohort 3: Has received anti-PD-1/PD-L1 therapy previously. Cohorts 4, 5, and 6: For subjects who received prior CPI, a treatment-free interval >12 months between the last
    treatment administration and the date of recurrence is required.
    26. Cohort 4 and Cohort 6: Hypersensitivity or anaphylaxis to cisplatin, CARBO, or GEM.
    27. Cohorts 1 to 6: Have inability to tolerate or are allergic to SG, or CPIs, or are unable or unwilling to receive the doses specified in the protocol.
    28. Cohort 4: ≥Grade 2 hearing loss.
    E.5 End points
    E.5.1Primary end point(s)
    In Cohorts 3, 4 and 6, the primary endpoint is ORR based on BICR by RECIST 1.1 criteria; In Cohort 5, the primary endpoint is PFS as assessed based on BICR by RECIST 1.1 criteria (Cohorts 1 and 2 by central review).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End Of Trial
    E.5.2Secondary end point(s)
    Secondary endpoints include DOR, CBR, and PFS based on central review by RECIST 1.1 criteria and ORR, DOR, CBR, and PFS based
    on investigator assessment by RECIST 1.1 criteria. In Cohort 3, 4 and 6, these secondary endpoints (ORR, DOR, CBR, and PFS) will also be evaluated by the investigator according to iRECIST 1.1 criteria
    E.5.2.1Timepoint(s) of evaluation of this end point
    The ORR is defined as the rate of the best overall response as CR or partial response (PR).
    The DOR will be calculated as the date of the first evaluation showing documented response, PR, or CR, to the date of the first PD or death.
    PFS will be defined as the time from first dose until objective tumor progression, as assessed based on central review, or death, whichever comes first.
    CBR is defined as CR + PR + stable disease (SD) for at least 6 months.
    OS will be measured from the date of first dose to death from any cause.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Greece
    Italy
    Korea, Republic of
    Spain
    United Kingdom
    United States
    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
    Last patient last visit
    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
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days10
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 337
    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 state81
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 181
    F.4.2.2In the whole clinical trial 421
    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)
    Standard of care
    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 Decision2023-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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