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A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03473743
Enrollment
125
Registered
2018-03-22
Start date
2018-04-05
Completion date
2026-12-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

Brief summary

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.

Detailed description

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.

Interventions

DRUGErdafitinib

Participants will receive erdafitinib orally.

DRUGCetrelimab

Participants will receive cetrelimab by intravenous infusion.

DRUGCisplatin

Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.

DRUGCarboplatin

Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.

Sponsors

Janssen Research & Development, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable * Metastatic or locally advanced urothelial cancer * Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline * Prior systemic therapy for metastatic urothelial cancer: (a) For Phase 1b erdafitinib + cetrelimab cohort: Any number of lines of prior therapy; (b) For Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: No prior systemic therapy for metastatic disease; and renal function for participants must have a creatinine clearance (CrCl) greater than (\>) 30 milliliter per minute (mL/min) to receive carboplatin and \>60 mL/min to receive cisplatin as calculated by Cockcroft Gault and (c) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible based on: ECOG PS 0-1 and at least one of the following criteria: Renal function defined as creatinine clearance (CrCl) less than (˂) 60 mL/min as calculated by Cockcroft-Gault; Grade 2 or higher peripheral neuropathy per NCI-CTCAE version 5.0; Grade 2 or higher hearing loss per NCI-CTCAE version 5.0 OR ECOG PS 2 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: (a) Phase 1b erdafitinib + cetrelimab cohort: ECOG 0-2; (b) Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort: ECOG 0-1 for cisplatin and 0-2 for carboplatin (c) Phase 2: ECOG 0-2

Exclusion criteria

* Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks * Phase 1b erdafitinib + cetrelimab cohort: Chemotherapy within 3 weeks of Cycle 1 Day 1; Phase 1b erdafitinib + cetrelimab + platinum chemotherapy cohort and Phase 2: Prior neoadjuvant/adjuvant chemotherapy is allowed if the last dose was given \>12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation * Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (\>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation. PD-1 for non-muscle invasive bladder cancer is also allowed * Active malignancies requiring concurrent therapy other than urothelial cancer * Symptomatic central nervous system metastases

Design outcomes

Primary

MeasureTime frameDescription
Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)Up to 8 weeksNumber 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.
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator AssessmentFrom Day 1 up to 36 monthsORR 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.
Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)From Day 1 up to 36 monthsNumber 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.

Secondary

MeasureTime frame
Phase 1b and Phase 2: Plasma Concentration of ErdafitinibUp to 6 years 1 month
Phase 1b and Phase 2: Serum Concentration of CetrelimabUp to 6 years 1 month
Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) ChemotherapyUp to 6 years 1 month
Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab AntibodiesUp to 6 years 1 month
Phase 2: Number of Participants With Serious Adverse Events (SAEs)Up to 6 years 1 month
Phase 2: Number of Participants With Abnormal Laboratory ValuesUp to 6 years 1 month
Phase 2: Duration of Response (DoR)Up to 6 years 1 month
Phase 2: Time to Response (TTR)Up to 6 years 1 month
Phase 2: Progression-free Survival (PFS)Up to 6 years 1 month
Phase 2: Overall Survival (OS)Up to 6 years 1 month

Countries

Belarus, Belgium, Brazil, France, Italy, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States

Contacts

STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial

Janssen Research & Development, LLC

Participant flow

Participants by arm

ArmCount
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 6 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by intravenous (IV) injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
4
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met..
3
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 2 Day 1 up to Cycle 4 Day 15. Based on phosphate (PO4) levels, erdafitinib dose was up-titrated to 9 mg once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
11
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)
Participants received an oral tablet of recommended Phase 2 dose (RP2D) of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
12
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and cisplatin 50 milligrams per meter square (mg/m\^2) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
3
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/Min
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 along with single dose of IV injection of cetrelimab 360 mg and carboplatin area under the curve (AUC) 4 milligrams per milliliter per minute (mg/mL/min) (chemotherapy) every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
3
Arm A (Phase 2): Erdafitinib 8/9 mg Monotherapy
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1. Based on PO4 levels, erdafitinib dose was up-titrated to 9 mg, orally, once daily starting from Cycle 1 Day 15 until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
43
Arm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mg
Participants received an oral tablet of erdafitinib 8 mg once daily in 28-day cycle starting from Cycle 1 Day 1 followed by IV injection of cetrelimab 240 mg every 2 weeks in 28-day cycle starting from Cycle 1 Day 1 up to Cycle 4 Day 15. From Cycle 5 Day 1, all participants received an increased dose of cetrelimab 480 mg every 4 weeks in 28-day cycle until disease progression, unacceptable toxicity (based on investigator assessment), or another treatment discontinuation criterion was met.
44
Total123

