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NCT02921269

Atezolizumab and Bevacizumab in Treating Patients With Recurrent, Persistent, or Metastatic Cervical Cancer

Completed Phase 2 Results posted Last updated 21 February 2023
What this trial tests

Phase 2 trial testing Atezolizumab in Cervical Adenocarcinoma in 11 participants. Completed in 13 January 2021.

Timeline
10 March 2017
Primary endpoint
1 October 2020
13 January 2021

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment11
Start date10 March 2017
Primary completion1 October 2020
Estimated completion13 January 2021
Sites22 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, female only, with Cervical Adenocarcinoma or Cervical Adenosquamous Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Objective Response Rate (ORR, Either Partial or Complete Response) Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Criteria Primary · Up to 2 years

Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Complete Response (CR) is the disappearance of all lesions and Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) is CR+PR.

GroupValue95% CI
Treatment (Atezolizumab, Bevacizumab)0
Progression Free Survival Secondary · From start of treatment to investigator determined date of progression, or death due to any cause, whichever occurs first, assessed up to 2 years

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm (0.5 cm) or the appearance of one or more new lesions.

GroupValue95% CI
Treatment (Atezolizumab, Bevacizumab)2.91.8 – 6
Overall Survival (OS) Secondary · From start of treatment to death, assessed up to 2 years

The duration of OS will be estimated.

GroupValue95% CI
Treatment (Atezolizumab, Bevacizumab)8.93.4 – 21.9
Percent of Participants With Adverse Events Secondary · Up to 30 days after the last dose of study treatment, on average of 4 months

The frequency and severity of adverse events will be assessed in those patients who initiate their study treatment.

GroupValue95% CI
Treatment (Atezolizumab, Bevacizumab)36.4
PD-L1 Expression on Tumor and Immune Cells Measured by Semi-quantitative Immunohistochemistry Secondary · Up to 2 years

The efficacy of the combination of atezolizumab and bevacizumab as measured by objective response, will be described in patients according to PD-L1 positive and PD-L1 negative.

GroupValue95% CI
Treatment (Atezolizumab, Bevacizumab)3
Intratumoral and Peripheral T-cell Receptor (TCR) Clonality Assessed by TCR Sequencing Secondary · Up to 2 years

Will be used to describe the efficacy of the combination of atezolizumab and bevacizumab.

GroupValue95% CI
Treatment (Atezolizumab, Bevacizumab)0
Tumor Infiltrating Lymphocyte Proportion Secondary · Up to 2 years

Will be used to describe the efficacy of the combination of atezolizumab and bevacizumab.

GroupValue95% CI
Treatment (Atezolizumab, Bevacizumab)1.170.06 – 2.77

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 30 days after the last dose of study treatment, on average of 4 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Atezolizumab, Bevacizumab)
Serious: 0/11 (0%)
Deaths: 11/11
Other adverse events (36 terms — click to expand)

ReactionSystemTreatment (Atezolizumab, B…
FatigueGeneral disorders
NauseaGastrointestinal disorders
DiarrheaGastrointestinal disorders
Aspartate aminotransferase increasedGastrointestinal disorders
FeverGeneral disorders
HypertensionCardiac disorders
Alanine aminotransferase increasedGastrointestinal disorders
Gastrointestinal fistulaGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Sinus tachycardiaCardiac disorders
StrokeCardiac disorders
Thromboembolic eventCardiac disorders
HyperthyroidismEndocrine disorders
HypothyroidismEndocrine disorders
AnorexiaGastrointestinal disorders
VomitingGastrointestinal disorders
PancreatitisGastrointestinal disorders
Lipase increasedGastrointestinal disorders
Alkaline phosphatase increasedGastrointestinal disorders
Gastrointestinal bleedingGastrointestinal disorders
PainGeneral disorders
NeutropeniaBlood and lymphatic system disorders
AnemiaBlood and lymphatic system disorders
Muscle weaknessMusculoskeletal and connective tissue disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
MyalagiaMusculoskeletal and connective tissue disorders
Peripheral sensory neuropathyNervous system disorders
ArachnoiditisNervous system disorders
Sensorineural hearing lossNervous system disorders
HeadacheNervous system disorders
DepressionNervous system disorders
EncephalopathyNervous system disorders
MeningitisNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
PneumonitisRespiratory, thoracic and mediastinal disorders

Data from ClinicalTrials.gov NCT02921269 adverse events section.

Sponsor's own description

This phase II trial studies how well atezolizumab and bevacizumab work in treating patients with cervical cancer that has come back, remains despite treatment, or has spread to other places in the body. Monoclonal antibodies, such as atezolizumab and bevacizumab, may shrink tumor cell and interfere with the ability of tumor cells to grow and spread.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Synergistic effect of immune checkpoint blockade and anti-angiogenesis in cancer treatment.
    Yi M, Jiao D, Qin S, Chu Q, et al · · 2019 · cited 487× · PMID 30925919 · DOI 10.1186/s12943-019-0974-6
  2. Cervical Cancer Immunotherapy: Facts and Hopes.
    Ferrall L, Lin KY, Roden RBS, Hung CF, et al · · 2021 · cited 255× · PMID 33888488 · DOI 10.1158/1078-0432.ccr-20-2833
  3. Anti-angiogenic Agents in Combination With Immune Checkpoint Inhibitors: A Promising Strategy for Cancer Treatment.
    Song Y, Fu Y, Xie Q, Zhu B, et al · · 2020 · cited 198× · PMID 32983126 · DOI 10.3389/fimmu.2020.01956
  4. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
    Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
  5. PD-1/PD-L1 Inhibitors in Cervical Cancer.
    Liu Y, Wu L, Tong R, Yang F, et al · · 2019 · cited 113× · PMID 30774597 · DOI 10.3389/fphar.2019.00065
  6. Tumor Vasculatures: A New Target for Cancer Immunotherapy.
    Liu Z, Wang Y, Huang Y, Kim BYS, et al · · 2019 · cited 88× · PMID 31331639 · DOI 10.1016/j.tips.2019.07.001
  7. NAT10/ac4C/FOXP1 Promotes Malignant Progression and Facilitates Immunosuppression by Reprogramming Glycolytic Metabolism in Cervical Cancer.
    Chen X, Hao Y, Liu Y, Zhong S, et al · · 2023 · cited 87× · PMID 37818745 · DOI 10.1002/advs.202302705
  8. Recurrent or primary metastatic cervical cancer: current and future treatments.
    Gennigens C, Jerusalem G, Lapaille L, De Cuypere M, et al · · 2022 · cited 87× · PMID 36108558 · DOI 10.1016/j.esmoop.2022.100579

Verify or expand the search:

Other trials of Atezolizumab

Trials testing the same drug.

Other recruiting trials for Cervical Adenocarcinoma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02921269.

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