Health Trials

PD-1 (Programmed Death-1) Versus PD-L1 (Programmed Death-ligand 1) Immune Check Point Inhibitors Combined With Chemotherapy, With or Without Bevacizumab, In Patients With Metastatic, Persistent Or Recurrent Cervical Cancer

ConditionsMetastatic Cervical CancerPersistent Cervical CancerRecurrent Cervical Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorN.N. Alexandrov National Cancer Centre

About this trial

This is a randomized trial evaluating the results of using of PD-1 and PD-L1 immune checkpoint inhibitors combined with chemotherapy, with or without bevacizumab, in patients with metastatic, persistent, and recurrent cervical cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18-≤75 years.

Histologically confirmed diagnosis.

Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018);

Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018);

Disqualifiers

Presence of another active malignant invasive neoplasm.

Pregnancy or lactation period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PD-1 antibody

    Drug

    Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.

  • PD-L1 antibody

    Drug

    Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 + PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of treatment according to the regimen of PD-L1 inhibitor ± bevacizumab 7-10 mg/kg every 21 days.

  • Chemotherapy and bevacizumab (CT-BEV)

    Drug

    Patients will receive 6 courses of chemotherapy according to the regimen of cisplatin 75 mg/m2 or carboplatin AUC 5-6 + paclitaxel 175 mg/m2 ± bevacizumab 7-10 mg/kg every 21 days. In case of a complete or partial response or stabilization maintenance therapy is carried out until disease progression or intolerable toxicity of bevacizumab 7-10 mg/kg every 21 days.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: PD-1Experimental treatment 1 intervention
Group B: PD-L1Experimental treatment 1 intervention
Group C: StandardActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Time from randomization to the death of any cause

Time frame
From enrollment through study completion, an average of 2 year
2

Median overall survival

The timepoint at which 50% of patients are still alive following treatment initiation

Time frame
From date of treatment initiation until the date of death from any cause, assessed up to 36 months

Secondary outcomes

1

Objective response rate

The percentage of patients whose cancer shrinks or disappears (complete or partial response) after treatment

Time frame
From randomization until progression or study completion, average of 60 months
2

Duration of response

The length of time from the first sign of a treatment response (partial or complete) until disease progression or death

Time frame
From date of first documented response until progression or death, assessed up to 60 months
3

Disease-free survival

Time from randomization to any sign or symptom of the cancer or death from the disease

Time frame
From enrollment through study completion, an average of 2 year
4

Median Disease-free survival

The time at which 50% of patients remain alive without any signs or symptoms of cancer

Time frame
From date of treatment initiation until the date of death from any cause, assessed up to 36 months

Other outcomes

1

The frequency of immune-related adverse events

Time frame
Through From date of first immunotherapy dose through 60 months, or date of last patient contact
2

The frequency of discontinuation of immunotherapy

Time frame
From date of first immunotherapy dose through 60 months, or date of last patient contact

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

N.N. Alexandrov National Cancer Centre

Lead sponsor

Source ClinicalTrials.gov
Apply now