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Cervical CancerPhase 3CIMAHOPENCT03413579

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

A Phase 3 study testing Nimotuzumab ( h-R3) in people with Cervical Cancer, run by El Kendi Pharmaceuticals Manufacturing Company at 5 sites in Algeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Nimotuzumab ( h-R3)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
5 sitesAlgeria
Study dates
Nov 2015to Feb 2021
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 20Show fewer
  • 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)
  • Albumin ≥ 2 g/dL (3,5 - 5,0 g /dl)
  • Serum Glutamopyruvate Transférase (SGPT) and SErum Glutamooxaloacetate Transferase (SGTO) < or = 2.5 ULN
  • Serum creatinine within the normal limits and the calculation of glomerular filtration according to Cockcroft formula ≥ 60ml and according to MDRD formula for patients whose age is 70 years ≥ 60ml . Glomerular filtration will be performed only on clinical discretion for patients suspected to have a kidney problem. (The normal laboratory values will be appropriate to the techniques and equipment used in the place where they are done).
  • The determination or expression of EGF-R (epidermal growth factor receptor), p53, Ki67 and Bcl-2 by immuno-histochemistry in the primary tumor before treatment integrated in a paraffin block.
  • The results are not an inclusion criterion, but will be evaluated as an indicator of prognostic response in the final assessment.

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Algeria5 sites

  • Centre Pierre et Marie Curie (CPMC)

    Algiers

  • CAC Annaba

    Annaba

  • CAC Batna

    Batna City

  • CHU Frantz Fanon

    Blida

  • CHU Sidi Belloua

    Tizi Ouzou

Other trials in Algeria

About this study

Official title: Multicenter Randomised Double-blind Study to Compare HR3 or Placebo in Combination With Cisplatin-navelbine for Patients With Cervical Carcinoma, Followed in Case of Progression by a Second Line.

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.

Read the detailed description

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.

The patients included will be divided into two treatment groups. The first group receive a 200 mg dose of hR3 monoclonal antibody (weekly for 18 weeks), and chemotherapy (6 cycles, every 21 days: Cisplatin (CDDP) 70 mg / m2 on day 1, Vinorelbine 60 mg / m2 on day 1 and day 8) and then 80mg / m2. The second group receive a placebo in addition to the listed chemotherapy.

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.

The survival overall will be considered as the main variable of the response and survival without progression from the antitumor response, the toxicity assessment and the quality of life will be the secondary variables. In addition, the effects may arise during treatment will be identified, and tumor biopsy markers such as, EGF-R and HPV will be determined and those of p53, Ki67 and Bcl-2 by immunohistochemistry (IHC).

It is expected to achieve a difference in survival between the treatment groups of 6.5 vs 10.5 months (0.278 vs 0.62) in favor of the group with mAb hR3.

Conditions
Cervical Cancer
Being tested
Nimotuzumab ( h-R3), Placebo
Keywords
Cervix, Oncology,, hR3,, Nimotuzumab,, Chemotherapy,, Survival, Monoclonal antibody, RECIST, Cisplatin, Vinorelbine, Paclitaxel, Carboplatine, Randomisation, Placebo, cancer, cimahope
Medical subject headings
Uterine Cervical Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nimotuzumab ( h-R3)Biological

    Also called CIMAHOPE

    Humanized monoclonal antibody

  • PlaceboOther

Study groups in NCT03413579
Study groupRoleWhat they receive
NimotuzumabExperimentalInjection 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.
Receives: Biological: Nimotuzumab ( h-R3)
PlaceboPlacebo comparatorInjection 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.
Receives: Other: Placebo

What is being measured

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

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

    Measured: Calculated from patient randomisation to death (36 months)

Secondary outcomes (4)

  1. Antitumor Response

    Measured: up to 24months (every 3 months)

  2. Duration of response

    Measured: 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

  3. Time to progression

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

  4. Progression-free survival

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

Timeline

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

  1. First posted29 Jan 2018
  2. Study startNov 2015
  3. Primary completionMar 2020
  4. Study completionFeb 2021

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
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03413579
Sponsor's protocol ID
CIMA-I3-05D143-01
Acronym
CIMAHOPE
Status last verified
Mar 2020
First submitted
11 Jan 2018
Last updated
25 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nimotuzumab ( h-R3) in people with Cervical Cancer, run by El Kendi Pharmaceuticals Manufacturing Company at 5 sites in Algeria.

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 20 inclusion and 8 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: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Algeria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival in patients who received hR3 mAb treatment combined with Chemotherapy (time frame: Calculated from patient randomisation to death (36 months)). 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 NCT03413579.

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 25 Aug 2021.

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