Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma
Conditions
Keywords
Urothelial carcinoma, fibroblast growth factor receptor (FGFR) inhibitor, FGFR3 mutation, FGFR3 rearrangement, metastatic, unresectable, cisplatin-ineligible
Brief summary
The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.
Interventions
DRUGPemigatinib
13.5 mg once a day orally
DRUGPembrolizumab
200 mg Q3W intravenously
DRUGGemcitabine
1000 mg/m\^2 IV over 30 minutes on Days 1 and 8 of each 3-week cycle
DRUGCarboplatin
Dosed to target AUC of 5 mg/mL/min or 4.5 mg/mL/min if required per local guidelines on Day 1 or 2 of each 3-week cycle
Sponsors
Incyte Corporation
Study design
Allocation
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 documented metastatic or unresectable urothelial carcinoma. Both transitional cell and mixed transitional cell histologies are allowed, provided urothelial component is ≥ 50%. * At least 1 measurable target lesion per RECIST v1.1. * Must be ineligible to receive cisplatin. Patients ineligible for any platinum-based chemotherapy are allowed. * Known FGFR3 mutation or rearrangement confirmed by the central laboratory prior to randomization. * Central laboratory test result of PD-L1 status is mandatory at screening. * Have received no prior systemic chemotherapy for metastatic or unresectable urothelial carcinoma (except adjuvant platinum-based chemotherapy following radical cystectomy, with recurrence \> 12 months from completion of therapy, or neo-adjuvant platinum-based chemotherapy, with recurrence \> 12 months since completion of therapy). * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Willingness to avoid pregnancy or fathering children.
Exclusion criteria
* Prior receipt of a selective FGFR inhibitor for any indication or reason. * Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor. * Receipt of anticancer medications or investigational drugs for unresectable and/or metastatic disease. * Concurrent anticancer therapy, except for treatment allowed per protocol. * Has disease that is suitable for local therapy administered with curative intent. * Has tumor with any neuroendocrine or small cell component. * Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination. * Has received prior radiotherapy to a metastatic site without the use of chemotherapy radiosensitization within 3 weeks of the first dose of study treatment, with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks before the start of study treatment. * Has central nervous system metastases, unless the participant has completed local therapy (eg, whole brain radiation therapy, surgery, radiosurgery) and has discontinued use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. * Known additional malignancy that is progressing or required active treatment within the past 3 years * Laboratory values outside the protocol-defined range at screening. * Clinically significant or uncontrolled cardiac disease. * History of autoimmune disease that has required systemic treatment in past 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | up to 130 days | PFS was defined as the time from the randomization date until the date of disease progression (as measured by a blinded independent central review \[BICR\] per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) or death due to any cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | up to 148 days | ORR was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 (as measured by BICR). |
| Duration of Response (DOR) | up to 148 days | DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression (per RECIST v1.1) or death, whichever occurred first (as measured by BICR). |
| Number of Participants With Treatment-emergent Adverse Events | up to 178 days | A treatment-emergent adverse event was defined as an adverse event that was either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug. |
| Overall Survival (OS) | up to 225 days | OS was defined as the time from the date of randomization until death due to any cause. |
| Change From Baseline in the EORTC QLQ-C30 Score | Baseline; up to 160 days | The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Number of Participants With the Indicated EQ-5D-5L Dimension Scores | up to 160 days | The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 \[worst overall health\] to 100 \[best overall health\]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health. |
| Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score | Baseline; up to 160 days | The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 \[worst overall health\] to 100 \[best overall health\]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health. |
| EORTC QLQ-C30 Score | up to 160 days | The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual. |
Countries
Austria, Belgium, Canada, Finland, France, Germany, Ireland, Italy, Japan, Poland, Portugal, Romania, Slovakia, Spain, United Kingdom, United States
Participant flow
Recruitment details
This study was conducted (enrolled participants) at 7 sites located in France, Italy, Spain, and Japan.
