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    Summary
    EudraCT Number:2021-001009-56
    Sponsor's Protocol Code Number:MK-7684A-005
    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:2021-06-22
    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 number2021-001009-56
    A.3Full title of the trial
    A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Coformation of Vibostolimab (MK-7684) with Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants with Selected Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-7684A With or Without Other Anticancer Therapies in Participants with Selected Solid Tumors
    A.3.2Name or abbreviated title of the trial where available
    MK-7684A With or Without Other Anticancer Therapies in Participants with Selected Solid Tumors
    A.4.1Sponsor's protocol code numberMK-7684A-005
    A.5.4Other Identifiers
    Name:INDNumber:155349
    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 SponsorMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGCTO
    B.5.3 Address:
    B.5.3.1Street Address126 East Lincoln Ave., P.O. Box 2000
    B.5.3.2Town/ cityRahway, NJ
    B.5.3.3Post code07065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+17325947601
    B.5.6E-mailmsd42bamg@msd.de
    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 nameMK-7684A
    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 INNVibostolimab
    D.3.9.1CAS number 2231305-30-7
    D.3.9.2Current sponsor codeMK-7684
    D.3.9.4EV Substance CodeSUB203865
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    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.IMP: 2
    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 KEYTRUDA (pembrolizumab, MK-3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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 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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Yes
    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.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 nameLenvatinib
    D.3.2Product code E7080
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENVATINIB MESILATE
    D.3.9.1CAS number 857890-39-2
    D.3.9.2Current sponsor codeMK-7902
    D.3.9.3Other descriptive nameLENVATINIB MESILATE
    D.3.9.4EV Substance CodeSUB72971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 nameLenvatinib
    D.3.2Product code E7080
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENVATINIB MESILATE
    D.3.9.1CAS number 857890-39-2
    D.3.9.2Current sponsor codeMK-7902
    D.3.9.3Other descriptive nameLENVATINIB MESILATE
    D.3.9.4EV Substance CodeSUB72971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) No
    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
    Advanced solid tumors
    E.1.1.1Medical condition in easily understood language
    Cancer of the cervix, Uterine (endometrial), Head and Neck, Bile duct, Esophagus, Breast, Liver, Bladder, Ovarian and Gastric cancer.
    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 10065252
    E.1.2Term Solid tumor
    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
    1. To compare MK-7684A to pembrolizumab alone with respect to objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) in participants with cervical cancer enrolled in Cohort A1.
    2. To compare MK-7684A to pembrolizumab alone with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in participants with cervical cancer enrolled in Cohort A1.
    3. To evaluate MK-7684A alone or with anticancer therapies with respect to ORR per RECIST 1.1 as assessed by the investigator in participants with selected solid tumors.
    4. To evaluate MK-7684A in combination with anticancer therapies with respect to PFS per RECIST 1.1 at 9 months (PFS-9) and 12 months (PFS-12) as assessed by the investigator in participants with previously untreated advancec epithelial ovarian cancer enrolled in Cohort I.
    E.2.2Secondary objectives of the trial
    1.To evaluate MK-7684A alone or with other anticancer therapies for overall survival.
    2.To evaluate MK-7684A alone or with other anticancer therapies for PFS per RECIST 1.1, per investigator in participants with selected solid tumors.
    3.To evaluate MK-7684A alone for duration of response per RECIST 1.1 per BICR in participants in Cohort A1.
    4.To evaluate MK-7684A alone or with other anticancer therapies for DOR per RECIST 1.1, per investigator in participants with selected solid tumors.
    5.To compare MK-7684A to pembrolizumab for ORR per RECIST 1.1, per investigator in participants with cervical cancer enrolled in Cohort A1.
    6.To compare MK-7684A to pembrolizumab for PFS per RECIST 1.1, per investigator in participants with cervical cancer enrolled in Cohort A1.
    7.To evaluate change from baseline in health-related quality-of-life (HRQoL) in participants enrolled in Cohort A1.
    8. To evaluate the safety and tolerability of MK-7684A alone or with other anticancer therapies.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A participant will be eligible for inclusion in the study if the participant:
    1. Has histologically or cytologically confirmed, advanced (unresectable or metastatic) solid tumor as follows:
    • Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
    • Endometrial cancer
    • Head and neck squamous cell carcinoma (HNSCC)
    • Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma)
    • Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
    • Triple-negative breast cancer (TNBC)
    • Hepatocellular carcinoma (HCC)
    • Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
    • Ovarian cancer
    • Gastric cancer
    2. Has measurable disease per RECIST 1.1 as assessed by the BICR (Cohort A1 only) or local site investigator/radiology (all other cohorts).
    3. Can provide a newly obtained core or excisional biopsy of a tumor lesion
    4. Is male or female, who is at least 18 years of age at the time of providing informed consent.
    Note: For Cohort I: participant must be female
    5. Has an ECOG Performance Status of either 0 or 1 (ECOG PS of 2 allowed for Cohort H only), as assessed within 7 days before starting study intervention.
    Note: For Cohort I: ECOG performance status must meet eligibility before start of lead-in chemotherapy and before C1D1
    6. Has a predicted life expectancy of at least 3 months.
    7. Male participants must agree to follow contraceptive guidance
    8. Female participants are not pregnant or breastfeeding, not women of child-bearing potential (WOCBP) or are WOCBP and agree to follow contraceptive guidance.
