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)
Multicenter Open-Label Single-Arm Trial of the Efficacy and Safety of BCD-100 in Combination With Platinum-Based Chemotherapy and Bevacizumab as First Line Treatment in Patients With Recurrent, Persistent or Metastatic Cervical Cancer
1 other identifier
interventional
49
1 country
24
Brief Summary
This is a multicenter, open-label, single-arm study of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) in combination with platinum-based chemotherapy and bevacizumab as first-line treatment in patients with recurrent/persistent or metastatic cervical cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2018
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 25, 2018
CompletedFirst Submitted
Initial submission to the registry
April 10, 2019
CompletedFirst Posted
Study publicly available on registry
April 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2020
CompletedMay 9, 2019
May 1, 2019
1.5 years
April 10, 2019
May 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
ORR is defined as the percentage of the participants in the mITT population who have a Complete Response or a Partial Response. The ORR will be assessed by a blind independent central reviewer per RECIST 1.1 and iRECIST.
6 months
Secondary Outcomes (3)
Median Progression-free Survival (PFS)
1 year
1-year Progression-free Survival (PFS)
1 year
1-year Overall Survival (OS)
1 year
Study Arms (1)
BCD-100
EXPERIMENTALBCD-100 mg/kg Q3W
Interventions
Eligibility Criteria
You may qualify if:
- Signed Informed Consent Form and the subject's ability to follow the Protocol requirements;
- Age: 18 years and older at the signing of the informed consent;
- Histologically verified (documented) adenomatous, adenosquamous, or squamous cervical cancer;
- Newly diagnosed metastatic cervical cancer or recurrent/persistent cervical cancer;
- Availability of archival histological tumor material (paraffin blocks) or consent to biopsy;
- ECOG performance status of 0 or 1;
- At least one RESICT 1.1-defined measurable target lesion confirmed by an independent review;
- 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.
You may not qualify if:
- Indications for radical therapy (surgical or radiotherapy);
- Prior systemic treatment for recurrent, secondarily progressive or initially metastatic disease;
- 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;
- Patients with severe concomitant factors or the effects of their treatment (hemorrhage, perforation, fistula);
- Central nervous system (CNS) metastases;
- Concomitant diseases or conditions which pose a risk of AE development during study treatment:
- uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg;
- stable angina functional class III-IV;
- unstable angina or myocardial infarction less than 6 months prior to randomization;
- NYHA Grade III-IV congestive heart failure;
- atopic asthma, Stage III-IV COPD, angioedema;
- severe respiratory failure;
- any other diseases which pose unacceptable risk of AE development during study treatment in Investigator's opinion;
- 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);
- Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days prior to randomization;
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocadlead
Study Sites (24)
City Hospital No. 5
Barnaul, Altayskiy Kray, 656045, Russia
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, Arkhangelskaya oblast, 163045, Russia
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
Chelyabinsk, Chelyabinsk Oblast, 454087, Russia
National Medical Radiology Research Center
Obninsk, Kaluga Oblast, 249036, Russia
Clinical Oncologic Dispensary No. 1
Krasnodar, Krasnodar Kari, 350040, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky
Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia
Murmansk Regional Clinical Hospital named after P.A. Bayandina
Murmansk, Murmansk Oblast, 183047, Russia
Clinical Oncology Dispensary
Omsk, Omsk Oblast, 644013, Russia
Republican Oncology Center
Saransk, Respublika Mordoviya, 430005, Russia
N.N. Petrov National Medical Research Center of Oncology (2)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
LLC "New Clinic"
Pyatigorsk, Stavropol Kray, 357500, Russia
Stavropol Regional Clinical Oncology Center
Stavropol, Stavropol Kray, 355047, Russia
Sverdlovsk Regional Oncology Center
Yekaterinburg, Sverdlovsk Oblast, 620036, Russia
Republican Clinical Oncology Cente
Kazan', Tatarstan Republic, 420029, Russia
Regional Clinical Oncology Hospital
Yaroslavl, Yaroslavl Oblast, 150054, Russia
Moscow Clinical Scientific and Practical Center named A.S. Loginova
Moscow, 111123, Russia
N.N. Blokhin National Medical Research Center of Oncology (2)
Moscow, 115478, Russia
N.N. Blokhin National Medical Research Center of Oncology
Moscow, 115478, Russia
JSC "Medsi Group of Companies"
Moscow, 123056, Russia
Moscow City Oncology Hospital No. 62
Moscow, 143423, Russia
JSC "Modern Medical Technologies"
Saint Petersburg, 190013, Russia
LLC "AB Medical Group"
Saint Petersburg, 197082, Russia
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 197758, Russia
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Saint Petersburg, 197758, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Roman A Ivanov, PhD
Vice President R&D, JSC BIOCAD
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2019
First Posted
April 11, 2019
Study Start
December 25, 2018
Primary Completion
July 7, 2020
Study Completion
July 7, 2020
Last Updated
May 9, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share