Baseline characteristics

CharacteristicCohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mgCohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mgCohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mgCohort 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^2Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/MinArm A (Phase 2): Erdafitinib 8/9 mg MonotherapyArm B (Phase 2): Erdafitinib 8 mg + Cetrelimab 240/480 mgTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants2 Participants4 Participants8 Participants0 Participants3 Participants31 Participants31 Participants82 Participants
Age, Categorical
Between 18 and 65 years
1 Participants1 Participants7 Participants4 Participants3 Participants0 Participants12 Participants13 Participants41 Participants
Age, Continuous72.8 years
STANDARD_DEVIATION 6.5
66.7 years
STANDARD_DEVIATION 9.07
61.3 years
STANDARD_DEVIATION 11.14
63.5 years
STANDARD_DEVIATION 11.41
60.3 years
STANDARD_DEVIATION 0.58
69 years
STANDARD_DEVIATION 3.61
71.1 years
STANDARD_DEVIATION 10.18
70.2 years
STANDARD_DEVIATION 8.61
68.8 years
STANDARD_DEVIATION 9.96
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants1 Participants2 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants0 Participants9 Participants10 Participants3 Participants3 Participants39 Participants37 Participants105 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants2 Participants1 Participants0 Participants0 Participants3 Participants5 Participants13 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants2 Participants0 Participants1 Participants1 Participants3 Participants2 Participants9 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants3 Participants1 Participants0 Participants0 Participants4 Participants6 Participants16 Participants
Race (NIH/OMB)
White
4 Participants1 Participants6 Participants11 Participants2 Participants2 Participants36 Participants36 Participants98 Participants
Region of Enrollment
BELARUS
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants4 Participants6 Participants10 Participants
Region of Enrollment
BELGIUM
0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants2 Participants1 Participants5 Participants
Region of Enrollment
BRAZIL
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants1 Participants3 Participants
Region of Enrollment
FRANCE
0 Participants2 Participants2 Participants1 Participants0 Participants0 Participants3 Participants4 Participants12 Participants
Region of Enrollment
ITALY
0 Participants0 Participants1 Participants2 Participants0 Participants0 Participants3 Participants2 Participants8 Participants
Region of Enrollment
POLAND
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants
Region of Enrollment
RUSSIAN FEDERATION
0 Participants0 Participants1 Participants1 Participants2 Participants1 Participants8 Participants8 Participants21 Participants
Region of Enrollment
SOUTH KOREA
0 Participants0 Participants2 Participants0 Participants1 Participants1 Participants2 Participants2 Participants8 Participants
Region of Enrollment
SPAIN
2 Participants1 Participants4 Participants6 Participants0 Participants0 Participants4 Participants8 Participants25 Participants
Region of Enrollment
TAIWAN
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants
Region of Enrollment
TURKEY
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants9 Participants8 Participants17 Participants
Region of Enrollment
UNITED KINGDOM
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants3 Participants0 Participants3 Participants
Region of Enrollment
UNITED STATES
2 Participants0 Participants0 Participants2 Participants0 Participants0 Participants2 Participants3 Participants9 Participants
Sex: Female, Male
Female
0 Participants1 Participants2 Participants5 Participants0 Participants1 Participants10 Participants11 Participants30 Participants
Sex: Female, Male
Male
4 Participants2 Participants9 Participants7 Participants3 Participants2 Participants33 Participants33 Participants93 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
4 / 43 / 35 / 113 / 122 / 32 / 321 / 4317 / 44
other
Total, other adverse events
4 / 43 / 311 / 1112 / 123 / 33 / 343 / 4343 / 44
serious
Total, serious adverse events
3 / 41 / 34 / 116 / 123 / 31 / 322 / 4319 / 44

Outcome results

Primary

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

Population: Treated analysis set included all participants who had received at least one dose of study drug.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mgPhase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)0 Participants
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mgPhase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)0 Participants
Cohort DL2B (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mgPhase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)0 Participants
Cohort DL2 (Phase 1b): Erdafitinib 8/9 mg + Cetrelimab 240/480 mg (RP2D)Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)0 Participants
Cohort DL2C (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Cisplatin 50 mg/m^2Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)0 Participants
Cohort DL2D (Phase 1b): Erdafitinib 8 mg + Cetrelimab 360 mg + Carboplatin AUC 4 mg/mL/MinPhase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)0 Participants
Primary

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

Population: Treated analysis set included all participants who had received at least one dose of study drug.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mgPhase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)43 Participants
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mgPhase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)44 Participants
Primary

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

Population: Treated analysis set included all participants who had received at least one dose of study drug.

ArmMeasureValue (NUMBER)
Cohort Dose Level (DL) 1 (Phase 1b): Erdafitinib 6 Milligrams (mg) + Cetrelimab 240/480 mgPhase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment44.2 Percentage of Participants
Cohort DL2A (Phase 1b): Erdafitinib 8 mg + Cetrelimab 240/480 mgPhase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment54.5 Percentage of Participants
Secondary

Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies

Time frame: Up to 6 years 1 month

Secondary

Phase 1b and Phase 2: Plasma Concentration of Erdafitinib

Time frame: Up to 6 years 1 month

Secondary

Phase 1b and Phase 2: Serum Concentration of Cetrelimab

Time frame: Up to 6 years 1 month

Secondary

Phase 1b: Plasma Concentration of Platinum (Cisplatin and Carboplatin) Chemotherapy

Time frame: Up to 6 years 1 month

Secondary

Phase 2: Duration of Response (DoR)

Time frame: Up to 6 years 1 month

Secondary

Phase 2: Number of Participants With Abnormal Laboratory Values

Time frame: Up to 6 years 1 month

Secondary

Phase 2: Number of Participants With Serious Adverse Events (SAEs)

Time frame: Up to 6 years 1 month

Secondary

Phase 2: Overall Survival (OS)

Time frame: Up to 6 years 1 month

Secondary

Phase 2: Progression-free Survival (PFS)

Time frame: Up to 6 years 1 month

Secondary

Phase 2: Time to Response (TTR)

Time frame: Up to 6 years 1 month

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026