    9. The participant (or legally acceptable representative) has provided documented informed consent/assent for the study.
    10. Has adequately controlled BP with or without antihypertensive medications,
    Note: this criterion applies to participants who will receive lenvatinib or bevacizumab
    11. HIV-infected participants must have well controlled HIV on ART
    12. Participants who are HbsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization/allocation.
    13. Participants with history of HCV infection are eligible if HCV viral load is undetectable at Screening.
    14. Has adequate organ function
    Note: For Cohort I: Adequate organ functions must meet eligibility before start of lead-in chemotherapy and before C1D1.
    For the complete list of criteria, please refer to the protocol.
    E.4Principal exclusion criteria
    1. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
    2. HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
    3. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-TIGIT agent
    4. Has received prior systemic anticancer therapy including investigational agents within 4 weeks. Note: This does not include leadin chemotherapy in Cohort I
    5. Has received prior radiotherapy within 2 weeks or radiation-related toxicities requiring corticosteroids
    6. Has received a live or live-attenuated vaccine within 30 days
    7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days
    8. Has known active CNS metastases and/or carcinomatous meningitis
    9. Known severe hypersensitivity (≥Grade 3) to study medication or any of their excipients
    10. Has an active autoimmune disease that has required systemic treatment in past 2 years
    11. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    12. Has an active infection requiring systemic therapy
    13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation
    14. Has present accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks
    15. Has concurrent active hepatitis B and hepatitis C infection
    16. Has not adequately recovered from major surgery
    17. Participants unlikely to comply with the requirements of the study
    18. Has had an allogenic organ transplant
    19. Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
    All Cohorts except B1:
    20. Has known MSI-H or MMR deficient cancer
    Cohort B1 and B2 only:
    21. Greater than 1 prior systemic chemotherapy regimen
    For participants who will receive Lenvatinib: Cohort B2 & G:
    22. Has had major surgery within 3 weeks
    23. Has current, clinically relevant ≥Grade 3 fistula
    24. Has urine protein ≥1 g/24 hours
    25. Has a LVEF below the normal range
    26. Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
    27. Has prolongation of QTc interval to >480 ms
    28. Has clinically significant cardiovascular disease within 12 months
    29. Has serious nonhealing wound, ulcer, or bone fracture
    30. Has GI malabsorption
    31. Has active hemoptysis
    32. Has had esophageal or gastric variceal bleeding within the last 6 months (G only)
    Cohort D2:
    33. Has had previous systemic therapy for advanced or unresectable biliary tract cancer
    Cohort F:
    34. Has a history of class II-IV congestive heart failure or myocardial infarction within 6 months
    Cohort H:
    35. Has disease suitable for local therapy administered with curative intent
    36. Is receiving hemodialysis
    Cohort I:
    37. Has mucinous, germ cell, or borderline tumor of the ovary
    38. Has ongoing Grade 3 or 4 toxicity, excluding alopecia, following chemotherapy administered during the Lead-in Period
    39. Has received colony-stimulating factors within 4 weeks prior to receiving chemotherapy during the Lead-in Period
    40. Is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
    41. Has had surgery <6 months prior to screening to treat borderline tumors, early stage EOC or early stage fallopian tube cancer.
    42. Has uncontrolled hypertension
    43. Has current, clinically relevant bowel obstruction (incl. subocclusive disease), abdominal fistula or gastrointestinal perforation, related to underlying EOC
    44. Has a history of hemorrhage, hemoptysis or active gastrointestinal bleeding within 6 months prior to allocation
    45. Has received prior treatment for any stage of OC
    46. Is a participant for whom intraperitoneal chemotherapy is planned or has been administered as 1L therapy
    47. Has severe hypersensitivity (≥Grade 3) to pembrolizumab, carboplatin, paclitaxel, or bevacizumab and/or any of their excipients
    48. Has resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator or participant has congenital long QT syndrome
    49. Had either major surgery within 3 weeks of allocation or has not recovered from major surgery
    Cohort J
    50. Has squamous cell or undifferentiated gastric cancer
    51. Has preexisting peripheral neuropathy >Grade 1
    52. Has had previous therapy for locally advanced, unresectable or
    metastatic gastric cancer
    53. Has received prior therapy with an agent directed to a stimulatory or coinhibitory T-cell receptor within 4 weeks of randomization/allocation
    E.5 End points
    E.5.1Primary end point(s)
    1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR).
    2. Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR.
    3. ORR per RECIST 1.1 as Assessed by Investigator.
    4. PFS per RECIST 1.1 as Assessed by Investigator at 9 months
    5. PFS per RECIST 1.1 as Assessed by Investigator at 12 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 2 years.
    2. Up to approximately 2 years.
    3. Up to approximately 2 years.
    4. 9 months
    5. 12 months
    E.5.2Secondary end point(s)
    1. Overall Survival (OS).
    2. PFS per RECIST 1.1 as Assessed by Investigator.
    3. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR.
    4. DOR per RECIST 1.1 as Assessed by Investigator.
    5. ORR per RECIST 1.1 as Assessed by Investigator
    6. Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30).
    7. Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5).
    8. Number of Participants Who Experienced One or More Adverse Events (AEs).
    9. Number of Participants Who Discontinued Study Intervention Due to an AE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 5.5 years.
    2. Up to approximately 2 years.
    3. Up to approximately 2 years.
    4. Up to approximately 2 years.
    5. Up to approximately 2 years.
    6. Baseline and up to approximately 2 years.
    7. Baseline and up to approximately 2 years.
    8. Up to approximately 2 years.
    9. Up to approximately 2 years.
    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 Yes
    E.6.13.1Other scope of the trial description
    Exploratory biomarker analysis
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Basket Study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial9
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Chile
    Colombia
    Taiwan
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Turkey
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Receipt the last laboratory test result or LVLS, whichever comes last.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    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: 244
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 366
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 610
    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 Decision2021-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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