AzTrials
AzTrials

Locally Advanced Cervical CancerPhase 2ATEZOLACCNCT03612791

Trial Assessing the Inhibitor of Programmed Cell Death Ligand 1 (PD-L1) Immune Checkpoint Atezolizumab

A Phase 2 study testing Atezolizumab, Radiotherapy and Cisplatin in people with Locally Advanced Cervical Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

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

Official record
Search all trials

Trial summary

The primary objective of this randomized phase II trial is to evaluate the clinical benefits of the addition of atezolizumab to standard chemoradiotherapy (CRT) (first given concurrently with CRT, then continued as adjuvant treatment), compared with CRT alone, on investigator-assessed progression-free survival (PFS)… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Locally Advanced Cervical Cancer
What is being tested?
Atezolizumab, Radiotherapy and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteFrance
Study dates
13 Aug 2018to 13 May 2025
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent (after informing the patient).
  • Age ≥18 years old. Patients above 70 years old will be screened according to the G-8 screening tool. If required (G-8 score ≤14), a consultation with an onco-geriatrician will be held in order to confirm the patient eligibility
  • Histologically confirmed cancer of the uterine cervix: squamous cell carcinoma (SCC), adenocarcinoma, or adenosquamous carcinoma.
  • At least one evaluable lesion according to RECIST v1.1 criteria for the assessment of the principal judgment criteria. At baseline, lesion(s) must be ≥10 mm in the longest diameter (except lymp nodes which must have a short axis ≥15 mm).
  • International Federation of Gynecology and Obstetrics (FIGO 2009) classification (confirmed by both clinical staging and/or imaging):
  • stage IB1-IIA tumour with positive pelvic nodal status, as assessed by magnetic resonance imaging (MRI) and/or fluorine-18 fluorodeoxyglucose positron emission tomography (18-FDG PET)/computerised tomography (CT); (ii) stage IIB-IVA tumour, regardless of pelvic lymph node involvement; (iii) stage IVB tumours only if the metastases are limited to the paraaortic lymph nodes.
Show all 28Show fewer
  • No evidence of metastatic disease outside the para-aortic area by primary staging (including clinical examination, pelvic MRI, 18-FDG PET, +/- laparoscopic para-aortic lymph node staging).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate haematologic and end-organ function, defined by the following laboratory results obtained within 15 calendar days prior to the first study treatment:
  • Absolute neutrophil count (ANC) ≥1,500/mm3 (≥1.5 x 10^9/L) without granulocyte colony-stimulating factor (G-CSF) support.
  • Total white blood cells (WBC) >2,000/mm3 (>2.0 x 10^9/L) (including Polymorphonuclear neutrophils > 1,500/mm3 or 1.5 x 10^9/L)
  • Lymphocyte count ≥500/mm3 (≥ 0.5 x 10^9/L)
  • Platelet count ≥ 100,000/mm3 (≥ 100 x 10^9/L) without transfusion.
  • Haemoglobin ≥ 9.0 g/dL (90 g/L; patients may be transfused to meet this criterion).
  • International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal (ULN) for patients not receiving therapeutic anticoagulation.
  • Patients receiving therapeutic anticoagulation should be on a stable dose.
  • Creatinine <1.5 ULN or calculated creatinine clearance (CrCL) ≥ 45 mL/min (calculated using the Cockcroft-Gault formula).
  • Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase <2.5 x ULN.
  • Serum bilirubin <1.5 x ULN.
  • Proteinuria < 200 mg/dL (2 g/L). Patients with ureteral stent or with bladder invasion are eligible if the proteinuria is above the former threshold
  • Ability to comply with the study protocol.
  • Geographical, social and psychological ability to undergo the followup required by the study.
  • Women who are not postmenopausal (≥ 12 months of non-therapy induced amenorrhoea) and not surgically sterile:
  • Must agree to either use an acceptable contraceptive method* or to remain abstinent** (refrain from heterosexual intercourse) during the treatment period and for at least 5 months after the last dose of atezolizumab in arm B and at least 6 months after the last cisplatin/carboplatin dose in arm A.
  • Acceptable contraceptive methods include single or combined contraceptive methods that result in a failure rate of < 1% per year, such as: tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year. Barrier methods must always be supplemented with the use of a spermicide.
  • Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
  • Must have a negative serum pregnancy test result within 7 days prior to initiation of study drug.
  • Patients must be affiliated to a social security system or beneficiary of the same, as per local regulatory requirements

