Clinical Trials Register

Summary
EudraCT Number:	2017-001483-38
Sponsor's Protocol Code Number:	BAY1163877/19131
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-02-12
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2017-001483-38

A.3

Full title of the trial

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

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Phase 1b/2 study of rogaratinib (BAY 1163877) in combination with atezolizumab in urothelial carcinoma

A.3.2

Name or abbreviated title of the trial where available

Phase 1b/2 study of pan FGFR inhibitor

A.4.1

Sponsor's protocol code number

BAY1163877/19131

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Bayer AG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bayer AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	n/a
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.6	E-mail	clinical-trials-contact@bayer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Rogaratinib
D.3.2	Product code	BAY 1163877
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ROGARATINIB
D.3.9.3	Other descriptive name	BAY1163877
D.3.9.4	EV Substance Code	SUB188629
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Tecentriq 1,200 mg concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Atezolizumab
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ATEZOLIZUMAB
D.3.9.1	CAS number	1380723-44-3
D.3.9.2	Current sponsor code	Atezolizumab
D.3.9.4	EV Substance Code	SUB178312
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

FGFR-positive locally advanced or metastatic urothelial carcinoma

E.1.1.1

Medical condition in easily understood language

urothelial carcinoma

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10064467
E.1.2	Term	Urothelial carcinoma
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part A:
• To determine the safety and tolerability of rogaratinib in combination with atezolizumab in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma
• To determine the recommended Phase 2 dose (RP2D) of rogaratinib in combination with atezolizumab in this patient population.

Part B:
• To compare progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR positive locally advanced or metastatic urothelial carcinoma.

E.2.2

Secondary objectives of the trial

Part A:
• To assess the efficacy of the combination of rogaratinib and atezolizumab in this patient population.
• To characterize the pharmacokinetics (PK) of rogaratinib in combination with atezolizumab in this patient population

Part B:
• To further characterize the pharmacokinetics of rogaratinib in combination with atezolizumab in this patient population
• To further assess the efficacy of the combination of rogaratinib and atezolizumab in this patient population
• To evaluate the safety and tolerability of rogaratinib in combination with atezolizumab in this patient population

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Part A:
•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:
oHistologically confirmed.
oPatients with mixed histology required to have dominant transitional cell pattern
oLocally advanced (T4, any N; or any T, N2-3) or metastatic disease (any T, any N +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], any grade peripheral neuropathy, impaired renal function (GFR>30ml/min/1.73m2), hearing loss and/or hypothyroidism that is adequately controlled by hormone replacement 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 + 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 admin. Regionally available standard of care options must be considered for all patients
•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 atezolizumab administration or until at least one week after the last rogaratinib intake, whichever is later. 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+progesterone containing: oral, intravaginal, transdermal) +progesterone-only (oral, injectable, implantable) hormonal contraception associated with inhibition of ovulation
•IUD/IUS
•Bilateral tubal occlusion/vasectomized partner
•Sexual abstinence
oPeriodic 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 and until 5 months after last atezolizumab administration or until at least one week after the last rogaratinib intake, whichever is later.
Part B:
•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:
oHistologically confirmed
oPatients with mixed histology are required to have a dominant transitional cell pattern.
oLocally advanced (T4, any N; or any T, N2-3) or metastatic disease (any T, any N, +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 haematological 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 for Cohort B1, +/ 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 or local immunotherapy is allowed if completed at least 4 weeks before randomization
•Ineligibility for cisplatin-based chemotherapy
•Pregnancy serum test+contraception part identical with Part A

E.4

Principal exclusion criteria

Part A:
• Inability to swallow oral medications
• Any malabsorption condition
• Current diagnosis of retinal disorders including retinal detachment, retinal pigment epithelial detachment (RPED), central 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

Part B:
• 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 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 randomization, 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 randomization
• Evidence or history of bleeding diathesis or coagulopathy
• Any hemorrhage / bleeding event CTCAE v.4.03 ≥ Grade 3 within 4 weeks before randomization.

E.5 End points

E.5.1

Primary end point(s)

Part A:
• The incidence of DLTs used to determine the MTD and/or RP2D
• The incidence of treatment-emergent adverse events (TEAEs)
• The incidence of treatment-emergent drug-related TEAEs
• The incidence of treatment-emergent serious adverse events

Part B:
• Treatment efficacy as assessed by progression-free survival, as assessed by RECIST 1.1

E.5.1.1

Timepoint(s) of evaluation of this end point

Part A:
• Safety - throughout the study
• MTD – up to 21 days

Part B:
• RECIST - every 9 weeks

E.5.2

Secondary end point(s)

Part A:
• Treatment efficacy as assessed by Objective response rate (ORR), as assessed by RECIST 1.1
• Cmax of rogaratinib
• AUC(0-8) of rogaratinib

Part B:
• The incidence of treatment-emergent adverse events (TEAEs)
• The incidence of treatment-emergent drug-related TEAEs
• The incidence of treatment-emergent serious adverse events
• Change in vital signs, physical finding and clinical laboratory results
• Treatment efficacy as assessed by Disease control rate (DCR), as assessed by RECIST 1.1
• Treatment efficacy as assessed by Duration of response (DOR), as assessed by RECIST 1.1
• Treatment efficacy as assessed by Objective response rate (ORR), as assessed by RECIST 1.1
• Treatment efficacy as assessed by Overall survival (OS), as assessed by RECIST 1.1
• Rogaratinib and Atezolizumab pharmacokinetic concentration data

E.5.2.1

Timepoint(s) of evaluation of this end point

Part A:
• RECIST - every 9 weeks
• PK – up to C5D1

Part B:
• Safety - throughout the study
• PK – up to C5D1

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

efficacy, PK, safety

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Part A open design; Part B double blind design

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Japan

Korea, Republic of

United States

Austria

France

Spain

Germany

Italy

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

114

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

140

F.4.2.2

In the whole clinical trial

210

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-03-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-07-10

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