Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent or Metastatic Cervical Cancer (CAESURA)
NCT ID: NCT03912402
Last Updated: 2019-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
49 participants
INTERVENTIONAL
2018-12-25
2020-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BCD-100
BCD-100 mg/kg Q3W
BCD-100
Anti-PD-1 monoclonal antibody, IV infusion
Bevacizumab
IV infusion
Paclitaxel
IV infusion
Cisplatin (or carboplatin)
IV infusion
Interventions
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BCD-100
Anti-PD-1 monoclonal antibody, IV infusion
Bevacizumab
IV infusion
Paclitaxel
IV infusion
Cisplatin (or carboplatin)
IV infusion
Eligibility Criteria
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Inclusion Criteria
2. Age: 18 years and older at the signing of the informed consent;
3. Histologically verified (documented) adenomatous, adenosquamous, or squamous cervical cancer;
4. Newly diagnosed metastatic cervical cancer or recurrent/persistent cervical cancer;
5. Availability of archival histological tumor material (paraffin blocks) or consent to biopsy;
6. ECOG performance status of 0 or 1;
7. At least one RESICT 1.1-defined measurable target lesion confirmed by an independent review;
8. Patients with reproductive potential must agree to practice acceptable methods of birth control throughout the entire trial period, starting from signing the informed consent and up to 24 weeks after the last dose of investigational product.
Exclusion Criteria
2. Prior systemic treatment for recurrent, secondarily progressive or initially metastatic disease;
3. Chemotherapy, and / or radiation therapy, and / or chemo-radiation therapy for early stages of cervical cancer with disease progression / recurrence earlier than 6 months after the end of therapy;
4. Patients with severe concomitant factors or the effects of their treatment (hemorrhage, perforation, fistula);
5. Central nervous system (CNS) metastases;
6. Concomitant diseases or conditions which pose a risk of AE development during study treatment:
1. uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg;
2. stable angina functional class III-IV;
3. unstable angina or myocardial infarction less than 6 months prior to randomization;
4. NYHA Grade III-IV congestive heart failure;
5. atopic asthma, Stage III-IV COPD, angioedema;
6. severe respiratory failure;
7. any other diseases which pose unacceptable risk of AE development during study treatment in Investigator's opinion;
7. Active or known or suspected autoimmune disease (subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll);
8. Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to randomization;
9. Established diagnosis of coagulopathy and / or clinically significant bleeding, including nasal bleeding;
10. The need for regular intake of anticoagulants, antiplatelet agents, platelet function inhibitors, or their course application less than 1 month before being included in the study;
11. Hematologic disorders: neutrophils \<1500/mcl or platelets \<100 000/mcl or hemoglobin \<90 g/l;
12. Renal disorders: creatinine ≥ 1.5 x UNL;
13. Hepatic disorders: bilirubin ≥ 1.5 x UNL (excluding Gilbert's syndrome if bilirubin \< 50 µmol/l) or AST/ALT ≥ 3 x UNL (excluding subjects with liver metastases if AST/ALT \< 5 x UNL) or alkaline phosphatase ≥ 5 x UNL;
14. Any anti-cancer therapy less than 28 days prior to randomization;
15. Previous use of PD-1/PD-L1/PD-L2/CTLA-4 agent;
16. Previous use of VEGF/VEGFR inhibitors, including bevacizumab, ramucirumab, aflibercept and tyrosine kinase inhibitors;
17. Concomitant cancer (except for cervical carcinoma in situ after radical surgery or basal cell/ squamous cell carcinoma after radical surgery);
18. Clinically significant (≥2 degree) peripheral neuropathy or hearing impairment;
19. Any condition that prevents a patient from following the Protocol procedures (dementia, neurological or mental disorders, drug/alcohol abuse, etc.);
20. Simultaneous participation in other clinical trials , participation in other clinical trials within 30 days prior to the first dose of the investigational product;
21. Acute infection or the acute phase of chronic infection within 28 days prior the first dose of the investigational product;
22. Active HBV/HCV/HIV infection, active syphilis;
23. Patients unable to receive an IV infusions;
24. Patients unable to receive an IV contrast agent;
25. Hypersensitivity to any of the components of BCD-100, bevacizumab, paclitaxel, cisplatin (or carboplatin);
26. Life expectancy less than 6 months;
27. Significant adverse events (AE) of previous therapy excluding chronic and/or irreversible events which cannot affect study drug safety evaluation (e.g. alopecia);
28. Pregnancy or breast-feeding.
18 Years
FEMALE
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Principal Investigators
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Roman A Ivanov, PhD
Role: STUDY_DIRECTOR
Vice President R&D, JSC BIOCAD
Locations
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City Hospital No. 5
Barnaul, Altayskiy Kray, Russia
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, Arkhangelskaya oblast, Russia
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
Chelyabinsk, Chelyabinsk Oblast, Russia
National Medical Radiology Research Center
Obninsk, Kaluga Oblast, Russia
Clinical Oncologic Dispensary No. 1
Krasnodar, Krasnodar Kari, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky
Krasnoyarsk, Krasnoyarsk Krai, Russia
Murmansk Regional Clinical Hospital named after P.A. Bayandina
Murmansk, Murmansk Oblast, Russia
Clinical Oncology Dispensary
Omsk, Omsk Oblast, Russia
Republican Oncology Center
Saransk, Respublika Mordoviya, Russia
N.N. Petrov National Medical Research Center of Oncology (2)
Saint Petersburg, Sankt-Peterburg, Russia
LLC "New Clinic"
Pyatigorsk, Stavropol Kray, Russia
Stavropol Regional Clinical Oncology Center
Stavropol, Stavropol Kray, Russia
Sverdlovsk Regional Oncology Center
Yekaterinburg, Sverdlovsk Oblast, Russia
Republican Clinical Oncology Cente
Kazan', Tatarstan Republic, Russia
Regional Clinical Oncology Hospital
Yaroslavl, Yaroslavl Oblast, Russia
Moscow Clinical Scientific and Practical Center named A.S. Loginova
Moscow, , Russia
N.N. Blokhin National Medical Research Center of Oncology (2)
Moscow, , Russia
N.N. Blokhin National Medical Research Center of Oncology
Moscow, , Russia
JSC "Medsi Group of Companies"
Moscow, , Russia
Moscow City Oncology Hospital No. 62
Moscow, , Russia
JSC "Modern Medical Technologies"
Saint Petersburg, , Russia
LLC "AB Medical Group"
Saint Petersburg, , Russia
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, , Russia
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BCD-100-4/CAESURA
Identifier Type: -
Identifier Source: org_study_id
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