Who cannot join

  • Histological types of cervical cancer other than those listed in the inclusion criteria (based on FIGO 2009 classification), including:
  • Stage IB1 and IIA cervical cancer with no regional lymph node metastases (N0).
  • Stage IVB cervical cancer with presence of distant metastases other than para-aortic lymph node metastases.
  • Prior surgery for cervical cancer unless cone resection and paraaortic lymphadenectomy.
  • Prior pelvic radiotherapy, other radiotherapy, chemotherapy or immunotherapy.
  • Any malignancy other than the disease under study in the past 5 years excepting skin cancers such as BCC or SCC.
Show all 26Show fewer
  • Pregnant or lactating women, or intending to become pregnant during the study.
  • For patient ≥ 70 years old with a G-8 score ≤ 14, unconfirmation of patient eligibility done by the onco-geriatrician at screening
  • History of clinically relevant cardiovascular disease, congestive heart failure (New York Heart Association [NYHA] Class II or greater), or a known left ventricular ejection fraction (LVEF) <50%, symptomatic coronary artery disease, poorly controlled cardiac arrhythmia, or myocardial infarction.
  • Active inflammatory bowel disease, lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome.
  • Serious infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
  • Treatment with another investigational therapy within 30 days prior to initiation of the study drug.
  • Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the study other than for diagnosis. The following are not considered a major surgical procedure and are therefore permitted:
  • placement of central venous access catheter(s) (e.g., port or similar); (ii) surgical lymph node staging with no perioperative complications; (iii) placement of ureteral catheters.
  • History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins.
  • Known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation.
  • Any contraindication to the use of Cisplatin and/or carboplatin
  • History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, meningoencephalitis, or glomerulonephritis (see Appendix 6 for a more comprehensive list of autoimmune diseases) with the following exceptions: patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone, patients with controlled Type 1 diabetes mellitus on a stable insulin regimen, and patients with mild autoimmune skin disorders (such as eczema or atopic dermatitis involving <10% of the skin) may be eligible for this study.
  • History of idiopathic pulmonary fibrosis (IPF, including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or active pneumonitis.
  • Pre-existing hearing impairment.
  • Peripheral neuropathy ≥grade 2
  • Positive test for human immunodeficiency virus (HIV).
  • Active hepatitis B (positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C (positive hepatitis C virus antibody [HCVAb] test at screening). Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive hepatitis B core antibody [HBcAb] test) are eligible.
  • Known active tuberculosis.
  • Receipt of a live, attenuated vaccine within 4 weeks prior to randomisation or anticipation that such a live, attenuated vaccine will be required during the study. Note: Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 28 days prior to randomisation, during treatment or within 5 months following the last dose of atezolizumab.
  • Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or immune checkpoint targeting agents.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val de Marne, 94805

Other trials in France

About this study

Official title: Randomized Phase II Trial Assessing the Inhibitor of Programmed Cell Death Ligand 1 (PD-L1) Immune Checkpoint Atezolizumab in Locally Advanced Cervical Cancer

The primary objective of this randomized phase II trial is to evaluate the clinical benefits of the addition of atezolizumab to standard chemoradiotherapy (CRT) (first given concurrently with CRT, then continued as adjuvant treatment), compared with CRT alone, on investigator-assessed progression-free survival (PFS), as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Being tested
Atezolizumab, Radiotherapy, Cisplatin

What participants receive

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

  • AtezolizumabDrug

    atezolizumab administered IV 1200 mg Q3W, starting one week before EBRT (Week -1) and continued as an adjuvant for a total maximum of 20 cycles.

