Bladder Cancer, Cholangiocellular Carcinoma, Pancreas Cancer
Conditions
Brief summary
This multicenter, non-randomized, Phase II study will assess the efficacy, safety, and pharmacokinetics of trastuzumab emtansine in participants with HER2 overexpressing locally advanced (unresectable and not treatable with curative intent) or metastatic urothelial bladder cancer (UBC), locally advanced (unresectable and not treatable with curative intent) or metastatic pancreatic cancer/cholangiocarcinoma with advanced disease where cure is no longer possible and where no other treatment options are available anymore. Participants will receive intravenous (IV) infusion of trastuzumab emtansine as Regimen A (2.4 milligrams per kilogram \[mg/kg\], weekly \[qw\]) or Regimen B (3.6 mg/kg, every 3 weeks \[q3w\]) until unacceptable toxicity, withdrawal of consent, disease progression (PD), or death, whichever occurs first. Based on tolerability and safety aspects, steering committee and Independent Data Monitoring Committee (iDMC) will decide on expansion of the study to include more participants with other carcinoma types.
Interventions
DRUGTrastuzumab Emtansine
Trastuzumab emtansine will be administered as Regimen A (2.4 mg/kg qw via IV infusion) or Regimen B (3.6 mg/kg q3w via IV infusion) until unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically centrally confirmed HER2-positive (immunohistochemistry \[IHC\]3+ in greater than or equal to \[\>/=\] 30 percent \[%\] of tumor cells): locally advanced (unresectable and not treatable with curative intent), or metastatic UBC or locally advanced (unresectable and not treatable with curative intent) or metastatic pancreatic cancer/cholangiocarcinoma * There must be no standard treatment options available for participants with the above HER2 overexpressing tumors and they must have undergone at least one prior platinum-based treatment for locally advanced (unresectable and not treatable with curative intent) or metastatic tumor (Note: for pancreatic cancer/cholangiocarcinoma, prior treatments are not required to be platinum-based.) * Participant's lesion should be measurable according to RECIST V1.1 on diagnostic computed tomography (CT) scan/magnetic resonance imaging (MRI); Target lesion(s) should not have been previously irradiated * At least one formalin-fixed paraffin-embedded (FFPE) biopsy of the primary tumor and/or from a metastatic site is required * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 * No significant cardiac history and a current left ventricular ejection fraction (LVEF) \>/=50% * Adequate organ function * Life expectancy of at least 12 weeks
Exclusion criteria
* Participants with previous exposure to HER2-targeted therapies in any setting * Participants showing histologically confirmed focal HER2-expression, that is, less than (\<) 30% of positively stained tumor cells * Participants with brain metastasis as the sole site of metastatic disease and/or are symptomatic or require therapy to control symptoms * Current uncontrolled hypertension (systolic greater than \[\>\] 150 millimeters of mercury \[mmHg\] and/or diastolic \>100 mmHg) * Current unstable angina pectoris * History of symptomatic congestive heart failure (CHF) of any New York Heart Association (NYHA) criteria or ventricular arrhythmia that requires treatment * History of myocardial infarction within the last 6 months * Peripheral neuropathy, Grade \>/=3 * Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy * Current severe, uncontrolled systemic disease * History of other malignancy within the last 5 years * Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C * Known prior severe hypersensitivity to trastuzumab and trastuzumab emtansine or the excipients of the investigational medicinal product (IMP) * Clinically significant bleeding within 30 days before enrollment * Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment * Concurrent participation in any other therapeutic clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months) | BOR was defined as having best objective response as complete response (CR) or partial response (PR), as assessed by investigator and confirmed at least 28 days after initial response, according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis less than \[\<\] 10 millimeter \[mm\]). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of CR or PR are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months) | PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. |
| Overall Survival (OS) | Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months) | OS was determined as the time from beginning of treatment to death from any cause. |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to approximately 18 months | Incidence, type and severity of all adverse events (AEs) and serious adverse events (SAEs), based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03). |
| Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria | Baseline up to approximately 18 months | Participants from both cohorts (UBC and Pancreatic cancer/cholangiocarcinoma) were analyzed for drug-induced liver injury following Hy's Law. Hy's Law criteria for potential drug-induced liver injury includes an elevated ALT (alanine aminotransferase) or AST (aspartate aminotransferase) in combination with either elevated bilirubin or clinical jaundice. |
| Plasma/Serum Concentrations of Trastuzumab Emtansine | Regimen A: predose (0 minutes [min]) and 15-30 min postinfusion on Days (D) 1, 8, 15 of Cycle (C) 1 and D1C4; predose on D1C2. Regimen B: predose and 15-30 min postinfusion on D1C1 and D1C4; predose on D1C2. 1 Cycle=21 days | Samples for evaluation of trastuzumab emtansine, DM1, and total trastuzumab were obtained from all participants from both cohorts at specified time points. |
