. 2018 Sep 12;18:888. doi: 10.1186/s12885-018-4764-0

Table 1.

DURVIT Inclusion/Exclusion criteria

Inclusion criteria	Exclusion criteria
1. Age > 18 years at time of study entry 2. Willing and able to undergo the planned study procedures 3. World Health Organization (WHO) performance status of 0 or 1 4. Written informed consent 5. Histologically confirmed cervical cancer of all histological types 6. Scheduled to undergo (radical) hysterectomy with lymphadenectomy 7. No indication of an active infectious disease: HIV, HCV and HBV negative 8. No history of autoimmune disease or systematic underlying disease which might affect immunocompetence 9. Adequate bone marrow function 10. Subjects must either be of non-reproductive potential or must have a negative urine pregnancy test before study entry 11. Ability of subject to understand Dutch language	1. Prior treatment with immunotherapy including therapeutic vaccines 2. Involvement in the planning and/or conduct of the study 3. Participation in a study with another investigational drug within 30 days prior to enrolment in this study 4. Major surgery within 28 days before inclusion (conization or biopsy is not major surgery) 5. Severe cardiac, respiratory, or metabolic disease 6. Use of oral anticoagulant drugs (except ascal) 7. Severe infections requiring antibiotics 8. Lactation or pregnancy 9. 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 10. Any prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous therapy, or any unresolved irAE >Grade 1 11. Active or prior documented autoimmune disease within the past 2 years 12. Active or prior documented inflammatory bowel disease 13. History of primary immunodeficiency/allogeneic organ transplant/previous clinical diagnosis of tuberculosis/uncontrolled intercurrent illness 14. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab 15. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results

Inclusion criteria

Exclusion criteria

1. Age > 18 years at time of study entry
2. Willing and able to undergo the planned study procedures
3. World Health Organization (WHO) performance status of 0 or 1
4. Written informed consent
5. Histologically confirmed cervical cancer of all histological types
6. Scheduled to undergo (radical) hysterectomy with lymphadenectomy
7. No indication of an active infectious disease: HIV, HCV and HBV negative
8. No history of autoimmune disease or systematic underlying disease which might affect immunocompetence
9. Adequate bone marrow function
10. Subjects must either be of non-reproductive potential or must have a negative urine pregnancy test before study entry
11. Ability of subject to understand Dutch language

1. Prior treatment with immunotherapy including therapeutic vaccines
2. Involvement in the planning and/or conduct of the study
3. Participation in a study with another investigational drug within 30 days prior to enrolment in this study
4. Major surgery within 28 days before inclusion (conization or biopsy is not major surgery)
5. Severe cardiac, respiratory, or metabolic disease
6. Use of oral anticoagulant drugs (except ascal)
7. Severe infections requiring antibiotics
8. Lactation or pregnancy
9. 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
10. Any prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous therapy, or any unresolved irAE >Grade 1
11. Active or prior documented autoimmune disease within the past 2 years
12. Active or prior documented inflammatory bowel disease
13. History of primary immunodeficiency/allogeneic organ transplant/previous clinical diagnosis of tuberculosis/uncontrolled intercurrent illness
14. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
15. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results