Trial Outcomes & Findings for Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma (NCT NCT03737123)

Last Updated: 2023-09-13

Results Overview

Evaluate PFS among patients to be treated with atezolizumab in combination with carboplatin + gemcitabine or docetaxel, who have cisplatin-ineligible metastatic urothelial carcinoma and who have progressed on prior PD-1 or PD-L1 inhibitor. PFS defined as duration from date of treatment start until progression according to RECIST 1.1 criteria, or death from any cause. Per RECIST 1.1 criteria, Progressive disease can be defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

From C1D1 until progression or death or up to a maximum of 26 months

Results posted on

2023-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle	Phase IIB : Docetaxel + Atezolizumab Subjects that received sequential or concurrent PD1/PDL1 inhibitor and carboplatin-based regimen will be treated with docetaxel + atezolizumab on trial. Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each 21 day Cycle. Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle.
Study Treatment STARTED	6	0
Study Treatment COMPLETED	0	0
Study Treatment NOT COMPLETED	6	0
Follow up STARTED	6	0
Follow up COMPLETED	0	0
Follow up NOT COMPLETED	6	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle	Phase IIB : Docetaxel + Atezolizumab Subjects that received sequential or concurrent PD1/PDL1 inhibitor and carboplatin-based regimen will be treated with docetaxel + atezolizumab on trial. Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each 21 day Cycle. Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle.
Study Treatment Adverse Event	2	0
Study Treatment Disease Progression	2	0
Study Treatment Withdrawal by Subject	2	0
Follow up Death	1	0
Follow up Withdrawal by Subject	1	0
Follow up Termination of study	4	0

Baseline Characteristics

Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From C1D1 until progression or death or up to a maximum of 26 months

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Progression Free Survival (PFS)	11.3 months Interval 3.2 to insufficient number of participants with events

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 8 months

Assess the safety and tolerability of the combination of atezolizumab plus chemotherapy (carboplatin + gemcitabine or docetaxel) using CTCAE v4.03. Number of subjects who had any adverse events or events greater than grade 3 were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Carboplatin + Gemcitabine or Docetaxel Number of patients had at least one adverse event of any grade	6 Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Carboplatin + Gemcitabine or Docetaxel Number of patients had at least one grade 3 or greater adverse event	6 Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Carboplatin + Gemcitabine or Docetaxel Number of patients had at least one grade 3 or greater treatment related adverse event	6 Participants
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Carboplatin + Gemcitabine or Docetaxel Number of patients having serious adverse event	3 Participants

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 28 months.

Objective response rate (ORR) using RECIST 1.1 defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=5 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Objective Response Rate (ORR) With RECIST 1.1	40 percentage of participants Interval 5.3 to 85.3

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 28 months.

ORR defined as the proportion of all subjects with confirmed PR or CR using immunerelated response criteria (irRECIST), from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Per irRECIST for target lesions Complete Response (irCR), Disappearance of all target lesions; Partial Response (irPR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = irCR + irPR.

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=5 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Objective Response Rate (ORR) With irRECIST	40 percentage of participants Interval 5.3 to 85.3

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 28 months.

Clinical benefit rate (CBR) of treatment (defined by proportion of all subjects with stable disease for at least 3 months, partial response, or complete response) using RECIST 1.1 from the start of treatment until disease/recurrence(taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started; Clinical Benefit Rate (CBR) = CR +PR +SD (for atleast 3 months).

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Clinical Benefit Rate (CBR) With RECIST 1.1	100 percentage of participants Interval 47.8 to 100.0

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 28 months.

Clinical benefit rate (CBR) of treatment (defined by proportion of all subjects with stable disease for at least 3 months, partial response, or complete response) using irRECIST from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Per irRECIST for target lesions: Complete Response (irCR), Disappearance of all target lesions; Partial Response (irPR), \>=30% decrease in the sum of the longest diameter of target lesions, neither sufficient shrinkage to qualify for irPR nor sufficient increase to qualify for irPD, taking as reference the smallest sum longest diameter since the treatment started; Clinical Benefit Rate (CBR) = irCR +irPR +irSD (for atleast 3 months).

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Clinical Benefit Rate (CBR) With irRECIST	100 percentage of participants Interval 47.8 to 100.0

SECONDARY outcome

Timeframe: From C1D1 until progression or death or up to a maximum of 26 months

PFS defined as duration from date of treatment start until progression according to irRECIST criteria or death from any cause. Per irRECIST criteria, Progressive disease can be defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
PFS by irRECIST	11.3 months Interval 5.3 to insufficient number of participants with events

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 28 months

OS defined by the date of treatment start to date of death from any cause.

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Overall Survival (OS)	NA months Interval 5.3 to insufficient number of participants with events

SECONDARY outcome

Timeframe: From C1D1 until progression or death or up to a maximum of 26 months

To compare Progression Free Survival(PFS) with the historical control, Null hypothesis - Patients receiving atezolizumab plus chemotherapy (carboplatin +gemcitabine or docetaxel) will have a median PFS of 4 months. Alternative hypothesis - Patients receiving atezolizumab plus chemotherapy (carboplatin + gemcitabine or docetaxel) will have a median PFS of 7.2 months. Progression Free Survival defined as duration from date of treatment start until progression according to RECIST 1.1 criteria, or death from any cause.Per RECIST 1.1 criteria, Progressive disease can be defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=5 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Progression Free Survival (PFS) Compared to Historical Controls	11.3 months Interval 3.2 to insufficient number of participants with events prevents determining the upper confidence interval

SECONDARY outcome

Timeframe: From C1D1 until death or progression or up to a maximum of 26 months

Evaluate PFS for atezolizumab + carboplatin and gemcitabine. PFS defined as duration from date of treatment start until progression according to RECIST 1.1 criteria, or death from any cause.Per RECIST 1.1 criteria, Progressive disease can be defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Progression Free Survival (PFS) for Atezolizumab + Carboplatin and Gemcitabine	11.3 months Interval 3.2 to insufficient number of participants with events

SECONDARY outcome

Timeframe: From C1D1 until progression or death

Population: No subject was enrolled in this arm.