  • RadiotherapyRadiation

    • Pelvic +/- para-aortic EBRT (IMRT): 45 Gy in 25 fractions over 5 weeks (Weeks 1-5, with simultaneously integrated boosts to macroscopically involved lymph nodes, if any, in order to deliver a total dose of 60 Gy to macroscopic lymph nodes (including the dose delivered by brachytherapy).
    • Uterovaginal brachytherapy (Week 7; maximum interval between EBRT and brachytherapy: 14 days). If appropriate and feasible, dose escalation will be assumed, particularly for advanced disease, with the objective to deliver a total dose of 85 Gy (equivalent dose in 2-Gy fractions with α/β=10 Gy) to 80% of the High Risk-Clinical Target Volume (HR-CTV), including 45 Gy through EBRT. The total dose might be lower in case of close proximity to organs at risk (OARs).
    • Total duration of RT (including brachytherapy) should be ≤ 55 days.

  • CisplatinDrug

    • Cisplatin infused 40 mg/m2 (maximum 70 mg) weekly IV during EBRT (Weeks 1-5).
    • Not administered: during the interval between EBRT and brachytherapy, or during brachytherapy, or if radiotherapy is interrupted.
Study groups in NCT03612791
Study groupRoleWhat they receive
Standard Treatment ArmActive comparatorRadiotherapy (RT): * Pelvic +/- para-aortic EBRT (IMRT): 45 Gy in 25 fractions over 5 weeks (Weeks 1-5, with simultaneously integrated boosts to macroscopically involved lymph nodes, if any, in order to deliver a total dose of 60 Gy to macroscopic lymph nodes (including the dose delivered by brachytherapy). * Uterovaginal brachytherapy (Week 7; maximum interval between EBRT and brachytherapy: 14 days). If appropriate and feasible, dose escalation will be assumed, particularly for advanced disease, with the objective to deliver a minimal total dose of 85 Gy (equivalent dose in 2-Gy fractions with α/β=10 Gy) to 80% of the High Risk-Clinical Target Volume (HR-CTV), including 45 Gy through EBRT. The total dose might be lower in case of close proximity to organs at risk (OARs). * Total duration of RT (including brachytherapy) should be ≤ 55 days. Chemotherapy: - Cisplatin infused 40 mg/m2 (maximum 70 mg) weekly IV during EBRT (Weeks 1-5).
Receives: Radiation: Radiotherapy; Drug: Cisplatin
Experimental Treatment ArmExperimental* Same treatment as described above (CRT, followed by uterovaginal brachytherapy), plus * atezolizumab administered IV 1200 mg Q3W, starting on the same week as EBRT (Week 1) and continued as an adjuvant for a total maximum of 20 cycles (approximately 14 months total of treatment).
Receives: Drug: Atezolizumab; Radiation: Radiotherapy; Drug: Cisplatin

What is being measured

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

  1. Progression Free Survival (PFS)

    The primary endpoint is progression free survival (PFS), defined as the time from randomization to the first documented occurrence of disease progression

    Measured: from randomization to the first documented occurrence of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurs first, up to 24 months

Timeline

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

  1. First posted2 Aug 2018
  2. Study start13 Aug 2018
  3. Primary completion26 Feb 2024
  4. Study completion13 May 2025

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03612791
Sponsor's protocol ID
2017-003622-33
Other IDs
2017/2608, 2017
Acronym
ATEZOLACC
Status last verified
Mar 2026
First submitted
20 Jul 2018
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Radiotherapy and Cisplatin in people with Locally Advanced Cervical Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

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 28 inclusion and 26 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Progression Free Survival (PFS) (time frame: from randomization to the first documented occurrence of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurs first, up to 24 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 NCT03612791.

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 3 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in