Trial Outcomes & Findings for Atezolizumab Before Surgery for the Treatment of Regionally Metastatic Head and Neck Squamous Cell Cancer With an Unknown or Historic Primary Site (NCT NCT05110781)

Last Updated: 2023-09-05

Results Overview

pCR is defined as having no residual invasive squamous cell carcinoma within the primary tumor and all resected lymph nodes as assessed by the pathologist at the time of primary resection. The rate of pCR is defined as the proportion of patients demonstrating pCR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

At time of surgery (up to 10 weeks from time of enrollment)

Results posted on

2023-09-05

Participant Flow

Not applicable; only one participant was enrolled and the enrolled participant received study treatment.

Participant milestones

Participant milestones
Measure	Treatment (Atezolizumab, Surgery, Radiation Therapy) Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity. Atezolizumab: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgery
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atezolizumab Before Surgery for the Treatment of Regionally Metastatic Head and Neck Squamous Cell Cancer With an Unknown or Historic Primary Site

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Atezolizumab, Surgery, Radiation Therapy) n=1 Participants Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity. Atezolizumab: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgery
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	78 Years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 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	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of surgery (up to 10 weeks from time of enrollment)

Outcome measures

Outcome measures
Measure	Treatment (Atezolizumab, Surgery, Radiation Therapy) n=1 Participants Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity. Atezolizumab: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgery
Pathologic Complete Response (pCR)	0 Participants

SECONDARY outcome

Timeframe: At time of surgery (up to 10 weeks from time of enrollment)

mPR is defined as having =\< 10% residual invasive squamous cell carcinoma within the primary tumor and all resected lymph nodes as assessed by the pathologist at the time of primary resection. The rate of mPR is defined as the proportion of patients demonstrating mPR.

Outcome measures

Outcome measures
Measure	Treatment (Atezolizumab, Surgery, Radiation Therapy) n=1 Participants Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity. Atezolizumab: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgery
Major Pathologic Response (mPR)	0 Participants

SECONDARY outcome

Timeframe: From randomization to the first day of radiographic evidence of recurrence or disease progression, clinical evidence of recurrence or disease progression, or death due to any cause, whichever occurs first, assessed at 2 years

A non-parametric Kaplan-Meier (KM) method will be used to estimate the 2-year EFS curve. Participants who do not experience recurrence or disease progression at the time of their last follow-up will be censored. Recurrence, all-cause death and disease-specific death will be likewise examined using the KM method to determine estimates of 2-yr disease-free survival, overall survival and disease-specific survival.

Outcome measures

Outcome measures
Measure	Treatment (Atezolizumab, Surgery, Radiation Therapy) n=1 Participants Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity. Atezolizumab: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgery
Number of Participants With Recurrence or Disease Progression	1 Participants

SECONDARY outcome

Timeframe: At baseline and 3 months after completion of treatment

FDG avidity of nodal sites will be quantified according to standardized uptake value (SUV). The SUV is the ratio of the image derived radioactivity concentration of the lesion of interest and the whole body concentration of the injected radioactivity. Standard of care staging positron emission tomography (PET)/computed tomography (CT) will be performed prior to initiation of treatment and as a post-treatment scan 3 months after completion. The association of the SUV of the regionally metastatic focus of disease to the pathologic response to neoadjuvant therapy at the time of surgery will be examined. A t-test (or nonparametric counterpart) and multiple regression will be used to compare mean SUV between patients who experience cPR to the mean SUV of those with residual disease after neoadjuvant therapy, where the latter will adjust patient characteristics and potential confounders. In addition, the mean SUV of additional sites of regionally metastatic disease will be studied.

Outcome measures

Outcome measures
Measure	Treatment (Atezolizumab, Surgery, Radiation Therapy) n=1 Participants Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity. Atezolizumab: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgery
Standardized Uptake Value (SUV) of Primary Lesion Assessed at Baseline and 3 Months After Completion of Treatment Baseline SUV	9.2 Ratio
Standardized Uptake Value (SUV) of Primary Lesion Assessed at Baseline and 3 Months After Completion of Treatment Month 3 SUV	2.99 Ratio

SECONDARY outcome

Timeframe: Up to 3 years

Measured by CT or magnetic resonance imaging (MRI) of the head and neck per immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.

Outcome measures

Outcome measures
Measure	Treatment (Atezolizumab, Surgery, Radiation Therapy) n=1 Participants Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity. Atezolizumab: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgery
Number of Participants With Overall Response	0 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Plasma exosome level was not measured as the study was terminated early due to low accrual and only 1 evaluable participant was enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From study treatment initiation through 1 year post-surgery

Determined by Common Terminology Criteria for Adverse Events version 5. Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events, laboratory tests, and vital signs. Descriptive statistics will be provided for adverse events.

Outcome measures

Outcome measures
Measure	Treatment (Atezolizumab, Surgery, Radiation Therapy) n=1 Participants Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity. Atezolizumab: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgery
Number of Adverse Events	3 adverse events

Adverse Events

Treatment (Atezolizumab, Surgery, Radiation Therapy)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Atezolizumab, Surgery, Radiation Therapy) n=1 participants at risk Patients receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Beginning 6 weeks after surgery, patients with residual disease undergo standard of care radiation therapy and receive atezolizumab IV over 30-60 minutes on day 1. Treatment with atezolizumab repeats every 21 days for up to 15 cycles in the absence of disease progression and unacceptable toxicity. Atezolizumab: Given IV Radiation Therapy: Undergo radiation therapy Therapeutic Conventional Surgery: Undergo surgery
General disorders Edema face	100.0% 1/1 • Number of events 1 • From study treatment initiation through 1 year post-surgery
General disorders Pain	100.0% 1/1 • Number of events 1 • From study treatment initiation through 1 year post-surgery
Gastrointestinal disorders Gastrointestinal disorders - Other	100.0% 1/1 • Number of events 1 • From study treatment initiation through 1 year post-surgery

Additional Information

Principal Investigator

University of California, Davis

Phone: 916-734-2790

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place