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Klinische Studien

CV-8102-008

PrüfplancodeISRCTNEudraCTClinicaltrials.govDRKS
CV-8201-0082016-003429-41NCT03291002

Phase I Studie mit intratumoraler Applikation von CV8102 bei Patienten mit fortgeschrittenem Melanom, Plattenepithelkarzinom der Haut, Kopf-Hals-Tumoren oder adenoidzystischem Karzinom der Speicheldrüsen

Status: Aktiv

Studienziel / Fragestellung

Primäres Prüfziel

  • Bestimmung der maximal verträglichen Dosis (maximum tolerated dose, MTD) und der empfohlenen Dosis (recommended dose, RD) einer Monotherapie mit intratumoral verabreichtem (IT) CV8102
  • Beurteilung und Beschreibung des Verträglichkeits- und Sicherheitsprofils von intratumoral verabreichtem CV8102 als Monotherapie oder in Kombination mit einem Anti-PD-1-Antagonisten.

Sekundäre Prüfziele

  • Beurteilung der Antitumoraktivität von intratumoral verabreichtem CV8102 anhand von Standardkriterien (irRECIST) und (RECIST) 1.1.
  • Beurteilung der Dauer des Ansprechens (duration of response, DOR), des progressionsfreien Überlebens (progression free survival, PFS) und der Krankheitskontrollrate (disease control rate, DCR) nach 6 Monaten gemäß irRECIST und RECIST 1.1.
  •  Beurteilung des Umfangs des Therapieansprechens bei injizierten und nicht-injizierten Läsionen, falls zutreffend.
  • •Beurteilung der Überlebenszeit

Diagnose

Patientenmerkmale

Alter

18-99

Einschlusskriterien

Key Inclusion Criteria:

  1. Patients enrolled into Cohorts A and B (single agent CV8102) must have:

    • histologically confirmed advanced cutaneous melanoma, cutaneous squamous cell carcinoma, head and neck squamous cell carcinoma, or adenoid cystic carcinoma with documented disease progression
    • not amenable to resection or locoregional radiation therapy with curative intent
    • failed approved standard therapies or for whom no standard therapy is available
    • at least 1 line of anti-cancer therapy for advanced disease (except adenoid cystic carcinoma)
  2. Patients enrolled into Cohort C (CV8102 in combination with anti-PD-1 therapy) must have

    • histologically confirmed advanced cMEL or hnSCC
    • indication for anti-PD-1 therapy or currently receiving anti-PD-1 therapy with stable of slowly progressing disease after at last 8 weeks (hnSCC) or 12 weeks (cMEL) of anti-PD-1
  3. Patients enrolled into Cohort D1 (CV8102 in combination with anti-PD-1 therapy) must have

    • histologically confirmed advanced cMEL
    • either anti-PD-1 naive patients with indication for anti-PD-1 therapy (Cohort D1a) or patients refractory to anti-PD-1 (Cohort D1b)
  4. Patients enrolled into Cohort D2 (CV8102 in combination with anti-PD-1 therapy) must have

    • histologically confirmed advanced hnSCC
    • patients refractory to anti-PD-1
  5. Presence of at least one injectable lesion that is measurable acc. to RECIST 1.1
  6. Recovered from prior toxicities to grade ≤ 1
  7. ECOG PS 0 or 1
  8. 18 years of age or older
  9. Adequate hematologic, renal, hepatic and coagulation function
  10. Use of effective contraception

Ausschlusskriterien

Key Exclusion Criteria:

  1. Rapidly progressing multi-focal metastatic or acutely life threatening disease
  2. Prior use of topical/localTLR-7/8 agonists within the past 6 months
  3. Clinically active central nervous system metastases and/or carcinomatous meningitis (patients with stable brain metastases are eligible)
  4. Ocular and mucosal melanoma
  5. Prior anti-cancer therapy administered 2-4 weeks prior to the first dose of study drug depending on the indication
  6. Tumors to be injected lying close to major blood vessels or nerves, or whose injection could potentially result in clinical adverse effects if post-treatment tumor swelling or inflammation were to occur
  7. Lesions that are to be injected in previously irradiated areas unless progressive tumor growth has been demonstrated (no prior irradiation of injected lesions on patients with melanoma)
  8. History of active coagulation or bleeding disorder or full dose anticoagulation within one week prior to enrollment; patients with melanoma and cutaneous squamous cell carcinoma with controlled oral anticoagulation are eligible
  9. Treatment with any investigational anticancer agent within 4 weeks prior to the first dose of study drug
  10. Acute hypophysitis or endocrinopathies that are not adequately controlled by hormonal replacement therapy or thyreostatic treatment
  11. Use of immune modulating drugs or immunologically active topical therapies within 28 days of administration of the first dose of study drug
  12. Systemic treatment with corticosteroids or other immunosuppressive medication within 28 days of the first dose of study drug (except physiological maintenance/replacement steroid doses, topical steroids outside the injected lesion or inhaled steroids); patients are eligible if steroid requirement is < 10 mg/day of prednisone (or equivalent) for at least 2 weeks
  13. History of active autoimmune disease requiring immunosuppressive medication (except vitiligo)
  14. Known malignancies or other types that have occured or reoccurred within the previous 5 years
  15. Recent thromboembolic complications, or clinically significant cardiovascular disease, or any other uncontrolled illness that would pose a risk to patient safety
  16. Severe infection or acute inflammatory state

Studiendesign

  • Phase I
  • Multizentrisch
  • Prospektiv
  • Kohorte
  • Open Label

Intervention

Experimental: Cohort A
Dose escalation of CV8102
Biological: CV8102
CV8102 alone
Experimental: Cohort B
Optional expansion cohorts of CV8102
Biological: CV8102
CV8102 alone
Experimental: Cohort C
Dose escalation of CV8102 + anti-PD-1 therapy
Biological: CV8102 + anti-PD-1 therapy
CV8102 in combination with standard of care anti-PD-1 therapy
Experimental: Cohort D
Optional expansion of CV8102 + anti-PD-1 therapy
Biological: CV8102 + anti-PD-1 therapy
CV8102 in combination with standard of care anti-PD-1 therapy

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

CureVac GmbH

    Prüfzentren

    Medizinische Klinik & Poliklinik III (Bonn)

    Studienbüro

    Status

    Aktiv

    Prüfer (Hauptprüfer im Zentrum)

    Univ.-Prof. Dr. med. Peter Brossart

    Stellvertretender Prüfer

    • Dr. Franz-Georg Bauernfeind

    Studienkontakt im Prüfzentrum

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