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Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile C...

ConditionsSmall Cell Carcinoma of the BladderSmall Cell Carcinoma of the Urinary TractSquamous Cell Carcinoma of the BladderSquamous Cell Carcinoma of the Urinary TractPrimary Adenocarcinoma of the BladderPrimary Adenocarcinoma of the Urinary TractRenal Medullary CarcinomaSquamous Cell Carcinoma of the Penis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)

About this trial

Background:

Rare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments. Two drugs-sacituzumab govitecan (SG) and atezolizumab-are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with GU.

Objective:

To test SG, either alone or combined with atezolizumab, in people with rare GU tumors.

Eligibility:

Adults aged 18 years and older with rare GU tumors. These may include high grade neuroendocrine carcinomas; squamous cell carcinoma of the bladder; primary adenocarcinoma of the bladder; renal medullary carcinoma; or squamous cell carcinoma of the penis.

Design:

Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of heart function. They will have imaging scans. They may need a biopsy: A small needle will be used to remove a sample of tissue from the tumor.

Both SG and atezolizumab are given through a tube attached to a needle inserted into a vein in the arm.

All participants will receive SG on days 1 and 8 of each 21-day treatment cycle. Some participants will also receive atezolizumab on day 1 of each cycle.

Blood and urine tests, imaging scans, and other exams will be repeated during study visits.

Treatment may continue for up to 5 years.

Follow-up visits will continue for 5 more years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HGNEC, including, but not limited to, small cell carcinoma and large cell neuroendocrine carcinoma of the bladder or urinary tract

Squamous cell carcinoma of the bladder or urinary tract

Primary adenocarcinoma of the bladder or urinary tract (urachal or non-urachal)

Renal medullary carcinoma

Disqualifiers

History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to SG, SN-38, irinotecan, or atezolizumab, or hypersensitivity to Chinese hamster ovary cell products.

Symptomatic or untreated brain/CNS metastases.

Positive serum or urine Beta-human chorionic gonadotropin (Beta-hCG) test at screening.

Participants unwilling to accept blood products as medically indicated.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sacituzumab govitecan

    Drug

    Sacituzumab govitecan is administered IV at 10 mg/kg on days 1 and 8 of each 21-day cycle.

  • Atezolizumab

    Drug

    Atezolizumab is administered IV at 1200 mg on day 1 each 21-day cycle.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Percentage of participants by best overall response (e.g., CR, PR, SD, PD) to therapy

Time frame
On days 1 and 8 of each cycle and at every restaging (every 9 weeks) until the end of the study therapy and every 9 weeks during follow-up until PD.

Secondary outcomes

1

Duration of response (DoR)

Time from start of treatment to disease progression or death in participants who achieve CR or PR

Time frame
On days 1 and 8 of each cycle and at every restaging (every 9 weeks) until the end of the study therapy and every 9 weeks during follow-up until PD.
2

Overall survival (OS)

Time from the start of treatment that participants are still alive.

Time frame
Days 1 and 8 of each cycle, at EoT, at the Safety visit, at follow-up, and every 90 days for up to a total of 5 years after the end of therapy
3

Progression-free survival (PFS)

Duration of time from start of treatment to time of progression or death, whichever occurs first

Time frame
At every restaging (every 9 weeks) until the end of the study therapy and every 9 weeks during follow-up until PD
4

Clinical benefit rate (CBR)

Percentage of participant who have achieved CR, PR, and SD while on treatment.

Time frame
At every restaging (every 9 weeks) until the end of the study therapy and every 9 weeks during follow-up until PD

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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