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

Updated on 10 May 2022
bladder cancer
bladder carcinoma
metastatic urothelial carcinoma
urothelial carcinoma


The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.


Condition Bladder Carcinoma, Bladder Cancer Metastatic or Unresectable Urothelial Carcinoma Metastatic Urothelial Carcinoma
Clinical Study IdentifierTX233310
Last Modified on10 May 2022


Yes No Not Sure

Inclusion Criteria

Histologically documented metastatic or unresectable urothelial carcinoma. Both transitional cell and mixed transitional cell histologies are allowed, provided urothelial component is ≥ 50%
At least 1 measurable target lesion per RECIST v1.1
Must be ineligible to receive cisplatin. Patients ineligible for any platinum-based chemotherapy are allowed
Known FGFR3 mutation or rearrangement confirmed by the central laboratory prior to randomization
Central laboratory test result of PD-L1 status is mandatory at screening
Have received no prior systemic chemotherapy for metastatic or unresectable urothelial carcinoma (except adjuvant platinum-based chemotherapy following radical cystectomy, with recurrence > 12 months from completion of therapy, or neo-adjuvant platinum-based chemotherapy, with recurrence > 12 months since completion of therapy)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Prior receipt of a selective FGFR inhibitor for any indication or reason
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
Receipt of anticancer medications or investigational drugs for unresectable and/or metastatic disease
Concurrent anticancer therapy, except for treatment allowed per protocol
Has disease that is suitable for local therapy administered with curative intent
Has tumor with any neuroendocrine or small cell component
Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination
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
Has central nervous system 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
Known additional malignancy that is progressing or required active treatment within the past 3 years
Laboratory values outside the protocol-defined range at screening
Clinically significant or uncontrolled cardiac disease
History of autoimmune disease that has required systemic treatment in past 2 years
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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