Efficacy and Safety of BCD-100 (Anti-PD-1) in Combination With Platinum-Based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer (FERMATA)
NCT ID: NCT03912415
Last Updated: 2020-09-18
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
PHASE3
316 participants
INTERVENTIONAL
2019-10-01
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BCD-100
BCD-100 3 mg/kg Q3W
BCD-100
Anti-PD-1 monoclonal antibody, IV infusion
Bevacizumab
IV infusion
Paclitaxel
IV infusion
Cisplatin (or Carboplatin)
IV infusion
Placebo
Bevacizumab
IV infusion
Paclitaxel
IV infusion
Cisplatin (or Carboplatin)
IV infusion
Placebo
Placebo
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
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Females ≥ 18 years of age on day of signing informed consent
3. Histologically confirmed squamous carcinoma of the cervix
4. Progressing thru or recurrent disease treated for curative intent or primary metastatic cervical cancer stage FIGO IVB
5. Agreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (using archival biopsy material is only acceptable in subjects in whom obtaining a new sample is contraindicated)
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to use a contraceptive method with a failure rate of \< 1% per year from the moment of signing informed consent, during the treatment period and at least 6 months after administration of the last dose of study drug. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). Examples of contraceptive methods with a failure rate of \< 1% per year include but are not limited to bilateral tubal ligation and/or occlusion, male sterilization, and intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) is not acceptable method of contraception.
Exclusion Criteria
2. Prior systemic treatment for recurrent, secondarily progressive or initially metastatic disease
3. Previous use of chemotherapy other than initial treatment for curative intent (e.g. chemotherapy used concurrently with radiation therapy, neoadjuvant or consolidation chemotherapy cycles before radiotherapy or 2 chemotherapy cycles after completion of chemoradiotherapy are allowed)
4. Contraindications to cisplatin, carboplatin, paclitaxel, or bevacizumab
5. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with known brain metastases may participate provided that the brain metastases have been previously treated with radiotherapy or surgery only and are radiographically stable
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. serious cardiac arrhythmia requiring medication (subjects with asymptomatic atrial fibrillation can be enrolled if controlled ventricular rate);
6. atopic asthma, Stage III-IV COPD, angioedema;
7. severe respiratory failure;
8. 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. History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis
10. Neutrophils \<1500/mcl or platelets \<100 000/mcl or hemoglobin \<90 g/l.
11. Creatinine ≥ 1.5 x UNL.
12. 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 ≥ 2.5 x UNL.
13. Chemotherapy or radiation therapy less than 28 days prior to randomization.
14. Major surgery procedure less than 28 days prior to randomization.
15. Previous use of PD-1/PD-L1/PD-L2 agent or another agent directed to stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX 40, CD137).
16. Previous use of VEGF/VEGFR inhibitors, including bevacizumab, ramucirumab, aflibercept and tyrosine kinase inhibitors.
17. Prior invasive malignancy with any evidence of disease within the last 3 years. Subjects with non-melanoma skin cancer or carcinoma in situ (e.g. breast cancer) who have undergone potentially curative therapy are not excluded.
18. Pre-existing clinically significant (≥ grade 2) peripheral neuropathy or hearing impairment
19. Any conditions or circumstances that limit subject's ability to comply with protocol requirements
20. Active hepatitis B, active hepatitis С or history of positive HIV.
21. Active infection requiring therapy or systemic antibiotics use less than 14 days prior to enrollment. Severe infections within 28 days prior to first study drug administration.
22. Administration of a live vaccine within 28 days prior to enrollment
23. Current using of another investigational device or drug study, or less than 30 days since ending of using of another investigational device or drug study
24. Life expectancy less than 12 weeks
25. Significant adverse events (AE) of previous therapy excluding chronic and/or irreversible events which cannot affect study drug safety evaluation (e.g. alopecia)
26. Known hypersensitivity or allergy to paclitaxel, cisplatin, carboplatin, bevacizumab, BCD-100 or any of their excipients. Known hypersensitivity or allergy to drugs derived from Chinese hamster (CHO) ovary cells or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
27. 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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Yulia N Linkova, MD, PhD
Role: STUDY_DIRECTOR
Director of Clinical Development Department, BIOCAD
Locations
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Shanghai Tenth People's Hospital
Shanghai, , China
High technology Hospital Medcenter
Batumi, , Georgia
Acad. F.Todua Medical center "Research institute of Clinical Medicine"
Tbilisi, , Georgia
High Technology Medical Centre, University Clinic
Tbilisi, , Georgia
Institute for Personalized Medicine Ltd.
Tbilisi, , Georgia
Institute of Clinical Oncology
Tbilisi, , Georgia
LEPL First University Clinic of Tbilisi State Medical University
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla
Tbilisi, , Georgia
Neo Medi
Tbilisi, , Georgia
City Hospital No. 5
Barnaul, , Russia
Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky
Krasnoyarsk, , 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
State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department
Moscow, , Russia
Murmansk Regional Clinical Hospital named after P.A. Bayandina
Murmansk, , Russia
Clinical Oncology Dispensary
Omsk, , Russia
LLC "New Clinic"
Pyatigorsk, , Russia
AV Medical Group
Saint Petersburg, , Russia
JSC "Modern Medical Technologies"
Saint Petersburg, , Russia
N.N. Petrov National Medical Research Center of Oncology (2)
Saint Petersburg, , Russia
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Saint Petersburg, , Russia
Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
Saransk, , Russia
Stavropol Regional Clinical Oncology Center
Stavropol, , Russia
Regional Clinical Oncology Hospital
Yaroslavl, , Russia
Sverdlovsk Regional Oncology Center
Yekaterinburg, , Russia
Memorial Şişli Istanbul
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Zheng-yu Lu, MD
Role: primary
Tamta Makharadze, MD
Role: primary
Tamar Melkadze, MD
Role: primary
Miranda Gogishvili, MD
Role: primary
Alexandre Tavartkiladze, MD, PhD
Role: primary
Gia Nemsadze, MD, PhD
Role: primary
Nana Chikhladze, MD
Role: primary
David Karsimashvili, MD
Role: primary
Mikheil Shavdia, MD
Role: primary
Denis A Tancyirev, MD
Role: primary
Ruslan A Zukov, MD, PhD
Role: primary
Ludmila G Zhukova, MD, PhD
Role: primary
Elena V Artamonova, MD, PhD
Role: primary
Daniil Stroyakovsky, MD
Role: primary
Evgeny A Fomin, MD
Role: primary
Mikhail V Dvorkin, MD, PhD
Role: primary
Valery M Chistyakov, MD, PhD
Role: primary
Timur T Andabekov, MD, PhD
Role: primary
Svetlana V Odintsova, MD
Role: primary
Adilia F Urmancheeva, MD, PhD
Role: primary
Vladimir M Moiseenko, MD, PhD
Role: primary
Pavel Skopin, PhD
Role: primary
Oksana N Shkodenko, MD
Role: primary
Nikolay V Kislov, MD, PhD
Role: primary
Dmitry E Emelyanov, MD, PhD
Role: primary
Fazilet E Dinsbas, MD
Role: primary
Other Identifiers
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BCD-100-5
Identifier Type: -
Identifier Source: org_study_id
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