A Phase 1/2 interventional study of Erdafitinib and Cetrelimab in Urothelial Carcinoma, sponsored by Janssen Research & Development, LLC. Active, not recruiting at 127 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1/2, Interventional, and Treatment
The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.
This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study to establish the recommended phase 2 dose (RP2D) for erdafitinib and cetrelimab and/or platinum (cisplatin or carboplatin) chemotherapy, and to evaluate the safety of erdafitinib in combination with cetrelimab and platinum chemotherapy in Phase 1b and to evaluate the safety and efficacy of the RP2D of erdafitinib plus cetrelimab versus erdafitinib in Phase 2 in participants with advanced urothelial cancer with select fibroblast growth factor receptor (FGFR) gene alterations. Participants enrolled in Phase 1b erdafitinib + cetrelimab cohort may have received any number of lines of prior therapy, and participants enrolled in Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort will have had no prior systemic therapy for metastatic disease and participants enrolled in Phase 2 will have had no prior systemic therapy for metastatic disease and will be cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will identify safety and RP2Ds of erdafitinib + cetrelimab and erdafitinib + cetrelimab + platinum (cisplatin or carboplatin) chemotherapy, and Part 2 (Phase 2: Dose Expansion) will evaluate erdafitinib monotherapy and the RP2D regimen of the erdafitinib + cetrelimab combination to further characterize safety and clinical activity. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.
633 studies on the registry are indexed under Carcinoma, Transitional Cell; 181 are open to participants now.
This study's enrollment of 125 is above the median of 50 across 500 interventional studies indexed under Carcinoma, Transitional Cell.
Browse Carcinoma, Transitional Cell studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two dosing cohorts (erdafitinib and cetrelimab; and erdafitinib, cetrelimab and cisplatin/carboplatin) are explored in Phase 1b of the study. Participants will receive erdafitinib orally followed by cetrelimab intravenously (IV) and carboplatin/cisplatin IV as a part of platinum chemotherapy. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
Drug: Erdafitinib · Drug: Cetrelimab · Drug: Cisplatin · Drug: Carboplatin
The participants will be randomized in a 1:1 manner to receive either erdafitinib alone (orally) or the identified RP2D of Phase 1b for erdafitinib (orally) in combination with cetrelimab (IV).
Drug: Erdafitinib · Drug: Cetrelimab
Participants will receive erdafitinib orally.
Also known as: JNJ-42756493
Participants will receive cetrelimab by intravenous infusion.
Also known as: JNJ-63723283
Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.
Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.
Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
Time frame: Up to 8 weeks
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (\>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
Time frame: From Day 1 up to 36 months
Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.
Time frame: From Day 1 up to 36 months
Phase 1b and Phase 2: Plasma Concentration of Erdafitinib
Time frame: Up to 6 years 1 month
Phase 1b and Phase 2: Serum Concentration of Cetrelimab
Time frame: Up to 6 years 1 month
Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) Chemotherapy
Time frame: Up to 6 years 1 month
Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies
Time frame: Up to 6 years 1 month
Phase 2: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 6 years 1 month
Phase 2: Number of Participants With Abnormal Laboratory Values
Time frame: Up to 6 years 1 month
Phase 2: Duration of Response (DoR)
Time frame: Up to 6 years 1 month
Phase 2: Time to Response (TTR)
Time frame: Up to 6 years 1 month
Phase 2: Progression-free Survival (PFS)
Time frame: Up to 6 years 1 month
Phase 2: Overall Survival (OS)
Time frame: Up to 6 years 1 month
| Milestone | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg |
|---|---|---|---|---|---|---|---|---|
| Started | 4 | 3 | 11 | 12 | 3 | 3 | 44 | 45 |
| Treated (treated analysis set) | 4 | 3 | 11 | 12 | 3 | 3 | 43 | 44 |
| Completed | 4 | 3 | 5 | 3 | 2 | 2 | 21 | 17 |
| Not completed | 0 | 0 | 6 | 9 | 1 | 1 | 23 | 28 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Withdrew: Other | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Ongoing | 0 | 0 | 6 | 8 | 1 | 1 | 22 | 24 |
| Withdrew: Randomized but not treated | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
Number of participants with DLTs were reported. The DLTs as per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE version 5.0) are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) non-hematological toxicity or hematological toxicity.
