A Phase 1 interventional study of Rogaratinib (BAY1163877) and Atezolizumab in Urothelial Carcinoma, sponsored by Bayer. Completed at 30 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Bayer · Phase 1, Interventional, and Treatment
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Among 60 studies in Carcinoma, Transitional Cell with a site in Italy — 16 open to participants now, 24 under way, 5 of them phase 3. Carcinoma, Transitional Cell · Italy.
Among the 60 studies in Carcinoma, Transitional Cell with a site in Italy, this one is the 44th largest by enrollment of the 53 interventional ones that give a count, is one of 5 that started in 2018, is one of 6 in phase 1, and was the 23rd registered.
633 studies on the registry are indexed under Carcinoma, Transitional Cell; 180 are open to participants now.
Browse Carcinoma, Transitional Cell studies →16 of the 60 studies in Carcinoma, Transitional Cell with a site in Italy are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Italy, United States, Australia and 13 more countries
Ages 18+
Istituto Clinico Humanitas · Sites in Italy
Ages 18+
Eli Lilly and Company · Sites in Italy, United States, Australia and 16 more countries
Ages 18+
Daiichi Sankyo · Sites in Italy, United States, Austria and 4 more countries
Ages 18+
Alentis Therapeutics AG · Sites in Italy, United States, France and 5 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 147 Carcinoma, Transitional Cell studies recruiting now, 121 (82%) set no upper age limit and 11 (7%) stop at 75 or younger; 4 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
60 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 18 · Phase 2 36 · Phase 3 13
First in 2005; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 37 is below the median of 50 across 500 interventional studies indexed under Carcinoma, Transitional Cell.
Median enrollment 144 across the 53 interventional studies, 367 across the 7 observational. Of the 33 that completed or were terminated, 20 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
44 of 60 have an industry lead sponsor. The 10 most frequent:
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Bayer has 3 studies filed under Carcinoma, Transitional Cell — fewer than ten, so there is no comparison to draw.
5 of the studies in Carcinoma, Transitional Cell with a site in Italy that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT05911295Phase 3Seagen, a wholly owned subsidiary of PfizerDisitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | 2027-01-29 |
| NCT04879329Seagen, a wholly owned subsidiary of PfizerA Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 | 2026-12-11 |
| NCT05176483ExelixisStudy of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors | 2027-01-31 |
| NCT05845814Merck Sharp & Dohme LLCA Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04) | 2027-05-31 |
Add all 5 to your calendar (.ics) → With an account.
Among the 60 studies in Carcinoma, Transitional Cell with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, objectives, and treatment.
The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability, RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients.
The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma.
Of note, patients who participate in Part A are not allowed to participate in Part B.
Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development.
Part B of the study will no longer be conducted.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ineligibility for cisplatin-based chemotherapy as defined by any one of the following criteria:
Exclusion criteria:
History or current condition of an uncontrolled cardiovascular disease including any of the following conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part A: Part A is conducted in patients who are cisplatin-ineligible and have had no prior systemic treatment for locally advanced or metastatic disease. Patients will receive rogaratinib plus atezolizumab combination treatment.
Drug: Rogaratinib (BAY1163877) · Drug: Atezolizumab
Part A:Rogaratinib will be administered orally until disease progression, unacceptable toxicity or consent withdrawal. The starting dose of 800 mg b.i.d. will be confirmed using a dose selection design.
Part A: A fixed dose of 1200 mg atezolizumab will be administered through intravenous (i.v.) infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity or consent withdrawal.