Countries
Italy, Netherlands, Slovakia, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (UBC) First six participants with locally advanced (unresectable and not treatable with curative intent) or metastatic UBC initially received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w). | 13 |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) First six participants with metastatic pancreatic cancer/cholangiocarcinoma received Regimen A (trastuzumab emtansine at a dose of 2.4 mg/kg qw). An iDMC assessed the safety among the first six participants and decided whether dose would be switched to Regimen B (trastuzumab emtansine at a dose of 3.6 mg/kg q3w). | 7 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Progressive Disease | 9 | 5 |
| Overall Study | Study Terminated by Sponsor | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Total | Cohort 1 (UBC) |
|---|---|---|---|
| Age, Continuous | 62.9 Years STANDARD_DEVIATION 7.2 | 59.3 Years STANDARD_DEVIATION 12.2 | 57.4 Years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 16 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 19 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 16 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 13 | 1 / 7 |
| other Total, other adverse events | 11 / 13 | 7 / 7 |
| serious Total, serious adverse events | 6 / 13 | 2 / 7 |
Outcome results
Primary
Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).
BOR was defined as having best objective response as complete response (CR) or partial response (PR), as assessed by investigator and confirmed at least 28 days after initial response, according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis less than \[\<\] 10 millimeter \[mm\]). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of CR or PR are reported.
Time frame: Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months)
Population: Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (UBC) | Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | CR | 0 Percentage of Treated Participants |
| Cohort 1 (UBC) | Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | PR | 38.5 Percentage of Treated Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | CR | 0 Percentage of Treated Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). | PR | 14.3 Percentage of Treated Participants |
Secondary
Overall Survival (OS)
OS was determined as the time from beginning of treatment to death from any cause.
Time frame: Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months)
Population: Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 (UBC) | Overall Survival (OS) | 7.03 Months |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Overall Survival (OS) | NA Months |
Secondary
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Incidence, type and severity of all adverse events (AEs) and serious adverse events (SAEs), based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03).
Time frame: Baseline up to approximately 18 months
Population: Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAEs | 46.2 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AEs | 84.6 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 1 AE | 7.7 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 2 AE | 23.1 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 3 AE | 30.8 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 4 AE | 0 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 5 AE | 23.1 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE greater than Grade 3 | 53.8 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE related to Trastuzumab Emtansine (TE) | 84.6 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE related to TE | 0 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE with fatal outcome | 23.1 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE leading to discontinuation of TE | 23.1 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE leading to modification of TE | 61.5 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE of special interest | 0 Percentage of Participants |
| Cohort 1 (UBC) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE of special interest | 0 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE leading to discontinuation of TE | 0 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE related to Trastuzumab Emtansine (TE) | 85.7 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AEs | 100 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAEs | 28.6 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 1 AE | 14.3 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE of special interest | 0 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 2 AE | 57.1 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE related to TE | 0 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 3 AE | 28.1 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE leading to modification of TE | 57.1 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 4 AE | 0 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE with fatal outcome | 0 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Grade 5 AE | 0 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | SAE of special interest | 0 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AE greater than Grade 3 | 28.6 Percentage of Participants |
Secondary
Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria
Participants from both cohorts (UBC and Pancreatic cancer/cholangiocarcinoma) were analyzed for drug-induced liver injury following Hy's Law. Hy's Law criteria for potential drug-induced liver injury includes an elevated ALT (alanine aminotransferase) or AST (aspartate aminotransferase) in combination with either elevated bilirubin or clinical jaundice.
