Study of Sacituzumab Govitecan and Pembrolizumab Compared to Physician's Choice Treatment and Pembrolizumab in Adults with Previously Untreated, Locally Advanced, Unresectable or Metastatic Triple-Negative Breast Cancer
Résumé de l'étude
This study investigates an investigational drug called Sacituzumab Govitecan in combination with Pembrolizumab in previously untreated, advanced, PD L1-positive, triple-negative breast cancer (TNBC). Advanced TNBC is defined as TNBC that cannot be surgically removed or has spread from the breast to other parts of the body. • Sacituzumab Govitecan (trade name: Trodelvy®) is currently approved by Swissmedic and other regulatory authorities for previously treated advanced TNBC. • Pembrolizumab (trade name: e.g., Keytruda®) is approved in Switzerland and some other countries and is available as a prescription treatment for various cancers, including TNBC. • The combination of Sacituzumab Govitecan and Pembrolizumab has not yet been approved by any health authority for previously untreated advanced TNBC. The aim of this study is to find out whether Sacituzumab Govitecan in combination with Pembrolizumab can improve the survival of patients with advanced, PD L1 positive TNBC whose tumor is not growing or spreading, compared to Pembrolizumab in combination with chemotherapy (Paclitaxel or nab-Paclitaxel or the combination of Gemcitabine and Carboplatin). How long patients participate in the study depends on how the cancer responds to the study treatment. Active participation in the study, including treatment with the investigational drug, may continue as long as you tolerate the treatment safely and your cancer does not worsen (i.e., the tumor has grown or metastasized) or the study is not discontinued. Participation in this study may last up to 4 years or longer, as long as the treatment is well tolerated. During treatment, participants must visit the clinic at least 2-3 times per cycle.
(BASEC)
Intervention étudiée
• Participants eligible for the study will be randomly assigned (1:1) to either the investigational drug Sacituzumab Govitecan in combination with Pembrolizumab OR to one of the following three standard chemotherapy treatments selected by the investigator (control group):
o Pembrolizumab (trade name: e.g., Keytruda®) in combination with Paclitaxel (trade name: e.g., Taxol®)
o Pembrolizumab (trade name: e.g., Keytruda®) in combination with nab Paclitaxel (trade name: e.g., Abraxane®)
o Pembrolizumab in combination with Gemcitabine and Carboplatin (trade name: e.g., Paraplatin®)
(BASEC)
Maladie en cours d'investigation
Previously Untreated, Locally Advanced, Unresectable or Metastatic Triple-Negative Breast Cancer that Expresses PD-L1
(BASEC)
Individuals with locally advanced, unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for advanced disease and whose tumors are positive for programmed cell death ligand 1 (PD-L1) upon examination. (BASEC)
Critères d'exclusion
- Positive serum pregnancy test or women who are breastfeeding. - Prior therapy with an agent targeting another stimulating or co-inhibitory T-cell receptor. - Participants must not have received any systemic anticancer treatment within the last 6 months or radiation therapy within the last 2 weeks prior to study entry. (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Gilead Sciences Switzerland Sàrl General-Guisan-Strasse 8, 6300 Zug, Schweiz
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. med. Elena Kralidis
+41 44 533 81 05
Elena.Kralidis@clutteraffidea.chAffidea Brust-Care, Seefeldstrasse 214, 8008 Zürich
(BASEC)
Informations générales
Gilead Sciences
(ICTRP)
Informations scientifiques
Gilead Sciences
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Ostschweiz EKOS
(BASEC)
Date d'approbation du comité d'éthique
27.10.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT05382286 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients with Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (BASEC)
Titre académique
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (ICTRP)
Titre public
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ICTRP)
Maladie en cours d'investigation
Triple Negative Breast CancerPD-L1 Positive (ICTRP)
Intervention étudiée
Drug: Sacituzumab Govitecan-hziyDrug: PembrolizumabDrug: PaclitaxelDrug: nab-PaclitaxelDrug: GemcitabineDrug: Carboplatin (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Key Inclusion Criteria:
- Individuals with locally advanced, inoperable, or metastatic triple-negative breast
cancer (TNBC) who have not received previous systemic therapy for advanced disease
and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
- Individuals must have completed treatment for Stage I to III breast cancer, if
indicated, and = 6 months must have elapsed between completion of treatment
with curative intent and first documented local or distant disease recurrence.
- Individuals presenting with de novo metastatic TNBC are eligible for this
study.
- TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed
centrally on a recent or archival tumor specimen.
- Individuals must have measurable disease by computed tomography (CT) or
magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid
Tumors (RECIST) Version 1.1 criteria as evaluated locally.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Demonstrates adequate organ function
- Male and female individuals of childbearing potential who engage in heterosexual
intercourse must agree to use protocol-specified method(s) of contraception.
- Individuals with HIV must be on antiretroviral therapy (ART) and have a
well-controlled HIV infection/disease.
Key Exclusion Criteria:
- Positive serum pregnancy test or women who are lactating.
- Received prior therapy with an agent directed to another stimulatory or coinhibitory
T-cell receptor.
- Individuals may not have received systemic anticancer treatment (with the exception
of endocrine therapy) within the previous 6 months or radiation therapy within 2
weeks prior to enrollment.
- Individuals may not be participating in a study with an investigational agent or
investigational device within 4 weeks prior to randomization. Individuals
participating in observational studies are eligible.
- Have previously received topoisomerase 1 inhibitors or antibody drug conjugates
containing a topoisomerase inhibitor.
- Have an active second malignancy.
- Have active serious infection requiring antibiotics.
- Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or
Multicentric Castleman Disease.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Has an active autoimmune disease that has required systemic treatment in the past 2
years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply. (ICTRP)
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Critères d'évaluation principaux et secondaires
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (ICTRP)
Overall Survival (OS);Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1;Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1;Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1;Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs);Percentage of Participants Experiencing Clinical Laboratory Abnormalities;Time to Deterioration (TTD) in Global Health Status/Quality of Life (QoL) Scale as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30);TTD of Pain Score as Measured by EORTC QLQ-C30;TTD of Fatigue Score as Measured by EORTC QLQ-C30;TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30;TTD of Role Functioning Score as Measured by EORTC QLQ-C30 (ICTRP)
Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
Merck Sharp & Dohme LLC (ICTRP)
Contacts supplémentaires
Gilead Study Director, Gilead Sciences (ICTRP)
ID secondaires
2021-005742-14, KEYNOTE-D19, jRCT2041220123, MK-3475-D19, 2023-504194-21, GS-US-592-6173 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT05382286 (ICTRP)
Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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