Trial Outcomes & Findings for Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer (NCT NCT03018249)

Last Updated: 2021-11-16

Results Overview

The H-score is defined as the percent cells staining positive (0-100) multiplied by the staining intensity (0, 1, 2 or 3) measured in the tumor by immunohistochemistry and averaged over 3 reviewers. This score can range from 0 to 300. In general, PRs are expected to decrease in response to medroxyprogesterone acetate. It was hypothesized that entinostat would mitigate the decrease in PR relative to the medroxyprogesterone acetate only arm post treatment. Higher PR H-scores post treatment in the arm with entinostat relative to the medroxyprogesterone alone arm would be consistent with this hypothesis. Arm II was thought to result in higher scores which was expected to have a more favorable outcome when treated with MPA therapy.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

50 participants

Primary outcome timeframe

Specimens were collected at hysterectomy on day 21-24 and analyzed in batch.

Results posted on

2021-11-16

Participant Flow

The study was open to accrual on 8/17/2017. The first patient was enrolled on October 11, 2017. The study closed to accrual 4 months later on 2/9/2018 after 50 patients were enrolled across 13 unique sites.

Participant milestones

Participant milestones
Measure	Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.	Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
Overall Study STARTED	25	25
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.	Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Medroxyprogesterone Acetate With or Without Entinostat Before Surgery in Treating Patients With Endometrioid Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA n=25 Participants Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.	Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat n=25 Participants Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.	Total n=50 Participants Total of all reporting groups
Age, Customized 30-49 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized 50-59 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Customized 60-69 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Customized 70-99 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Participants with Endometrioid Cell Type Cancer	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Specimens were collected at hysterectomy on day 21-24 and analyzed in batch.

Population: Randomized, treated, evaluable specimen. There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. There were two additional patients with insufficient tumor post-treatment and no slides were submitted; one in each reporting group. There was one additional patient with no specimens submitted in reporting group 2.

Outcome measures

Outcome measures
Measure	Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA n=22 Participants Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.	Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat n=21 Participants Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
Mean Post-treatment Tumor Progesterone Receptor H-score (Histology Score)	53.6 units on a scale Standard Deviation 64.8	42.7 units on a scale Standard Deviation 49.0

SECONDARY outcome

Timeframe: Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch.

Population: Randomized, treated, evaluable pre and post treatment specimen available. There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. There was one participant with an inevaluable pre-treatment slide. There were two additional patients with insufficient tumor post-treatment and no slides were submitted; one in each reporting group. There was one additional patient with no specimens submitted in reporting group 2.

Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. A histologic response was defined as either the absence of identifiable adenocarcinoma in the hysterectomy specimen section (complete) or, subjectively, as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample (partial).

Outcome measures

Outcome measures
Measure	Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA n=22 Participants Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.	Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat n=20 Participants Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
Percentage of Participants With a Histologic Response	16 Participants	14 Participants

SECONDARY outcome

Timeframe: Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch.

Population: Randomized, treated, evaluable pre and post treatment specimens available. There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. There was one participant with an inevaluable pre-treatment slide. There were two additional patients with insufficient tumor post-treatment and no slides were submitted; one in each reporting group. There was one additional patient with no specimens submitted in reporting group

A response was defined as a decrease in Ki-67 protein expression in tumor from pre- to post-treatment.

Outcome measures

Outcome measures
Measure	Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA n=22 Participants Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.	Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat n=20 Participants Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
Percent of Participants With a Ki67 Response	15 Participants	18 Participants

SECONDARY outcome

Timeframe: Up to 45 days after surgery

Population: Eligible and Treated Patients

Maximum grade of physician assessed adverse events reported during treatment and up to 45 days after surgery. Grades start with 1 which is considered mild through grade 5 which is death. Participants on this study had adverse event grades up to grade 3 which is considered moderately severe.

Outcome measures

Outcome measures
Measure	Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA n=23 Participants Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.	Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat n=23 Participants Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) Grade 1 AE	11 participants	9 participants
The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) Grade 2 AE	4 participants	6 participants
The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) Grade 3 AE	2 participants	2 participants
The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) Grade 4 AE	0 participants	0 participants
The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE) Grade 5 AE	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Will be compared between the arms.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA n=23 participants at risk Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.	Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat n=23 participants at risk Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
Blood and lymphatic system disorders Thromboembolic Event	4.3% 1/23 • Number of events 1 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	4.3% 1/23 • Number of events 1 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Skin and subcutaneous tissue disorders Skin infection	0.00% 0/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	4.3% 1/23 • Number of events 1 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.

Other adverse events

Additional Information

Linda Gedeon for Virginia Filiaci, PhD

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

Measure	Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA n=23 participants at risk Patients receive medroxyprogesterone acetate IM on day 1 and undergo hysterectomy between days 21-24.	Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat n=23 participants at risk Medroxyprogesterone acetate IM on day 1 and entinostat PO on days 1, 8, and 15. Followed by hysterectomy between days 21-24.
Blood and lymphatic system disorders Anemia	13.0% 3/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	13.0% 3/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Gastrointestinal disorders Abdominal Pain	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	34.8% 8/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Gastrointestinal disorders Constipation	21.7% 5/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Gastrointestinal disorders Diarrhea	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Gastrointestinal disorders Dry Mouth	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Gastrointestinal disorders Nausea	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
General disorders Edema Limbs	13.0% 3/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
General disorders Fatigue	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	34.8% 8/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
General disorders Injection Site Reaction	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	21.7% 5/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
General disorders Pain	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Investigations Neutrophil Count Decreased	0.00% 0/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Investigations Platelet Count Decreased	0.00% 0/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	13.0% 3/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Metabolism and nutrition disorders Anorexia	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	13.0% 3/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Metabolism and nutrition disorders Hypocalcemia	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Nervous system disorders Dysgeusia	0.00% 0/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	13.0% 3/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Nervous system disorders Headache	13.0% 3/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Psychiatric disorders Depression	0.00% 0/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Psychiatric disorders Insomnia	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Renal and urinary disorders Urinary Incontinence	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	0.00% 0/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Reproductive system and breast disorders Pelvic Pain	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Reproductive system and breast disorders Vaginal Discharge	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Reproductive system and breast disorders Vaginal Hemorrhage	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	17.4% 4/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	21.7% 5/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	21.7% 5/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Skin and subcutaneous tissue disorders Alopecia	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.
Vascular disorders Hypertension	4.3% 1/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.	8.7% 2/23 • From initiation of treatment up to 45 days post-surgery There were 2 participants in each reporting group who withdrew consent prior to treatment; no specimens were submitted for these patients. No AEs were reported.