Trial · NCT03738228

Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer

NCT03738228, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2023-07-20

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer. Trials, record NCT03738228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03738228

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer
NCT number: NCT03738228
Status: Completed
Phases: Phase 1
Enrollment: 40 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Stage IB2 Cervical Cancer AJCC v8, Stage II Cervical Cancer AJCC v8, Stage IIA Cervical Cancer AJCC v8, Stage IIA1 Cervical Cancer AJCC v8, Stage IIA2 Cervical Cancer AJCC v8, Stage IIB Cervical Cancer AJCC v8, Stage IIIB Cervical Cancer AJCC v8, Stage IVA Cervical Cancer AJCC v8
Interventions: Atezolizumab, Brachytherapy, Cisplatin, Radiation Therapy
First posted: 2018-11-13
Last updated: 2025-11-12
Results first posted: 2023-07-20

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Immune Response	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.
Secondary	Percentage of Participants With Dose Limiting Toxicities	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).
Secondary	Post-treatment 3-month PET/CT Metabolic Response	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.
Secondary	Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5	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.
Secondary	T Cell Receptor (TCR) Simpson Clonality	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.
Secondary	Pre-treatment PD-L1 Expression	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
Secondary	Disease-free Survival (DFS) at 2 Years	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.
Secondary	T Cell Receptor (TCR) Diversity	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Immune Response	Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab	Arm A: All eligible participants who received Atezolizumab at Day -21 and Day 0 with TCRB measurements Arm B: All eligible participants who received Atezolizumab at Day 0 with TCRB measurements	Total number of expanded clones	MEAN
SECONDARY	Percentage of Participants With Dose Limiting Toxicities	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).	Eligible participants who have a DLT and have at least one dose of Atezolizumab, or complete protocol therapy until 30 days after the completion of CRT (Chemoradiation Therapy).	Percentage of participants	NUMBER
SECONDARY	Post-treatment 3-month PET/CT Metabolic Response	3 months after completion of study treatment	Eligible and treated with PET/CT scans at post-treatment 3 months and baseline	Percentage of participants	NUMBER
SECONDARY	Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5	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	Eligible and Treated.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	T Cell Receptor (TCR) Simpson Clonality	Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab	Arm A: All eligible participants who received Atezolizumab at Day -21 and Day 0 with TCR measurements Arm B: All eligible participants who received Atezolizumab Day 0 with TCR measurements	Index	MEDIAN
SECONDARY	Pre-treatment PD-L1 Expression	Within 3 days after randomization but before start of study treatment	Eligible and treated without missing PD-L1 measurement	percentage of PDL-1 expression	MEDIAN
SECONDARY	Disease-free Survival (DFS) at 2 Years	Up to 2 years	Eligible and Treated	Percentage of participants	NUMBER
SECONDARY	T Cell Receptor (TCR) Diversity	Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab	Arm A: All eligible participants who received Atezolizumab at Day -21 and Day 0) with TCR measurements Arm B: All eligible participants who received Atezolizumab Day 0 with TCR measurements	number of unique rearrangements	MEDIAN

Source ClinicalTrials.gov

Results by group34

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Immune Response	Arm A		132.7	Standard Deviation 175.7	Total number of expanded clones
Immune Response	Arm B		192.8	Standard Deviation 174.4	Total number of expanded clones
Percentage of Participants With Dose Limiting Toxicities	Arm A		0	90% Confidence Interval 0 to 17.07	Percentage of participants
Percentage of Participants With Dose Limiting Toxicities	Arm B		21.43	90% Confidence Interval 6.11 to 46.57	Percentage of participants
Post-treatment 3-month PET/CT Metabolic Response	Arm A		71.4	90% Confidence Interval 34.1 to 94.7	Percentage of participants
Post-treatment 3-month PET/CT Metabolic Response	Arm B		50	90% Confidence Interval 24.5 to 75.5	Percentage of participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5	Arm A	Blood and lymphatic system disorders	4		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5	Arm B	Blood and lymphatic system disorders	6		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5	Arm A	Cardiac Disorders	1		Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5	Arm B	Cardiac Disorders	0		Participants

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A	21
Overall Study	STARTED	Arm B	19
Overall Study	COMPLETED	Arm A	19
Overall Study	COMPLETED	Arm B	17
Overall Study	NOT COMPLETED	Arm A	2
Overall Study	NOT COMPLETED	Arm B	2

Source ClinicalTrials.gov

Adverse events230

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Febrile Neutropenia	Blood and lymphatic system disorders	Arm A	0	19
other	Febrile Neutropenia	Blood and lymphatic system disorders	Arm B	2	17
other	Anemia	Blood and lymphatic system disorders	Arm A	10	19
other	Anemia	Blood and lymphatic system disorders	Arm B	9	17
other	Blood And Lymphatic System Disorders - Other	Blood and lymphatic system disorders	Arm A	0	19
other	Blood And Lymphatic System Disorders - Other	Blood and lymphatic system disorders	Arm B	1	17
other	Myocardial Infarction	Cardiac disorders	Arm A	1	19
other	Myocardial Infarction	Cardiac disorders	Arm B	0	17
other	Cardiac Disorders - Other	Cardiac disorders	Arm A	0	19
other	Cardiac Disorders - Other	Cardiac disorders	Arm B	1	17

1 to 10 of 230Source ClinicalTrials.gov

See all 230 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A	4	19
Total, all-cause mortality	Arm B	2	17
Total, other adverse events	Arm A	19	19
Total, other adverse events	Arm B	17	17
Total, serious adverse events	Arm A	6	19
Total, serious adverse events	Arm B	7	17

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31871115	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm A vs Arm B: deaths from any cause	Trial comparisons
Arm A vs Arm B: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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API reference For AI assistants