Number of Participants With Dose-limiting Toxicities(DLTs)
Time frame: Up to 21 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: up to 90 days after the last study medication intake, an average of 60 days
Number of Participants With Drug-related TEAEs
Time frame: up to 90 days after the last study medication intake, an average of 60 days
Number of Participants With Treatment-emergent Serious Adverse Events(TESAEs)
Time frame: up to 90 days after the last study medication intake, an average of 60 days
Objective Response Rate(ORR)
Objective response rate (ORR) was defined as the percentage of patients with complete response (CR) or partial response (PR). Patients for whom best overall tumor response was not CR or PR, as well as patients without any post-baseline tumor assessment were considered non-responders. For all patients, the best overall tumor response was determined locally by investigators using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 5 months
Maximal Plasma Concentration (Cmax) of Rogaratinib
Time frame: At cycle 1 Day 1
Area Under the Rogaratinib Concentration Versus Time Curve (AUC)
Time frame: At cycle 1 Day 1, 0-t(last)
The study was conducted at 30 study centers in 8 countries (4 in Austria, 3 in France, 3 in Germany, 5 in Italy, 4 in Japan, 3 in South Korea, 4 in Spain, and 4 in the US) between 15 May 2018 (first informed consent) and 10 July 2024 (last participant last visit). Only Part A of the study was completed. Part B was not started in line with the protocol. The decision not to conduct Part B was not related to safety concerns but was based on an overall strategic business decision
| Milestone | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| Started | 11 | 26 |
| Completed | 1 | 0 |
| Not completed | 10 | 26 |
| Withdrew: Withdrawal by subject | 1 | 4 |
| Withdrew: Adverse event | 6 | 7 |
| Withdrew: Lack of efficacy | 3 | 10 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: End of study treatment | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Participants | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities(DLTs) | 1 | 4 |
| Participants | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 11 | 26 |
| Participants | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| Number of Participants With Drug-related TEAEs | 11 | 26 |
| Participants | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events(TESAEs) | 8 | 14 |
Objective response rate (ORR) was defined as the percentage of patients with complete response (CR) or partial response (PR). Patients for whom best overall tumor response was not CR or PR, as well as patients without any post-baseline tumor assessment were considered non-responders. For all patients, the best overall tumor response was determined locally by investigators using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Participants | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| complete response | 1 | 4 |
| partial response | 1 | 10 |
| no response | 9 | 12 |
| µg/l | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| Maximal Plasma Concentration (Cmax) of Rogaratinib | 13207.846 ± 1.379 | 10372.864 ± 1.404 |
| µg*h/l | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| Area Under the Rogaratinib Concentration Versus Time Curve (AUC) | 59187.389 ± 1.513 | 45768.289 ± 1.449 |
Collected over Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rogaratinib 800 mg BID + Atezolizumab | 9/11 (81.8%) | 8/11 (72.7%) | 11/11 (100%) |
| Rogaratinib 600 mg BID + Atezolizumab | 11/26 (42.3%) | 14/26 (53.8%) | 26/26 (100%) |
| Event | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| Supraventricular tachycardiaCardiac disorders | 1/11 | 0/26 |
| Abdominal painGastrointestinal disorders | 1/11 | 1/26 |
| Intestinal obstructionGastrointestinal disorders | 1/11 | 0/26 |
| AstheniaGeneral disorders | 1/11 | 0/26 |
| PyrexiaGeneral disorders | 1/11 | 0/26 |
| General physical health deteriorationGeneral disorders | 1/11 | 0/26 |
| HepatotoxicityHepatobiliary disorders | 1/11 | 0/26 |
| Urinary tract infectionInfections and infestations | 1/11 | 1/26 |
| PyelonephritisInfections and infestations | 1/11 | 0/26 |
| Respiratory tract infectionInfections and infestations | 1/11 | 0/26 |
| Event | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 7/11 | 16/26 |
| HyperphosphataemiaMetabolism and nutrition disorders | 4/11 | 15/26 |
| FatigueGeneral disorders | 4/11 | 11/26 |
| NauseaGastrointestinal disorders | 3/11 | 10/26 |
| AnaemiaBlood and lymphatic system disorders | 4/11 | 4/26 |
| AstheniaGeneral disorders | 4/11 | 7/26 |
| PyrexiaGeneral disorders | 4/11 | 7/26 |
| Urinary tract infectionInfections and infestations | 4/11 | 9/26 |
| Back painMusculoskeletal and connective tissue disorders | 4/11 | 6/26 |
| Alanine aminotransferase increasedInvestigations | 1/11 | 8/26 |
| Age, Customized(Participants) | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab | Total |
|---|---|---|---|
| In utero | 0 | 0 | 0 |
| Preterm newborn infants (gestational age < 37 wks) | 0 | 0 | 0 |
| Newborns (0-27 days) | 0 | 0 | 0 |
| Infants and toddlers (28 days-23 months) | 0 | 0 | 0 |
| Children (2-11 years) | 0 | 0 | 0 |
| Adolescents (12-17 years) | 0 | 0 | 0 |
| Adults (18-64 years) | 2 | 2 | 4 |
| From 65-84 years | 9 | 23 | 32 |
| 85 years and over | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 9 | 23 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Rogaratinib 800 mg BID + Atezolizumab | Rogaratinib 600 mg BID + Atezolizumab | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 23 | 32 |
| Unknown or Not Reported | 2 | 3 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Ran from May 2018 to primary completion in Jul 2021, 38 months.
Results were first posted in Apr 2025, 3 years 8 months after primary completion.
Of 62 industry-sponsored phase 1 interventional studies under Carcinoma, Transitional Cell, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 57. This study's 38 months is below that.
Counting every sponsor, half of 99 studies reached it within 44 months; a quarter within 31 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rogaratinib
Carcinoma, Transitional Cell →