NL-OMON50047CompletedNot Applicable
'DURVIT': Single low-dose DURValumab IntraTumorally injected in cervical cancer: safety, toxicity and effect on the primary tumour- and lymph node microenvironment. - DURVIT
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •* Age > 18 years at time of study entry
- •* Willing and able to undergo the planned study procedures
- •* World Health Organisation (WHO) performance status of 0 or 1
- •* Written informed consent
- •* Histologically confirmed cervical cancer of all histological types
- •* Scheduled to undergo radical hysterectomy and lymphadenectomy
- •* No indication of an active infectious disease: HIV, HCV and HBV negative
- •* No history of autoimmune disease or systematic underlying disease which might affect immunocompetence
- •* Adequate bone marrow function
- •* Subjects must either be of non-reproductive potential or must have a negative urine pregnancy test upon study entry
- •* Ability of subject to understand Dutch language
Exclusion Criteria
- •* Prior treatment with immunotherapy, including therapeutic vaccines
- •* Involvement in the planning and/or conduct of the study
- •* Participation in a study with another investigational drug within 30 days prior to enrolment in this study
- •* Major surgery within 28 days before inclusion (conization or biopsy is not major surgery)
- •* Severe cardiac, respiratory, or metabolic disease
- •* Use of oral anticoagulant drugs (except ascal)
- •* Severe infections requiring antibiotics
- •* Lactation or pregnancy
- •* Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- •* Any prior Grade *3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
- •* Active or prior documented autoimmune disease within the past 2 years
- •* Active or prior documented inflammatory bowel disease
- •* History of primary immunodeficiency/allogeneic organ transplant/previous clinical diagnosis of tuberculosis/ uncontrolled intercurrent illness
- •* Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
- •* Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Investigators
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Single low-dose DURValumab IntraTumorally injected in cervical cancer: safety, toxicity and effect on the primary tumour- and lymph node microenvironment.Cervical cancer. Cervix carcinoma. PD-L1 checkpoint inhibition. Checkpoint inhibitor. Immunotherapy. Intratumoral. Human Papillomavirus. Cervixcarcinoom. Baarmoederhalskanker. Durvalumab. Immuuntherapie. Intratumoraal. Humaan Papilloma Virus.NL-OMON29031Academic Medical Center (AMC)24
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