| Participants | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min |
|---|---|---|---|---|---|---|
| Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs) | 0 | 0 | 0 | 0 | 0 | 0 |
ORR is defined as the percentage of participants who achieved confirmed complete response (CR) or confirmed partial response (PR), according to response evaluation criteria in solid tumors (RECIST) version1.1. As per RECIST version 1.1, CR: disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR: greater than or equal to (\>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
| Percentage of Participants | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg |
|---|---|---|
| Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment | 44.2 | 54.5 |
Number of participants with TEAEs were reported. An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment.
| Participants | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg |
|---|---|---|
| Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs) | 43 | 44 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over Phase 1b: From Day 1 up to 40 months; Phase 2: From Day 1 up to 36 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | 4/4 (100%) | 3/4 (75%) | 4/4 (100%) |
| Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | 3/3 (100%) | 1/3 (33.3%) | 3/3 (100%) |
| Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | 5/11 (45.5%) | 4/11 (36.4%) | 11/11 (100%) |
| Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | 3/12 (25%) | 6/12 (50%) | 12/12 (100%) |
| Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | 2/3 (66.7%) | 3/3 (100%) | 3/3 (100%) |
| Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | 21/43 (48.8%) | 22/43 (51.2%) | 43/43 (100%) |
| Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg | 17/44 (38.6%) | 19/44 (43.2%) | 43/44 (97.7%) |
| Event | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg |
|---|---|---|---|---|---|---|---|---|
| Disseminated Intravascular CoagulationBlood and lymphatic system disorders | 0/4 | 0/3 | 0/11 | 0/12 | 1/3 | 0/3 | 0/43 | 0/44 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/4 | 0/3 | 0/11 | 0/12 | 1/3 | 0/3 | 0/43 | 0/44 |
| Gastric UlcerGastrointestinal disorders | 0/4 | 0/3 | 0/11 | 0/12 | 1/3 | 0/3 | 0/43 | 0/44 |
| Intestinal MassGastrointestinal disorders | 0/4 | 0/3 | 0/11 | 0/12 | 1/3 | 0/3 | 0/43 | 0/44 |
| Intestinal ObstructionGastrointestinal disorders | 0/4 | 0/3 | 0/11 | 0/12 | 1/3 | 0/3 | 0/43 | 2/44 |
| Large Intestine PerforationGastrointestinal disorders | 0/4 | 0/3 | 0/11 | 0/12 | 1/3 | 0/3 | 0/43 | 0/44 |
| AstheniaGeneral disorders | 0/4 | 0/3 | 0/11 | 0/12 | 1/3 | 0/3 | 1/43 | 0/44 |
| General Physical Health DeteriorationGeneral disorders | 0/4 | 0/3 | 1/11 | 0/12 | 1/3 | 0/3 | 3/43 | 1/44 |
| PeritonitisInfections and infestations | 0/4 | 0/3 | 0/11 | 0/12 | 1/3 | 0/3 | 0/43 | 0/44 |
| PneumoniaInfections and infestations | 0/4 | 0/3 | 0/11 | 1/12 | 0/3 | 1/3 | 0/43 | 1/44 |
| Event | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg |
|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 1/4 | 1/3 | 2/11 | 3/12 | 3/3 | 2/3 | 16/43 | 17/44 |
| StomatitisGastrointestinal disorders | 3/4 | 3/3 | 3/11 | 9/12 | 1/3 | 2/3 | 31/43 | 26/44 |
| HyperphosphataemiaMetabolism and nutrition disorders | 1/4 | 2/3 | 8/11 | 10/12 | 3/3 | 3/3 | 36/43 | 30/44 |
