A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Male and female participants at least 18 years of age who have untreated metastatic or unresectable urothelial carcinoma.
- Registration Number
- EUCTR2019-000721-50-AT
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 372
1. Men and women, aged 18 years and older.
2. Histologically documented metastatic or unresectable UC; may include primary site from bladder, ureters, upper tract, renal pelvis, urethra, or urachus. Both transitional cell and mixed transitional cell histologies are allowed, provided urothelial component is = 50%.
Note: Participants with non-UC of the urinary tract are not allowed.
3. Have at least 1 measurable target lesion per RECIST v1.1 as assessed by the local site investigator/radiologist.
Eligibility for chemotherapy is defined as meeting either criterion #4 OR #5 as described below.
4. Cisplatin ineligibility, defined by the presence of one of the following criteria:
a. Creatinine clearance of < 60 mL/min but = 30 mL/min (measured by the Cockcroft-Gault formula or 24-hour urine).
b. ECOG performance status 2 (within 7 days prior to randomization).
c. = Grade 2 audiometric hearing loss (25 db in 2 consecutive wave ranges; CTCAE v4.03).
d. New York Heart Association Class III heart failure.
e. = Grade 2 peripheral neuropathy (CTCAE v4.03).
OR
5. Ineligibility to receive any platinum-based chemotherapy (ie, ineligible for cisplatin and carboplatin), defined as ECOG performance status 2 (within 7 days prior to
randomization) AND at least one of the following:
a. Documented visceral metastatic disease.
b. Creatinine clearance of < 60 mL/min but = 30 mL/min (measured by the Cockcroft-Gault formula or 24-hour urine).
c. = Grade 2 audiometric hearing loss (25 db in 2 consecutive wave ranges; CTCAE v4.03).
d. = Grade 2 peripheral neuropathy (CTCAE v4.03).
e. Other reason, identified on the eCRF, for the participant being unable to receive carboplatin safely. Additional criteria for platinum ineligibility will be considered and allowed on a case-by-case basis, following consultation with the sponsor.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 262
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110
1. Prior receipt of a selective FGFR inhibitor (eg, erdafitinib, rogaratinib, dovitinib, vofatamab) for any indication or reason.
2. 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.
3. Receipt of anticancer medications or investigational drugs for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment with platinumcontaining chemotherapy completed = 12 months prior to the start of treatment for this study).
4. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, tumor embolization), except for treatment allowed per protocol.
5. Has disease that is suitable for local therapy administered with curative intent.
6. Has tumor with any neuroendocrine or small cell component.
7. Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, etc) or retinal disorder (including but not limited to macular/retinal degeneration, diabetic retinopathy, retinal detachment, etc) as confirmed by ophthalmologic examination.
8. 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. Participants must have recovered from all radiation-related toxicities and must not require corticosteroids.
9. Has CNS 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. Any signs (eg, radiologic) or symptoms of CNS metastases must be stable for at least 4 weeks before starting study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method