Immunotherapy combo shows promise in advanced cervical cancer trial

NCT ID NCT03556839

Disease control Sponsor: Grupo Español de Investigación en Cáncer de Ovario Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding the immunotherapy drug atezolizumab to standard chemotherapy and bevacizumab helps women with advanced, persistent, or recurrent cervical cancer live longer. The study enrolled 410 participants and compared the new combination against the current standard treatment. Researchers measured progression-free and overall survival to see if the added drug makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Atezolizumab (Tecentriq) plus bevacizumab (Avastin) and chemotherapy (cisplatin or carboplatin with paclitaxel)
What this could lead to: If successful, this combination could become a new standard treatment option for women with advanced or recurrent cervical cancer, potentially improving survival.
What could go wrong: This trial is completed, but results may not show a significant benefit over the current standard. Adding immunotherapy also increases the risk of immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

410 people

The number who actually took part.

Started

Sep 2018

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female patients must be ≥18 years of age. 2. Signed informed consent before any study-specific procedure 3. Able (in the investigator´s judgment) to comply with the study protocol 4. GOG/Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. Life expectancy ≥3 months 6. Histologically- or cytologically-confirmed diagnosis of metastatic (stage IVB), persistent, or recurrent cervical cancer (histologies other than squamous cell, adenocarcinoma, or adenosquamous will be excluded) not amenable for curative treatment with surgery and/or radiation therapy. The inclusion of patients with adenocarcinoma histology will be capped to 20% of the whole study population. 7. No prior systemic anti-cancer therapy for metastatic or recurrent disease. 8. Measureable disease by RECIST v1.1 criteria. 9. A tumor specimen is mandatory at study entry. 10. Adequate organ function: Hemoglobin ≥9 g/dL ANC ≥1.5 × 109/L Lymphocyte count ≥0.5 × 109/L Platelet count ≥100 x 109/L 11. Adequate liver function: Serum albumin ≥2.5 g/dL Total serum bilirubin ≤1.5 ×ULN AST and ALT ≤2.5 × upper limit normal (ULN) or ≤5 × ULN if tumor involvement (liver) is present 12. Adequate renal function: Patients with serum creatinine \<1.5 × ULN Urine dipstick for proteinuria \<2+. 13. Adequate coagulation: Blood coagulation parameters (PTT, PT/INR): PT such that international normalized ratio (INR) is ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT \<1.5 × ULN. 14. Negative Test Results for Hepatitis: Negative hepatitis B surface antigen (HBsAg) test at screening Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening.The HBV DNA test will be performed only for patients who have a positive total HBcAb test. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.The HCV RNA test will be performed only for patients who have a positive HCV antibody test. 15. Toxicities related to previous treatments must be recovered to \< grade 2 (with the exception of alopecia). 16. Female participants must be postmenopausal (≥ 12 months of non-therapy-induced amenorrhoea) or surgically sterile (absence of ovaries and/or uterus, or who received therapeutic radiation to the pelvis) or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods that result in a failure rate of \<1% per year during the whole treatment period of the study and for at least 5 months (if the last study dose contained atezolizumab) or 6 months (if the last study dose contained bevacizumab) after the last dose of study treatment. * 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 Exclusion Criteria: 1. Disease that is suitable for local therapy administered with curative intent 2. Prior radiotherapy delivered using cobalt (rather than a linear accelerator) 3. Patients with Stage IVA not amendable to concurrent chemo-radiation as primary treatment will not be eligible. 4. Ongoing disease involving the bladder or rectum at screening/baseline 5. Evidence of abdominal free air 6. Bilateral hydronephrosis, unless it can be alleviated by ureteral stent(s) or percutaneous drainage 7. Patients previously treated with chemotherapy except when used concurrently with radiation therapy. Patients who have received either concurrent paclitaxel with radiation therapy or carboplatin/paclitaxel as adjuvant therapy are ineligible for the study. 