Cervical CancerPhase 2NCT03912402
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)
A Phase 2 study testing BCD-100, Bevacizumab and Paclitaxel in people with Cervical Cancer and Cervical Cancer Metastatic, run by Biocad at 24 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Cancer Metastatic, Cervical Cancer Recurrent
- What is being tested?
- BCD-100, Bevacizumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 24 sitesRussia
- Study dates
- 25 Dec 2018to 7 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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;
- Established diagnosis of coagulopathy and / or clinically significant bleeding, including nasal bleeding;
- 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;
- Hematologic disorders: neutrophils <1500/mcl or platelets <100 000/mcl or hemoglobin <90 g/l;
- Renal disorders: creatinine ≥ 1.5 x UNL;
- 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;
- Any anti-cancer therapy less than 28 days prior to randomization;
- Previous use of PD-1/PD-L1/PD-L2/CTLA-4 agent;
- Previous use of VEGF/VEGFR inhibitors, including bevacizumab, ramucirumab, aflibercept and tyrosine kinase inhibitors;
- Concomitant cancer (except for cervical carcinoma in situ after radical surgery or basal cell/ squamous cell carcinoma after radical surgery);
- Clinically significant (≥2 degree) peripheral neuropathy or hearing impairment;
- Any condition that prevents a patient from following the Protocol procedures (dementia, neurological or mental disorders, drug/alcohol abuse, etc.);
- Simultaneous participation in other clinical trials , participation in other clinical trials within 30 days prior to the first dose of the investigational product;
- Acute infection or the acute phase of chronic infection within 28 days prior the first dose of the investigational product;
- Active HBV/HCV/HIV infection, active syphilis;
- Patients unable to receive an IV infusions;
- Patients unable to receive an IV contrast agent;
- Hypersensitivity to any of the components of BCD-100, bevacizumab, paclitaxel, cisplatin (or carboplatin);
- Life expectancy less than 6 months;
- Significant adverse events (AE) of previous therapy excluding chronic and/or irreversible events which cannot affect study drug safety evaluation (e.g. alopecia);
- Pregnancy or breast-feeding.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Russia24 sites, 24 recruiting
- Recruiting
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, Arkhangelskaya oblast, 163045
Marina N Nechaeva, MD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
City Hospital No. 5
Barnaul, Altayskiy Kray, 656045
Denis A Tancyirev, MD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine
Chelyabinsk, Chelyabinsk Oblast, 454087
Natalya V Fadeeva, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Republican Clinical Oncology Cente
Kazan', Tatarstan Republic, 420029
Yana F Shasamutdinova, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Clinical Oncologic Dispensary No. 1
Krasnodar, Krasnodar Kari, 350040
Julia M Makarova, MD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky
Krasnoyarsk, Krasnoyarsk Krai, 660133
Ruslan A Zukov, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Moscow Clinical Scientific and Practical Center named A.S. Loginova
Moscow, 111123
Ludmila G Zhukova, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
N.N. Blokhin National Medical Research Center of Oncology (2)
Moscow, 115478
Elena V Artamonova, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
N.N. Blokhin National Medical Research Center of Oncology
Moscow, 115478
Sergey A Tulandin, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
JSC "Medsi Group of Companies"
Moscow, 123056
Evgeny V Ledin, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Moscow City Oncology Hospital No. 62
Moscow, 143423
Daniil L Stroyakovsky, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Murmansk Regional Clinical Hospital named after P.A. Bayandina
Murmansk, Murmansk Oblast, 183047
Evgeny A Fomin, MD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
National Medical Radiology Research Center
Obninsk, Kaluga Oblast, 249036
Natalya A Fetisova, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Clinical Oncology Dispensary
Omsk, Omsk Oblast, 644013
Mikhail V Dvorkin, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
LLC "New Clinic"
Pyatigorsk, Stavropol Kray, 357500
Valery M Chistyakov, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
N.N. Petrov National Medical Research Center of Oncology (2)
Saint Petersburg, Sankt-Peterburg, 197758
Adilia F Urmancheeva, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
JSC "Modern Medical Technologies"
Saint Petersburg, 190013
Svetlana V Odintsova, MD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
LLC "AB Medical Group"
Saint Petersburg, 197082
Timor T Andabekov, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 197758
Tatyana Y Semiglazova, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Saint Petersburg, 197758
Vladimir M Moiseenko, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Republican Oncology Center
Saransk, Respublika Mordoviya, 430005
Pavel I Skopin, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Stavropol Regional Clinical Oncology Center
Stavropol, Stavropol Kray, 355047
Oksana N Shkodenko, MD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Regional Clinical Oncology Hospital
Yaroslavl, Yaroslavl Oblast, 150054
Nikolay V Kislov, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
- Recruiting
Sverdlovsk Regional Oncology Center
Yekaterinburg, Sverdlovsk Oblast, 620036
Dmitry E Emelyanov, MD, PhD, +7-(812)-380-49-34, biocad@biocad.ru
About this study
Official title: 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
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.
