Trial Outcomes & Findings for INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (NCT NCT03502785)

Last Updated: 2026-09-02

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as any AEs that occurred on or after Day 0. AESIs were toxicities and immune-mediated AEs that may have occurred up to 90 days after the last dose of trial treatment. AESIs were reported by the investigator to the Sponsor within 24 hours after learning of the event.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Up to approximately 71 months

Results posted on

2026-09-02

Participant Flow

Participants took part at the investigative sites from 24 July 2018 to 09 May 2025.

A total of 35 participants were enrolled in the study to receive at least 1 dose of INO-5401 and INO-9012 or atezolizumab. Data for all participants, including those in the safety run-in, are included in the reported arms.

Participant milestones

Participant milestones
Measure	Cohort A: Prior Anti-PD-1/PD-L1 Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti- programmed death receptor-1/ programmed cell death-ligand 1 (PD-1/PD-L1) therapy received INO-5401 9 milligrams (mg) and INO-9012 1 mg, intramuscular (IM) injection, followed by electroporation (EP) by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, intravenous (IV) infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD L1 Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Overall Study STARTED	27	8
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	27	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A: Prior Anti-PD-1/PD-L1 Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti- programmed death receptor-1/ programmed cell death-ligand 1 (PD-1/PD-L1) therapy received INO-5401 9 milligrams (mg) and INO-9012 1 mg, intramuscular (IM) injection, followed by electroporation (EP) by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, intravenous (IV) infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD L1 Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Overall Study Adverse Event	3	1
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Progressive Disease	9	4
Overall Study Death	14	1
Overall Study Reason Unspecified	0	1

Baseline Characteristics

INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=27 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=8 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Total n=35 Participants Total of all reporting groups
Age, Continuous	68.6 Years STANDARD_DEVIATION 8.00 • n=136 Participants	65.0 Years STANDARD_DEVIATION 13.00 • n=136 Participants	67.7 Years STANDARD_DEVIATION 9.27 • n=272 Participants
Sex: Female, Male Female	12 Participants n=136 Participants	3 Participants n=136 Participants	15 Participants n=272 Participants
Sex: Female, Male Male	15 Participants n=136 Participants	5 Participants n=136 Participants	20 Participants n=272 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=136 Participants	0 Participants n=136 Participants	1 Participants n=272 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=136 Participants	8 Participants n=136 Participants	34 Participants n=272 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants
Race (NIH/OMB) Asian	2 Participants n=136 Participants	0 Participants n=136 Participants	2 Participants n=272 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants
Race (NIH/OMB) Black or African American	3 Participants n=136 Participants	0 Participants n=136 Participants	3 Participants n=272 Participants
Race (NIH/OMB) White	22 Participants n=136 Participants	8 Participants n=136 Participants	30 Participants n=272 Participants
Race (NIH/OMB) More than one race	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants

PRIMARY outcome

Timeframe: Up to approximately 71 months

Population: The safety analysis set included all participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=27 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=8 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) Treatment Participants with TEAEs	27 Participants	8 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) Treatment Participants with AESIs	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 71 months

Population: The safety analysis set included all participants who received at least one dose of study treatment.

Clinically significant changes in hematological parameters were determined based on the investigator's discretion.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=27 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=8 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Number of Participants With Clinically Significant Changes in Hematological Parameters	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 71 months

Population: The safety analysis set included all participants who received at least one dose of study treatment.

Clinically significant changes in serum chemistry parameters were determined based on the investigator's discretion.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=27 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=8 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Number of Participants With Clinically Significant Changes in Serum Chemistry Parameters	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At baseline, Weeks 3, 6, 9, then every 6 weeks thereafter, up to 71 months

Population: The safety analysis set included all participants who received at least one dose of study treatment.

Clinically significant changes in urinalysis parameters were determined based on the investigator's discretion.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=27 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=8 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Number of Participants With Clinically Significant Changes in Urinalysis Parameters	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 71 months

Population: Samples were collected prior to protocol amendment (Version 2.0 dated 23Jul2019). However, antigen-specific immune response assays were not performed because the sponsor decided to stop further enrollment due to the changing clinical landscape of advanced bladder cancer. No additional samples were collected following the amendment. The collected samples were not analyzed and will not be analyzed in the future. Therefore, no data is available for this outcome measure.

