Trial Outcomes & Findings for Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer (NCT NCT03738228)

Last Updated: 2025-11-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab

Results posted on

2025-11-12

Participant Flow

This study was activated on 10/26/2018 and closed to accrual on 6/11/2020.

Participant milestones

Participant milestones
Measure	Arm A Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
Overall Study STARTED	21	19
Overall Study COMPLETED	19	17
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
Overall Study Never received study treatment	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=19 Participants Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=17 Participants Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy	Total n=36 Participants Total of all reporting groups
Age, Customized 20-29 years	0 Participants n=10 Participants	3 Participants n=10 Participants	3 Participants n=20 Participants
Age, Customized 30-39 years	3 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=20 Participants
Age, Customized 40-49 years	3 Participants n=10 Participants	8 Participants n=10 Participants	11 Participants n=20 Participants
Age, Customized 50-59 years	8 Participants n=10 Participants	3 Participants n=10 Participants	11 Participants n=20 Participants
Age, Customized 60-69 years	4 Participants n=10 Participants	1 Participants n=10 Participants	5 Participants n=20 Participants
Age, Customized 70-79 years	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Sex: Female, Male Female	19 Participants n=10 Participants	17 Participants n=10 Participants	36 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=10 Participants	1 Participants n=10 Participants	8 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=10 Participants	16 Participants n=10 Participants	27 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	3 Participants n=10 Participants	4 Participants n=10 Participants	7 Participants n=20 Participants
Race (NIH/OMB) White	14 Participants n=10 Participants	13 Participants n=10 Participants	27 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants

PRIMARY outcome

Timeframe: Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab

Population: 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

Outcome measures

Outcome measures
Measure	Arm A n=17 Participants Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=13 Participants Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
Immune Response	132.7 Total number of expanded clones Standard Deviation 175.7	192.8 Total number of expanded clones Standard Deviation 174.4

SECONDARY outcome

Timeframe: 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).

Population: 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).

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).

Outcome measures

Outcome measures
Measure	Arm A n=16 Participants Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=14 Participants Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
Percentage of Participants With Dose Limiting Toxicities	0 Percentage of participants Interval 0.0 to 17.07	21.43 Percentage of participants Interval 6.11 to 46.57

SECONDARY outcome

Timeframe: 3 months after completion of study treatment

Population: Eligible and treated with PET/CT scans at post-treatment 3 months and baseline

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.

Outcome measures

Outcome measures
Measure	Arm A n=7 Participants Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=12 Participants Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
Post-treatment 3-month PET/CT Metabolic Response	71.4 Percentage of participants Interval 34.1 to 94.7	50 Percentage of participants Interval 24.5 to 75.5

SECONDARY outcome

Timeframe: 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

Population: Eligible and Treated.

Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v5.0.

Outcome measures

Outcome measures
Measure	Arm A n=19 Participants Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=17 Participants Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 Renal and Urinary Disorders	1 Participants	0 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 Reproductive System and Breast Disorders	1 Participants	2 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 Metabolism and Nutrition Disorders	0 Participants	4 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 Infections and Infestations	3 Participants	2 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 Investigations	2 Participants	7 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 Blood and lymphatic system disorders	4 Participants	6 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 Cardiac Disorders	1 Participants	0 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 Gastrointestinal Disorders	2 Participants	4 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 General disorders and administrative site conditions	1 Participants	0 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v)5 Musculoskeletal and Connective Tissue Disorders	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab

Population: 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

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.

Outcome measures

Outcome measures
Measure	Arm A n=17 Participants Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=13 Participants Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
T Cell Receptor (TCR) Simpson Clonality	0.0505 Index Interval 0.0102 to 0.2305	0.0448 Index Interval 0.0112 to 0.1355

SECONDARY outcome

Timeframe: Within 3 days after randomization but before start of study treatment

Population: Eligible and treated without missing PD-L1 measurement

Pre-treatment PD-L1 SP142 positive immune cells in tumor area in formalin-fixed paraffin-embedded (FFPE) biopsy primary tumor tissues

Outcome measures

Outcome measures
Measure	Arm A n=10 Participants Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=12 Participants Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
Pre-treatment PD-L1 Expression	0.75 percentage of PDL-1 expression Interval 0.0 to 8.0	0.5 percentage of PDL-1 expression Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: Eligible and Treated

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.

Outcome measures

Outcome measures
Measure	Arm A n=19 Participants Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=17 Participants Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
Disease-free Survival (DFS) at 2 Years	68.4 Percentage of participants Interval 47.0 to 85.3	52.9 Percentage of participants Interval 31.1 to 74.0

SECONDARY outcome

Timeframe: Arm A: 42 days from the first dose of Atezolizumab Arm B: 21 days from the first dose of Atezolizumab

Population: 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

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.

Outcome measures

Outcome measures
Measure	Arm A n=17 Participants Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=13 Participants Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
T Cell Receptor (TCR) Diversity	12118 number of unique rearrangements Interval 4448.0 to 14740.0	12237 number of unique rearrangements Interval 8366.0 to 14906.0

Adverse Events

Arm A

Serious events: 6 serious events

Other events: 19 other events

Deaths: 4 deaths

Arm B

Serious events: 7 serious events

Other events: 17 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=19 participants at risk Atezolizumab 1200mg day -21, 0, 21. Chemoradiation: Extended field RT weekly Cisplatin x6 doses, Image guided brachytherapy	Arm B n=17 participants at risk Atezolizumab 1200mg day 0, 21, 42 Chemoradiation: Extended field RT weekly Cisplatin x6 doses Image Guided Brachytherapy
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Blood and lymphatic system disorders Anemia	0.00% 0/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Cardiac disorders Myocardial Infarction	5.3% 1/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	0.00% 0/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Gastrointestinal disorders Diarrhea	10.5% 2/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Gastrointestinal disorders Nausea	0.00% 0/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
General disorders Flu Like Symptoms	5.3% 1/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	0.00% 0/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
General disorders Fever	0.00% 0/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Infections and infestations Urinary Tract Infection	5.3% 1/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	0.00% 0/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Metabolism and nutrition disorders Hypokalemia	0.00% 0/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder - O	0.00% 0/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Reproductive system and breast disorders Vaginal Hemorrhage	5.3% 1/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants
Reproductive system and breast disorders Pelvic Pain	0.00% 0/19 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants	5.9% 1/17 • 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. All Adverse Events (AEs) occurring during treatment and up to 30 days after completion of CRT are reported for eligible and treated participants

Other adverse events

Additional Information

Linda Gedeon for Wei Deng

NRG Oncology

Phone: 716-845-1169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60