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)

NCT03912415 | Unknown Phase 3 DMC

• 1 other identifier: BCD-100-5
• Study Type: interventional
• Target: 316
• Locations: 4 countries
• Sites: 26

Brief 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

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  The time from the date of randomization until death

  3 years

Secondary Outcomes (7)

• Progression-Free Survival (PFS) per RECIST 1.1

  3 years

• Progression-Free Survival (PFS) per iRECIST

  3 years

• Overall Response Rate per (ORR) RECIST 1.1

  1 year

• Overall Response Rate (ORR) per iRECIST

  1 year

• Disease Control Rate (DCR)

  1 year

Study Arms (2)

BCD-100

EXPERIMENTAL

BCD-100 3 mg/kg Q3W

Biological: BCD-100; Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin (or Carboplatin)

Placebo

PLACEBO COMPARATOR

Biological: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin (or Carboplatin); Other: Placebo

Interventions

BCD-100 BIOLOGICAL

Anti-PD-1 monoclonal antibody, IV infusion

BCD-100

Bevacizumab BIOLOGICAL

IV infusion

BCD-100; Placebo

Paclitaxel DRUG

IV infusion

BCD-100; Placebo

Cisplatin (or Carboplatin) DRUG

IV infusion

BCD-100; Placebo

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• Biocad: lead

Study Sites (26)

Shanghai Tenth People's Hospital

Shanghai, China

RECRUITING

High technology Hospital Medcenter

Batumi, Georgia

RECRUITING

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

Tbilisi, Georgia

RECRUITING

High Technology Medical Centre, University Clinic

Tbilisi, Georgia

RECRUITING

Institute for Personalized Medicine Ltd.

Tbilisi, Georgia

RECRUITING

Institute of Clinical Oncology

Tbilisi, Georgia

RECRUITING

LEPL First University Clinic of Tbilisi State Medical University

Tbilisi, Georgia

RECRUITING

Multiprofile Clinic Consilium Medulla

Tbilisi, Georgia

RECRUITING

Neo Medi

Tbilisi, Georgia

RECRUITING

City Hospital No. 5

Barnaul, Russia

RECRUITING

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

Krasnoyarsk, Russia

RECRUITING

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

Moscow, Russia

RECRUITING

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

Moscow, Russia

RECRUITING

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

Moscow, Russia

RECRUITING

Murmansk Regional Clinical Hospital named after P.A. Bayandina

Murmansk, Russia

RECRUITING

Clinical Oncology Dispensary

Omsk, Russia

RECRUITING

LLC "New Clinic"

Pyatigorsk, Russia

RECRUITING

AV Medical Group

Saint Petersburg, Russia

RECRUITING

JSC "Modern Medical Technologies"

Saint Petersburg, Russia

RECRUITING

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

Saint Petersburg, Russia

RECRUITING

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

Saint Petersburg, Russia

RECRUITING

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

Saransk, Russia

RECRUITING

Stavropol Regional Clinical Oncology Center

Stavropol, Russia

RECRUITING

Regional Clinical Oncology Hospital

Yaroslavl, Russia

RECRUITING

Sverdlovsk Regional Oncology Center

Yekaterinburg, Russia

RECRUITING

Memorial Şişli Istanbul

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Bevacizumab; Paclitaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Yulia N Linkova, MD, PhD

  Director of Clinical Development Department, BIOCAD

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GE (8); RU (16); TU (1); CN (1)