Blood and tissue samples were collected to evaluate the antigen-specific immune response to INO-5401 + INO-9012 in combination with atezolizumab. Planned assessments included: Enzyme Linked Immunosorbent Spot-forming (ELISpot) Assay, Flow cytometry, T cell receptor (TCR) sequencing, ELISA and/or gene expression analysis.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From date of treatment start until date of first PD or death (whichever occurred first), up to approximately 71 months

Population: Response-Evaluable Population included participants who received at least 3 of the first 4 doses of both study treatments (not necessarily at the same visits), had a baseline scan with measurable disease, no important protocol deviations, and at least 1 on-treatment scan or rapid clinical progression, toxicity, or death before the first on-treatment assessment. As pre-specified in the protocol and SAP, this outcome measure was planned to be analyzed in cohort A only.

ORR was defined as the percentage of participants who had a confirmed complete response (CR) or a partial response (PR). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters) per RECIST 1.1.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=13 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Review in Cohort A	0 Percentage of participants	—

SECONDARY outcome

Timeframe: From date of treatment start until date of first PD or death (whichever occurred first), up to approximately 71 months

ORR was defined as the percentage of participants who had a confirmed CR or a PR. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters) per RECIST 1.1.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=5 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
ORR as Assessed by RECIST Version 1.1 by Investigator Review in Cohort B	40 Percentage of participants	—

SECONDARY outcome

Timeframe: From date of treatment start until date of first PD or death (whichever occurred first), up to approximately 71 months

Population: Response-Evaluable Population included all participants who received at least 3 doses of the first 4 doses of both study treatments (not necessarily at the same visits), had a baseline scan with measurable disease, had no important protocol deviations, and had at least 1 on-treatment scan or experienced rapid clinical progression, toxicity, or death prior to their first on-treatment scan/response assessment.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=13 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=5 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Percentage of Participants With ORR by Immune Response Evaluation Criteria in Solid Tumors (iRECIST)	0 Percentage of participants	40 Percentage of participants

SECONDARY outcome

Timeframe: From first documented confirmed CR or PR until first documentation of PD or death, whichever occurred first (approximately 71 months)

DOR was defined as the time from the date of the first PR or CR to the date of death from any cause or date that progressive disease (PD) was objectively documented, whichever occurred first. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial (nadir), including baseline. The sum also had to demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=2 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Duration of Response (DoR)	—	NA months The median duration of response and corresponding 95% confidence interval were not estimable due to low number of participants with response.

SECONDARY outcome

Timeframe: From the first dose of study drug to date of PD or death, whichever occurred first (up to approximately 71 months)

PFS was defined as the time from the date of the start of investigational product treatment until the date of death from any cause or date that progression (+1 day) was objectively documented, whichever occurred first as assessed by RECIST Version 1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial (nadir), including baseline. The sum also had to demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=13 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=5 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Progression-Free Survival (PFS) Per RECIST Version 1.1	NA months The median PFS and corresponding 95% confidence interval were not estimable due to low number of participants with disease progression or event of death at the time of analysis.	NA months The median PFS and corresponding 95% confidence interval were not estimable due to low number of participants with disease progression or event of death at the time of analysis.

SECONDARY outcome

Timeframe: From Baseline to disease progression or death, whichever occurs first (up to approximately 71 months)

PFS was defined as the time from the date of the start of investigational product treatment until the date of death from any cause or date that progression (+1 day) was objectively documented, whichever occurred first as assessed by iRECIST Version 1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial (nadir), including baseline. The sum also had to demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=13 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=5 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
PFS Per Immune RECIST (iRECIST)	NA months The median PFS and corresponding 95% confidence interval were not estimable due to low number of participants with disease progression or event of death at the time of analysis.	NA months The median PFS and corresponding 95% confidence interval were not estimable due to low number of participants with disease progression or event of death at the time of analysis.

SECONDARY outcome

Timeframe: From date of first dose of study drug up to death from any cause, (approximately 71 months)

OS was defined as the time from the date of the start of investigational product treatment until the date of death from any cause.

