Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer
CompletedPhase 1Results postedLast updated 12 November 2025
What this trial tests
Phase 1 trial testing Atezolizumab in Cervical Adenocarcinoma in 40 participants. Completed in 12 September 2025.
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.
Immune ResponsePrimary· Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab
The immune response is measured by total T cell receptor beta (TCRB) clonal expansion in peripheral blood at day 21 from baseline using Adaptive Biotechnologies' immunoSEQ platform from Day -21 to Day 21 for group 1 (i.e., Arm A), and from Day 0 to Day 21 for group 2 (i.e., Arm B). The higher number of total TCR clonal expansion indicates better immune response.
Group
Value
95% CI
Arm A
132.7
± 175.7
Arm B
192.8
± 174.4
Percentage of Participants With Dose Limiting ToxicitiesSecondary· Arm A: 111 days, i.e., from start of the priming dose of atezolizumab until 30 days after the completion of CRT Arm B: 90 days, i.e., from start of CRT until 30 days after the completion of CRT(Chemoradiation therapy).
A DLT is defined as any drug related adverse effects that occur during treatment period until 30 days after the completion of CRT and meet the criteria as evaluated by NCI CTCAE v.5 unless clearly unrelated to study therapy (e.g., disease progression).
Group
Value
95% CI
Arm A
0
0 – 17.07
Arm B
21.43
6.11 – 46.57
Post-treatment 3-month PET/CT Metabolic ResponseSecondary· 3 months after completion of study treatment
Percentage of participants with complete post-treatment 3-month PET/CT metabolic response. The post-treatment 3-month PET/CT metabolic response is evaluated based on the ratio of post-treatment week-12 PET-CT SUVmax to base-line PET-CT scan SUV max, and the response will be classified as complete metabolic response for the ratio \< 0.34, or classified as partial metabolic response for 0.34 \<= the ratio \< 0.76, or classified as stable metabolic response for 0.76 \<= the ratio \< 1.25, or classified as progressive metabolic disease for the ratio \>= 1.25.
Group
Value
95% CI
Arm A
71.4
34.1 – 94.7
Arm B
50
24.5 – 75.5
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5Secondary· Arm A: 111 days, i.e., from start of the priming dose of atezolizumab until 30 days after the completion of CRT Arm B 90 days, i.e., from start of CRT until 30 days after the completion of CRT
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v5.0.
Blood and lymphatic system disorders
Group
Value
95% CI
Arm A
4
Arm B
6
Cardiac Disorders
Group
Value
95% CI
Arm A
1
Arm B
0
Gastrointestinal Disorders
Group
Value
95% CI
Arm A
2
Arm B
4
General disorders and administrative site conditions
Group
Value
95% CI
Arm A
1
Arm B
0
Infections and Infestations
Group
Value
95% CI
Arm A
3
Arm B
2
Investigations
Group
Value
95% CI
Arm A
2
Arm B
7
Metabolism and Nutrition Disorders
Group
Value
95% CI
Arm A
0
Arm B
4
Musculoskeletal and Connective Tissue Disorders
Group
Value
95% CI
Arm A
0
Arm B
2
T Cell Receptor (TCR) Simpson ClonalitySecondary· Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab
TCR Simpson clonality in peripheral blood is measured at day 21 using Adaptive Biotechnologies' immunoSEQ platform. It quantitates the extent of mono- or oligoclonal dominance within a TCR repertoire by measuring the shape of the clone frequency distribution ranging from 0 to 1, where values approaching 1 indicate a nearly monoclonal population.
Group
Value
95% CI
Arm A
0.0505
0.0102 – 0.2305
Arm B
0.0448
0.0112 – 0.1355
Pre-treatment PD-L1 ExpressionSecondary· Within 3 days after randomization but before start of study treatment
Pre-treatment PD-L1 SP142 positive immune cells in tumor area in formalin-fixed paraffin-embedded (FFPE) biopsy primary tumor tissues
Group
Value
95% CI
Arm A
0.75
0 – 8
Arm B
0.5
0 – 3
Disease-free Survival (DFS) at 2 YearsSecondary· Up to 2 years
Percentage of participants who survive disease-free at 2 years, where DFS is defined as the duration of time from study entry to date of first documented recurrence or progression of disease or death, whichever occurs first. Progression is assessed by RECIST 1.1.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Arm A
68.4
47 – 85.3
Arm B
52.9
31.1 – 74
T Cell Receptor (TCR) DiversitySecondary· Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab
TCR diversity in peripheral blood is measured at day 21 by counting the number of unique rearrangements to a common number of T cells using Adaptive Biotechnologies' immunoSEQ platform. A higher TCR diversity indicates a richer TCR repertoire.
Group
Value
95% CI
Arm A
12118
4448 – 14740
Arm B
12237
8366 – 14906
Adverse events — posted to ClinicalTrials.gov
Time frame: Arm A: 111 days, i.e., from start of the priming dose of atezolizumab until 30 days after the completion of CRT Arm B: 90 days, i.e., from start of CRT until 30 days after the completion of CRT. All-Cause Mortality monitored/assessed up to 2 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A
Serious: 6/19 (32%)
Deaths: 4/19
Arm B
Serious: 7/17 (41%)
Deaths: 2/17
Serious adverse events (13 terms)
Reaction
System
Arm A
Arm B
Diarrhea
Gastrointestinal disorders
—
—
Febrile Neutropenia
Blood and lymphatic system disorders
—
—
Anemia
Blood and lymphatic system disorders
—
—
Myocardial Infarction
Cardiac disorders
—
—
Small Intestinal Obstruction
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Flu Like Symptoms
General disorders
—
—
Fever
General disorders
—
—
Urinary Tract Infection
Infections and infestations
—
—
Hypokalemia
Metabolism and nutrition disorders
—
—
Musculoskeletal And Connective Tissue Disorder - O
Musculoskeletal and connective tissue disorders
—
—
Vaginal Hemorrhage
Reproductive system and breast disorders
—
—
Pelvic Pain
Reproductive system and breast disorders
—
—
Other adverse events (102 terms — click to expand)
This phase I trial studies how well atezolizumab before and/or with standard of care chemoradiotherapy works in immune system activation in patients with stage IB2, II, IIIB, or IVA cervical cancer that has spread to the lymph nodes. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab before and/or with chemoradiotherapy may lower the chance of tumors growing or spreading.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07388524 — Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer
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· not yet recruiting
NCT07322341 — SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer
· Phase 2
· not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce
· Phase 2
· recruiting
NCT07461675 — Effects of Neoadjuvant Immunotherapy on Anti-tumour Immunity in Hepatocellular Carcinoma Patients Undergoing Liver Resec
· Phase 3
· not yet recruiting
NCT07291076 — A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants Wit
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 12 November 2025
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/NCT03738228.