Evaluate Efficacy of the Association Nimotuzumab(HR3) /Cisplatin-Vinorelbine on Patients With Cervical Carcinom

NCT03413579 | Completed Phase 3

• 1 other identifier: CIMA-I3-05D143-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of the present study is to estimate the overall survival of patients with cervical cancer after the administration of monoclonal antibody (mAb) Nimotuzumab (hR3) in combination with chemotherapy of first intention. Patients will be randomized in two parallel treatment groups. The first group will receive a dose of 200 mg of monoclonal antibody anti-hR3 (weekly during 18 weeks), combined with a chemotherapy (6 cycles, every 21 days of Cisplatin 70mg/m2, Vinorelbine 60 mg/m2 (Per Os) at D1 and D8 and then 80mg / m2. The second group will receive a placebo in combination with the same chemotherapy regimen as the first group. At the end of the first intention chemotherapy treatment, a dose of maintenance of Nimotuzumab will be administered at the dose of 200mg every 14 days until progression. A second chemotherapy in the second intention is proposed, this one is based on Carboplatin ( CBP) in an AUC (area under curve) of 6, and Paclitaxel (Txl) in 175 mg / m2 / BSA (body surface area ) in drip of 3 hours, every 3 weeks, concomitant with the administration of hR3, every 14 days, until a limit of toxicity or an ECOG (Eastern Cooperative Oncology Group) status superior to 3, appears.

Conditions

Cervical Cancer

Keywords

Cervix; Oncology,; hR3,; Nimotuzumab,; Chemotherapy,; Survival; Monoclonal antibody; RECIST; Cisplatin; Vinorelbine; Paclitaxel; Carboplatine; Randomisation; Placebo; cancer; cimahope

Outcome Measures

Primary Outcomes (1)

• Overall survival in patients who received hR3 mAb treatment combined with Chemotherapy

  Calculated from patient randomisation to death (36 months)

Secondary Outcomes (4)

• Antitumor Response

  up to 24months (every 3 months)

• Duration of response

  from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

• Time to progression

  Time from randomization until objective tumor progression assessed up to 60 months

• Progression-free survival

  Time from randomization until disease progression or death, assessed up to 60 months

Study Arms (2)

Nimotuzumab

EXPERIMENTAL

Injection of 200 mg of Nimotuzumab (weekly during 18 weeks), in combination with chemotherapy (6 cycles, every 21 days: 70 mg / m2 Cisplatin and Vinorelbine 60 mg / m2 (Per Os) at day 1 and day 8. The objective of the present study is to assess the overall survival of patients after administration of Nimotuzumab hR3 monoclonal antibodies (combined with a chemotherapy) in the treatment of patients with cervix epithelial tumors as first-line treatment. After the first line , a 200mg dose of hR3 monoclonal antibodies will be given every 14 days until progress. A second -line chemotherapy is proposed, this is based on Carboplatin (CBP) at AUC of 6, and Paclitaxel (Txl) 175 mg / m2 / SC as 3 hour infusion, every 3 weeks, concomitant with the administration of hR3, every 14 days, until a toxicity limit or an ECOG status greater than 3 appears.

Biological: Nimotuzumab ( h-R3)

Placebo

PLACEBO COMPARATOR

Injection of the Placebo in the same procedures (weekly during 18 weeks), in combination with chemotherapy (6 cycles, every 21 days: 70 mg / m2 Cisplatin and Vinorelbine 60 mg / m2 (Per Os) at day 1 and day 8. After the first line , a 200mg dose of hR3 monoclonal antibodies will be given every 14 days until progress. A second -line chemotherapy is proposed, this is based on Carboplatin (CBP) at AUC of 6, and Paclitaxel (Txl) 175 mg / m2 / SC as 3 hour infusion, every 3 weeks, concomitant with the administration of hR3, every 14 days, until a toxicity limit or an ECOG status greater than 3 appears.

Other: Placebo

Interventions

Nimotuzumab ( h-R3) BIOLOGICAL

Humanized monoclonal antibody

Also known as: CIMAHOPE

Nimotuzumab

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 to 75, including both limits.
• Patients who give their written consent to participate to the study.
• Chemonaive patients with local cervical cancer and / or persistent or recurrent metastatic disease with measurable disease (RECIST criteria) by a physical examination (scanner or MRI).
• A confirmation by biopsy is necessary in case there is a single lesion less than 2 cm.
• Patients who had pelvic CT + radiotherapy may also be included in the study (concomitant chemotherapy as a radiotherapy stabilizer).
• Patients having a histopathological report: epidermoid carcinoma, adenocarcinoma, adenosquamous carcinoma and / or clear cells carcinoma.
• Patients with an ECOG score between 0-2
• Patients with a life expectancy greater than six months.
• Patients with Left Ventricular Ejection Fraction (LVEF) ≥50%, through Echocardiography.
• Patients with normal function of organs and bone marrow, defined by the following parameters:
• Haemoglobin ≥ 9 g / dL
• White Blood cell ≥ 4000 /mm3
• Absolute neutrophil count≥ 1500 /mm3
• Platelet count≥ 100000 /mm3
• Total bilirubin up to 1.5 the upper limit of normal (ULN)

You may not qualify if:

• Pregnant or breastfeeding patients
• Patients with small cells and / or neuroendocrine cervical cancer.
• Patients receiving another onco-specific drug, for other clinical trial,
• Patients with a history of allergy attributed to chemical or biological compounds similar to the monoclonal antibody being evaluated or to chemotherapeutic agents.
• Patients having uncontrolled intercurrent diseases, including active infections, symptomatic congestive heart failure , unstable angina, cardiac arrhythmia, decompensated diabetes, uncontrolled hypertension and psychiatric disorders.
• Patients having a second tumor . Excepting for those receiving appropriate therapy for skin cancer (basal or squamous)
• Previous or concomitant malignancy with exception for non-melanoma skin carcinomas
• Patients having special conditions or circumstances that could significantly limit the complete follow up of the study

Sponsors & Collaborators

• El Kendi Pharmaceuticals Manufacturing Company: lead

Study Sites (5)

Centre Pierre et Marie Curie (CPMC)

Algiers, Algeria

Location

CAC Annaba

Annaba, Algeria

Location

CAC Batna

Batna City, Algeria

Location

CHU Frantz Fanon

Blida, Algeria

Location

CHU Sidi Belloua

Tizi Ouzou, Algeria

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohamed MECHETI, MD.

  El Kendi, Part of MS Pharma, Manufacturing Company

  STUDY DIRECTOR

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: January 11, 2018
• First Posted: January 29, 2018
• Study Start: November 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: February 1, 2021
• Last Updated: August 25, 2021

Record last verified: 2020-03

Locations

AL (5)