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) (FERMATA)

September 16, 2020 updated by: Biocad

An International Randomized Double-blind Clinical Trial of BCD-100 Plus Platinum-based Chemotherapy With and Without Bevacizumab Versus Placebo Plus Platinum-based Chemotherapy With and Without Bevacizumab as First-Line Treatment of Subjects With Advanced Cervical Cancer

This is a randomized, multicenter, double-blind, Phase 3 study of efficacy and safety of BCD-100 plus platinum-based chemotherapy with and without bevacizumab versus placebo plus platinum-based chemotherapy with and without bevacizumab

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects will be randomized in a 1:1 ratio to receive either Test Regimen or Comparator Regimen as the first-line treatment for advanced cervical cancer. Subjects will receive study therapy Q3W until progression of the disease or signs of unacceptable toxicity. In the absence of dose-limiting toxicity chemotherapy should be continued for at least 6 cycles, then, upon Investigator's decision and/or subjects' wish, the use of chemotherapy can be stopped while maintenance therapy with BCD-100/Placebo with or without bevacizumab (depending on initial therapy choice) continues until disease progression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
316

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fedor B Krykov, MD, PhD
  • Phone Number: +7-(812)-380-49-33
  • Email: biocad@biocad.ru

Study Contact Backup

  • Name: Sergey N Fogt, MD, PhD
  • Phone Number: +7-(812)-380-49-33
  • Email: biocad@biocad.ru

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
          • Zheng-yu Lu, MD
  • Georgia
      • Batumi, Georgia
        • Recruiting
        • High Technology Hospital Medcenter
        • Contact:
          • Tamta Makharadze, MD
      • Tbilisi, Georgia
        • Recruiting
        • Acad. F.Todua Medical center "Research institute of Clinical Medicine"
        • Contact:
          • Tamar Melkadze, MD
      • Tbilisi, Georgia
        • Recruiting
        • High Technology Medical Centre, University Clinic
        • Contact:
          • Miranda Gogishvili, MD
      • Tbilisi, Georgia
        • Recruiting
        • Institute for Personalized Medicine Ltd.
        • Contact:
          • Alexandre Tavartkiladze, MD, PhD
      • Tbilisi, Georgia
        • Recruiting
        • LEPL First University Clinic of Tbilisi State Medical University
        • Contact:
          • Nana Chikhladze, MD
      • Tbilisi, Georgia
        • Recruiting
        • Institute Of Clinical Oncology
        • Contact:
          • Gia Nemsadze, MD, PhD
      • Tbilisi, Georgia
        • Recruiting
        • Multiprofile Clinic Consilium Medulla
        • Contact:
          • David Karsimashvili, MD
      • Tbilisi, Georgia
        • Recruiting
        • Neo Medi
        • Contact:
          • Mikheil Shavdia, MD
  • Russian Federation
      • Barnaul, Russian Federation
        • Recruiting
        • City Hospital No. 5
        • Contact:
          • Denis A Tancyirev, MD
      • Ekaterinburg, Russian Federation
        • Recruiting
        • Sverdlovsk Regional Oncology Center
        • Contact:
          • Dmitry E Emelyanov, MD, PhD
      • Krasnoyarsk, Russian Federation
        • Recruiting
        • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky
        • Contact:
          • Ruslan A Zukov, MD, PhD
      • Moscow, Russian Federation
        • Recruiting
        • State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department
        • Contact:
          • Daniil Stroyakovsky, MD
      • Moscow, Russian Federation
        • Recruiting
        • Moscow Clinical Scientific and Practical Center named A.S. Loginova
        • Contact:
          • Ludmila G Zhukova, MD, PhD
      • Moscow, Russian Federation
        • Recruiting
        • N.N. Blokhin National Medical Research Center of Oncology (2)
        • Contact:
          • Elena V Artamonova, MD, PhD
      • Murmansk, Russian Federation
        • Recruiting
        • Murmansk Regional Clinical Hospital named after P.A. Bayandina
        • Contact:
          • Evgeny A Fomin, MD
      • Omsk, Russian Federation
        • Recruiting
        • Clinical Oncology Dispensary
        • Contact:
          • Mikhail V Dvorkin, MD, PhD
      • Pyatigorsk, Russian Federation
        • Recruiting
        • LLC "New Clinic"
        • Contact:
          • Valery M Chistyakov, MD, PhD
      • Saint Petersburg, Russian Federation
        • Recruiting
        • AV Medical Group
        • Contact:
          • Timur T Andabekov, MD, PhD
      • Saint Petersburg, Russian Federation
        • Recruiting
        • JSC "Modern medical technologies"
        • Contact:
          • Svetlana V Odintsova, MD
      • Saint Petersburg, Russian Federation
        • Recruiting
        • N.N. Petrov National Medical Research Center of Oncology (2)
        • Contact:
          • Adilia F Urmancheeva, MD, PhD
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
        • Contact:
          • Vladimir M Moiseenko, MD, PhD
      • Saransk, Russian Federation
        • Recruiting
        • Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "
        • Contact:
          • Pavel Skopin, PhD
      • Stavropol', Russian Federation
        • Recruiting
        • Stavropol Regional Clinical Oncology Center
        • Contact:
          • Oksana N Shkodenko, MD
      • Yaroslavl, Russian Federation
        • Recruiting
        • Regional Clinical Oncology Hospital
        • Contact:
          • Nikolay V Kislov, MD, PhD
  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Memorial Şişli Istanbul
        • Contact:
          • Fazilet E Dinsbas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Signing an IRB/EC-approved informed consent
  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:

  1. Indications for potentially curative treatment (surgery or radiation therapy)
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Placebo
Drug: Paclitaxel
IV infusion
Biological: Bevacizumab
IV infusion
Drug: Cisplatin (or Carboplatin)
IV infusion
Experimental: BCD-100
BCD-100 3 mg/kg Q3W
Drug: Paclitaxel
IV infusion
Biological: BCD-100
Anti-PD-1 monoclonal antibody, IV infusion
Biological: Bevacizumab
IV infusion
Drug: Cisplatin (or Carboplatin)
IV infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 3 years
The time from the date of randomization until death
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Response (TTR)
Time Frame: 1 year
TTR will be calculated from the randomization date
1 year
Progression-Free Survival (PFS) per RECIST 1.1
Time Frame: 3 years
The time from the date of randomization until progression of disease according to RECIST 1.1 criteria or death
3 years
Progression-Free Survival (PFS) per iRECIST
Time Frame: 3 years
The time from the date of randomization until progression of disease according to iRECIS criteria or death
3 years
Overall Response Rate per (ORR) RECIST 1.1
Time Frame: 1 year
The percentage of the participants who have a Complete Response or a Partial Response as assessed by a blind independent central reviewer per RECIST 1.1
1 year
Overall Response Rate (ORR) per iRECIST
Time Frame: 1 year
The percentage of the participants who have a Complete Response or a Partial Response as assessed by a blind independent central reviewer per iRECIST
1 year
Disease Control Rate (DCR)
Time Frame: 1 year
The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease as assessed by a blind independent central reviewer
1 year
Duration of Response (DOR)
Time Frame: 1 year
DOR will be calculated from the moment of registration of response till event (progression or death)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biocad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yulia N Linkova, MD, PhD, Director of Clinical Development Department, BIOCAD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCD-100-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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