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Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence

ConditionsUrothelial CarcinomaMuscle-invasive Bladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years at the time of study consent.

ECOG Performance Status of 0, 1 or 2 (see Appendix A).

Histologically confirmed muscle-invasive UC originating in the bladder, ureter, or renal pelvis. Variant histology, except small cell carcinoma, is allowed.

Underwent curative-intent surgery (i.e. RC or nephroureterectomy), performed within 180 days prior to study treatment initiation.

Disqualifiers

Underwent a partial cystectomy or partial nephrectomy.

History of adjuvant platinum-based chemotherapy or any other type of adjuvant therapy, including investigational agents, following surgical removal of UC.

History of treatment with PD-1/PD-L1 inhibitors or sacituzumab govitecan prior to study treatment initiation.

History of previous radiation therapy for treatment of UC.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab Govitecan (SG)

    Drug

    Given IV

  • Nivolumab

    Drug

    Given IV

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Sacituzumab Govitecan PLUS NivolumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Primary Objective

To determine investigator-assessed disease-free survival (DFS) at 6 months.

Time frame
6 months after last patient enrollment

Secondary outcomes

1

Secondary (1)

To determine investigator-assessed DFS (i.e. time from Cycle 1 Day 1 (C1D1) of study treatment to first occurrence of a DFS event), defined as any of the following: 1. Local (pelvic) recurrence of UC (including regional lymph nodes) 2. Urinary tract recurrence of UC (including all pathological stages and grades) 3. Distant metastasis of UC 4. Death from any cause

Time frame
Time from Cycle1 Day 1 of study treatment to first occurrence of a disease free survival event, up to 5 years.
2

Secondary (2)

To determine investigator-assessed distant metastasis-free survival (MFS) (i.e. time from Cycle 1 Day 1 of study treatment to diagnosis of distant metastases or death from any cause).

Time frame
Time from Cycle 1 Day 1 of study treatment to diagnosis of distant metastases or death from any cause, up to 5 years.
3

Secondary (3)

To determine overall survival (OS) (i.e. time from Cycle 1 Day 1 of study treatment to death of any cause).

Time frame
Time from C1D1 of study treatment to death of any cause, up to 5 years.
4

Secondary (4)

To determine incidence of Grade 3 or higher AEs.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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

University of California, Irvine

Lead sponsor

Gilead Sciences

Collaborator

Source ClinicalTrials.gov
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