Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FI… (NCT04003610) | Clinical Trial Compass
TerminatedPhase 2
Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)
Stopped: The reason this study was terminated was due to a business decision. There were no safety concerns that contributed to this decision.
United States7 participantsStarted 2020-05-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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 c…