Participants by arm
| Arm | Count |
|---|---|
| Pemigatinib 13.5 mg Pemigatinib was self-administered at 13.5 milligrams (mg) once daily (QD) orally (PO) until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/deciliter \[dL\]) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related adverse event (AE). | 0 |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg Pemigatinib was self-administered at 13.5 mg QD PO until disease progression during each 21-day treatment cycle. Participants not reaching the target serum phosphate level (\> 5.5 mg/dL) during Cycle 1 despite being study drug compliant increased the daily pemigatinib dose to 18 mg starting at Cycle 2 as long as they were not experiencing an ongoing Grade 2 or higher treatment-related AE. Pembrolizumab 200 mg was administered intravenously (IV) on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression. | 1 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg Participants received either gemcitabine plus carboplatin or pembrolizumab as standard of care. Participants received gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8 of each 3-week treatment cycle, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or Day 2 of each 3-week treatment cycle. Treatment continued for 4 to 6 cycles (or per institutional standards) until disease progression or intolerable toxicity. Pembrolizumab 200 mg was administered IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression. | 6 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Study Terminated by Sponsor | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Total | Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Pemigatinib 13.5 mg |
|---|---|---|---|---|
| Age, Customized 57 to 84 years old | 7 Participants | 1 Participants | 6 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | NA Participants | NA Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | NA Participants | NA Participants | 5 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants | 1 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | NA Participants | NA Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | NA Participants | NA Participants | 3 Participants | — |
| Race (NIH/OMB) Black or African American | NA Participants | NA Participants | 0 Participants | — |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants | 0 Participants | — |
| Race (NIH/OMB) White | NA Participants | NA Participants | 3 Participants | — |
| Sex: Female, Male Female | NA Participants | NA Participants | 4 Participants | — |
| Sex: Female, Male Male | NA Participants | NA Participants | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 | 3 / 6 |
| other Total, other adverse events | 0 / 0 | 1 / 1 | 6 / 6 |
| serious Total, serious adverse events | 0 / 0 | 1 / 1 | 1 / 6 |
Outcome results
Primary
Progression-free Survival (PFS)
PFS was defined as the time from the randomization date until the date of disease progression (as measured by a blinded independent central review \[BICR\] per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) or death due to any cause, whichever occurred first.
Time frame: up to 130 days
Population: Intent-to-Treat (ITT) Population: all participants who were randomized into the study. Treatment groups for this population were to be determined according to the treatment assignment at the time of randomization. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Progression-free Survival (PFS) | 1.81 months |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Progression-free Survival (PFS) | 2.12 months |
Secondary
Change From Baseline in the EORTC QLQ-C30 Score
The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; up to 160 days
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Dyspnea, Cycle 3 Day 1 | 0.0 scores on a scale | Standard Deviation 0 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Emotional Functioning, Follow Up | 41.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Fatigue, Cycle 3 Day 1 | -11.1 scores on a scale | Standard Deviation 15.71 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Fatigue, Cycle 6 Day 1 | 11.1 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Fatigue, Follow Up | -44.4 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Financial Difficulties, Cycle 3 Day 1 | 0.0 scores on a scale | Standard Deviation 0 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Insomnia, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Insomnia, Follow Up | -33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Nausea and Vomiting, Cycle 3 Day 1 | 0.0 scores on a scale | Standard Deviation 0 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Social Functioning, Cycle 6 Day 1 | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Social Functioning, Follow Up | 66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Appetite Loss, Cycle 3 Day 1 | -16.7 scores on a scale | Standard Deviation 23.57 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Diarrhea, Follow Up | -66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Appetite Loss, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Appetite Loss, Follow Up | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Cognitive Functioning, Cycle 3 Day 1 | 33.3 scores on a scale | Standard Deviation 23.57 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Cognitive Functioning, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Cognitive Functioning, Follow Up | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Constipation, Cycle 3 Day 1 | -33.3 scores on a scale | Standard Deviation 0 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Constipation, Cycle 6 Day 1 | -33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Constipation, Follow Up | -33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Diarrhea, Cycle 3 Day 1 | -50.0 scores on a scale | Standard Deviation 70.71 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Diarrhea, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Dyspnea, Cycle 6 Day 1 | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Dyspnea, Follow Up | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Emotional Functioning, Cycle 3 Day 1 | 12.5 scores on a scale | Standard Deviation 29.46 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Emotional Functioning, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Financial Difficulties, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Financial Difficulties, Follow Up | -33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Global Health Status/QoL, Cycle 3 Day 1 | 33.3 scores on a scale | Standard Deviation 35.36 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Global Health Status/QoL, Cycle 6 Day 1 | 16.