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

  • STATUS
    Recruiting
  • End date
    Jul 5, 2022
  • participants needed
    189
  • sponsor
    Gustave Roussy, Cancer Campus, Grand Paris
Updated on 5 March 2021

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 on5 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Are you female?
Do you have Locally Advanced Cervical Cancer?
Do you have any of these conditions: Do you have Locally Advanced Cervical Cancer??
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: Do you have Locally Advanced Cervical Cancer??
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: Do you have Locally Advanced Cervical Cancer??
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-geriatrian 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, Sjgren's
syndrome, Guillain-Barr 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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