Evaluate PFS for atezolizumab + docetaxel. PFS defined as duration from date of treatment start until progression according to RECIST 1.1 criteria, or death from any cause. Per RECIST 1.1 criteria, Progressive disease can be defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome data not reported

Adverse Events

Phase IIA : Atezolizumab + Carboplatin + Gemcitabine

Serious events: 3 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 participants at risk Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Blood and lymphatic system disorders ANEMIA	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Metabolism and nutrition disorders HYPERCALCEMIA	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Nervous system disorders STROKE	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Vascular disorders THROMBOEMBOLIC EVENT	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Infections and infestations URINARY TRACT INFECTION	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.

Other adverse events

Other adverse events
Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 participants at risk Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
Gastrointestinal disorders ABDOMINAL PAIN	33.3% 2/6 • Number of events 3 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Investigations ALANINE AMINOTRANSFERASE INCREASED	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Blood and lymphatic system disorders ANEMIA	83.3% 5/6 • Number of events 29 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Metabolism and nutrition disorders ANOREXIA	50.0% 3/6 • Number of events 4 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	33.3% 2/6 • Number of events 2 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Musculoskeletal and connective tissue disorders BACK PAIN	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Cardiac disorders CHEST PAIN - CARDIAC	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Gastrointestinal disorders CONSTIPATION	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Respiratory, thoracic and mediastinal disorders COUGH	16.7% 1/6 • Number of events 2 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Metabolism and nutrition disorders DEHYDRATION	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Gastrointestinal disorders DIARRHEA	50.0% 3/6 • Number of events 6 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Nervous system disorders DIZZINESS	50.0% 3/6 • Number of events 6 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Gastrointestinal disorders DUODENAL ULCER	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Respiratory, thoracic and mediastinal disorders DYSPNEA	50.0% 3/6 • Number of events 9 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
General disorders EDEMA LIMBS	33.3% 2/6 • Number of events 3 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Injury, poisoning and procedural complications FALL	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
General disorders FATIGUE	50.0% 3/6 • Number of events 12 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
General disorders FEVER	33.3% 2/6 • Number of events 2 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Vascular disorders HEMATOMA	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Renal and urinary disorders HEMATURIA	16.7% 1/6 • Number of events 2 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Metabolism and nutrition disorders HYPERCALCEMIA	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Vascular disorders HYPERTENSION	16.7% 1/6 • Number of events 3 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Metabolism and nutrition disorders HYPOKALEMIA	16.7% 1/6 • Number of events 2 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Metabolism and nutrition disorders HYPONATREMIA	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Endocrine disorders HYPOTHYROIDISM	16.7% 1/6 • Number of events 2 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	33.3% 2/6 • Number of events 2 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Investigations LIPASE INCREASED	33.3% 2/6 • Number of events 4 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Gastrointestinal disorders NAUSEA	50.0% 3/6 • Number of events 6 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Investigations NEUTROPHIL COUNT DECREASED	50.0% 3/6 • Number of events 6 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
General disorders PAIN	50.0% 3/6 • Number of events 4 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	50.0% 3/6 • Number of events 9 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Gastrointestinal disorders PANCREATITIS	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Nervous system disorders PARESTHESIA	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Reproductive system and breast disorders PELVIC PAIN	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	50.0% 3/6 • Number of events 4 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Investigations PLATELET COUNT DECREASED	66.7% 4/6 • Number of events 10 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Skin and subcutaneous tissue disorders PRURITUS	33.3% 2/6 • Number of events 3 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	33.3% 2/6 • Number of events 3 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Nervous system disorders SYNCOPE	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Vascular disorders THROMBOEMBOLIC EVENT	33.3% 2/6 • Number of events 2 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Renal and urinary disorders URINARY FREQUENCY	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Infections and infestations URINARY TRACT INFECTION	33.3% 2/6 • Number of events 2 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Renal and urinary disorders URINARY TRACT PAIN	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Gastrointestinal disorders VOMITING	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Investigations WEIGHT LOSS	16.7% 1/6 • Number of events 1 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.
Investigations WHITE BLOOD CELL DECREASED	33.3% 2/6 • Number of events 4 • From C1D1 for every treatment cycle of 21 days until death or up to a maximum of 8 months. No subjects had been enrolled in Phase II Arm B.

Additional Information

Annesha Majumdar

Hoosier Cancer Research Network

Phone: 3179212050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase IIA : Atezolizumab + Carboplatin + Gemcitabine n=6 Participants Subjects that received a PD 1 or PD-L1 inhibitor with no prior platinum chemotherapy for metastatic disease will be treated with atezolizumab + carboplatin + gemcitabine on trial. Carboplatin: Carboplatin AUC 4 IV Day 1 of each 21 day cycle Gemcitabine: Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle	Phase IIB : Docetaxel + Atezolizumab Subjects that received sequential or concurrent PD1/PDL1 inhibitor and carboplatin-based regimen will be treated with docetaxel + atezolizumab on trial. Docetaxel: Docetaxel 75 mg/m2 IV Day 1 of each 21 day Cycle. Atezolizumab: Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle.	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	0 Participants n=7 Participants	5 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	0 Participants n=7 Participants	5 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	0 Participants n=7 Participants	0 Participants n=5 Participants
ECOG Performance Status 0	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
ECOG Performance Status 1	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants