Trial Outcomes & Findings for Functional Imaging of T-Cell Activation With [18F]F-AraG in Urothelial Carcinoma Patients Receiving Neoadjuvant Therapy or Patients With Cancer Receiving Standard of Care Anti-PD-1/L1 (NCT NCT03007719)

Last Updated: 2020-01-21

Results Overview

The nonparametric paired Wilcoxon Signed-rank test will be used to assess differences in SUVmax before and after treatment. The log2 ratio of post-treatment versus baseline SUVmax within the tumor and lymphoid tissues will also be calculated

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Up to 2 weeks

Results posted on

2020-01-21

Participant Flow

This study was closed due to low accrual. Only 4 patients were enrolled to this protocol and all were assigned to cohort 2

Participant milestones

Participant milestones
Measure	Cohort 1: Neoadjuvant Patients with localized bladder cancer who are eligible for the University of California, San Francisco (UCSF) phase 2 clinical trial of neoadjuvant atezolizumab before definitive surgery (NCT02451423) (Cohort 1).	Cohort 2: Standard of Care (SOC) Patients with any cancer type who are planned to initiate standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment (Cohort 2).
Overall Study STARTED	0	4
Overall Study COMPLETED	0	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Functional Imaging of T-Cell Activation With [18F]F-AraG in Urothelial Carcinoma Patients Receiving Neoadjuvant Therapy or Patients With Cancer Receiving Standard of Care Anti-PD-1/L1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Neoadjuvant Patients with localized bladder cancer who are eligible for the University of California, San Francisco (UCSF) phase 2 clinical trial of neoadjuvant atezolizumab before definitive surgery (NCT02451423) (Cohort 1).	Cohort 2: Standard of Care (SOC) n=4 Participants Patients with any cancer type who are planned to initiate standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment (Cohort 2).	Total n=4 Participants Total of all reporting groups
Age, Customized 60-69	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 70-79	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized 80-89	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	3 Participants n=7 Participants	3 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	—	4 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks

Population: SUVmax data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: SUVmax data not collected

To correlate change in SUVmax to clinical and/or pathologic response, patients will be divided into two groups: those who achieved clinical response and/or pathologic downs-staging, and those who did not. The median and interquartile range of change in SUVmax from baseline to pre-surgery in the different groups will be descriptively reported. For Cohort 1, clinical response will be determined by abdominal imaging performed \<30 days after the last dose of atezolizumab prior to cystectomy compared to baseline pre-treatment imaging using RECIST v1.1 criteria, as specified in the companion treatment protocol. For Cohort 1, pathologic response will be determined by evidence of down-staging (e.g. from muscle invasive to non-muscle invasive, or complete pathologic response) at the time of cystectomy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 8 days

Population: SUVmax data not collected

Outcome measures

Outcome data not reported

Adverse Events

Cohort 2: Standard of Care (SOC)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 2: Standard of Care (SOC) n=4 participants at risk Patients with any cancer type who are planned to initiate standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment.
Renal and urinary disorders Hematuria	25.0% 1/4 • Number of events 1 • Patients were evaluated one day and one week via telephone visit after each radiopharmaceutical injection for safety follow-up, up to 6 weeks. No patients were enrolled in Cohort 1. All patients who receive any dose of \[18F\]F-AraG were analyzed for safety, all adverse events were recorded. Patients removed from study for unacceptable treatment related adverse event(s) were followed until resolution or stabilization of all treatment related adverse events (AE) to Grade 0-1.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lawrence Fong

University of California, San Francisco

Phone: (415) 353-2051

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place