Outcome measures

Outcome measures
Measure	Cohort A: Prior Anti-PD-1/PD-L1 n=13 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B: Naïve Anti-PD-1/PD-L1 n=5 Participants Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Overall Survival (OS)	NA months The median overall survival and corresponding 95% confidence interval were not estimable due low number of participants with event of death at the time of analysis.	NA months The median overall survival and corresponding 95% confidence interval were not estimable due low number of participants with event of death at the time of analysis.

Adverse Events

Cohort A

Serious events: 8 serious events

Other events: 27 other events

Deaths: 15 deaths

Cohort B

Serious events: 3 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A n=27 participants at risk Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with an anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA™ 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B n=8 participants at risk Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA™ 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Blood and lymphatic system disorders Anaemia	0.00% 0/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Abdominal pain	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Constipation	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Enteritis	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Infections and infestations Clostridium difficile colitis	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Infections and infestations Urosepsis	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Injury, poisoning and procedural complications Urostomy complication	0.00% 0/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Investigations Liver function test increased	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Nervous system disorders Demyelinating polyneuropathy	0.00% 0/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Psychiatric disorders Mental status changes	0.00% 0/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Reproductive system and breast disorders Pelvic pain	0.00% 0/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Vascular disorders Hypotension	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.

Other adverse events

Additional Information

Jeffrey Skolnik

Inovio Pharmaceuticals

Phone: 267-440-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort A n=27 participants at risk Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with an anti-PD-1/ PD-L1 therapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA™ 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.	Cohort B n=8 participants at risk Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA™ 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
Blood and lymphatic system disorders Anaemia	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Cardiac disorders Sinus tachycardia	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Endocrine disorders Hyperthyroidism	0.00% 0/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Endocrine disorders Hypothyroidism	0.00% 0/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Eye disorders Vision blurred	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Abdominal distension	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Abdominal pain	14.8% 4/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Constipation	18.5% 5/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Diarrhoea	25.9% 7/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Dyspepsia	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Flatulence	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Nausea	44.4% 12/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Stomatitis	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Gastrointestinal disorders Vomiting	18.5% 5/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
General disorders Fatigue	25.9% 7/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	50.0% 4/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
General disorders Gait disturbance	14.8% 4/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
General disorders Injection site pain	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
General disorders Oedema peripheral	14.8% 4/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
General disorders Pyrexia	11.1% 3/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Infections and infestations COVID-19	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Infections and infestations Upper respiratory tract infection	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Infections and infestations Urinary tract infection	11.1% 3/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Injury, poisoning and procedural complications Fall	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Investigations Blood alkaline phosphatase increased	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Investigations Blood creatinine increased	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Investigations Lymphocyte count decreased	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Investigations Weight decreased	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Investigations Weight increased	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Metabolism and nutrition disorders Decreased appetite	22.2% 6/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Metabolism and nutrition disorders Hyponatraemia	11.1% 3/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Musculoskeletal and connective tissue disorders Arthralgia	18.5% 5/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Musculoskeletal and connective tissue disorders Back pain	25.9% 7/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	37.5% 3/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Musculoskeletal and connective tissue disorders Muscular weakness	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Musculoskeletal and connective tissue disorders Pain in extremity	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Nervous system disorders Dizziness	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Nervous system disorders Headache	25.9% 7/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Psychiatric disorders Anxiety	11.1% 3/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Renal and urinary disorders Chronic kidney disease	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Renal and urinary disorders Haematuria	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Reproductive system and breast disorders Pelvic pain	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Respiratory, thoracic and mediastinal disorders Cough	14.8% 4/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Skin and subcutaneous tissue disorders Night sweats	7.4% 2/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Skin and subcutaneous tissue disorders Pruritus	11.1% 3/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	0.00% 0/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	37.5% 3/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Surgical and medical procedures Hernia repair	0.00% 0/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	12.5% 1/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Vascular disorders Hot flush	3.7% 1/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	25.0% 2/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.
Vascular disorders Hypertension	11.1% 3/27 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.	37.5% 3/8 • Up to approximately 71 months The safety analysis set included all participants who received at least 1 dose of INO-5401 and INO-9012 or atezolizumab.