8. Prior treatment with any anti-VEGF drug, including bevacizumab, CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA 4. 9. Patients with a concomitant malignancy other than non-melanoma skin cancer. Patients with a prior invasive malignancy (except non-melanoma skin cancer ) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy. 10. Known brain metastases or spinal cord compression. It is mandatory to perform a scan of the brain in cases of suspected brain metastases (CT or MRI) or spinal cord compression (MRI). 11. History or evidence, following a neurological examination, of central nervous system (CNS) disorders, unless properly treated with standard medical treatment,(e.g. uncontrolled epileptic seizures). History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study. 12. Patients with serious non-healing wound, ulcer, or bone fracture. 13. Acute intestinal obstruction or sub-occlusion episode in the last 6 months. 14. Active GI bleeding or GI ulcer 15. History of Crohn's disease or inflammatory bowel disease 16. Prior bowel resection ≤6 weeks preceding first study dose 17. History of diverticulitis requiring medical intervention 18. NCI CTCAE (version 5.0) grade ≥2 enteritis 19. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1, Cycle 1. 20. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1, Cycle 1. 21. Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels. 22. Current or recent (within 10 days before the first dose of study drug) chronic daily treatment with aspirin (\>325 mg/day), clopidogrel (\>75 mg/day), or current or recent (within 10 days before first dose of bevacizumab) use of therapeutic oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. 23. Patients with pre-existing Grade 2 or greater peripheral neuropathy. 24. History of any grade ≥3 venous thromboembolic event (VTE) 25. Patients with clinically significant cardiovascular disease. 26. Left ventricular ejection fraction defined by MUGA/ECHO below the institutional lower limit of normal. 27. Uncontrolled tumor-related pain 28. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed. 29. Uncontrolled hypercalcemia (\>1.5 mmol/L ionized calcium or calcium \>12 mg/dL or corrected serum calcium \> ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab. 30. 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, vasculitis, glomerulonephritis or celiac disease. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan 31. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. 32. Active tuberculosis 33. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia 34. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 35. Received therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 36. Known human immunodeficiency virus (HIV) 37. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study Influenza vaccination should be given during influenza season only 38. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications 39. Treatment with systemic immunostimulatory agents (including but not limited to IFNs, IL-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1 40. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to Cycle 1, Day 1 The use of corticosteroids is allowed as premedication for paclitaxel-based regimen. All patients should be premedicated prior to receiving chemotherapy (including with corticosteroids) according to the prescription information of paclitaxel and cisplatin/carboplatin and the institutional standard of care guidance. 41. Currently participating or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study treatment. 42. Prior anti-cancer monoclonal antibody (mAb), prior chemotherapy, targeted small molecule therapy as first line treatment for the treatment of metastatic or recurrent cervical cancer. 43. Women that are breastfeeding or pregnant 44. Known hypersensitivity to bevacizumab, atezolizumab or any of theirs excipients (including Cremophor) 45. Demonstration of any other neurological or metabolic dysfunction, found upon physical examination or laboratory tests involving a reasonable suspicion of the existence of a disease or condition that contraindicates the use of an experimental drug, or that involves an increased risk to the patient of treatment-related complications 46. No medical or psychiatric illness that may impede the performance of a systemic or surgical treatment.

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Conditions

The condition(s) this trial relates to.

carcinoma cervical cancer Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma of the cervix, stage IVB

