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

Sponsor

Fox Chase Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03291028

Collaborator

(none)

Enrollment

Location

60.1

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma Urothelial Carcinoma Bladder Cancer Ureter Cancer Urethral Cancer	Biological: Immune checkpoint inhibitor targeting PD1

Study Design

Study Type:

Observational

Anticipated Enrollment :

16 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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)

Actual Study Start Date :

Nov 27, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients treated with immune check point blocker Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later	Biological: Immune checkpoint inhibitor targeting PD1 RCC and UC patients treated with immune checkpoint blockade
Patients treated with targeted/ observational therapy Patients who were not treated with immune checkpoint inhihibitor and developed metastatic lesion following other targeted therapy

Arm

Intervention/Treatment

Patients treated with immune check point blocker

Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later

Biological: Immune checkpoint inhibitor targeting PD1

RCC and UC patients treated with immune checkpoint blockade

Patients treated with targeted/ observational therapy

Patients who were not treated with immune checkpoint inhihibitor and developed metastatic lesion following other targeted therapy

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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