Read the detailed description
The study will be conducted in two stages. At the first stage patients will receive up to 6 cycles of BCD-100 in combination with platinum-based chemotherapy and bevacizumab or until unacceptable toxicity or disease progression. Patients who have demonstrated a positive antitumor effect (stabilization of the disease, partial or complete response) and who have no signs of unacceptable toxicity could continue to receive up to 12 cycles of maintenance therapy of BCD-100 in combination with bevacizumab or until unacceptable toxicity or disease progression.
- Being tested
- BCD-100, Bevacizumab, Paclitaxel, Cisplatin (or carboplatin)
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-100Biological
Anti-PD-1 monoclonal antibody, IV infusion
BevacizumabBiological
IV infusion
PaclitaxelDrug
IV infusion
Cisplatin (or carboplatin)Drug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| BCD-100 | Experimental | BCD-100 mg/kg Q3W Receives: Biological: BCD-100; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin (or carboplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Median Progression-free Survival (PFS)
Measured: 1 year
1-year Progression-free Survival (PFS)
Measured: 1 year
1-year Overall Survival (OS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start25 Dec 2018
- Primary completion7 Jul 2020 (estimated)
- Study completion7 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman A Ivanov, PhD, Study director, Vice President R&D, JSC BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912402
- Sponsor's protocol ID
- BCD-100-4/CAESURA
- Status last verified
- May 2019
- First submitted
- 10 Apr 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03912402
- Acronym / sponsor ID
- BCD-100-4/CAESURA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 7 Jul 2020 (estimated)
- Study completion
- 7 Jul 2020 (estimated)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted in two stages. At the first stage patients will receive up to 6 cycles of BCD-100 in combination with platinum-based chemotherapy and bevacizumab or until unacceptable toxicity or disease progression. Patients who have demonstrated a positive antitumor effect (stabilization of the disease, partial or complete response) and who have no signs of unacceptable toxicity could continue to receive up to 12 cycles of maintenance therapy of BCD-100 in combination with bevacizumab or until unacceptable toxicity or disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCD-100 | Experimental | Biological: BCD-100, Biological: Bevacizumab, Drug: Paclitaxel, Drug: Cisplatin (or carboplatin)BCD-100 mg/kg Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (35 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-100Anti-PD-1 monoclonal antibody, IV infusion | Biological | BCD-100 |
| BevacizumabIV infusion | Biological | BCD-100 |
| PaclitaxelIV infusion | Drug | BCD-100 |
| Cisplatin (or carboplatin)IV infusion | Drug | BCD-100 |
Primary outcome
Objective Response Rate (ORR)
Time frame: 6 months
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.
3 secondary outcomes
Median Progression-free Survival (PFS)
Time frame: 1 year
1-year Progression-free Survival (PFS)
Time frame: 1 year
1-year Overall Survival (OS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman A Ivanov, PhD study director
Vice President R&D, JSC BIOCAD
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCD-100, Bevacizumab and Paclitaxel in people with Cervical Cancer and Cervical Cancer Metastatic, run by Biocad at 24 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariia S Shustova, MD (+7-(812)-380-49-33, biocad@biocad.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.