Time frame: Baseline up to approximately 18 months
Population: Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 (UBC) | Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria | 0 Percentage of Participants |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria | 0 Percentage of Participants |
Secondary
Plasma/Serum Concentrations of Trastuzumab Emtansine
Samples for evaluation of trastuzumab emtansine, DM1, and total trastuzumab were obtained from all participants from both cohorts at specified time points.
Time frame: Regimen A: predose (0 minutes [min]) and 15-30 min postinfusion on Days (D) 1, 8, 15 of Cycle (C) 1 and D1C4; predose on D1C2. Regimen B: predose and 15-30 min postinfusion on D1C1 and D1C4; predose on D1C2. 1 Cycle=21 days
Population: Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (UBC) | Plasma/Serum Concentrations of Trastuzumab Emtansine | 15-30 min post-infusion, D1C4 | 62.5 ng/mL | Standard Deviation 13.6 |
| Cohort 1 (UBC) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D1C1 | NA ng/mL | — |
| Cohort 1 (UBC) | Plasma/Serum Concentrations of Trastuzumab Emtansine | 15-30 min post-infusion, D1C1 | 57.9 ng/mL | Standard Deviation 16.1 |
| Cohort 1 (UBC) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D8C1 | 8.27 ng/mL | Standard Deviation 2.59 |
| Cohort 1 (UBC) | Plasma/Serum Concentrations of Trastuzumab Emtansine | 15-30 min post-infusion, D8C1 | 57.4 ng/mL | Standard Deviation 12 |
| Cohort 1 (UBC) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D15C1 | 14.8 ng/mL | Standard Deviation 3.78 |
| Cohort 1 (UBC) | Plasma/Serum Concentrations of Trastuzumab Emtansine | 15-30 min post-infusion, D15C8 | 59.3 ng/mL | Standard Deviation 8.75 |
| Cohort 1 (UBC) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D1C2 | 10.5 ng/mL | Standard Deviation 9.38 |
| Cohort 1 (UBC) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D1C4 | 12.5 ng/mL | Standard Deviation 8.63 |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D1C2 | 2.02 ng/mL | Standard Deviation 2.08 |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D15C1 | 9.96 ng/mL | — |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D1C1 | NA ng/mL | — |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Plasma/Serum Concentrations of Trastuzumab Emtansine | 15-30 min post-infusion, D1C4 | 65.7 ng/mL | Standard Deviation 10.5 |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Plasma/Serum Concentrations of Trastuzumab Emtansine | 15-30 min post-infusion, D1C1 | 52.3 ng/mL | Standard Deviation 16.5 |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Plasma/Serum Concentrations of Trastuzumab Emtansine | 15-30 min post-infusion, D15C8 | 49.2 ng/mL | — |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D8C1 | 5.82 ng/mL | Standard Deviation 1.96 |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Plasma/Serum Concentrations of Trastuzumab Emtansine | Predose, D1C4 | 11.7 ng/mL | Standard Deviation 8.99 |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Plasma/Serum Concentrations of Trastuzumab Emtansine | 15-30 min post-infusion, D8C1 | 50.3 ng/mL | Standard Deviation 8.87 |
Secondary
Progression-Free Survival (PFS)
PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Time frame: Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months)
Population: Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 (UBC) | Progression-Free Survival (PFS) | 2.20 Months |
| Cohort 2 (Pancreatic Cancer/Cholangiocarcinoma) | Progression-Free Survival (PFS) | 2.58 Months |