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Cervical CancerPhase 3FERMATANCT03912415

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)

A Phase 3 study testing BCD-100, Bevacizumab and Paclitaxel in people with Cervical Cancer, run by Biocad at 26 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
BCD-100, Bevacizumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
316 participants
Where
26 sitesin 4 countries
Study dates
1 Oct 2019to 1 Dec 2024
Phase
Phase 3
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

  • Signing an IRB/EC-approved informed consent
  • Females ≥ 18 years of age on day of signing informed consent
  • Histologically confirmed squamous carcinoma of the cervix
  • Progressing thru or recurrent disease treated for curative intent or primary metastatic cervical cancer stage FIGO IVB
  • 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)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 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.

Who cannot join

  • Indications for potentially curative treatment (surgery or radiation therapy)
  • Prior systemic treatment for recurrent, secondarily progressive or initially metastatic disease
  • 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)
  • Contraindications to cisplatin, carboplatin, paclitaxel, or bevacizumab
  • 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
  • Concomitant diseases or conditions which pose a risk of AE development during study treatment:
Show all 35Show fewer
  • 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;
  • serious cardiac arrhythmia requiring medication (subjects with asymptomatic atrial fibrillation can be enrolled if controlled ventricular rate);
  • 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.
  • History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis
  • Neutrophils <1500/mcl or platelets <100 000/mcl or hemoglobin <90 g/l.
  • Creatinine ≥ 1.5 x UNL.
  • 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.
  • Chemotherapy or radiation therapy less than 28 days prior to randomization.
  • Major surgery procedure less than 28 days prior to randomization.
  • 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).
  • Previous use of VEGF/VEGFR inhibitors, including bevacizumab, ramucirumab, aflibercept and tyrosine kinase inhibitors.
  • 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.
  • Pre-existing clinically significant (≥ grade 2) peripheral neuropathy or hearing impairment
  • Any conditions or circumstances that limit subject's ability to comply with protocol requirements
  • Active hepatitis B, active hepatitis С or history of positive HIV.
  • 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.
  • Administration of a live vaccine within 28 days prior to enrollment
  • 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
  • Life expectancy less than 12 weeks
  • Significant adverse events (AE) of previous therapy excluding chronic and/or irreversible events which cannot affect study drug safety evaluation (e.g. alopecia)
  • 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.
  • Pregnancy or breast-feeding

Trial locations and contacts

26 sites in 4 countries.

Sergey N Fogt, MD, PhD contact

+7-(812)-380-49-33

biocad@biocad.ru

Fedor B Krykov, MD, PhD contact

+7-(812)-380-49-33

biocad@biocad.ru

26 sites in 4 countries

Russia16 sites, 16 recruiting

  • City Hospital No. 5

    Barnaul

    Denis A Tancyirev, MD

    Recruiting

  • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky

    Krasnoyarsk

    Ruslan A Zukov, MD, PhD

    Recruiting

  • Moscow Clinical Scientific and Practical Center named A.S. Loginova

    Moscow

    Ludmila G Zhukova, MD, PhD

    Recruiting

  • N.N. Blokhin National Medical Research Center of Oncology (2)

    Moscow

    Elena V Artamonova, MD, PhD

    Recruiting

  • State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department

    Moscow

    Daniil Stroyakovsky, MD

    Recruiting

  • Murmansk Regional Clinical Hospital named after P.A. Bayandina

    Murmansk

    Evgeny A Fomin, MD

    Recruiting

  • Clinical Oncology Dispensary

    Omsk

    Mikhail V Dvorkin, MD, PhD

    Recruiting

  • LLC "New Clinic"

    Pyatigorsk

    Valery M Chistyakov, MD, PhD

    Recruiting

  • AV Medical Group

    Saint Petersburg

    Timur T Andabekov, MD, PhD

    Recruiting

  • JSC "Modern Medical Technologies"

    Saint Petersburg

    Svetlana V Odintsova, MD

    Recruiting

  • N.N. Petrov National Medical Research Center of Oncology (2)

