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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)

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ClinicalTrials.gov Identifier: NCT03912402
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Biocad

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Cervical Cancer Metastatic Cervical Cancer Recurrent Biological: BCD-100 Biological: Bevacizumab Drug: Paclitaxel Drug: Cisplatin (or carboplatin) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 25, 2018
Estimated Primary Completion Date : July 7, 2020
Estimated Study Completion Date : July 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: BCD-100
BCD-100 mg/kg Q3W
Biological: BCD-100
Anti-PD-1 monoclonal antibody, IV infusion

Biological: Bevacizumab
IV infusion

Drug: Paclitaxel
IV infusion

Drug: Cisplatin (or carboplatin)
IV infusion




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Median Progression-free Survival (PFS) [ Time Frame: 1 year ]
  2. 1-year Progression-free Survival (PFS) [ Time Frame: 1 year ]
  3. 1-year Overall Survival (OS) [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form and the subject's ability to follow the Protocol requirements;
  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:

  1. Indications for radical therapy (surgical or radiotherapy);
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912402


Contacts
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Contact: Mariia S Shustova, MD +7-(812)-380-49-33 biocad@biocad.ru
Contact: Fedor B Kryukov, MD, PhD +7-(812)-380-49-33 biocad@biocad.ru

Locations
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Russian Federation
City Hospital No. 5 Recruiting
Barnaul, Altai Krai, Russian Federation, 656045
Contact: Denis A Tancyirev, MD    +7-(812)-380-49-34    biocad@biocad.ru   
Arkhangelsk Clinical Oncology Dispensary Recruiting
Arkhangel'sk, Arkhangelsk Oblast, Russian Federation, 163045
Contact: Marina N Nechaeva, MD    +7-(812)-380-49-34    biocad@biocad.ru   
Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine Recruiting
Chelyabinsk, Chelyabinsk Oblast, Russian Federation, 454087
Contact: Natalya V Fadeeva, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
National Medical Radiology Research Center Recruiting
Obninsk, Kaluga Oblast, Russian Federation, 249036
Contact: Natalya A Fetisova, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Clinical Oncologic Dispensary No. 1 Recruiting
Krasnodar, Krasnodar Kari, Russian Federation, 350040
Contact: Julia M Makarova, MD    +7-(812)-380-49-34    biocad@biocad.ru   
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky Recruiting
Krasnoyarsk, Krasnoyarsk Krai, Russian Federation, 660133
Contact: Ruslan A Zukov, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Murmansk Regional Clinical Hospital named after P.A. Bayandina Recruiting
Murmansk, Murmansk Oblast, Russian Federation, 183047
Contact: Evgeny A Fomin, MD    +7-(812)-380-49-34    biocad@biocad.ru   
Clinical Oncology Dispensary Recruiting
Omsk, Omsk Oblast, Russian Federation, 644013
Contact: Mikhail V Dvorkin, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Republican Oncology Center Recruiting
Saransk, Republic Of Mordovia, Russian Federation, 430005
Contact: Pavel I Skopin, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Republican Clinical Oncology Cente Recruiting
Kazan, Republic Of Tatarstan, Russian Federation, 420029
Contact: Yana F Shasamutdinova, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
N.N. Petrov National Medical Research Center of Oncology (2) Recruiting
Saint Petersburg, Saint-Petersburg, Russian Federation, 197758
Contact: Adilia F Urmancheeva, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
LLC "New Clinic" Recruiting
Pyatigorsk, Stavropol Krai, Russian Federation, 357500
Contact: Valery M Chistyakov, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Stavropol Regional Clinical Oncology Center Recruiting
Stavropol', Stavropol Krai, Russian Federation, 355047
Contact: Oksana N Shkodenko, MD    +7-(812)-380-49-34    biocad@biocad.ru   
Sverdlovsk Regional Oncology Center Recruiting
Ekaterinburg, Sverdlovsk Oblast, Russian Federation, 620036
Contact: Dmitry E Emelyanov, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Regional Clinical Oncology Hospital Recruiting
Yaroslavl, Yaroslavskaya Oblast, Russian Federation, 150054
Contact: Nikolay V Kislov, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Moscow Clinical Scientific and Practical Center named A.S. Loginova Recruiting
Moscow, Russian Federation, 111123
Contact: Ludmila G Zhukova, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
N.N. Blokhin National Medical Research Center of Oncology (2) Recruiting
Moscow, Russian Federation, 115478
Contact: Elena V Artamonova, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
N.N. Blokhin National Medical Research Center of Oncology Recruiting
Moscow, Russian Federation, 115478
Contact: Sergey A Tulandin, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
JSC "Medsi Group of Companies" Recruiting
Moscow, Russian Federation, 123056
Contact: Evgeny V Ledin, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Moscow City Oncology Hospital No. 62 Recruiting
Moscow, Russian Federation, 143423
Contact: Daniil L Stroyakovsky, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
JSC "Modern Medical Technologies" Recruiting
Saint Petersburg, Russian Federation, 190013
Contact: Svetlana V Odintsova, MD    +7-(812)-380-49-34    biocad@biocad.ru   
LLC "AB Medical Group" Recruiting
Saint Petersburg, Russian Federation, 197082
Contact: Timor T Andabekov, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
N.N. Petrov National Medical Research Center of Oncology Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Tatyana Y Semiglazova, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Vladimir M Moiseenko, MD, PhD    +7-(812)-380-49-34    biocad@biocad.ru   
Sponsors and Collaborators
Biocad
Investigators
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Study Director: Roman A Ivanov, PhD Vice President R&D, JSC BIOCAD

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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT03912402     History of Changes
Other Study ID Numbers: BCD-100-4/CAESURA
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Bevacizumab
Carboplatin
Antineoplastic Agents
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors