Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma

NCT03291028 — Active not recruiting, 15 participants, Fox Chase Cancer Center

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Defining the Genomic and Histologic Landscape of Primary and Metastatic Tumors With Divergent Kinetics in Patients With Renal Cell Carcinoma (RCC) and Urothelial Carcinoma (UC) Treated With Immune Checkpoint Blockade (ICB)

Registry	NCT03291028
Status	Active not recruiting
Study type	Observational
Enrollment	15 (Actual)
Sponsor	Fox Chase Cancer Center (Other)
Conditions	Renal Cell Carcinoma, Urothelial Carcinoma, Bladder Cancer, Ureter Cancer, Urethral Cancer
Interventions	Immune checkpoint inhibitor targeting PD1 (Biological)
Dates	start 2017-11-27, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2017-09-25, last updated 2026-05-22
Locations	1 site in United States

-Summary

This is a comparative study using resected/ biopsied tumors samples collected from renal cell carcinoma and urothelial carcinoma patients who underwent surgical removal of lesions, followed by immune checkpoint blockade (ICB) treatment targting programmed cell death 1 (PD1) but developed new lesions later were also removed and stored in the biosample repository (BSR). The histology and genomic analysis of the pre-treatment and metastatic samples from the same patient would be used to find out the changes that may have lead to metastasis. Also, metastatic samples from ICB naive patients would be collected and compared with those from ICB treated patients to find out if the metastasis in treated patients was due to development of reistance.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients treated with immune check point blocker		Biological: Immune checkpoint inhibitor targeting PD1	Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later
Patients treated with targeted/ observational therapy			Patients who were not treated with immune checkpoint inhihibitor and developed metastatic lesion following other targeted therapy

Immune checkpoint inhibitor targeting PD1 (Biological): RCC and UC patients treated with immune checkpoint blockade

+Outcome measures

Primary outcomes

Histopathological characterization of samples from ICB treated patients [18 months]: To characterize differences in histopathology and patterns of genomic expression between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)
Genomic characterization of samples from ICB treated patients [18 months]: To characterize expression of different genes between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)

Secondary outcomes

Histopathological characterization of samples from patients treated with targeted or observational therapy [18 months]: To characterize differences in histopathology between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy.
Comparison of Histopathological characteristics of metastatic samples from ICB naive and treated patients [18 months]: To characterize differences in histopathology and patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation.
Genomic characterization of samples from patients treated with targeted or observational therapy [18 months]: To characterize differences in patterns of genomic expression between baseline tumors and metastases in patients with RCC treated with observation or targeted therapy
Comparison of genomic characteristics of metastatic samples from ICB naive and treated patients [18 months]: To characterize differences in patterns of genomic expression between "escape" metastases in patients treated with ICB from patients treated with targeted therapy or observation.

+Eligibility

Sex: All

Inclusion Criteria:

* Eligible patients will include retrospectively identified patients with RCC or UC who have received treatment with ICB and achieved clinical benefit but subsequently developed a solitary new/progressive lesion that was removed surgically. Patients with other tumor types who otherwise meet criteria may be included at a later time
* Additionally, a group of patients with RCC who have undergone a metastasectomy but who did not receive treatment with ICB will be identified. These patients may be approached for study participation to serve as a comparator group

Exclusion Criteria:

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+Locations (1)

Facility	City	Country	Status
Fox Chase Cancer Center - Philadelphia	Philadelphia, Pennsylvania	United States

My Notes

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