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Global Health Status/QoL, Follow Up | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Insomnia, Cycle 3 Day 1 | -16.7 scores on a scale | Standard Deviation 23.57 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Nausea and Vomiting, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Nausea and Vomiting, Follow Up | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Pain, Cycle 3 Day 1 | -8.3 scores on a scale | Standard Deviation 58.93 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Pain, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Physical Functioning, Cycle 3 Day 1 | -26.7 scores on a scale | Standard Deviation 37.71 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Physical Functioning, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Physical Functioning, Follow Up | -13.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Role Functioning, Cycle 3 Day 1 | 0.0 scores on a scale | Standard Deviation 0 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Role Functioning, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Role Functioning, Follow Up | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Social Functioning, Cycle 3 Day 1 | 41.7 scores on a scale | Standard Deviation 11.79 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EORTC QLQ-C30 Score | Pain, Follow Up | -83.3 scores on a scale | — |
Secondary
Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 \[worst overall health\] to 100 \[best overall health\]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health.
Time frame: Baseline; up to 160 days
Population: ITT Population. Only participants with available data were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score | Baseline | 40 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score | Baseline | 52 scores on a scale | Standard Deviation 30.54 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score | Cycle 4 Day 1 | 5 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score | Cycle 7 Day 1 | 5 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Change From Baseline in the EQ-5D-5L EQ Visual Analog Scale Score | Follow Up | 30 scores on a scale | — |
Secondary
Duration of Response (DOR)
DOR was defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression (per RECIST v1.1) or death, whichever occurred first (as measured by BICR).
Time frame: up to 148 days
Population: As measured by BICR, there were no responders; thus, DOR was not calculated.
Secondary
EORTC QLQ-C30 Score
The European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) contains 30 items and measures 5 functional dimensions (i.e., physical, role, emotional, cognitive, and social), 3 symptom items (i.e., fatigue, nausea/vomiting, and pain), 6 single items (i.e., dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and quality of life scale. For each scale and single item, a linear transformation was applied to standardize the scores between 0 (worst) and 100 (best) as described in the EORTC QLQ-C30 Scoring Manual.
Time frame: up to 160 days
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Role Functioning, Baseline | 66.7 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Social Functioning, Baseline | 66.7 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Insomnia, Baseline | 33.3 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Diarrhea, Baseline | 0.0 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Appetite Loss, Baseline | 33.3 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Financial Difficulties, Baseline | 33.3 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Emotional Functioning, Baseline | 50.0 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Nausea and Vomiting, Baseline | 0.0 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Constipation, Baseline | 0.0 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Cognitive Functioning, Baseline | 66.7 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Physical Functioning, Baseline | 73.3 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Global Health Status/Quality of Life (QoL), Baseline | 16.7 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Pain, Baseline | 50.0 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Dyspnea, Baseline | 0.0 scores on a scale | — |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Fatigue, Baseline | 44.4 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Appetite Loss, Cycle 3 Day 1 | 16.7 scores on a scale | Standard Deviation 23.57 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Appetite Loss, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Appetite Loss, Follow Up | 66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Cognitive Functioning, Baseline | 66.7 scores on a scale | Standard Deviation 20.41 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Cognitive Functioning, Cycle 3 Day 1 | 91.7 scores on a scale | Standard Deviation 11.79 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Cognitive Functioning, Cycle 6 Day 1 | 66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Cognitive Functioning, Follow Up | 83.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Constipation, Baseline | 40.0 scores on a scale | Standard Deviation 27.89 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Constipation, Cycle 3 Day 1 | 16.7 scores on a scale | Standard Deviation 23.57 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Constipation, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Constipation, Follow Up | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Diarrhea, Baseline | 20.0 scores on a scale | Standard Deviation 44.72 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Diarrhea, Cycle 3 Day 1 | 0.0 scores on a scale | Standard Deviation 0 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Diarrhea, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Diarrhea, Follow Up | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Dyspnea, Baseline | 26.7 scores on a scale | Standard Deviation 27.89 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Dyspnea, Cycle 3 Day 1 | 16.7 scores on a scale | Standard Deviation 23.57 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Dyspnea, Cycle 6 Day 1 | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Dyspnea, Follow Up | 66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Emotional Functioning, Baseline | 73.3 scores on a scale | Standard Deviation 19 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Emotional Functioning, Cycle 3 Day 1 | 87.5 scores on a scale | Standard Deviation 5.89 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Emotional Functioning, Cycle 6 Day 1 | 91.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Emotional Functioning, Follow Up | 100.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Fatigue, Baseline | 46.7 scores on a scale | Standard Deviation 36.35 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Fatigue, Cycle 3 Day 1 | 50.0 scores on a scale | Standard Deviation 39.28 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Fatigue, Cycle 6 Day 1 | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Fatigue, Follow Up | 55.6 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Financial Difficulties, Baseline | 20.0 scores on a scale | Standard Deviation 18.26 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Financial Difficulties, Cycle 3 Day 1 | 16.7 scores on a scale | Standard Deviation 23.57 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Financial Difficulties, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Financial Difficulties, Follow Up | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Global Health Status/Quality of Life (QoL), Baseline | 51.7 scores on a scale | Standard Deviation 31.95 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Global Health Status/QoL, Cycle 3 Day 1 | 66.7 scores on a scale | Standard Deviation 11.79 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Global Health Status/QoL, Cycle 6 Day 1 | 66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Global Health Status/QoL, Follow Up | 50.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Insomnia, Baseline | 46.7 scores on a scale | Standard Deviation 38.01 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Insomnia, Cycle 3 Day 1 | 33.3 scores on a scale | Standard Deviation 47.14 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Insomnia, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Insomnia, Follow Up | 66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Nausea and Vomiting, Baseline | 6.7 scores on a scale | Standard Deviation 9.13 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Nausea and Vomiting, Cycle 3 Day 1 | 8.3 scores on a scale | Standard Deviation 11.79 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Nausea and Vomiting, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Nausea and Vomiting, Follow Up | 16.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Pain, Baseline | 40.0 scores on a scale | Standard Deviation 43.46 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Social Functioning, Follow Up | 83.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Pain, Cycle 3 Day 1 | 41.7 scores on a scale | Standard Deviation 11.79 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Pain, Cycle 6 Day 1 | 0.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Pain, Follow Up | 16.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Physical Functioning, Baseline | 65.3 scores on a scale | Standard Deviation 26.83 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Physical Functioning, Cycle 3 Day 1 | 33.3 scores on a scale | Standard Deviation 47.14 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Physical Functioning, Cycle 6 Day 1 | 66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Physical Functioning, Follow Up | 40.0 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Role Functioning, Baseline | 56.7 scores on a scale | Standard Deviation 40.14 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Role Functioning, Cycle 3 Day 1 | 33.3 scores on a scale | Standard Deviation 47.14 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Role Functioning, Cycle 6 Day 1 | 66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Role Functioning, Follow Up | 33.3 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Social Functioning, Baseline | 53.3 scores on a scale | Standard Deviation 36.13 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Social Functioning, Cycle 3 Day 1 | 66.7 scores on a scale | Standard Deviation 0 |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Social Functioning, Cycle 6 Day 1 | 66.7 scores on a scale | — |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | EORTC QLQ-C30 Score | Appetite Loss, Baseline | 26.7 scores on a scale | Standard Deviation 36.51 |
Secondary
Number of Participants With the Indicated EQ-5D-5L Dimension Scores
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system is composed of 5 dimensions (mobility, self-case, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ-5D-5L also includes a graded (0 \[worst overall health\] to 100 \[best overall health\]) vertical visual analog scale that provides a quantitative measure of the participant's perception of their overall health.
