A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Participants With Metastatic or Surgically Unresectable Urothelial Cancer With Selected FGFR Gene Alterations
Status: | Recruiting |
---|---|
Conditions: | Prostate Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/31/2019 |
Start Date: | April 5, 2018 |
End Date: | June 17, 2021 |
Contact: | Study Contact |
Email: | JNJ.CT@sylogent.com |
Phone: | 844-434-4210 |
A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib Plus JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With Selected FGFR Gene Alterations
The purpose of this study is to identify the recommended Phase 2 dose (RP2D) and schedule of
erdafitinib in combination with JNJ-63723283 (Phase 1b) and to evaluate the safety and
clinical activity of erdafitinib alone and in combination with JNJ-63723283 (Phase 2).
erdafitinib in combination with JNJ-63723283 (Phase 1b) and to evaluate the safety and
clinical activity of erdafitinib alone and in combination with JNJ-63723283 (Phase 2).
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 of erdafitinib
plus JNJ-63723283 in participants with advanced urothelial cancer with selected fibroblast
growth factor receptor (FGFR) gene alterations who have progressed on or after one or more
prior lines of systemic therapy, will consists of 2 parts. Part 1 (Phase 1b: Dose Escalation)
will establish recommended Phase 2 dose (RP2D) for erdafitinib in combination with
JNJ-63723283, and Part 2 (Phase 2: Dose Expansion) will evaluate safety and efficacy of RP2D.
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.
one hospital or medical school team work on a medical research study) study of erdafitinib
plus JNJ-63723283 in participants with advanced urothelial cancer with selected fibroblast
growth factor receptor (FGFR) gene alterations who have progressed on or after one or more
prior lines of systemic therapy, will consists of 2 parts. Part 1 (Phase 1b: Dose Escalation)
will establish recommended Phase 2 dose (RP2D) for erdafitinib in combination with
JNJ-63723283, and Part 2 (Phase 2: Dose Expansion) will evaluate safety and efficacy of RP2D.
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.
Inclusion Criteria:
- Histologic demonstration of transitional cell carcinoma of the urothelium. Minor
components (less than [<] 50 percent [%] overall) of variant histology such as
glandular or squamous differentiation, or evolution to more aggressive phenotypes such
as sarcomatoid or micropapillary change are acceptable
- Stage IV disease
- Documented progression of disease per Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1, defined as any progression that requires a change in treatment, prior to
randomization
- Prior systemic therapy: (a) Phase 1b: Any number of lines of prior therapy; (b) Phase
2: Progressed after 1 or 2 lines of prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: 0 or 1
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
- Chemotherapy within 3 weeks of Cycle 1 Day 1
- Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1),
or anti-programmed death ligand-2 (PD-L2) therapy
- Active malignancies (that is, requiring treatment change in the last 24 months) other
than urothelial cancer (except skin cancers within the last 24 months that are
considered completely cured)
- Symptomatic central nervous system metastases
We found this trial at
18
sites
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1021 Morehead Medical Drive
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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