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

  • STATUS
    Recruiting
  • End date
    Jul 14, 2024
  • participants needed
    189
  • sponsor
    Gustave Roussy, Cancer Campus, Grand Paris
Updated on 14 March 2022

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), as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Details
Condition Locally Advanced Cervical Cancer
Treatment cisplatin, Radiotherapy, Atezolizumab
Clinical Study IdentifierNCT03612791
SponsorGustave Roussy, Cancer Campus, Grand Paris
Last Modified on14 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
(i) 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
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

Exclusion Criteria

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
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
(i) 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
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