| DiarrhoeaGastrointestinal disorders | 1/4 | 1/3 | 9/11 | 10/12 | 1/3 | 0/3 | 21/43 | 20/44 |
| ConstipationGastrointestinal disorders | 0/4 | 2/3 | 5/11 | 4/12 | 0/3 | 1/3 | 14/43 | 7/44 |
| Dry MouthGastrointestinal disorders | 2/4 | 2/3 | 6/11 | 7/12 | 1/3 | 2/3 | 16/43 | 26/44 |
| VomitingGastrointestinal disorders | 1/4 | 1/3 | 2/11 | 2/12 | 0/3 | 2/3 | 4/43 | 3/44 |
| Aspartate Aminotransferase IncreasedInvestigations | 0/4 | 0/3 | 3/11 | 2/12 | 2/3 | 1/3 | 10/43 | 8/44 |
| Weight DecreasedInvestigations | 0/4 | 2/3 | 2/11 | 1/12 | 0/3 | 0/3 | 7/43 | 8/44 |
| Bone PainMusculoskeletal and connective tissue disorders | 0/4 | 2/3 | 0/11 | 0/12 | 0/3 | 0/3 | 0/43 | 1/44 |
Safety analysis set was defined as all participants who had received at least one dose of study drug.
| Age, Categorical(Participants) | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 7 | 4 | 3 | 0 | 12 | 13 | 41 |
| >=65 years | 3 | 2 | 4 | 8 | 0 | 3 | 31 | 31 | 82 |
| Age, Continuous(years) | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 72.8 ± 6.5 | 66.7 ± 9.07 | 61.3 ± 11.14 | 63.5 ± 11.41 | 60.3 ± 0.58 | 69 ± 3.61 | 71.1 ± 10.18 | 70.2 ± 8.61 | 68.8 ± 9.96 |
| Sex: Female, Male(Participants) | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 2 | 5 | 0 | 1 | 10 | 11 | 30 |
| Male | 4 | 2 | 9 | 7 | 3 | 2 | 33 | 33 | 93 |
| Ethnicity (NIH/OMB)(Participants) | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 2 | 5 |
| Not Hispanic or Latino | 4 | 0 | 9 | 10 | 3 | 3 | 39 | 37 | 105 |
| Unknown or Not Reported | 0 | 2 | 2 | 1 | 0 | 0 | 3 | 5 | 13 |
| Race (NIH/OMB)(Participants) | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 2 | 0 | 1 | 1 | 3 | 2 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 4 | 1 | 6 | 11 | 2 | 2 | 36 | 36 | 98 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 3 | 1 | 0 | 0 | 4 | 6 | 16 |
| Region of Enrollment(Participants) | Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg | Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg | Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D) | Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2 | Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min | Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy | Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| BELARUS | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 6 | 10 |
| BELGIUM | 0 | 0 | 1 | 0 | 0 | 1 | 2 | 1 | 5 |
| BRAZIL | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 3 |
| FRANCE | 0 | 2 | 2 | 1 | 0 | 0 | 3 | 4 | 12 |
| ITALY | 0 | 0 | 1 | 2 | 0 | 0 | 3 | 2 | 8 |
| POLAND | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| RUSSIAN FEDERATION | 0 | 0 | 1 | 1 | 2 | 1 | 8 | 8 | 21 |
| SOUTH KOREA | 0 | 0 | 2 | 0 | 1 | 1 | 2 | 2 | 8 |
| SPAIN | 2 | 1 | 4 | 6 | 0 | 0 | 4 | 8 | 25 |
| TAIWAN | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| TURKEY | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 8 | 17 |
| UNITED KINGDOM | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 3 |
| UNITED STATES | 2 | 0 | 0 | 2 | 0 | 0 | 2 | 3 | 9 |
Showing the first 100 of 127 sites across 13 countries. Choose a country and city above to see the rest.
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Studies of the drug tested here: Erdafitinib
Carcinoma, Transitional Cell →
Janssen Research & Development, LLC →