Contacts and locations

Locations

AOU Città della Salute e della Scienza di Torino, Presidio Sant'Anna

Torino, Italy
ASST Lecco

Lecco, Italy
AUSL Romagna - P.O. di Ravenna, Lugo, Faenza, Rimini e Cattolica

Ravenna, Italy
Azienda Ospedaliero Universitaria Pisana

Pisa, Italy
Azienda Ospedaliero-Universitaria Di Ferrara

Ferrara, Italy
Azienda Sanitaria Universitaria Integrata Di Udine

Udine, Italy
Azienda Usl - Irccs Di Reggio Emilia

Reggio Emilia, Italy
CHU Jean Minjoz

Besançon, France
Cancer Institute Hospital

Kōtoku, Japan
Centre Antoine Lacassagne

Nice, France
Centre CARIO-HPCA

Plérin, France
Centre François Baclesse

Caen, France
Centre Hospitalier Lyon Sud

Pierre-Bénite, France
Centre Léon Bérard

Lyon, France
Centre Oscar Lambret

Lille, 59000, France
Complejo Hospitalario Regional de Málaga

Málaga, Málaga, 29010, Spain
Fondazione Del Piemonte Per L'Oncologia

Candiolo, Italy
Groupe Hospitalier Diaconesses-Croix Saint-Simon

Paris, France
Gustave Roussy

Villejuif, France
H. Clínic Barcelona

Barcelona, Barcelona, 08036, Spain
HEGP

Paris, France
Haukeland University Hospital

Bergen, Norway
Helios-Klinikum Wuppertal

Wuppertal, 42283, Germany
Hokkaido Cancer Center

Hokkaido, Japan
Hospital Clinico Universitario Virgen Arrixaca

Murcia, Murcia, 30120, Spain
Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain
Hospital Miguel Servet

Zaragoza, Zaragoza, 50009, Spain
Hospital Quirón de Valencia

Valencia, 46010, Spain
Hospital Ramon y Cajal

Madrid, Madrid, 28034, Spain
Hospital Reina Sofía Cordoba

Córdoba, Cordoba, 14004, Spain
Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain
Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea

Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain
Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Virgen de la Salud

Toledo, 45004, Spain
Hospital de la Vall d'Hebron

Barcelona, Barcelona, 08035, Spain
Hosptial Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Santiago de Compostela, 15706, Spain
Hyogo Cancer Center

Hyōgo, Japan
Hôpital Privé du Confluent S.A.S.

Nantes, France
Hôpitaux Universitaires

Strasbourg, France
ICM Val d'Aurelle

Montpellier, France
ICO Centre René Gauducheau

Saint-Herblain, France
ICO Girona

Girona, Girona, 17007, Spain
ICO Paul Papin

Angers, 49055, France
Institut Bergonié

Bordeaux, France
Institut Claudius Régaud

Toulouse, France
Instituto Valenciano de Oncología

Valencia, Valencia, 46009, Spain
Intitut Català d' Oncolgia L' Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Irccs S. Raffaele - Milano

Milan, Italy
Irst Irccs

Meldola FC, Italy
Istituto Europeo di Oncologia

Milan, Italy
Istituto Nazionale Tumori Di Napoli Irccs Pascale

Naples, Italy
Istituto Oncologico Veneto (IOV) IRCCS

Padova, Italy
Karolinska University Hospital

Stockholm, Sweden
Keio University Hospital

Tokyo, Japan
Kurume University Hospital

Fukuoka, Japan
Lindköping University Hospital

Linköping, Sweden
Massey Cancer Center

Richmond, Virginia, 980037, United States
Niigata University Medical & Dental Hospital

Niigata, Japan
Oslo University Hospital

Oslo, Norway
Ospedale Lecce 'Vito Fazzi'

Lecce, Italy
Ospedale Ordine Mauriziano

Torino, Italy
Ospedale San Gerardo

Monza, Italy
Parc Taulí

Sabadell, Barcelona, 08208, Spain
Policlinico Universitario A. Gemelli

Roma, Italy
Saitama medical university international medical center

Hidaka, Japan
Shizuoka Cancer Center

Shizuoka, Japan
Skane University Hospital

Lund, Sweden
University Hospital of North Norway

Tromsø, Norway
Universitätsmedizin Mainz

Mainz, 55131, Germany
Uppsala University Hospital

Uppsala, Sweden
Willis Knighton Cancer Center

Shreveport, Louisiana, 71103, United States