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Pembrolizumab Concurrent With and Following Carbon-ion Radiotherapy for Locally Advanced Cervical Adenocarcinoma

ConditionsCervical AdenocarcinomaCervical Adenosquamous Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGunma University

About this trial

The goal of this clinical trial is to learn if pembrolizumab works for cervical adenocarcinoma treat with concurrent chemo-carbon-ion radiaotherapy (CIRT).

The main questions it aims to answer are:

• Does concurrent chemo-CIRT with pembrolizumab improves 2-year progression-free survival (PFS), compared with concurrent chemoradiotherapy with conventional X-rays?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed adenocarcinoma or adenosquamous carcinoma of the uterine cervix and Stage ⅡA2, ⅡB, ⅢA, ⅢB, ⅢC1r, IVA according to FIGO classification (2018) will be enrolled in this study.

Absolute neutrophil count (ANC) ≥ 1500/µL, Platelets ≥ 100000/µ, Hemoglobin ≥9.0 g/dL or ≥ 5.6 mmol/L, Creatinine clearance ≥ 50 mL/min, Total bilirubin ≤1.5 ×ULN or direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN, AST and ALT ≤2.5 × ULN, International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.

Disqualifiers

1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).

Trial design

Design model

Single group

Treatments tested in this trial

  • Pembrolizumab (KEYTRUDA®)

    Drug

    Pembrolizumab is administered at 200 mg every 3 weeks for the first 2 cycles during Chemo-CIRT, after completion of radiotherapy, the dose is increased to 400 mg and given every 6 weeks for a total of 17 cycles over 2 years.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: CIRT＋CDDP＋PembroExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

It is based on the investigator's RECIST 1.1 assessment, or in the absence of imaging evidence of disease progression based on RECIST 1.1, histologically confirmed PD, after concurrent chemo-CIRT with pembrolizumab.

Time frame
At 2 years after the start of trial treatment

Secondary outcomes

1

Overall survival (OS)

To evaluate the 2-year overall survival after concurrent chemo-CIRT with pembrolizumab.

Time frame
At 2 years after the start of trial treatment
2

Complete response (CR) rate

To evaluate the complete response (CR) rate, defined as the maximum response of the primary tumor based on RECIST 1.1 assessment at 6 months after initiation of CIRT.

Time frame
At 6 months after the start of trial treatment
3

Local control (LC)

To evaluate the 2-year local control (LC) after concurrent chemo-CIRT with pembrolizumab.

Time frame
At 2 years after the start of trial treatment
4

Acute and late toxicities

To evaluate the acute and late toxicities of concurrent chemo-CIRT with pembrolizumab.

Time frame
Acute (≤ 90 days) and late toxicities (> 90 days) over 2 years after the start of trial treatment.

Other outcomes

Sponsors and contacts

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

Gunma University

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: