Trial Outcomes & Findings for Neoadjuvant Atezolizumab in Surgically Resectable Advanced Cutaneous Squamous Cell Carcinoma (NCT NCT04710498)
NCT ID: NCT04710498
Last Updated: 2025-02-03
Results Overview
Percentage of patients that are able to complete 3 cycles of neoadjuvant atezolizumab and were eligible for curative surgical resection will be measured.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
9 weeks
Results posted on
2025-02-03
Participant Flow
Participant milestones
| Measure |
Atezolizumab
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Atezolizumab in Surgically Resectable Advanced Cutaneous Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Atezolizumab
n=20 Participants
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Age, Customized
18 to 29 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
30 to 39 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
40 to 49 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
50 to 59 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
60 to 69 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
70 to 79 years
|
8 Participants
n=5 Participants
|
|
Age, Customized
80 to 89 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 weeksPercentage of patients that are able to complete 3 cycles of neoadjuvant atezolizumab and were eligible for curative surgical resection will be measured.
Outcome measures
| Measure |
Atezolizumab
n=20 Participants
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Percentage of Patients Who Complete Neoadjuvant Therapy and Were Eligible for Curative Surgical Resection
|
16 Participants
|
SECONDARY outcome
Timeframe: After cycle 3 (duration of each cycle 21 days)Objective response rate will be measured based on RECIST v1.1 criteria at baseline, after cycle 2, and at the time or surgery. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of diameters of all target lesions; Progressive Disease (PD), at least a 20% increase in the sum of diameters of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Atezolizumab
n=20 Participants
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Objective Response Rate
Complete response
|
1 Participants
|
|
Objective Response Rate
Partial response
|
7 Participants
|
|
Objective Response Rate
Disease progression
|
1 Participants
|
|
Objective Response Rate
Stable disease
|
10 Participants
|
|
Objective Response Rate
No imaging
|
1 Participants
|
SECONDARY outcome
Timeframe: After cycle 3 (duration of each cycle 21 days)Pathological response will be assessed by local pathological review at baseline, after cycle 2, and and at the time or surgery Patients with no viable tumor seen will be classified as a complete pathological response. Patients with \< 10% of viable tumor will be classified as a major pathological response.
Outcome measures
| Measure |
Atezolizumab
n=20 Participants
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Pathological Response Rate
Pathological major response (<= 10% viable tumor cells)
|
4 Participants
|
|
Pathological Response Rate
No pathological response (>10% viable tumor cells)
|
8 Participants
|
|
Pathological Response Rate
No pathological evaluation (surgery declined)
|
1 Participants
|
|
Pathological Response Rate
Pathological complete response (no viable tumor cells)
|
7 Participants
|
SECONDARY outcome
Timeframe: 9 weeksAssessed changes in vital structures preserved following neoadjuvant treatment
Outcome measures
| Measure |
Atezolizumab
n=19 Participants
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Changes in Vital Structures
Smaller surgical resection
|
10 Participants
|
|
Changes in Vital Structures
Larger surgical resection
|
1 Participants
|
SECONDARY outcome
Timeframe: 9 weeksAssess change in surgical margins preserved following neoadjuvant treatment
Outcome measures
| Measure |
Atezolizumab
n=19 Participants
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Changes in Surgical Margins
Microscopically positive margins
|
1 Participants
|
|
Changes in Surgical Margins
Microscopically negative margins
|
18 Participants
|
SECONDARY outcome
Timeframe: 9 weeksA secondary outcome measure was to assess safety and tolerability of neoadjuvant atezolizumab. Adverse events (AE), serious adverse events (SAE), and treatment-related toxicities were recorded at each study-related visit.
Outcome measures
| Measure |
Atezolizumab
n=20 Participants
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Safety and Tolerability of Neoadjuvant Atezolizumab
AE's (patients affected)
|
20 Participants
|
|
Safety and Tolerability of Neoadjuvant Atezolizumab
SAE's (patients affected)
|
1 Participants
|
Adverse Events
Atezolizumab
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atezolizumab
n=20 participants at risk
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure with Hypoxia
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
Other adverse events
| Measure |
Atezolizumab
n=20 participants at risk
Subjects received a neoadjuvant atezolizumab intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 (+/- 3 days) of each 21-day cycle for a total of 3 doses prior to surgery, unless there is clinical or radiographic evidence of disease progression.
Atezolizumab: Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
|
|---|---|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Ear and labyrinth disorders
Fluid sensation in left ear
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Ear and labyrinth disorders
Lack of Balance
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Eye disorders
Dry Eye
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Eye disorders
Eye Pain
|
5.0%
1/20 • Number of events 2 • 9 weeks
|
|
Eye disorders
Eye Pressure
|
10.0%
2/20 • Number of events 2 • 9 weeks
|
|
Eye disorders
Eyelid Swelling
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Eye disorders
Periorbital Edema
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
General disorders
Facial Pain
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
General disorders
Facial Rash
|
10.0%
2/20 • Number of events 2 • 9 weeks
|
|
General disorders
Fatigue
|
55.0%
11/20 • Number of events 14 • 9 weeks
|
|
General disorders
Flu like symptoms
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
General disorders
Lack of Appetite
|
10.0%
2/20 • Number of events 2 • 9 weeks
|
|
General disorders
Leg pain
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
General disorders
Night Sweats
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
General disorders
Weight Loss
|
10.0%
2/20 • Number of events 2 • 9 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 4 • 9 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Gastrointestinal disorders
Gout
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Gastrointestinal disorders
Lip Sensitivity
|
5.0%
1/20 • Number of events 2 • 9 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
5.0%
1/20 • Number of events 2 • 9 weeks
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Investigations
Elevated C-Reactive Protein
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Investigations
Elevated TSH
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Investigations
Increased Creatinine
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Investigations
Increased Total Bilirubin
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 2 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Nocturnal Muscle Spasms
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
35.0%
7/20 • Number of events 8 • 9 weeks
|
|
Nervous system disorders
Dizziness, Lightheadedness
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Nervous system disorders
Facial Nerve Paresis
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Nervous system disorders
Headache(s)
|
15.0%
3/20 • Number of events 5 • 9 weeks
|
|
Nervous system disorders
Paresthesia
|
10.0%
2/20 • Number of events 2 • 9 weeks
|
|
Nervous system disorders
Peripheral Neuropathy
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Sinus Congestion
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
10.0%
2/20 • Number of events 2 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Cheek Fistula
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Facial Rash
|
10.0%
2/20 • Number of events 2 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Fungal Rash/Dermatitis
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
1/20 • Number of events 1 • 9 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place