EUCTR2017-001483-38-ESActive, not recruitingPhase 1
An international, multicenter, Phase 1b/2 study of rogaratinib (BAY 1163877) in combination with atezolizumab as first-line treatment in cisplatin-ineligible patients with FGFR-positive locally advanced or metastatic urothelial carcinoma - Phase 1b/2 study of pan FGFR inhibitor
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Bayer AG
- Enrollment
- 190
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Male/female patients >= 18 years of age (at least age of legal maturity)
- •Urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra, meeting all of the following criteria:
- •o Histologically confirmed.
- •o Patients with mixed histology are required to have a dominant transitional cell pattern
- •o Locally advanced (T4, any N; or any T, N2-3) or metastatic disease (any T, any N and M1)
- •Note: Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3)
- •High FGFR1 or 3 mRNA expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh tumor biopsy specimen
- •Measurable disease according to RECIST v1.1
- •ECOG PS 0 or 1
- •Adequate hematological and end organ function
- •Recovery to NCI CTCAE v.4.03 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug / procedure-related toxicity (patients with persistent alopecia, anemia [hemoglobin >= 9 g/dl], and / or hypothyroidism can be included)
- •No prior systemic treatment for locally advanced or metastatic urothelial carcinoma. For patients who received prior adjuvant/neoadjuvant chemotherapy or chemo-radiation for urothelial carcinoma, a treatment-free interval > 12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment-naïve in the metastatic setting. Prior local intra-vesical chemotherapy/local immunotherapy allowed if completed at least 4 weeks before first study drug administration
- •Ineligibility for cisplatin-based chemotherapy
- •Negative serum pregnancy test in women of childbearing potential (performed within 7 days before the first treatment). Negative results must be available before the first study drug administration
- •WOCBP + fertile men must agree to use adequate contraception when sexually active from signing of ICF for study treatment eligibility until at least 5 months after last study drug administration. Investigator or designated associate is requested to advise patient how to achieve highly effective birth control. Highly effective (failure rate of less than 1% per year) contraception methods include:
- •Combined (estrogen and progesterone containing: oral, intravaginal, transdermal) and progesterone-only (oral, injectable, implantable) hormonal contraception associated with inhibition of ovulation
- •Bilateral tubal occlusion/vasectomized partner
- •Sexual abstinence
- •o Periodic abstinence + withdrawal are not acceptable methods of contraception.
- •Male patients with female partner of childbearing potential must use condom+ ensure that an additional form of contraception is also used during treatment + until 12 weeks after last study drug administration
- •Male/female patients >= 18 years of age (at least age of legal maturity)
- •Urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra, meeting all of the following criteri
Exclusion Criteria
- •Inability to swallow oral medications
- •Any malabsorption condition
- •Current diagnosis of retinal disorders including retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
- •Previous or concurrent cancer except
- •o cervical carcinoma in situ
- •o treated basal-cell carcinoma or squamous cell skin cancer
- •o localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (T1/T2a, Gleason score <= 6 and PSA < 10 ng/mL undergoing active surveillance and treatment-naïve)
- •o any other cancer curatively treated > 3 years before the first study drug administration
- •Investigational drug treatment outside of this study during or within 4 weeks before the first study drug administration
- •Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR-specific antibodies)
- •Previous assignment to treatment during this study
- •Severe (CTCAE v.4.03 Grade 3) infections within 4 weeks before the first study drug administration, including but not limited to hospitalization for complication of infection, bacteremia, or severe pneumonia
- •History of autoimmune disease except: a) autoimmune-related hypothyroidism clinically stable on thyroid replacement hormone; b) controlled Type-I diabetes mellitus on a stable dose of insulin regimen
- •History or current condition of uncontrolled cardiovascular disease
- •Systolic/diastolic blood pressure <= 100/60 mmHg and heart rate >= 100/min
- •Renal failure requiring peritoneal dialysis or hemodialysis
- •Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)
- •Concomitant therapies that are known to increase serum calcium or phosphate levels and that cannot be discontinued or switched to a different medication before start of study treatment
- •Evidence or history of bleeding diathesis or coagulopathy
- •Any hemorrhage / bleeding event CTCAE v.4.03 >= Grade 3 within 4 weeks before the first study drug administration
- •Inability to swallow oral medications
- •Any malabsorption condition
- •Current diagnosis of retinal disorders including retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
- •Previous or concurrent cancer except
- •o cervical carcinoma in situ
- •o treated basal-cell carcinoma or squamous cell skin cancer
- •o localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (T1/T2a, Gleason score <= 6, and PSA <= 10 ng/mL undergoing active surveillance and treatment-naïve
- •o any other cancer curatively treated > 3 years before randomization
- •Ongoing or previous anti-cancer treatment within 4 weeks before randomization
- •Ongoing o
Investigators
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