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Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC

ConditionsBreast CancerTriple Negative Breast CancerPD-L1 Negative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative.

The names of the study interventions involved in this study are:

* Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically or cytologically confirmed invasive breast cancer with unresectable locally advanced or metastatic disease. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.

Estrogen-receptor and progesterone-receptor expression both ≤ 5% by immunohistochemistry (IHC), and HER2-negative status as determined by the current ASCO/CAP guidelines. If a patient has more than one histological result, the most recent sample will be considered for inclusion.

Participants must have PD-L1-negative metastatic breast cancer defined as less than 1% expression of PD-L1 on tumor-infiltrating immune cells (IC) by the PD-L1 IHC SP142 assay or a Combined Positive Score (CPS) less than 10 by the PD-L1 IHC 22C3 assay measured with standard of care testing.

Participants must be treatment-naïve in the metastatic setting.

Disqualifiers

Has received prior systemic anti-cancer therapy, including investigational agents, within 4 weeks of study treatment initiation or during the course of this study (bisphosphonates and RANK ligand inhibitors are allowed).

Prior therapy with any anti-PD-1, PD-L1, or PD-L2 agent or sacituzumab govitecan (IMMU-132). Prior therapy with irinotecan or topoisomerase I-containing antibody drug conjugates at any time for early stage or metastatic disease.

Prior hypersensitivity to pembrolizumab or the excipients of pembrolizumab or sacituzumab govitecan (IMMU-132 therapy).

Known history of UDP-glucuronosyltransferase 1A1 (UGT1A1) *28 allele homozygosity, which is associated with increased risk for neutropenia and diarrhea related to irinotecan. Note: Concurrent administration of strong UGT1A1 inhibitors or inducers is not allowed during the course of the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sacituzumab Govitecan

    Drug

    Intravenous Infusion

  • Pembrolizumab

    Drug

    Intravenous Infusion

Treatment groups

110 Participants
are divided into 3 treatment groups
Group A: Sacituzumab Govitecan + PembrolizumabExperimental treatment 2 interventions
Group B: Sacituzumab GovitecanExperimental treatment 1 intervention
Group C: RetreatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Compare PFS of patients randomized to receive sacituzumab govitecan in combination with pembrolizumab (Arm A) versus those randomized to receive sacituzumab govitecan monotherapy (Arm B). Defined as the time from study randomization to disease progression, per RECIST 1.1 or medical judgment, the latter based on established clinical parameters, such as rising tumor markers and physical exam evidence of progression, i.e. worsening chest wall disease, or death due to any cause, whichever occurred first.

Time frame
3 years

Secondary outcomes

1

Overall Survival (OS)

Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Overall Survival (OS), defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive, will be reported with Kaplan Meier estimates.

Time frame
3 years
2

Objective Response Rate (ORR)

Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Objective Response Rate by RECIST 1.1.

Time frame
3 years
3

Duration of response (DOR)

Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing the duration of response (the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death due to any cause. Participants without events reported are censored at the last disease evaluation).

Time frame
3 years
4

Time to objective response (TTOR)

Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing the time to objective response defined as the time from randomization to the date of the first documented CR or PR (whichever is first recorded).

Time frame
3 years

Other outcomes

Sponsors and contacts

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

Dana-Farber Cancer Institute

Lead sponsor

Gilead Sciences

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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