    Saint Petersburg

    Adilia F Urmancheeva, MD, PhD

    Recruiting

  • Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

    Saint Petersburg

    Vladimir M Moiseenko, MD, PhD

    Recruiting

  • Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "

    Saransk

    Pavel Skopin, PhD

    Recruiting

  • Stavropol Regional Clinical Oncology Center

    Stavropol

    Oksana N Shkodenko, MD

    Recruiting

  • Regional Clinical Oncology Hospital

    Yaroslavl

    Nikolay V Kislov, MD, PhD

    Recruiting

  • Sverdlovsk Regional Oncology Center

    Yekaterinburg

    Dmitry E Emelyanov, MD, PhD

    Recruiting

Other trials in Russia

Georgia8 sites, 8 recruiting

  • High technology Hospital Medcenter

    Batumi

    Tamta Makharadze, MD

    Recruiting

  • Acad. F.Todua Medical center "Research institute of Clinical Medicine"

    Tbilisi

    Tamar Melkadze, MD

    Recruiting

  • High Technology Medical Centre, University Clinic

    Tbilisi

    Miranda Gogishvili, MD

    Recruiting

  • Institute for Personalized Medicine Ltd.

    Tbilisi

    Alexandre Tavartkiladze, MD, PhD

    Recruiting

  • Institute of Clinical Oncology

    Tbilisi

    Gia Nemsadze, MD, PhD

    Recruiting

  • LEPL First University Clinic of Tbilisi State Medical University

    Tbilisi

    Nana Chikhladze, MD

    Recruiting

  • Multiprofile Clinic Consilium Medulla

    Tbilisi

    David Karsimashvili, MD

    Recruiting

  • Neo Medi

    Tbilisi

    Mikheil Shavdia, MD

    Recruiting

Other trials in Georgia

China1 site, 1 recruiting

  • Shanghai Tenth People's Hospital

    Shanghai

    Zheng-yu Lu, MD

    Recruiting

Other trials in China

Turkey (Türkiye)1 site, 1 recruiting

  • Memorial Şişli Istanbul

    Istanbul

    Fazilet E Dinsbas, MD

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Conditions
Cervical Cancer
Being tested
BCD-100, Bevacizumab, Paclitaxel, Cisplatin (or Carboplatin), Placebo
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

  • PlaceboOther

    Placebo

Study groups in NCT03912415
Study groupRoleWhat they receive
BCD-100ExperimentalBCD-100 3 mg/kg Q3W
Receives: Biological: BCD-100; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin (or Carboplatin)
PlaceboPlacebo comparatorNot described
Receives: Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin (or Carboplatin); Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    The time from the date of randomization until death

    Measured: 3 years

Secondary outcomes (7)

  1. Progression-Free Survival (PFS) per RECIST 1.1

    The time from the date of randomization until progression of disease according to RECIST 1.1 criteria or death

    Measured: 3 years

  2. Progression-Free Survival (PFS) per iRECIST

    The time from the date of randomization until progression of disease according to iRECIS criteria or death

    Measured: 3 years

  3. Overall Response Rate per (ORR) RECIST 1.1

    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

    Measured: 1 year

  4. Overall Response Rate (ORR) per iRECIST

    The percentage of the participants who have a Complete Response or a Partial Response as assessed by a blind independent central reviewer per iRECIST

    Measured: 1 year

  5. Disease Control Rate (DCR)

    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

    Measured: 1 year

  6. Time to Response (TTR)

    TTR will be calculated from the randomization date

    Measured: 1 year

  7. Duration of Response (DOR)

    DOR will be calculated from the moment of registration of response till event (progression or death)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2019
  2. Study start1 Oct 2019
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03912415
Sponsor's protocol ID
BCD-100-5
Acronym
FERMATA
Status last verified
Sep 2020
First submitted
10 Apr 2019
Last updated
18 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCD-100, Bevacizumab and Paclitaxel in people with Cervical Cancer, run by Biocad at 26 sites in 4 countries.

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 7 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Russia, Georgia, China, Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Sergey N Fogt, MD, PhD (+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?

Overall Survival (OS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03912415.

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 18 Sep 2020.

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