Time frame: up to 160 days
Population: ITT Population. Only participants with available data were analyzed
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 2 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 5 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 2 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 1 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 5 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 2 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 1 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 3 | 1 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 2 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 3 | 1 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 3 | 1 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 3 | 1 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 4 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 4 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 5 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 4 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 5 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 1 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 4 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 2 | 1 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 5 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 3 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 1 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 4 | 0 Participants |
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 7 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 7 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Follow Up | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Follow Up | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Follow Up | 3 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Follow Up | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Follow Up | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 1 | 3 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 3 | 2 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Baseline | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 4 Day 1 | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 4 Day 1 | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 4 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 4 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 7 Day 1 | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 7 Day 1 | 2 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 7 Day 1 | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 7 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 7 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Follow Up | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Follow Up | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Follow Up | 3 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Follow Up | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Follow Up | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 1 | 2 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 2 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 3 | 2 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Baseline | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 4 Day 1 | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 4 Day 1 | 2 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 4 Day 1 | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 4 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 4 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 7 Day 1 | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 7 Day 1 | 2 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 7 Day 1 | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 7 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Cycle 7 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Follow Up | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Follow Up | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Follow Up | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Follow Up | 4 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Usual Activities, Follow Up | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 4 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 4 Day 1 | 1 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 4 Day 1 | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 4 Day 1 | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 4 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 4 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 7 Day 1 | 1 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 7 Day 1 | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 7 Day 1 | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 7 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Cycle 7 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Follow Up | 1 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Follow Up | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Follow Up | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Follow Up | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Follow Up | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 1 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 2 | 2 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 3 | 2 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Baseline | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 4 Day 1 | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 4 Day 1 | 2 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 4 Day 1 | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 4 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 4 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 7 Day 1 | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 7 Day 1 | 2 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 7 Day 1 | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 7 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 1 | 3 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 3 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Anxiety/Depression, Baseline | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Self-care, Cycle 4 Day 1 | 2 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Cycle 7 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Follow Up | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Follow Up | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Follow Up | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Follow Up | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Mobility, Follow Up | 5 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 1 | 2 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 2 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 4 | 2 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Baseline | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 4 Day 1 | 1 | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 4 Day 1 | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 4 Day 1 | 3 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 4 Day 1 | 4 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 4 Day 1 | 5 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 7 Day 1 | 1 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 7 Day 1 | 2 | 0 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With the Indicated EQ-5D-5L Dimension Scores | Pain/Discomfort, Cycle 7 Day 1 | 3 | 1 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events
A treatment-emergent adverse event was defined as an adverse event that was either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 30 days after the last dose of study drug.
Time frame: up to 178 days
Population: Safety Population: all randomized participants who received at least one dose of study treatment. Treatment groups for this population were to be determined according to the actual treatment the participant received regardless of assigned study drug treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Number of Participants With Treatment-emergent Adverse Events | 1 Participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Number of Participants With Treatment-emergent Adverse Events | 6 Participants |
Secondary
Objective Response Rate (ORR)
ORR was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 (as measured by BICR).
Time frame: up to 148 days
Population: Intent-to-Treat (ITT) Population: all participants who were randomized into the study. Treatment groups for this population were to be determined according to the treatment assignment at the time of randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Objective Response Rate (ORR) | 0 percentage of participants |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Objective Response Rate (ORR) | 0 percentage of participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the date of randomization until death due to any cause.
Time frame: up to 225 days
Population: ITT Population. The 95% confidence intervals were calculated using the Brookmeyer and Crowley's method.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pemigatinib 13.5 mg Plus Pembrolizumab 200 mg | Overall Survival (OS) | NA months |
| Gemcitabine 1000 mg/m^2 Plus Carboplatin or Pembrolizumab 200 mg | Overall Survival (OS) | NA months |